VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on July 02, 2018, 02:40:30 AM



Title: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:40:30 AM
Model Number 103
Event Date 08/25/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient experienced bradycardia with a possible 10 second asystole event that occurred when performing system diagnostics on (b)(6) 2015. Radial and brachial pules were nonpalpable and heart rate was non-audible during this 10 second period. The patient suddenly slumped in his chair and was unresponsive. The physician attributed the asystole event to vns stimulation. The patient's heartbeat prior to the suspected asystole event was 56 bpm. The patient did not display any symptoms and did not experience any traumatic events leading up to the event. No changes to device settings or medications preceded the onset of the event. Before performing system diagnostics, x-rays were taken and were reported by the physician to be unremarkable. The device was subsequently disabled. The patient did not have a prior history of cardiac events. The patient underwent a 14-day holter monitoring period on (b)(6) 2013 which was reported by the physician to be unremarkable. The patient was admitted to the hospital and evaluated by the emergency department to preclude a serious injury to the patient. The event has not reoccurred and the patient has been doing well following the event. System diagnostic results showed lead impedance within normal limits. It was noted that the patient had been experiencing painful stimulation for 12-24 hours prior to the asystole event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5092187


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:41:23 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 03/27/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported that she was having pain around her generator site and sometimes had a lead pulling situation. She stated that it had been happening for a long time. She was instructed on how to use the magnet to disable the device, and she said that she hadn't tried that yet. No further relevant information has been received to date.
 
Event Description
It was reported that the patient went to the emergency department due to feeling painful stimulation in her chest and right eye for the past 5 days. The patient was informed how to use the magnet to disable the device, but it was unknown if that was done. Attempts for further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6530315



Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:42:12 AM
Model Number 102
Event Date 03/26/2011
Event Type  Malfunction   
Event Description
A physician reported that a vns pt was experiencing some tingling numbness around her generator site and the pt wanted the device disabled. There had been no reported trauma recently. A company rep was able to visit with the pt and found the pt to have high impedance. Furthermore, the pt occasionally had painful stimulation in her chest, but she now did not want the device to be disabled. The pt did not have a neurologist at the time. The pt underwent a revision surgery. The surgeon opened up the pt's chest site and noticed the setscrew was loose. The surgeon tightened the screw and ran system diagnostic tests and received within normal limit results. The surgeon prophylactically replaced the generator and all diagnostics were again within normal limits. The pt was reported to be "fine" post surgery. Furthermore, an update indicated that the physician felt the pt's tingling numbness was related to the setscrew's looseness. Good faith attempts for further info have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092180


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:42:44 AM
Model Number 302-20
Event Date 07/21/2010
Event Type  Injury   
Event Description
It was reported that a vns patient was scheduled to have an urgent vns replacement as the patient was experiencing painful stimulation. Moreover, information from the treating nurse indicated the painful stimulation resolved once the device was turned off. The patient underwent full revision surgery as scheduled. Good faith attempts to obtain additional information and product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1817120


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:44:10 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 03/04/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
The physician did not believe that the patient had vocal cord paralysis, but instead just had hoarseness. The dysphagia was occurring with stimulation, and the patient felt the painful stimulation at the neck and electrode and generator incision sites. Diagnostic results from (b)(6) 2015 were within normal limits and did not indicate a device malfunction.
 
Event Description
It was reported that a patient was experiencing tightness in her chest, vocal cord paralysis, dysphagia, and sleeping difficulties due to the tightness in her chest. These events started after she had thyroid surgery in (b)(6) 2014, but they just started getting worse recently. The physician programmed the device off on (b)(6) 2015 to determine if the issues were related to stimulation, but left the patient's magnet output current at 1. 5ma. The physician attempted to perform system diagnostics, but the patient felt pain during the stimulation and was unable to complete the test. The physician planned to turn the patient's device back on at the next appointment, but the patient did not go to the appointment because she was no longer feeling tightness in her chest, the dysphagia had resolved, her voice had come back, and she was no longer feeling painful stimulation. The patient did not want to have her device turned on for at least a month because she did not want to experience the side effects and she could not afford to go to another appointment. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5171609


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:44:46 AM
Model Number 103
Event Date 02/02/2011
Event Type  Injury   
Event Description
A medical assistant stated that a vns pt was having painful stimulation at the generator site, which started the previous night. The pt's device had recently been turned up due to an increase in seizures, but the output current had to be decreased due to intolerance. The medical professional expressed concern that the pt was seeking medications as no treatments seemed to please the pt. Good faith attempts to date for more info on the reported events have been unsuccessful to date.
 
Event Description
Additional information was received indicating that the patient had a seizure and lost feeling of her left side. The patient was told by the er staff that it was todd's syndrome. The patient still has not followed up with a neurologist about her seizures. The patient now reports that the increase in seizures began (b)(6) 2011 even though the initial report came in (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2008509


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:45:28 AM
Model Number 106
Event Date 12/22/2015
Event Type  Malfunction   
Event Description
It was later reported by the physician's assistant that they started the titration really slow, but the patient is still having these dramatic reactions and always coughs every time the device is titrated, but the patient states she wants to continue programming the settings up. The patient is determined to get up to 1. 5ma because she knows these are getting into the therapeutic level, but the patient is currently still at 1. 0ma. The patient's seizures are noted to be about the same as pre-vns baseline levels and the patient is also on multiple medications and medical marijuana. It was noted that some of these issues may be in the patient's head. It was noted system diagnostics are always checked and the device is performing as expected. It was also explained that the patient has these same types of reactions with medication changes, too. It was confirmed the patient has not had any serious injuries and the only interventions which have been taken are setting changes.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported by the by the patient that she was having painful stimulation and increase in seizures, dysphagia, and coughing. It was noted by the physician's office that the patient's increase in seizures were not above pre-vns baseline levels and that simple vns setting adjustments resolved the issues and were not considered as serious injuries. However, the patient called again reported painful stimulation, voice alteration, and the inability to turn vns settings up. Additionally, the patient stated she has a feeling of being hungover for 72 hours after every settings change, which is described as a post-ictal state, including symptoms of blurred vision, headaches, very tired and lethargic. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5889627


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:46:39 AM
Device Problem Electrical issue
Event Date 02/25/2015
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
It was inadvertently not provided in follow-up report#6 that the surgery had occurred on (b)(6) 2016. The explant date of the device was inadvertently not provided.
 
Event Description
Additional information was received that the patient sustained damage to his vocal cords following a cardioversion procedure.
 
Event Description
It was reported that the patient experienced sharp painful stimulation every 90 seconds after undergoing an electrical cardioversion for atrial fibrillation with rapid ventricular rate. Prior to the cardioversion, patient had a transesophageal echocardiogram but was reported to be able to swallow without issues following this procedure. After the cardioversion, the patient was having significant and periodic bradycardic events with a heart rate drop from the high 90's into the 30's. Patient would simultaneously moan, bear down, and complain of severe neck pain. Once the vns was turned off, the events ceased. When a system diagnostic test was attempted, the patient again had bradycardia and the programming wand was quickly removed. I didn't think it wise to try that again. With the device off, the patient was tested with modified barium swallow and found to have a complete dysphagia. This test will likely be repeated within a few days to assess any improvement. It is unknown if the device was programmed off when the patient had the cardioversion procedure. X-rays were taken of the neck and there were no obvious anomalies identified in the images received. The physician believes there may be a micro fracture in the lead and stimulating the neck near the vagus nerve causing the pain that triggered a vagal response in a physiologic manner as opposed to via direct vagal stimulation. The physician is concerned that the patient now has a vagus neurapraxia due to electrical injury. It was also reported that there is no definitive way to test for this to be sure. Additional relevant information have not been received to date.
 
Event Description
Additional data was received and review of the programming/diagnostic history shows that the device is still functioning within normal limits. Additional information was received that the patient underwent the cardioversion procedure on (b)(6) 2015. There were no precautions taken during the procedure. A magnet was not used to disable it during the procedure as the operators thought the device was end of life.
 
Event Description
It was reported that the patient still experienced pain in neck area due to the cardioversion procedure. It was also mentioned that the vns therapy was working well for the patient until the cardioversion incident. The patient also underwent surgery on the throat and reported to have probably burnt his vocal cords. The physician mentioned the theory that the lead passed the energy to the nerve during the cardioversion procedure, which resulted in the patient's adverse events. Review of the programming and diagnostic data for this patient indicates that the impedance value was 2107 ohms on (b)(6) 2015 and has been consistently between 2100 and 2400 prior to cardioversion procedure. On (b)(6) 2015, the impedance value was 1350 ohms. The impedance value on (b)(6) 2015 is 1379 ohms.
 
Event Description
Additional information was received that the patient still has pain despite vns being off. A report on the cardioversion procedure was also received stating that the procedure occurred on (b)(6) 2015 at 15:02. Synchronized bi-phasic cardioversion was performed with a medtronic lifespak 12 cardioversion device. Adhesive patches were used and 200j of energy was used to shock. The patient has a history of hypertension, a vns for seizure disorder, restless leg syndrome, and a new onset of atrial fibrillation. Echo findings showed no laa thrombus. The ejection fraction from the echo was 65%. During the procedure, the patient was brought to the electrophysiology lab in a fasting state after informed consent was obtained. Hemodynamic monitoring was established, and anesthesia was administered. Synchronized biphasic cardioversion was performed, the patient was reassessed, and the patient left the lab in a stable condition. Results showed that pre-rhythm was atrial defibrillation, and the post-rhythm was sinus. 200j of energy was delivered externally. There were no noted complications, and the dc cardioversion was deemed successful. Clinical course was to be observed.
 
Event Description
An abstract written by the patient's physician was received on 12/10/2015. The abstract stated that the patient was admitted to the hospital for new-onset atrial fibrillation. Chemical cardioversion was attempted, but was unsuccessful. After being cleared with a tee for an intracardiac thrombus, the patient underwent dc cardioversion to sinus rhythm. Shortly after the dc cardioversion, the patient experienced persistent dysphagia and periodic (in synch with stimulation) throat irritation, dry hacking cough, and symptomatic bradycardia with heart rate dropping to the 20s. The periodic symptoms resolved after the device was deactivated with the magnet, but the patient remained dysphagic. On fluoroscopy for swallow evaluation, the vns leads could be seen exposed in the soft tissue of the neck. The physician believed that the patient's nerve was burned, which caused the persistent dysphagia, and that the vns lead was "naked" and was shocking the patient's neck soft tissue and causing the periodic issues. There were still no plans to replace the generator, as this would aggravate the patient's condition.
 
Manufacturer Narrative
Date received by manufacturer: 12/20/2017. (b)(4).
 
Event Description
The patient was referred for full revision surgery. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explant facility does not return devices to the manufacturer per policy, and it was reported the product may have been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4618197


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:47:16 AM
Model Number 302-20
Event Date 04/14/2010
Event Type  Malfunction   
Event Description
It was initially reported that the patient's device was disabled 2 1/2 years prior due to some painful stimulation experienced in her back. The patient's device was later explanted due to lack of efficacy as the patient was able to be controlled with medications. The explanted lead and pulse generator were returned to the manufacturer for analysis. During the product analysis of the returned lead portion, an abraded opening in the inner tubing was observed, which appeared to be the result of wear of the device. The product analysis of the explanted pulse generator there were no performance or any other type of adverse conditions found with the pulse generator. Last known diagnostics performed at the time of explant were within normal limits. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774373


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:47:53 AM
Model Number 302-20
Event Date 01/01/2007
Event Type  Injury   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that a vns patient experienced painful stimulation in the neck and shoulders, which resolved when the device was turned off. The treating psychiatrist indicated device diagnostics were within normal limits, indicating proper device function. The patient was referred to a surgeon for evaluation. The surgeon indicated that a ct scan showed a "gap" in the "wire. " x-rays were sent to the manufacturer for review, and no obvious lead discontinuities were observed. Followup with the surgeon revealed that he planned to replace the lead even though device diagnostics are ok. He indicated that the ct scan showed the lead to be "frayed" at the clavicle, where the patient is feeling the shocking. Revision surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1153358


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:48:26 AM
Model Number 102
Event Date 06/04/2008
Event Type  Injury   
Event Description
Initial reporter indicated that the pt was experiencing dyspnea with stimulation. Taping the magnet over the vns resolved the dyspnea. The pt had their vns programming adjusted a month earlier for painful stimulation and resolved but then started having the dyspnea with stimulation. All diagnostics were within normal limits. The pt reported an episode where she "stops breathing". The pt additionally reported neck "spasms". Reported "that it grabs at the neck and then results in her sweating, can't breathe, and heartbeat increasing. She's not sure whether the last three symptoms are due to the vns or due to her getting nervous about the grabbing. She feels like it paralyzes her neck where she can't get air down and her mom said she turned purple yesterday. It happens about once a day and using the magnet won't make it go away". The pt normally doesn't feel stimulation so did not know whether the neck spasm is during stimulation or not but it doesn't seem to occur every few mins. There was no report of any trauma or accident. X-ray review by mfr did not reveal any gross lead discontinuities or anomalies that may have contributed to the reported event. The pt underwent generator replacement surgery. During the surgery a large amount of scar tissue was noted around the pt's lead. Good faith attempts are being made for the prod return for analysis.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead discontinuities or anomalies noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077469


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:49:07 AM
Model Number 102
Event Date 03/07/2011
Event Type  Injury   
Event Description
Additional information was received that indicated that the generator replacement was done prophylactically and for patient comfort as it was believed the painful stimulation was related to the generator nearing end of service. The patient is not having an increase in seizures. The patient reports that she is having an increase in seizures but the family and physician confirm that she is not. The patient is having more nocturnal seizures but they are within normal ranges of frequency and she does not consider it an increase. The patient had their generator replaced. Good faith attempts for product return are in process.
 
Event Description
Additional information was received that indicated that the generator was returned to the manufacturer for evaluation. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was initially reported that the patient was being explanted due to lack of efficacy. Further information was received that indicated that the patient was experiencing painful erratic stimulation and pain. The pain was believed to be due to the patient's significant weight loss due to a gallbladder infection, not related to vns, and the potential that the generator may have migrated. The patient went to see a surgeon and he disabled the device for a time but then turned it back to the previous settings with no additional reported issue. The plan is to continue with the generator replacement which as not occurred to date. The patient has also had an increase in nocturnal seizures, unknown if above or below baseline, which was treated with an increase in medication dose. At a later appointment it was reported that her seizures were doing well. Good faith attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative
Follow-up report #1 inadvertently did not provide the explant date for the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2250798


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:49:39 AM
Model Number 102
Event Date 02/04/2011
Event Type  Injury   
Event Description
It was reported that a pt was in the hospital due to pre-term labor at (b)(6). The pt was experiencing painful stimulation; therefore, the physician on call programmed the device off. The pt later had a miscarriage and was discharged from the hospital. Follow up with the pt's treating neurologist revealed that they have not seen the pt since the last dosing appointment in (b)(6) 2010 at which time, the off time was decreased from 0. 8 minutes to 0. 5 minutes. The pt did not report any pain or discomfort to the physician following the programming change. The neurologist did not know the relationship of the pre-term labor and subsequent miscarriage to vns and referred the mfr to the pt's primary care physician for additional info. Good faith attempts for additional info are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2009543


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:50:20 AM
Model Number 302-20
Event Date 07/27/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2011 when it was discovered that the vns patient was scheduled for a full revision surgery on (b)(6) 2011. The manufacturer's consultant reported that the diagnostics prior to surgery were within normal limits and the diagnostics after the replacement surgery were also within normal limits. No breaks in the tubing were noticed during the revision good faith attempts for product return have been made but the explanted product has not been returned to the manufacturer for product analysis to date. An investigation was initiated in response to the identification of aspire generator hardware design issue. As a result of this design issue, a portion of the stimulation output delivered by the generator through the lead to the positive electrode may be unintentionally redirected to the generator-can away from the intended path, i. E. , through the vagus nerve and then to the negative electrode. As a result the stimulation current intended for the vagus nerve is less than what is programmed by the physician. In addition, the current diversion may cause a charge imbalance at the lead cathode and generator-can during stimulation. Thus, the device does not meet its design intent. The magnitude of these effects is dependant upon patient programmed settings and physiology. As a result of the charge imbalance, it is possible for localized ph changes to develop leading to pain, inflammation and edema formation. In this instance, though it is possible that a charge imbalance may have been present based upon patient programmed settings, the reported event of painful stimulation does not appear to be related to the m105 design issue because the onset of painful stimulation did not occur until two weeks after the patient's device was programmed on following generator revision surgery. The presence of neck pain, inflammation and swelling/edema that may occur as a result of this generator design issue are expected to be noted shortly, possibly as soon as 24-48 hours, after initiating stimulation at a combination of output currents and on-times that lead to an injected charge that is higher than the electrodes charge storage capacity. Also, the patient's lead had been implanted for approximately 3 years prior to the onset of the painful stimulation, thus there has been ample time for tissue encapsulation, or fibrosis, to develop between and, more importantly, around the electrode and the nerve. The presence of this encapsulation is expected to significantly reduce the diversion of current from the positive electrode to the generator- can due to its resistivity, making the charge imbalance issue negligible. Lastly, patient tolerability issues were present, even when the device was programmed to an output current setting of output=0. 25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min. The current diversion/charge imbalance issue associated with this investigation will not occur at these settings.
 
Event Description
Additional information was received on (b)(6), 2011 when the physician reported that they did not perform x-rays on the patient. Although surgery is likely, it has not yet occurred.
 
Event Description
On (b)(4) 2011, a vns treating physician reported that the vns patient recently had a prophylactic battery replacement on (b)(6) 2011 and while gardening on (b)(6) 2011, the patient experienced painful stimulation in her neck every time the device stimulated. The patient taped her magnet over the device and was seen by the physician on (b)(6) 2011. Diagnostics were performed which showed results within normal limits, specific results not provided. The physician decreased the patient's output down to 3ma, then 2ma, but the patient still could not tolerate the pain so the device was eventually turned off. The physician is worried that there is something wrong with her vns. There was no trauma or manipulation to the device. The patient was programmed back up to original settings on date of implant. The patient's settings were output=3. 25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min. On (b)(6) 2011, the physician performed normal mode diagnostics with patient set to an output of 0. 25ma and results were within normal limits with an impedance value of 1677 ohms. The physician then performed system diagnostics and the results were within normal limits with an impedance value again of 1677 ohms. The consultant was concerned because the impedance value remained the same. A copy of the patient's programming history was requested for review by the manufacturer. The programming history was reviewed by the manufacturer and it seems possible that the same impedance measurement could be obtained several times in a row, especially when the diagnostics are performed back to back within a short time frame. Everything in the diagnostic data appears that the device is operating correctly, and the lead impedance value is normal. Clinic notes from the physician were received. The clinic notes were dated (b)(4) 2011 and revealed that with the patient's first vns generator, he never experienced any difficulties and had an excellent response. The physician reports that it is presumed that she has had a lead break that is not able to be picked up running the diagnostics. Even on an output of 0. 25ma, the patient still had a severe amount of pain and felt as though his esophagus was closing. The physician reported that the device is disabled and he is referring him for a full revision surgery. Although surgery is likely, it has not yet occurred. When additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2220076


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:51:16 AM
Model Number 106
Device Problem No Information
Event Date 10/16/2013
Event Type  Malfunction   
Manufacturer Narrative
This information was inadvertently left off of supplemental mfr. Report #01.
 
Event Description
It was reported that the patient¿s seizure history has not changed as of (b)(6) 2013 and varies from month to month. The patient has an extreme amount of seizures historically. The patient complaint was that the vns had not helped with her seizure activity as well as they had hoped for, but did state it had decreased the duration of the seizures. The physician reportedly has not indicated that the patient¿s seizure pattern/occurrence is a profound worsening and should be considered an adverse event. The vns normal mode current was decreased to 1. 0ma from 1. 75ma, and the painful stimulation resolved totally during post adjustment period in the office. The increased current on (b)(6) 2013 was a contributor to the pain with no other know contributing factors.
 
Manufacturer Narrative

Manufacturer Narrative
The information reported on the supplemental report #3 was not in relation to the events in this report #. The information was relevant and reported accurately in mfr report #: 1644487-2014-00695. If remedial action initiated, corrected data: the information reported on the supplemental report #3 was not in relation to the events in this report #. The information was relevant and reported accurately in mfr report #: 1644487-2014-00695. No remedial action was taken in relation to the events captured in this mfr report #. Action reported to fda under 21 usc 360i(f), list correction/removal reporting number, corrected data: the information reported on the supplemental report #3 was not in relation to the events in this report #. The information was relevant and reported accurately in mfr report #: 1644487-2014-00695. No actions are taken in relation to the events captured in this mfr report #.
 
Event Description
The information reported on the supplemental report #3 was not in relation to the events in this report #. The information was relevant and reported accurately in mfr report #: 1644487-2014-00695.
 
Event Description
Further manufacturer investigation was completed. Based on the information gathered through the investigation, the root cause was determined to be an unintended design issue, which allows the burst watchdog timeout event to occur when all of the following conditions are met: 1. Sensing is enabled and autostim burst is in progress. 2. Magnet output current = autostim output current. 3. Autostim output current = 0. 25ma and frequency = 10hz (i. E. Ramp enabled). 4. Magnet is repeatedly applied (i. E. Reed switch closed) for >300ms and = 3 seconds. The issue is caused by the method by which the device firmware calculates the remaining time in autostim on time after a magnet activation occurs when conditions 1 through 3 above are present. When recalculating the stimulation burst time following a magnet activation, an additional two seconds is added to the time to account for ramp up. If the magnet is repeatedly swiped at a pace with less than two seconds between magnet activations, multiple recalculations can add enough time to allow the stimulation to exceed the watchdog timer.
 
Event Description
Patient¿s husband reported an increase in seizures after vns implantation. Patient is implanted with a model 106 generator, currently under (b)(4) undergoing clinical study evaluation. The model 106 device delivers stimulation in the same manner as other commercially distributed devices, and is therefore considered similar to those devices for the purposes of this event. Seizure activity in (b)(6) was noted to be higher than during other months since implantation. Patient¿s record of seizures (from husband¿s record) during month of october includes: (b)(6) ¿ 7: 18 seizures; (b)(6) ¿ 12: 56 seizures; (b)(6) ¿ 16: 13 seizures; (b)(6) ¿ 21: 5-12 seizures/night each night; (b)(6) ¿ 28: 35 seizures. From (b)(6), the patient was not receiving vns stimulation. Output current was at 0 ma during this time. According to physician, patient has had seizure control with intermittent seizures, but experienced marked increase in nightly seizures approximately 1 year prior to vns implant. Physician has indicated that patient has cyclical seizure pattern, and that while the total seizures may be more than pre-vns state, they are not dissimilar to prior exacerbations. Physician indicates that increased seizures could have been a possible secondary effect of painful stimulation reported by the patient due to intensity of stimulation resulting in increased anxiety and insomnia. Physician has since lowered settings to resolve painful stimulation; patient's seizure frequency, intensity, and duration have all reportedly decreased within the last month.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3520124


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:51:58 AM
Model Number 302-20
Event Date 09/21/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that the vns patient had pain in the neck, high impedance, and heard a clicking sound. The patient was sent for x-rays and turned the device off. Additional information was received that the patient was experiencing intermittent pain with magnet use and that she is hearing a clicking noise from the device. The physician received a message on his handheld device indicating "unable to get an "up-arrow" impedance. " because of this warning, the physician feels that there is a lead issue and has referred the patient to the surgeon for consult. " the patient was referred for full revision. The generator would be revised for prophylactic reasons. Clinic notes with the patient's programming history from (b)(6)2012 were received. The patient's impedance on (b)(6) 2011, was 2833 ohms. The patient was reportedly having some trouble with her vns: the patient experienced painful magnet activations in the neck. The patient also had intermittent clicking noises which the patient's mother attributed to the inappropriate stimulation of the vns. The device was interrogated and there appeared to be a problem as there was a significant increase in impedance that could not be detected, suggesting that there may be a disconnect of the lead at the neck. The patient was referred for x-rays, and the radiography report was provided. It was noted that the patient had two wire leads extending from a generator battery pack in the upper left chest along the chest wall to the left neck (the vns). The wire leads appeared to be intact in the visualized segments of the device. There were two leads projecting from a cranial similarity of pain structure dorsally to the prevertebral tissues. The single device is not visibly connected to any of the other white leads. It is possible that this is a detached segment from the remainder of the apparatus. The leads that connect the more caudal wires to the lower left neck appear intact and lead to a battery pacemaker device. There are 2 wire leads leading to a semi-radiopaque structure that is most cranial in location. It is possible that this device has been detached from the remainder of the apparatus. Vns battery in left anterior chest wall. Leads appear intact. No detached leads were seen. Impression: no lead detachment from vns visible. X-rays were reviewed by the manufacturer. The generator was visible in the upper, left chest. The generator was placed normally. The connector pin did not appear to be fully inserted into the connector block. The feedthru wires appeared to be intact. Lead was present behind the generator and could not be assessed for continuity. No sharp angles were present. Lead wires appeared intact at the connector pins. There is a gross lead discontinuity in the lead body near the generator. Based on the x-rays images received, a gross lead fracture and improper pin insertion would explain the high impedance. Additional clinic notes dated (b)(6) 2012, were received indicating that the patient had a marked clinical improvement now that her vns was disabled. The patient had no neck pain. There was no increased in seizure activity. Surgery is likely but has not taken place to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2797881


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:53:02 AM
Model Number 102
Event Date 09/17/2010
Event Type  Injury   
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized.
 
Event Description
It was reported by a rep that the pt was being referred for adverse events for revision surgery. The vns pt said that she experienced swelling and painful stimulation on her neck at the electrode site. The pt was seen by her treating surgeon who indicated there was no swelling in the neck area but indicated there was muscle twitching in the pt's neck around the electrodes with stimulation. The surgeon lowered pt's output current to tolerable levels. Moreover, the pt denied any trauma to the site and was referred to x-rays. The surgeon further stated that the pt complained of acid reflux but was unsure if the event was related to vns or not. Add'l info was received from a company rep indicating she was present at the pt's f/u appointment on (b)(6) 2010. The pt mentioned to the company rep that she was in a car wreck about a year prior to visit and that's when the symptoms began. Clinic notes were received from the company rep indicating "pt presented for treatment on (b)(6) 2007. She was experiencing pain with dosing. She suffered mva on (b)(6) 2009 but dosing remained at 2 and increased to 2. 25 as depression worsened with treatment for ms. Records note sudden onset of neck and jaw pain on (b)(6) 2010. No change in dosing. Dosing had to be decreased to 1 ma to ameliorate the pain. " x-rays were received by the mfr. No gross fractures or acute angles were visualized in the visible portion of the lead body. However, further info indicated that the pt was being referred for a full revision. All diagnostics on the device were said to be within normal limits (no specifics available), but the pt was unable to tolerate previous settings. Since this was occurring, the physician had to add another medication to help the pt. The pt underwent the full revision. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129986


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:53:44 AM
Model Number 102
Event Date 02/18/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2012, when it was reported that the patient would like to have her vns tested. The patient was dismissed by her last physician and none of the other physicians were willing to see her. The patient was given contact information for additional physicians in her area.
 
Event Description
Additional information was received stating that the vns patient had not felt stimulation from her device for quite some time and wants to have the device replaced or removed. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. The explanted generator has been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator was completed. The generator could not be interrogated at two orientations, but was successfully interrogated once the programming wand was repositioned. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Monitoring of the device output current showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. There were no anomalies found with the pulse generator. The generator performed according to functional specifications.
 
Event Description
It was reported by a vns patient that she was having painful stimulation in her neck and chest since her stress test on (b)(6) 2011. The patient said she was also having a loss of appetite with headaches during the stimulation. She alleged that her device was failing. However, her psychiatrist performed system and normal diagnostics which showed the device was within normal limits, dcdc=2, eos=no and dcdc=5, eos=no, respectively. The patient's current settings were 2/20/500/30/5; however, the doctor decreased the output current to 1. 75 ma. The psychiatrist did not want to disable the device because the patient was receiving efficacy. She called manufacturer again on (b)(6) 2011 and stated that her device was failing. She wanted her device removed. She was told to contact her physician; however, she stated that the physician will no longer see her and threatened to commit suicide over the phone. She was offered to be transferred to crisis help line or call 911 which she declined. Manufacturer contacted the treating physician and he stated that patient has had suicidal ideations before but has never followed through. The treating psychiatrist stated that patient's depression and threats of self harm had increased over the last month. The physician didn't feel the patient's issues were related to the vns therapy or the result of a malfunction, just that her disease condition was so severe that it didn't respond to the vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2055651


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:54:36 AM
Model Number 102
Event Date 04/18/2013
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency room on (b)(6) 2013 due to suspected problems with his vns device. The patient had the magnet taped over the device to shut it off. The patient's following neurologist advised the patient's mother to have a cardiologist check the patient as the patient was having chest pain and experiencing a shocking sensation. The patient was seen by the treating neurologist and implanting surgeon on (b)(6) 2013 and it was reported that the patient was doing fine. Device diagnostics were within normal limits. However, the treating physician planned to refer the patient to neurosurgery because he felt that the device is not working properly because the patient was experiencing a shocking feeling in the chest area, even though device diagnostics were within normal limits and the vns magnet was taped over the device to disable the stimulation. The physician believed the painful stimulation was related to the device since it occurred with stimulation on-times. The mother reported that when she attempted to disable the patient's device, the magnet did not appear to turn of the device. The patient was seen by cardiology with no issues found. The neurologist reported that the patient had fallen on multiple occasions but did not have details or dates of the falls. He believes these falls may have caused trauma to the device and/or lead. The neurologist believes that the generator is defective and wants the generator replaced due to the reported pain. The patient's device was turned off on (b)(6) 2013 which resolved the patient's pain. The surgeon was planning on scheduling the patient was revision surgery as soon as possible because the patient's seizures increased since the device was turned off. The plan was to replace the generator and possibly the lead if there was an issue identified with the lead during surgery. An x-ray reportedly did not show a lead fracture. The radiology report dated (b)(6) 2013 reported that the chest x-ray was performed due to "possible electrode disruption. " the visualized leads appeared intact per the report with no evidence of fracture. The patient saw another vns treating physician on (b)(6) 2013 for a second opinion regarding the shocking sensation. Attempts for additional information, including specific diagnostic results, have been unsuccessful to date. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that the patient was scheduled for generator and lead replacement surgery after seeing a different surgeon. It was later reported that the patient underwent generator replacement only on (b)(6) 2013. An implant card was received indicating that the generator was replaced due to "electrical shortage". The generator is expected to be returned for analysis; however, has not yet been received.
 
Event Description
Clinic notes from the surgeon dated (b)(6) 2013 reported that the patient was seen in clinic about his "shocking" vns and rsv (respiratory syncytial virus) to sort out if the shocking was the vns ¿device electronics vs. Just having the device in place in someone with rsv. ¿ the physician suggested that the device first be turned off (both normal and magnet output current) for two months. After two months, the patient will be re-evaluated. If the shocking events persisted, the physician noted that it would not be believed to be the electronics and to consider removing the device. If the shocking goes away but with no change in seizures, they can leave off the device or remove it. If the shocking goes away and the patient needs to the device for seizures, the patient may have generator and lead replacement.
 
Event Description
The patient¿s caregiver reported that the patient¿s vns device was still shocking him even though the generator was turned off. However, the patient¿s seizures became worse with the device turned off. The caregiver wants the generator and lead replaced as soon as possible. The patient¿s primary neurologist confirmed that he turned the patient¿s device back on because the patient¿s seizure became worse with the device turned off. The patient is being referred for replacement surgery. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
The surgeon reported that spite of it being turned off for two weeks or so, that he was still getting shocked. The surgeon said that it was not the ¿electronics shocking him but his disease¿ ((b)(6)). The company representative reported to the surgeon that the patient¿s mother wanted the complete vns system out (generator and leads), and then a new system put in. The surgeon reported that he would not do that and if he replaced the system with a new system he would continue to be shocked. He said he would remove it but not replace it with a new system. He also said he explained this to mom very carefully. The neurologist referred the patient for a telemetry workup. Additional information received on (b)(4) 2013 revealed that the patient had been admitted in the video monitoring unit for the last 10-days and the patient did not have any epileptic seizures, but appears to have psychogenic seizures. Additionally, the patient's device has been turned off and there is still reports of shocking, which the physician feels is due to another issue with the patient and unrelated to the vns. At this time, the physician wants the vns disabled for the next two months to see if there is any decline in the patient's seizure control since it was not clear how the vns was affecting the epileptic seizures that are thought to be present.
 
Event Description
The generator was returned for analysis. Analysis of the generator was completed on (b)(6) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. It was reported that the patient's generator replacement has helped significantly and the patient is no longer experiencing a shocking sensation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3116580


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:55:38 AM
Model Number 103
Event Date 06/01/2013
Event Type  Injury   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
The explanted generator and lead were reported to be available to return to the manufacturer. The products were received. However, analysis has not been completed to date.
 
Event Description
Analysis was completed on the returned generator and lead. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿painful stimulation¿). In the analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Note that a portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The incision and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. What appeared to be canted spring indentations were observed on the rear end of the small o-ring. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints.
 
Event Description
It was reported that the patient's generator has been programmed off since (b)(6) and the patient now wants the device explanted. The neurologist indicated that the vns has never helped the patient and has caused her pain. It is unknown if the pain occurred with device stimulation. Attempts to obtain additional information have been unsuccessful to date. Surgery is likely, but has not occurred to date.
 
Manufacturer Narrative
Date of event, corrected data: previously submitted mdr indicated an event date of (b)(6) 2013; however, additional information was received that the event date is (b)(6) 2013. This report is being submitted to correct this information.
 
Event Description
Follow up with the physician found that the patient's pain was first observed in (b)(6) 2013 following the motor vehicle accident. The lack of efficacy was seen since vns implant in 2010. In response to the question about the relationship of the vns to the patient's pain, the physician said that the vns device was turned off on the initial visit on (b)(6) 2013. The pain was associated with stimulation and was occuring on the left side of the neck. The lack of efficacy from the vns was attributed to injury during motor vehicle accident, per the physician. The physician stated that the device was disabled by taping the magnet over it on the first visit. No other information was provided.
 
Event Description
Clinic notes dated (b)(6) 2014 were received stating that the patient had a vns device which was turned off one year earlier due to discomfort and without relief of seizures. The patient wanted the device removed. Follow up with the tc showed that the device was actually programmed off. Explant surgery has not occurred to date. Programming history in the in-house database was reviewed again on (b)(6) 2014 for updates. The last available settings are from (b)(6) 2013 showing that the device was programmed to: output current: 1. 75 ma, frequency: 30 hz, pulsewidth: 500 usec, on time: 30 seconds, off time: 5 minutes, magnet output current: 2 ma, magnet pulsewidth: 500 usec, on time: 60 seconds. The device was programmed to these settings on (b)(6) 2012.
 
Manufacturer Narrative

Event Description
It was reported that the patient's physician kept trying to increase her vns programmed settings. As a result of settings programmed up too high in the patient's opinion, she reported having a "miserable" three months. After a severe accident which left her trauma icu care, she received a mri and the device went to "full force. ".
 
Event Description
It was reported that the patient had generator and lead explant surgery on (b)(6) 2014. The operative notes reported that the patient was involved in a car crash trauma over two years ago. "her seizures have resolved. Vagal nerve stimulator has been turned off for nearly 2 years. She has not had seizures and is desiring removal of her vagal nerve stimulator. " the lead was dissected free from scar and fibrous tissue. The lead was divided from adherence to the jugular vein and carotid artery, "allowing the metallic portion to reside within the inflated outer portion in a position close to the muscle away from the vessels. " the electrodes remained along the vagus nerve. The remaining generator and portion of the lead were removed. It was reported that the explanted devices are believed to have been discarded. The hospital representative reported that he did not receive the devices after the procedure to return to the manufacturer. Therefore, analysis cannot be performed.
 
Manufacturer Narrative
Describe event or problem, evaluation codes, corrected data: the supplemental report #4 inadvertently reported this data incorrectly. The product was not discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3559261


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:56:36 AM
Model Number 302-20
Event Date 08/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: previously submitted mdr stated that the events began on (b)(6) 2012. Additional information was received that the problems have been occurring for almost a year. This report is being submitted to correct this information.
 
Event Description
On (b)(6) 2012, a fax was received from the physician's office. The fax indicated that the painful stimulation at the generator site and the partial paralysis were related to vns. The patient's device was disabled as an intervention, and explant is planned. The patient denied any trauma. No programming history was available as the patient was implanted at another site. The patient did not have a medical history of paralysis; however, it was noted that the patient had a cva prior to vns. The patient had not been evaluated by an ent. The patient wished for the device to be explanted due to pain and paralysis. The device was reportedly not working due to the patient experiencing pain. The patient's mother reported that device was inconsistently on and off. Surgery is still likely, but has not taken place.
 
Manufacturer Narrative
Review of additional programming history.
 
Event Description
On (b)(6) 2012, this vns patient reported increased seizures, generator migration, partial paralysis, shocking generator, and jumping in the neck. The patient's physician believed that the temporary paralysis was due to the consecutive seizures, not vns. On (b)(6) 2012, the patient's family member reported that the patient was last seen by her physician three weeks prior to (b)(6) 2012. The family member stated that the patient needed the device disabled due to migration and pain and requested assistance finding a closer physician. On (b)(6) 2012, it was reported that the patient had a mini-stroke and needed an mri. Attempts for additional information are underway.
 
Event Description
On (b)(6) 2013, the patient was seen for consult for surgical removal of the device. The patient apparently some issues regarding pain and migration of the generator around the left breast area. The wound appears to be well healed in the cervical and pectoral area, and no infection appears to be present. Nonetheless, the implant is not helping her. The device was currently disabled. Surgery is likely but has not taken place. Review of additional programming history showed that the pt's's device was disabled on (b)(6) 2012. A system diagnostic from (b)(6) 2012 indicated normal results.
 
Event Description
On (b)(6) 2012, the physician's office reported that the patient wanted her vns explanted. On (b)(6) 2012, follow up with the physician's office revealed that the patient wanted the device explanted because she was being evaluated for a stroke, and the device was not working properly. The office could not clarify what was meant by "the device was not working properly. " the patient just wanted the device out, and the physician was agreeable to that. The patient was first evaluated in the office on (b)(6) 2012. The paralysis was on the left side of the patient's body. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.
 
Event Description
On (b)(6) 2012, this vns patient reported that her physician stated that something was wrong with the wiring at the patient's (b)(6) 2012 appointment. The patient did not have specifics about the issue with the wiring but reports that the physician did run tests on the device. The tests and results are unknown. The patient reported that she was experiencing generator protrusion, generator migration, lead body protrusion, numbness on the left side of her body, pain at the chest/generator site, and painful stimulation. The patient said she never had any issues prior to this. The patient also reported that she does sometimes fall but cannot associate any specific incident prior to the start of the adverse events. It was reported that an order had been sent in for x-rays; however, attempts for any additional information have been unsuccessful to date.
 
Manufacturer Narrative
Adverse event or product problem, outcomes: corrected data: previously submitted mdr stated that the reported event was a malfunction. Additional information was received indicating that a serious injury requiring intervention occurred. This report is being submitted to correct this information.
 
Manufacturer Narrative

Event Description
On (b)(6) 2012, this vns patient called complaining of a shocking sensation and generator movement. Attempts for additional information have been unsuccessful to date.
 
Event Description
On (b)(6) 2012, this vns patient reported that she wanted her generator explanted. She stated that the device had been causing her problems for almost a year. She stated that it is not sitting in the pocket like it should be, and when she lies down, it "floats up" causing discomfort. She stated that she had a mini stroke a few months ago and around the same time, her device was turned off because it was shocking her. She stated that about 4-5 months ago, she was to have her explant scheduled, but it just had not happened. She had spoken with the surgeon in regards to her discomfort and was told that she doesn't have enough tissue in the area where she is implanted which may be the cause for the discomfort. She stated she had not experienced any manipulation or trauma that may have caused either the migration or the shocking sensation. Surgery is still likely, but has not occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2554727


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:57:21 AM
Model Number 300-20
Event Date 08/30/2012
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012, it was reported that a vns patient had a generalized tonic-clonic seizure the earlier day (date unknown). After the seizure, the patient experienced painful stimulation in her chest. The patient's diagnostics were output status: limit, impedance: high ((b)(4);10000 ohms), eos = no. The last known diagnostics, current settings, device disablement after the event, and product information were unknown. X-rays were going to be taken and would be sent into the manufacturer for review. The patient was being referred for a full revision. On (b)(6) 2012, the patient's nurse indicated that the patient's chest and neck x-rays were available and would be sent into the manufacturer for review. The nurse stated that x-rays were taken because the patient was seen the previous day, and upon running diagnostics, high impedance (b)(4);10,000 ohms) was observed. The nurse also indicated that the patient has had very few seizures since being implanted with vns; however, the patient had a generalized tonic-clonic seizure the previous week. For the past month, the patient experienced discomfort in her chest with stimulation. (this was not a shock-like sensation. ) the nurse stated that high impedance was first seen on (b)(6) 2012. It was stated that the device was not disabled. The patient was still experiencing her normal voice alteration; therefore, the device was not programmed off as it appeared that the patient was still receiving stimulation. When asked about manipulation or trauma, the nurse stated that when the patient first called regarding the discomfort, she indicated that she was dizzy. The nurse was pretty sure, but could not confirm, that the patient had fallen at that time, which could explain the dizziness and the painful stimulation. Additional information was received with the patient's x-rays. On (b)(6) 2012, the patient had a partial complex seizure at 14:10 and had a grand mal seizure at 15:10. The patient felt pretty beat up: the patient bruised up her shoulder and back. The patient was evaluated in urgent care and was told that there were no fractures, only bruise. The patient denied any missed medication and no acute illnesses. On (b)(6) 2012, the patient reported dizziness and her medication was adjusted. On (b)(6) 2012, the patient reported that she had missed medications. Since (b)(6) 2012, the patient did not report dizziness and these were the first seizures since the appointment. The patient reported a "different" feeling regarding the generator. It was not a shock, but just different. The patient had a number of seizures since her last visit. The device was stimulation her voice but she felt a weight in her chest with stimulation. The seizures were possibly secondary to an automobile accident. The patient had significant ecchymosis and pain in the left upper arm and should from the fall on her should with the seizures. It was assessed that the patient had the gtc possibly secondary to a fractured lead on the vns. The x-rays were assessed and it was written that the vns wire appears to have a break or crack based on high impedance. Vns replacement including wires was likely. The device was interrogated and diagnostics were run. X-ray images were reviewed by the manufacturer. The generator was visible and appeared to be normally placed. The connector pins appeared to be fully inserted inside the connector blocks. The feedthru wires also appeared intact. The lead was also visible. Lead was present behind the generator. There were no suspect fractures, discontinuities, or sharp angles visible. The lead wires appeared intact at the connector pins. The patient underwent total revision on (b)(6) 2012. The explanted generator and lead were received on (b)(6) 2012 and are currently undergoing product analysis. The returned product form indicated that the lead was explanted due erosion of the lead and parasthesia in the chest.
 
Event Description
An analysis was performed on the returned lead portion. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Product analysis on the generator showed that the high impedance noted in the lead section was not duplicated in product analysis. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device x-rays reviewed by manufacturer; no gross lead discontinuities visualized.
 
Manufacturer Narrative
Review of programming history.
 
Event Description
Additional programming history was reviewed on (b)(6) 2012. High impedance was first seen on (b)(6) 2012. Impedance values and output status varied with diagnostics.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769777


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:58:10 AM
Model Number 102
Event Date 04/24/2004
Event Type  Injury   
Event Description
Product analysis was approved on (b)(6) 2012. It was found that the septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, it was reported that the patient would undergo prophylactic generator revision. During revision, the generator migration would be taken care of. Surgery was confirmed to have occurred on (b)(6) 2012. Attempts for the explanted generator have been unsuccessful. The patient initially reported generator migration since the original implant. Follow up with the physician showed that the date on which migration began is unknown. The patient is obese, and the patient has gained weight over the last few years: this has caused the patient to feel like the device is migrating. No interventions had been taken or planned at this point. No patient manipulation or trauma was noted as the migration was attributed to weight gain. It was unknown if a non-absorbable suture had been used during the initial implant. It was also stated that the patient's seizures were rather violent, as the patient was obese. The physician stated that the patient's mother was not convinced of the magnet's efficacy. The patient had reportedly been seizure-free for about one year. In earlier years, the patient was experiencing painful stimulation at an unknown location. The physician believed the lead had migrated because the patient reported painful stimulation. The physician was also unable to visualize or palpate a movement of the lead or generator on the patient: this was the physician's only indication for suspecting migration was the patient's painful stimulation. X-rays were ordered; however, no diagnostics were run. (the x-rays were not sent to the manufacturer for review. ) the physician also reported an increase in seizures but did not believe the increase was above the pre-vns baseline. Medications for the seizures were increased as an intervention. Follow up with the physician showed that both normal mode and system diagnostics were ok. Lead migration was not visually confirmed, and the physician's new assessment was that the lead had not migrated since both diagnostics were ok. The increase in seizures was attributed to some other factor (stress) and not vns. No dosing adjustment, trauma, or injury preceded the painful stimulation. The physician adjusted the patient's output current, and the patient was no longer experiencing pain.
 
Manufacturer Narrative

Event Description
The explanted generator was received on (b)(6) 2012 and is currently undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2701405


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:58:47 AM
Model Number 102
Event Date 09/18/2008
Event Type  Injury   
Event Description
Rptr indicated a vns therapy pt is being referred to surgeon for explant of the device. The reason for the explant is exacerbation of asthma and painful stimulation. Good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1202921


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:59:21 AM
Model Number 303-20
Event Date 12/07/2015
Event Type  Injury   
Event Description
It was reported that the patient had significant swelling at the electrode and generator sites. It was initially thought that the patient had an infection, but that was ruled out. The patient then had a nuclear medicine scan, which showed that the patient had lymphatic fluid in the soft tissue surrounding the electrode site and was leaking down to the chest pocket as well. The patient was feeling painful stimulation in the neck, which the physician attributed to the electrode site being irritated and swollen. It was determined that the fluid collection was due to the implant location of the electrodes. The physician performed lead revision surgery on (b)(6) 2016 to replace the lead and position the new electrodes in a different location on the nerve. The physician did not observe any fluid when he was performing the lead revision surgery. The explanted lead was received on (b)(6) 2016. Analysis was approved on (b)(6) 2016. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Other typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5851977


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 02:59:55 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
A patient reported that he has been experiencing painful stimulation in his chest and side, and an increase in seizure activity, following being in a coma for 3 days (coma was stated to be due to a grand mal seizure). The patient was subsequently seen by a new treating neurologist in (b)(6) 2016 and it was reported that the patient's vns system showed a normal lead impedance and battery status. Vns device parameters were adjusted to address the reported painful stimulation. A review of available programming and diagnostic history revealed no anomalies.
 
Event Description
Multiple requests for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5399489


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 03:00:36 AM
Event Date 08/11/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was having extremely painful stimulation every five minutes when his generator turned on. This began on (b)(6) 2013, when the physician first turned on the generator. The patient was initially implanted on (b)(6) 2013. The patient stated that the pain occurred every on time after the 5 minute period and has not changed since (b)(6) 2013. The patient stated he would try to disable the stimulation with the magnet, but the pain was severe and his follow up appointment with the physician had been cancelled. Follow up with the patient's caregiver found that the patient had sever nausea and vomiting that weekend, for which the physician requested the patient go to the emergency room. The patient was severely dehydrated and the patient and caregiver believed that the vns may be causing these issues, so the device was disabled with magnet. It was stated that the magnet did not turn off the vns and only lessened the output current. Afterwards, it was stated that the patient and caregiver now believe that the nausea and vomiting are due to dental work that was performed two weeks prior as the patient has been sick ever since. The patient had several teeth pulled and was getting ready for dentures when he started getting sick. Attempts have been made for additional information; however, they have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3390838


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 03:01:24 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 04/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had a revision surgery on (b)(6) 2016. The generator found to be "completely floating around" in the generator pocket and was "upside down". It was reportedly loose enough that the surgeon could spin it in a circle. During the surgery, the surgeon observed that a tie-down was not attached and was re-attached. The generator was also re-secured, and more slack was given in the neck for the lead. In the previous generator implant, the surgeon reportedly did not place a suture to secure the generator. The patient did not have an issue with vns placement until the mammogram. No additional pertinent information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient was reportedly still experiencing pain. The device was reported to still be set to not deliver current at the time the patient experienced the pain. No additional pertinent information has been received to date.
 
Event Description
Follow up with the office of the surgeon who performed the revision surgery showed that he likely used a suture to secure the generator in the previous generator replacement surgery. Attempts for additional pertinent information regarding the revision surgery have been unsuccessful to date. Further information showed that the patient was still experiencing pain and ¿shocking¿ sensations. The device was reported to be off at the time of this report. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient had her vns generator and lead explanted due to discomfort and painful stimulation. The explanted devices have not been returned to the manufacturer to date. No additional pertinent information has been received to date.
 
Event Description
Communication from the treating physician showed that the patient¿s pain had continued following cessation of stimulation. Settings and device diagnostic results were provided from the appointment where the device was disabled. The physician reportedly endorsed that the pain began following a mammogram procedure which pulled the vns lead. The explanted lead and generator were received by the manufacturer for product analysis. Product analysis was completed on the returned lead portion. The returned portion measured 336 mm. The continuity measurements taken during decontamination verified an electrical and mechanical contact between the generator and the connector block to the end of lead. Visual analysis showed that the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The set screw marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present at least at one time. Continuity checks of the returned lead portion were performed and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portion of the device. Note that a portion of the lead assembly including the electrodes was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs in a simulated body temperature environment. The pulse generator showed expected level of output currents and no signs of variation. Both interrogation and system diagnostic tests were performed. Various electrical loads were attached to the pulse generator, and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 051 volts during functional testing and showed an ifi=no condition. The internal device data showed that 12. 492% of the battery had been consumed. Review of the remainder of the internal device data showed no anomalies. There were no performance or any other type of adverse conditions found with the pulse generator. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient was experiencing pain, device protrusion and generator migration following a mammogram procedure. The pain and protrusion were stated to be at both the lead and generator sites. The patient stated that she was thin and that her lead was always visible, but since the mammogram it protruded more than it had previously. A revision surgery was reported to have been scheduled at the time of the report, but has not been known to occur to date. No additional pertinent information has been received to date.
 
Event Description
The patient reported that the stabbing pain she previously reported was still present. Her vns was subsequently turned off. The pain in the neck was reported to have resolved with the generator disabled. The patient reportedly still experienced occasional sharp pain at the generator site not coinciding with stimulation. This pain cannot be predicted and does not appear to happen with any specific movement or body position. The patient expressed that she wanted the generator explanted. She feels the m106 generator is too large for her thin body. No known additional surgical intervention has occurred to date. No additional relevant information has been received to date. ¿.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5909344


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 03:02:05 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 07/10/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Date of event, corrected data: initial report inadvertently listed wrong date of event.
 
Event Description
It was reported that this patient is experiencing vocal cord paralysis. The surgeon believes it might be due to the vns strangulating the nerve. Therefore a vns lead revision occurred to determine if nerve strangulation is the cause. It was later reported that the patient began having sharp pains up her left ear to her left suboccipital area when her output current was increased. The patient had numbness of her left neck, left throat and left tongue. This made swallowing difficult. This did not get better with time, and when the output current was turned back down, she did not feel any stimulation unless her head was tilted to the left. It was mentioned that the doctor reported that the patient's nerve was pretty sizeable. The sharp pain that led to the patient's ear and suboccipital area was occurring with stimulation. It was also reported that it was too early to know the cause of painful stimulation, numbness, and vocal cord paralysis. The doctor spent 8 hours in the operating room probing the patient to determine what to do, and decided to cut the anchor tether, and snipped off the end of the positive electrode, and per the doctor, he did not cut any wire. He also believed the negative electrode was kinked and he fixed that. Overall the doctor kept the implanted lead intact with some modifications. The patient's generator was programmed off to allow the nerve to rest after surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6878406


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 03:02:52 AM
Model Number 300-20
Event Date 04/01/2013
Event Type  Injury   
Event Description
It was reported that on (b)(6) 2013 the patient had a tumor removed from her neck.
 
Event Description
It was reported that the explanting facility discarded the explanted generator and it will not be returned for analysis.
 
Event Description
Additional information was received that the patient is going to have her generator and lead explanted. Surgery if likely but has not occurred to date.
 
Manufacturer Narrative

Event Description
It was initially reported that the patient was experiencing painful stimulation. The patient has requested to be explanted due to the painful stimulation and possible lead protrusion in the neck. Information of the surgeon's office was that there did not seem to be anything wrong with the patient's vns and indicated that the patient may not be proceeding with surgery but this was not able to be confirmed. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Additional information was received which changes the product the report is reported on.
 
Event Description
On (b)(4) 2013 clinic notes were received dated (b)(6) 2013. The clinic notes mention that the patient has a ¿lump in her neck that another doctor had said that the wire is wrapped around¿. The patient stated that her pump has not worked since (b)(6) 2013; that it has been ¿two years since the wire broke¿. The clinic notes mention that the patient has visual hallucinations. The patient was referred for x-rays to check her lead. A copy of the ct of the neck soft tissue was received dated (b)(6) 2012 which indicates that ¿at the site where there was previously felt to be some skin thickening close to the site of the neurostimulator leads, there is still some skin thickening but no increase in the size of the vague density. The apparent sebaceous cyst seen more anteriorly is unchanged¿. It was stated that the patient had complained of a left neck lump and dysphagia. It was stated that this palpable lump is just inferior to the parotid gland but there is no identifiable mass at this site. Slightly anterior to this, there is a small skin lesion which was noted to might be a small sebaceous cyst. The ct scan sated that there is no mass in the region of the palpable lump. The patient underwent a generator replacement on (b)(6) 2013. The explanted generator has not been received for product analysis to date.
 
Event Description
Additional information was received that the patient had seen the surgeon without a referral from her treating physician. The surgery was cancels and is not currently planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3116210


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 03:03:39 AM
Model Number 103
Event Date 03/29/2016
Event Type  Injury   
Event Description
It was reported that a patient had laparoscopic nissun fundoplication surgery on (b)(6) 2016. Postoperatively, the patient was complicated by a seizure and then had cardioversion at 125j for arrhythmia. A ct scan was obtained, which showed a pericardial effusion. The patient was then emergency transported to another hospital for exploration surgery. During the surgery, it was determined that there was a hole in the pericardium and a tear in an arterial branch of the circumflex coronary artery. The vns magnet was placed over the device during this surgery. After the reparative surgery, the patient experienced recurrent episodes of painful stimulation, bradycardia, drop in blood pressure, and asystole during vns stimulation. The patient's magnet was placed over the generator, but, due to the patient being morbidly obese, the skin where the magnet was taped would move and allow stimulation to occur. The patient then had a temporary pacemaker implanted, and the vns was programmed to 0ma on (b)(6) 2016. Diagnostics were performed, and the results were all within normal limits. The arrhythmias and painful stimulation no longer occurred after the device was programmed off. The physician planned to leave the device programmed off for a while and slowly reintroduce therapy after the patient stabilized. It was also reported that the patient had a history of mild bradycardia prior to this event. No further relevant information has been received to date.
 
Event Description
Data was received from 03/29/2016 and 03/30/2016. No anomalies were noted - the data indicated that the device was functioning within normal limits. It was observed that the impedance had dropped from 2674 ohms to 1419 ohms (-47. 0% change) on (b)(6) 2016, 5:57:24 (estimated). The sudden temporary drop in impedance could be attributed to the nerve¿s response to injury (i. E. Expel of ionic endoneurial fluids from damaged nerve cells; an observed increase in this fluid via mri is often used as an indicator of nerve injury). It was found that electrical current from the external defibrillator (cardioversion equipment) can transfer through the generator and leads to the vagus nerve, where the resulting charge density and energy delivered to the nerve from the defibrillation is at levels considerably higher than what the nerve experiences with vns therapy, even at maximal settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5598322



Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 03:04:33 AM
Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury. Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity. The patient¿s pain was occurring with stimulation and due to lead discontinuity. The explanted products have not been returned to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr. Report. Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr. Supplement report #3. Additional manufacturer narrative, corrected data: mfr. Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr. Report. ".
 
Event Description
It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea. The patient experienced pain and coughing at the time of device interrogation.
 
Event Description
Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.
 
Event Description
The patient¿s pain was occurring with stimulation and due to lead discontinuity. The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death. Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Brand name; corrected data: additional information indicates that the suspect device is the lead. Type of device, name; corrected data: additional information indicates that the suspect device is the lead. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead. Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.
 
Event Description
It was reported that the vns patient was experiencing very painful side-effects from vns. Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple. This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches. The patient was most uncomfortable at night and when she was lying down. The patient later reported that the pain was getting worse and that she was feeling sick and panicking. The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression. The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms. The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808957



Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 03:05:09 AM
Model Number 304-20
Event Date 03/01/2010
Event Type  Injury   
Event Description
It was initially reported that the patient was recently turned on a few prior and was now experiencing some swelling in her neck and throat, and has been unable to turn her head. It was said that the patient was diagnosed by her treating neurologist that she has a neuroma. The patient was said to have been given a steroid injection, which provided some improvement. It was also indicated that the patient is experiencing some painful stimulation in the neck. No further details have made available on the events. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1698103



Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 03:08:48 AM
Model Number 103
Device Problem Failure to shock or properly shock
Event Date 12/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the available programming and diagnostic history. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution.
 
Event Description
Further information was received indicating that the patient had undergone bi-phasic cardioversion in the morning with adhesive patches in anterior-lateral left position. The energy value used for the cardioversion was 100j. The generator's decoder spreadsheet was reviewed. On (b)(6) 2013 the patient underwent the first cardioversion treatment. On (b)(6) 2013 the battery voltage was 3. 440v and the lead impedance 3782 ohms. On (b)(6) 2013 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the patient underwent the second cardioversion. On (b)(6) 2014 the battery voltage was 2938v and the lead impedance 2401 to 2430 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms.
 
Event Description
It was reported that the vns patient was to be hospitalized in (b)(6) 2015 for disabling the vns stimulation and enabling it again in a controlled environment. It was reported that the patient had undergone cardioversion in (b)(6) 2013 as a treatment for heartbeat disorders that had followed myocardial infarction. The vns stimulation was turned off during cardioversion by fixing the magnet on the generator. After cardioversion and removal of the magnet the patient experienced an extreme burning sensation in the throat and neck, suffocation, flushing and eyes watering. The reported effects stopped when stimulation was stopped by fixing the magnet on the generator. The pulse generator was programmed at the mildest stimulation settings and the side effects improved. The pulse generator was programmed at output current 1. 50 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. Further information was received indicating that the patient¿s system was tested on (b)(6) 2013 and system diagnostics returned impedance within normal limits with 3119 ohms. On (b)(6) 2013 the pulse generator was programmed at output current 0. 75 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. On (b)(6) 2013 the pulse generator was programmed at output current 0. 5 ma, frequency 20 hz, pulse width 250usec, 30sec on and 5min off. It was later reported that the patient underwent cardioversion again on (b)(6) 2014 and that the pulse generator was disabled by fixing the magnet on the generator. After cardioversion was completing and the magnet was removed the patient experienced painful stimulation. The patient could not tolerate the output current set at 1. 75ma. The output current was programmed to 0. 5ma. The patients vns system was tested and system diagnostics returned impedance results within normal limits. Further information was received stating that before the first cardioversion session on (b)(6) 2013 system diagnostics returned impedance results within normal limits with impedance = 3781 ohms, and ifi=no. After the first cardioversion session, system diagnostics on (b)(6) 2013 returned impedance results within normal limits with impedance = 3119 ohms, and ifi=no. Before the second cardioversion session on (b)(6) 2014 system diagnostics returned impedance results within normal limits with impedance = 2922 ohms, and ifi=no. After the second cardioversion session, system diagnostics on (b)(6) 2014 returned impedance results within normal limits with impedance = 2429 ohms, and ifi=no. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4877621


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:01:48 AM
Model Number 102
Event Date 02/21/2013
Event Type  Injury   
Event Description
Reporter indicated that a patient's mania worsens at higher stimulation settings. The patient has had mood disorders and depression prior to ever having vns implanted. The patient's vns is currently disabled as it was causing painful stimulation in the neck. The vns was disabled on (b)(6) 2013. Attempts for additional information are in progress.
 
Manufacturer Narrative

Event Description
All attempts to the reporter for additional information about the mania event have been unsuccessful to date.
 
Event Description
Reporter indicated the mania did happen with vns stimulation and was strength-dependent. The patient has mental retardation and significant prior psychological trauma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3030699


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:02:27 AM
Model Number 302-20
Event Date 02/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that the patient was experiencing painful stimulation in the lead area after having a fall while playing football. System diagnostics showed everything working within normal limits. X-rays were done and sent to manufacturer for further review. No obvious anomalies were observed that could be contributing to the report of painful stimulation. Patient is not experiencing pain with every stimulation, but it occurs at certain positions. The physician believes that the lead tubing was compromised during the tackle which is possibly causing a passage for the leakage current to the body. Patient underwent a lead replacement surgery. Patient continued to have painful stimulation at the neck region after surgery but in a few days, the event disappeared. Explanted lead was returned to manufacturer for analysis. Analysis is currently pending on the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1689569


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:02:56 AM
Model Number 300-20
Event Date 03/12/2007
Event Type  Malfunction   
Event Description
Reporter indicated a vns patient was experiencing painful stimulation in the neck and generator site and felt that the generator was pulling on the leads. Diagnostics were within normal limits. The device was programmed off at the request of the patient. X-rays were reviewed and no anomies were noted. The patient underwent generator replacement surgery. The lead was not replaced because the surgeon did not believe a problem existed with the generator. The patient's painful stimulation persists. The patient is planning on vns lead replacement surgery. The lead will be implanted on the right vagus nerve. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1297765


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:03:32 AM
Model Number 302-20
Event Date 11/18/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the patient would have a vns replacement due to high impedance. Follow up found that replacement surgery was for patient comfort and they were not concerned with it resulting in a serious injury. Previously, the patient reported experiencing pain with stimulation which was felt at the neck and travelled up to the left ear. It was confirmed at the time that no trauma, manipulation, programming changes, or medication changes had occurred recently. The patient's settings were originally at 2. 5ma and 2. 75ma for normal and magnet output current respectively. The output currents were reducted to 0. 25ma and 0. 5 ma respectively. Diagnostics taken on this day, (b)(6) 2013, were all ok. X-rays were sent to the manufacturer for review. The generator was seen in the left chest area in normal orientation. The filter feedthru wires were intact and the lead pin could be seen past the second connector block indicating that it is fully inserted into the generator. A portion of the lead appears to be present behind the generator. The lead could not be assessed at the connector pin due to the x-ray image quality. The electrodes were observed in the neck and appear to be in proper alignment. A strain relief bend was present; however, no strain relief loop appeared to be present. There was one tie-down present. Lead is seen routing down toward the generator. No other information has been provided. Surgery is likely, but has not occurred to date. Received a phone call on (b)(6) 2013 from tc (b)(6) who stated that patient (b)(6) is experiencing painful stimulation which is felt at the neck and travels up to the left ear. He stated that he met with the patient yesterday, and the patient confirmed this has been occurring since monday ((b)(6) 2013). It had been confirmed that no trauma/manipulation/programming changes/medication changes had occurred recently. The patient¿s settings were originally 2. 5ma for output current and 2. 75ma for magnet output current, and the settings were decreased all the way down and the event was still occurring at 0. 25ma/0. 5ma. The physician decided to turn the device off and order x-rays. Diagnostics were all ok per tc. I stated that since diagnostics are ok x-rays are typically not recommended since the system appears to be fully intact. Tc insisted that the x-rays may show something and stated that he will be sending these x-rays to cts for review. He stated that he specifically wants these x-rays to be reviewed for a hairline fracture or fluid in the lead. I stated that this is very detailed and that it all depends on the images that are received. Tc inquired about other recommendations for this situation. I stated that it may be helpful to evaluate the patient after it has been disabled and for the physician to observe the patient after turning it back on. I inquired what the physician¿s assessment of this is and he stated the physician does not know. Tc stated they might undergo a full revision if nothing is found to help. I stated that this would be a medical decision which is up to the physician. No further information was discussed.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3562083


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:04:09 AM
Model Number 304-20
Device Problems Detachment of device component; No Known Device Problem
Event Date 10/30/2015
Event Type  Injury   
Event Description
The patient had full revision surgery. The generator was not sutured to the fascia, but was merely buried in subcutaneous tissue, which allowed for generator migration. The generator not being secured and the possible relationship to the pain experienced at the chest will be reported together in mfr. Report #1644487-2018-00847 as these issues now appear to be separate from the events in this report. The tie-downs were not sutured in place, and the surgeon noted that the electrodes were not properly coiled around the nerve. The explanting facility discards of product, so no evaluation could be performed on the devices. No further relevant information has been received to date.
 
Event Description
It was reported that the patient was experiencing multiple adverse events. The patient felt throbbing pain in her left neck and significant pain/tenderness at the neck incision and up her neck to her ear for four days. She also reported that she could feel the "clamp" prominently under the incision when she touched her neck. The patient also felt painful stimulation for the past four days, and she had not felt stimulation up to that point. She had been having left ear pain/trouble hearing/feeling like her ear was "stopped up" for about four months, but the physicians did not identify any ear infections. The patient also felt pain in her chest, neck, and left shoulder for two to three days after her vns magnet was swiped. The patient had been feeling pain since she was implanted, but the pain had just recently gotten unbearable. The patient was taking pain medication four times a day, but that did not make the pain go away. The patient's ear hurt so badly that she could not let the wind hit it. The patient's treating physician believed that the surgeon had poor implant technique and the pain was related to the placement of the device. The physician did not know the cause of the pain during magnet swipes, and he didn't know if the hearing loss was related to vns or not. The patient was referred for surgery, and it was being done to preclude a serious injury as the patient was in excruciating pain that was getting worse. X-rays were ordered, but they have not been reviewed to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7373200


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:04:54 AM
Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was experiencing painful stimulation in the neck area. It was reported that the painful stimulation had been occurring for approximately 3-4 months. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. No patient manipulation or trauma occurred that is believed to have caused or contributed to the painful stimulation. Clinic notes dated 06/03/2013 note that the patient has complained that the area that the device is implanted is sore and hurts, particularly at night. The notes indicate that device settings were decreased to see if the settings had any effect on the discomfort. It was later reported that the patient was scheduled to undergo device replacement at the patient's mother's request so that the patient could continue vns therapy. Both the lead and generator were replaced. The lead and generator were returned to device manufacturer for analysis on (b)(4) 2013. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Event Description
Lead analysis was approved on 08/22/2013. An analysis was performed on the returned lead portion. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Generator analysis was also performed. The septa do not appear to be cored and there was no evidence of dried body fluid or corrosion observed in the connector block areas, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Review of the programming history database revealed data from the date of implant through (b)(6) 2013. The last programmed settings were available. The device was returned at these settings.
 
Manufacturer Narrative
Analysis of programming history. Device failure occurred but did not cause or contribute to a death adverse event or product problem, corrected data: previously submitted indicated an adverse event; however, additional information is available that a product problem also occurred. This report is being submitted to correct this information. Type of reportable event, corrected data: previously submitted indicated an adverse event; however, additional information is available that a product problem also occurred. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3271718


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:05:37 AM
Model Number 303-20
Event Date 02/01/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Reporter indicated the patient had vns lead pin reinsertion surgery performed on (b)(6) 2013. After the lead pin was reinserted into the generator header, diagnostics were within normal limits (3218 ohms). No new devices were implanted.
 
Event Description
Additional x-rays were reviewed by the manufacturer. The lead pin did not appear to be fully inserted. No additional anomalies were noted. The surgeon indicated he felt the lead pin had been fully inserted as two audible clicks were heard when tightening the setscrew. However, the possibility of a lead fracture may also exist. Reporter indicated the patient was also having increased seizures and that the plan of care is to have vns revision surgery; however, this has not occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a serious injury.
 
Event Description
Reporter indicated intermittent high lead impedance was noted for a patient who recently had vns generator replacement on (b)(6) 2013. The patient had no known trauma. The patient is also experiencing painful stimulation at the electrode site in the neck. X-rays were reviewed by the manufacturer. The electrodes are visualized at approximately t1 and are in alignment; the electrodes are implanted lower than what is usually seen. The generator is implanted in the left axilla. This is much more lateral than what is normally seen. The view does not allow full assessment of the lead pin insertion. The lead wire is intact at the lead pin. The filter feedthroughs are intact. There is a small amount of lead behind the generator that cannot be assessed. The cause of the high lead impedance is unknown at this time, but may be due to inadequate pin insertion or a lead fracture. Attempts for additional information are in progress.
 
Event Description
Manufacturer review of the device history records for the vns lead and generator confirmed both devices passed all final testing prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993250


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:06:10 AM
Model Number 302-20
Event Date 03/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was initially reported to the mfr that the pt was admitted to the er because, the pt was experiencing neck swelling, painful stimulation and dyspnea. The pt was referred to a surgeon and was scheduled for a lead revision surgery due to a suspected lead break. The pt's treating neurologist believes the swelling and dyspnea are related to vns, dyspnea occurs with stimulation and the pt does not have any history of dyspnea pre-vns. The pt's lead body was replaced due to a lead break. It was indicated that there were no casual or contributing factors, or any pt manipulation or trauma that occurred to have contributed to the lead break. Good faith attempts to obtain more info regarding the suspected lead discontinuity have been unsuccessful to date. The explanted lead body has been returned to the mfr and analysis is in process.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1675414


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:06:46 AM
Model Number 302-20
Event Date 08/29/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis for the explanted generator was approved on (b)(6) 2012. The device performed according to functional specifications. Analysis of the generator in the (b)(4) lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the explanted lead was approved on (b)(6) 2012. The electrodes of the lead were not returned for product analysis. Setscrew marks on the connector pin provided evidence that proper contact between the setscrew and lead pin existed at least once. Abrasions were identified on the outer silicone tubing at multiple locations and on the connector boot. The outer silicone tubing had cuts at several locations. Some cuts did reach the inner silicone tubing. Abrasions were identified on the silicone tubing of the lead coils. The silicone tubing of the positive coil appears to be abraded and open in the vicinity of the coil end. It is believed that this condition could potentially contribute to the patient "pain" allegation. However, the exact impact of this condition and when it occurred is unknown. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred in the vicinity of the coil cut end. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified within the returned lead portion.
 
Event Description
On (b)(6) 2012, it was reported that the patient was experiencing painful stimulation in the neck area for the last day or so. X-rays were taken, and no lead issue was seen. The x-rays would not be sent to the manufacturer for review. High lead impedance was seen the day before and the patient's device was disabled late on (b)(6) 2012, or early on (b)(6) 2012. The patient underwent surgical consult. The patient was reported to have been seizure-free for three years, and there was no reported increase in seizures. There was no known trauma. On (b)(6) 2012, the patient reported that, during interrogation earlier in the day, an error message popped up which said that her leads are detached or there is tissue build up. The patient stated that x-rays were taken but did not show any detachment. The patient stated that the device was programmed off and that she was referred for lead replacement due to the detachment issue. The patient stated that there had been no trauma or manipulation that she was aware of; however, she occasionally lifted heavy things. The generator and lead were replaced on (b)(6) 2012. X-rays were observed prior to surgery and a definitive lead break was observed in the lead just above the bifurcation. During surgery, it was noticed that the electrode coils appeared to be pulling off of the nerve but that they were scarred in tightly. The patient's generator was replaced prophylactically. The lead and generator were returned on (b)(4) 2012 and are currently undergoing product analysis. A battery life calculation on (b)(4) 2012, resulted in 7. 67 years to neos.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2758863


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:07:24 AM
Model Number 300-20
Device Problem High impedance
Event Date 10/01/2015
Event Type  Malfunction   
Event Description
The explanted devices were discarded after surgery and will not be received for analysis.
 
Event Description
It was reported on (b)(6) 2015 that this patient is experiencing painful and erratic stimulation at an unspecified location. The pain only occurs at night for the patient. At a recent clinic visit high impedance was found on system diagnostics. The patient denies any incident that may have caused the high impedance. The physician was instructed to turn off the device or lower the device settings. The patient will likely receive a m106 to replace her existing system. Clinic notes state over the past month or more she has been having intermittent sensations of her device going off where as she had not really felt it come on at all in the past year. When she swipes her magnet she has no stimulation. Surgery is likely but has not occurred to date.
 
Manufacturer Narrative

Event Description
The patient reported muscle spasms (a fluttering feeling) in her neck and down into her left shoulder which the patient states began around the time of the high impedance.
 
Event Description
The patient had a full replacement on (b)(6) 2015. The explanted devices have not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5232625


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:08:06 AM
Model Number 102
Event Date 09/02/2012
Event Type  Injury   
Event Description
Additional information was received from the patient's explanting surgeon which revealed that the device explanted due to patient comfort. Only the generator was explanted. The pain was believed to be related to "misfiring - headaches, hoarseness, trouble breathing. " the relationship of these events to vns are unclear with the information provided. No causal or contributory programming or medication changes precede the onset of the continuous/erratic stimulation and pain. In addition, no patient manipulation or trauma occur that is believed to have caused/contributed to continuous/erratic stimulation and pain. As of (b)(6) 2012, it was unknown if the patient's symptoms have resolved since explant because the patient had not returned to the surgeon's office. Attempts for return of the explanted device are unsuccessful, as the explanting facility does not return products per hospital policy. A letter was received from the patient on (b)(6)2012. She indicated that on (b)(6) 2012, she had a "breathing problem and it was as if "she was suffocating". She reported that she did not relate these events vns. Then on (b)(6) 2012, she went to the emergency room and "wore a magnet for over a week. " she reported that her device was tuned off two years ago, and "the surgeon said it was malfunctioning" the neurologist at the emergency room "said this was not normal and also said it was malfunctioning". The patient continued to state that she was told (by an unknown source) that she "could have problems in the future from this problem". She was writing with regards for reimbursement for "pain and suffering". Attempts for additional information from the treating physicians have been unsuccessful to date. Previous follow up with the neurologist regarding the device disablement in 2010 was performed which revealed that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of energy during physical activity. These events were reportedly related to stimulation, except it is unknown if the decreased energy level was. The patient claimed her energy level decreased during physical activity, but this could not be confirmed by the physician's office. There were no noted causal or contributory factors, and no programming/diagnostics were provided. No additional interventions were taken in 2010, and no additional information was provided.
 
Manufacturer Narrative

Event Description
A nurse in the emergency room reported on (b)(6) 2012, that the vns patient had presented with constant pain in the chest that had started that day. The nurse indicated that the only intervention that they would take it using the vns magnet to disable the device temporarily because they did not think that anything is wrong with the device. She said that another nurse had submitted the report indicating that the patient believed the device was malfunctioning, but that is because she misunderstood what the nurse had said. The patient later reported on (b)(6) 2012, that she wanted to have her vns device removed to due to erratic stimulation which is now painful and constantly stimulating. She mentioned that her device was disabled in 2010 and she did not understand why it is now going off. The patient said that she did not like the way the therapy felt at the time which is why the device was disabled. Additional information was received on (b)(6) 2012, indicating that the patent was scheduled for explant. The patient had vns explant on (b)(6) 2012. Attempts for product return are unsuccessful as the explanting facility requires a patient signed release, and they reported that they will not return to the manufacturer. Follow up with the neurologist's office indicated that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of activity. There were no noted causal or contributory factors, and no programming/diagnostics were provided. The patient was being treated by a new ent surgeon. (b)(6) also indicated that the patient called their office on (b)(6) 2012, due to the pain and erratic stimulation in the chest for which she wanted the device removed. Follow up with the patient's treating ent surgeon have been unsuccessful to date.
 
Event Description
Additional information was received from the explant surgeon. The generator was explanted at request of patient. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769409


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:08:42 AM
Model Number 102
Event Date 10/27/2011
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2011, that the pt was admitted to the emergency room due to status epilepticus. The neurologist went to the hospital to interrogate the generator, but the battery was dead. The pt had generator replacement surgery due to battery depletion. The neurologist reported that the generator was at eri=yes and was unable to be interrogated. However, no troubleshooting was performed. No programming settings were provided by the neurologist, as the generator was reported dead prior to the generator replacement, so no programming changes were completely recently. The company rep reported that the neurologist attributed the pt's hospitalization to the generator being at end of service. As a result, they immediately scheduled replacement to get the generator changed. The generator was returned to the mfr for analysis. The generator product analysis was completed, and the results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The reported allegation of "end of service" was not duplicated in the pa lab. No eri flags were observed during eval. The pulse generator module performed according to functional specs. However, it was noted that the generator did not interrogate at two orientations at approx 135 and 315 degrees. Clinic notes were later received which revealed that the pt's increased seizures occurred in a different town and was not being treated by her usual physician. The pt's seizure frequency with vns was one to two seizures per week as generalized-tonic seizures lasting one to two minutes. However on (b)(6) 2011, the pt had at least three seizures back to back for at least two hours and had pain in the chest/neck area. She also reported headache during stimulation. She told the staff at the home that vns was continually firing. The magnet reportedly did not stop the vns. The pt was taken to the er in an ambulance which did not have a vns programming system. The pt was given diazepam which stopped the pain and twitching. The pt was transferred via ambulance to another hospital and during that time, she had pain and twitching again, so they stopped at another hospital because her pain was so bad. In the er, she still had pain and also had convulsions that involved both lower extremities. Another vns physician attempted to interrogate her device in the hospital multiple times and was unsuccessful. Dr. (b)(6) stated that indicated that the battery was depleted, as it is unusual for pt to be in so much pain if battery is depleted. The notes stated that a lead fracture is possible, so x-rays would be obtained and will get a ct to rule our brain abnormalities. Although the possibility of a lead fracture was mentioned in the notes, the pt's lead were not replaced. F/u revealed that there were no programming or medication changes that preceded this onset and there was also no trauma prior to the painful and erratic stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2427383


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:09:12 AM
Model Number 302-30
Device Problems Fracture; No Known Device Problem
Event Date 04/10/2017
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing painful stimulation when the settings are increased. The physician suspected a lead fracture and planned to refer the patient for a full revision surgery as the generator was at near end of service. It was noted from a previous office visit in 2017 that in 2007, the patient had a fall that resulted in pain in the left chest area, which led to the physician turning off the patient's device. The device was turned back on in 2017 to settings that the patient could tolerate. Systems and normal diagnostics were performed, indicating no device malfunction or anomalies. The physician still suspected a lead fracture, though it was unclear why. No surgery has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7490146


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:09:46 AM
Model Number ASKU
Event Date 01/01/2009
Event Type  Death   
Manufacturer Narrative

Event Description
A manuscript titled "efficacy of vagus nerve stimulation in intractable epilepsy patients in cyprus" was received by the manufacturer for review. The article discusses efficacy of vns over time, which was analyzed in 27 patients. Two patients died of sudden unexpected death in epilepsy (sudep). Date of death unknown and relationship to vns is unknown. The report of the other patient who died of sudden unexpected death in epilepsy (sudep) is captured in mfg report number: 1644487-2013-00104. Attempts for additional information have been unsuccessful to date. The report of one patient who developed an infection is captured in mfg report number: 1644487-2013-00102. The report of one patient who had vns explanted due to dysphagia associated with vns stimulation is captured in mfg report number: 1644487-2013-00103. The report of one focal patient who had worsening of seizures is reported in mfg report number: 1644487-2013-00101. The vns explant due to painful stimulation in the neck is captured in mfg report number: 1644487-2013-00100.
 
Manufacturer Narrative
Corrected data: the previously submitted mdr inadvertently provided an incorrect event date.
 
Event Description
The article titled " sudden unexpected death in epilepsy: experience from a tertiary epilepsy center in cyprus with review of the literature" was received by the manufacturer and reviewed. The patient died on the beach during the day.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2903591


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:10:28 AM
Model Number 105
Device Problem Device inoperable
Event Date 10/20/2015
Event Type  Malfunction   
Event Description
Additional information was received that the patient is able to inhibit stimulation by holding the magnet over the generator. Proper magnet swiping technique was verified and the magnet was not deep in the tissue or tilted. Troubleshooting revealed that the patient swiped her magnet and did feel stimulation, and the magnet swipe was registered upon interrogation. Information was received that the magnet is not often useful in aborting the patient's seizures because the patient normally cannot swipe the magnet in time, not suspected to be caused by a generator issue. It was reported that there are no longer any suspected issues with the patient's generator. No additional relevant information has been received to date.
 
Event Description
It was reported that vns was never efficacious per the mother. Per the mother, the seizures have never changed post-implant. No surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. It was reported by the patient's mother that they want the vns explanted due to painful stimulation in the neck, breathing difficulties with device stimulation during exertion. The mother reported that since the patient has had difficulty tolerating stimulation and they had not noticed any efficacy the device was disabled for three months. The device was then programmed back on to a very low setting. The stimulation is now tolerable. The mother reported that recently the patient has experienced a change in seizure type and has also had a transient ischemic attack which has contributed to her current state. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative
Corrected data: this information was inadvertently left off of supplemental mfr. Report #01. Corrected data: "it was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. " this information was inadvertently left off of supplemental mfr. Report #01.
 
Event Description
Follow-up with the surgeon's office revealed that the mother called their office in (b)(6) 2016 and wanted the patient to get a head mri due to increased headaches (with no allegation against vns). However, they had not seen the patient since 2014. The mother had mentioned wanting a mri and vns explant to the last treating physician's office. No surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient's vns magnet mode is not thought to be functioning. It was reported that the patient cannot feel magnet activations and the magnet swipes are (b)(6) 2015 and one on (b)(6) 2015. The patient also experienced a cluster of seizures on (b)(6) 2015 that the magnet was not able to abort. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5216170


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:11:11 AM
Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was experiencing painful stimulation in the neck area. It was reported that the painful stimulation had been occurring for approximately 3-4 months. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. No patient manipulation or trauma occurred that is believed to have caused or contributed to the painful stimulation. Clinic notes dated 06/03/2013 note that the patient has complained that the area that the device is implanted is sore and hurts, particularly at night. The notes indicate that device settings were decreased to see if the settings had any effect on the discomfort. It was later reported that the patient was scheduled to undergo device replacement at the patient's mother's request so that the patient could continue vns therapy. Both the lead and generator were replaced. The lead and generator were returned to device manufacturer for analysis on (b)(4) 2013. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Event Description
Lead analysis was approved on 08/22/2013. An analysis was performed on the returned lead portion. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Generator analysis was also performed. The septa do not appear to be cored and there was no evidence of dried body fluid or corrosion observed in the connector block areas, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Review of the programming history database revealed data from the date of implant through (b)(6) 2013. The last programmed settings were available. The device was returned at these settings.
 
Manufacturer Narrative
Analysis of programming history. Device failure occurred but did not cause or contribute to a death adverse event or product problem, corrected data: previously submitted indicated an adverse event; however, additional information is available that a product problem also occurred. This report is being submitted to correct this information. Type of reportable event, corrected data: previously submitted indicated an adverse event; however, additional information is available that a product problem also occurred. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3271718


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:11:46 AM
Event Date 01/01/1999
Event Type  Malfunction   
Manufacturer Narrative
Article citation: (b)(4).
 
Event Description
During manufacturer review of the published article (b)(4), it was identified that a patient had a vns generator that was still stimulating with magnet activation after the magnet mode had been disabled. The patient also had painful stimulation with the vns, along with severe painful dysesthesia in the left mandibular and cervical region. Replacement of the vns generator resolved the events. The time of the event is unknown, as the article was a retrospective review from 1999 through 2008. Attempts to the author for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2360570


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:12:24 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 05/13/2015
Event Type  Injury   
Event Description
High lead impedance was observed during a system diagnostic test during an outpatient visit. The patient underwent lead and generator replacement surgery several months later to resolve the high impedance. The explanted lead and generator were returned to the manufacturer for analysis. Information received indicated that the physician contacted the distributor for an emergency revision surgery because the patient was complaining of painful stimulation in the neck. The physician then performed diagnostics and saw the high impedance warning. The physician suspected a lead fracture based on x-ray images. The cause of the fracture was believed to be due to generator twiddling by the patient. Further information received indicates that the patient could recognize the auras associated with his seizures and would try to stop the seizures using the magnet on his own; he sometimes groped the location of the generator, strongly grabbing it and moving it. The treating physician believes the patient's manipulation of the device is the cause of the suspected lead fracture. A photo of the explanted lead and generator showed clear evidence of patient manipulation of the implanted device. Analysis of the returned generator revealed no anomalies with the performance of the generator. The generator performed according to functional specifications. Analysis of the returned lead revealed no anomalies. A portion of the lead assembly, including the electrodes, was not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, and no discontinuities were identified. The bilumen tubing appeared to be wavy in some areas and was returned in a coiled or twisted manner. An abstract from a research article comprised of post-market surveillance data from a hospital¿s vns patients implanted between december 2010 and march 2016 was received several years after the event occurred. The abstract indicated that four patients experienced recurrent vocal cord paralysis. The abstract also indicated that one patient experienced subsequent aspiration pneumonia. Three patients underwent explant due to surgical site infections, and one patient underwent explant due to a patient-influenced revolving of the generator which eventually resulted in lead fracture. The recurrent vocal cord paralysis is reported within mfr. Report # 1644487-2018-00123. A company representative received identifying patient information from the authoring physicians of the article for the patients who experienced surgical-site infections and generator migration and subsequent lead fracture, originally captured in mfr. Report #1644487-2018-00122. It was determined that the infections were previously reported to the manufacturer and are captured in mfr. Report #s 1644487-2013-02562, 1644487-2013-03225, and 1644487-2015-06368. The reported patient-influenced migration and subsequent lead fracture is captured within this report, mfr. Report # 1644487-2018-00289. Per the abstract, the patient revolved the generator underneath the skin, causing the lead fracture and necessitated vns explant. No additional relevant information has been received to date.
 
Manufacturer Narrative
Uchida, d & yamamoto, t. (2017). Experience and solution of complications of vagus nerve stimulation therapy in 139 implant patients. No shinkei geka, 45(12):1051-1057. Doi: 10. 11477/mf. 1436203646.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7298219


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:13:09 AM
Model Number 302-20
Event Date 03/28/2013
Event Type  Malfunction   
Event Description
On (b)(4) 2013 it was reported that the vns patient was seen on (b)(6) 2013 and low impedance was observed. It was unknown specifically what diagnostic test was run, or what the full results were of the diagnostics tests. The reporter did say that the patient recently started complaining of discomfort with stimulation, and twitching of the muscles in her neck with stimulation. The reporter stated that according to her notes, the patient was seen on (b)(6) 2012 and the parameter settings were increased at that time, and then about a month or two after, the patient reported this discomfort and neck spasms. The patient was then seen on (b)(6) 2013, but they did not change any settings because the patient was tolerating these issues, even though it was still bugging her. No diagnostic testing was performed at that time. The reporter stated that at the most recent appointment on (b)(6) 2013, the patient asked for the settings to be lowered because of the discomfort and neck spasms, so the physician lowered the output current from 2. 25ma to 1. 75ma. The physician then ran diagnostics which is when low impedance was observed. The manufacturing records for the lead were reviewed and the device met all specifications prior to distribution. A battery life calculation was performed which showed 3. 02 years remaining until eri=yes. The physician later reported that x-rays were performed but they have not been sent to the manufacturer to date. The patient reported that the muscle twitching began after the patient's mammogram in (b)(6) 2013. The physician noted that the output was disabled due to the low impedance. No further information was provided by the physician.
 
Event Description
On (b)(4) 2014 product analysis was completed on the explanted generator. The generator performed according to functional specifications; there were no anomalies found with the pulse generator. Product analysis on the lead was completed on (b)(4) 2014. Abraded openings were noted on the outer and the inner silicone tubing. A single broken strand was noted on the positive coil. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
On (b)(6) 2013, the patient reported that when she had a mammogram , they broke the vns wire and afterwards the device read low impedance. Surgery, although likely, still has not yet occurred.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
On (b)(6) 2013 it was reported that about a month ago, low impedance was observed. The device was turned off on (b)(6) 2013 due to the low impedance. X-rays had been performed and the radiologist was not able to see anything of significance. The patient explained that she had a mammogram performed within a week or two of the time that the device stopped working and was very specific with the technician about her implant. The patient believes that the mammogram may have been related to this low impedance condition. She explained that after the mammogram, she began to experience painful stimulation and felt that the muscles in her neck were ¿retracting. ¿ she also mentioned that she was feeling pain at her breast site like the area was being ¿pinched. ¿ a copy of the patient¿s x-rays were received for review. Whether the lead pin was fully inserted into the header of the generator could not be assessed based on the angle of the generator in the images. There was a portion of the lead located behind the generator that could not be assessed. There did not appear to be any lead discontinuities in the portion of the lead that could be visualized. There appeared to be a proper strain relief bend but there did not appear to be a strain relief loop. Based on the x-ray images provided, an exact cause for the reported events could not be determined. However, the lead pin could not be confirmed to be fully inserted and a portion of the lead could not be visualized in the chest due to it being behind the generator. Also, the presence of a micro-fracture in the lead cannot be ruled out. The patient stated that she had a mammogram on (b)(6) 2013 and that on (b)(6) 2013 the vns read low impedance. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted generator and lead have not been returned to the manufacturer to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3073476


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:13:56 AM
Model Number 304-20
Event Date 06/01/2012
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did show a breech in outer tubing and fluid in inner and outer tubing. The fluid in the inner tubing is likely explant related. Unknown cause of breech in outer tubing.
 
Event Description
A site reported to our consultant that their was a vns patient who was seen about two months ago regarding pain in the neck during stimulation. The event started at the beginning of (b)(6). Their vns was programmed off (b)(6) 2012. The patient was seen (b)(6) 2012 and they tried to turn the patient on again to 0. 25ma however her eyes were watering and the muscles on the left side of the neck and face were twitching. Diagnostics were then performed with all okay results an impedance value of 3500 ohms, and no indication of approaching eos. The was no report of any trauma reported by the patient that could be associated to the onset of the painful stimulation. There were also no other programming changes noted around that time. Their device was turned off the alleviate these events. Turning the device off resolved events. No medical history of this pre-vns. Although the impedance value was within the accepted limits, the md suspects a lead issue and has ordered xrays. It is unknown if the xrays will be sent to the manufacture for review. The md has decided to refer the patient for a complete revision. The patient seizures are back to baseline. The patient was having 2-3 seizures a week pre-vns but after vns was only having 2-3 a month. Since the pain began, the patient has returned to baseline at 2-3 a week. Their md believes their increase in seizures to baseline is due to the device not working properly and now because vns is programmed off. Surgery is scheduled for (b)(6) 2012.
 
Event Description
Additional information was received that the patient had full revision surgery. Our consultant was at the surgery. A breech in the outer insulation was noted near the generator in the chest pocket. Fluid was seen inside the tubing. The tubing was reported cracked and the internal wire was visable. System diagnostic testing in the or showed 3785 ohms. A section of the lead assembly was returned for analysis in one piece. The lead's electrodes were not returned for evaluation. Two tie-downs were returned with the lead. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. Also, the outer silicone tubing has what appear to be internal abrasions at multiple locations. The outer silicone tubing appears to have been compressed at multiple locations. Abrasions most likely caused by the presence of tie-downs were identified at approximately 32. 5cm and 33. 1cm from boot. An incision was identified on the outer silicone tubing at approximately 31. 9cm from boot resulting in an opening in the outer silicone tubing. No obvious damage to the inner tubing or the lead coils was identified at this location. The outer silicone tubing has a superficial cut at approximately 31. 6cm and 32. 2cm from boot. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. This is possibly explant related but not confirmed. No discontinuities were identified within the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other that typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2739576


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:14:32 AM
Model Number 302-20
Event Date 11/18/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the patient would have a vns replacement due to high impedance. Follow up found that replacement surgery was for patient comfort and they were not concerned with it resulting in a serious injury. Previously, the patient reported experiencing pain with stimulation which was felt at the neck and travelled up to the left ear. It was confirmed at the time that no trauma, manipulation, programming changes, or medication changes had occurred recently. The patient's settings were originally at 2. 5ma and 2. 75ma for normal and magnet output current respectively. The output currents were reducted to 0. 25ma and 0. 5 ma respectively. Diagnostics taken on this day, (b)(6) 2013, were all ok. X-rays were sent to the manufacturer for review. The generator was seen in the left chest area in normal orientation. The filter feedthru wires were intact and the lead pin could be seen past the second connector block indicating that it is fully inserted into the generator. A portion of the lead appears to be present behind the generator. The lead could not be assessed at the connector pin due to the x-ray image quality. The electrodes were observed in the neck and appear to be in proper alignment. A strain relief bend was present; however, no strain relief loop appeared to be present. There was one tie-down present. Lead is seen routing down toward the generator. No other information has been provided. Surgery is likely, but has not occurred to date. Received a phone call on (b)(6) 2013 from tc (b)(6) who stated that patient (b)(6) is experiencing painful stimulation which is felt at the neck and travels up to the left ear. He stated that he met with the patient yesterday, and the patient confirmed this has been occurring since monday ((b)(6) 2013). It had been confirmed that no trauma/manipulation/programming changes/medication changes had occurred recently. The patient¿s settings were originally 2. 5ma for output current and 2. 75ma for magnet output current, and the settings were decreased all the way down and the event was still occurring at 0. 25ma/0. 5ma. The physician decided to turn the device off and order x-rays. Diagnostics were all ok per tc. I stated that since diagnostics are ok x-rays are typically not recommended since the system appears to be fully intact. Tc insisted that the x-rays may show something and stated that he will be sending these x-rays to cts for review. He stated that he specifically wants these x-rays to be reviewed for a hairline fracture or fluid in the lead. I stated that this is very detailed and that it all depends on the images that are received. Tc inquired about other recommendations for this situation. I stated that it may be helpful to evaluate the patient after it has been disabled and for the physician to observe the patient after turning it back on. I inquired what the physician¿s assessment of this is and he stated the physician does not know. Tc stated they might undergo a full revision if nothing is found to help. I stated that this would be a medical decision which is up to the physician. No further information was discussed.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3562083


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:15:14 AM
Model Number 103
Event Date 06/01/2014
Event Type  Injury   
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the age incorrectly.
 
Event Description
Generator replacement surgery occurred on (b)(6) 2015. The reason for replacement was reported to be due to migration of the generator and painful stimulation, per the implant card. It was reported that the system impedance on the date of surgery was okay, suggesting no device failure. The product was discarded by the surgical facility and cannot be retrieved.
 
Manufacturer Narrative

Event Description
Clinic notes were received dated 11/05/2014 that indicate the patient has ¿¿noted the vns wires to be coiled¿ and that the vns is kind of loose since she has lost so much weight. It was reported that it hurts when she touches it. Good faith attempts for further information from the physician have been unsuccessful. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. The patient stated she had a 3 hour mri in (b)(6) of 2014 due to pancreatitis and that her vns generator came loose from the chest wall during this procedure. The generator was noted to move around, causing her pain. When she lifts her arm, the generator migrates into her arm pit.
 
Manufacturer Narrative
Brand name, corrected data: this information was not identified initially, but was later identified from internal records. The information is correction material as it was available at the time of the initial report, but was not identified at that time. Model#, serial#, lot#, expiration date, corrected data: this information was not identified initially, but was later identified from internal records. The information is correction material as it was available at the time of the initial report, but was not identified at that time. Device manufacture date, corrected data: this information was not identified initially, but was later identified from internal records. The information is correction material as it was available at the time of the initial report, but was not identified at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4559707


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:15:51 AM
Model Number 302-20
Event Date 04/25/2012
Event Type  Malfunction   
Event Description
It was reported through clinic notes received on (b)(6) 2012 that the patient had high impedance upon interrogation of her vns device on (b)(6) 2012. It was noted that the patient was last seen on (b)(6) 2012. The patient had been experiencing pain and soreness over the chest during stimulation which started on (b)(6) 2012 when the patient went to the er because she was experiencing burning in the neck. On (b)(6) 2012 it was stated that the patient had a fall approximately 1 week prior and the physician was uncertain if it was related to the patient's pain. At that time the patient described "mouth vibrations", chest pain near the generator radiating to her teeth head and arm with electrical qualities. Per the physician, an x-ray at that time did not show any gross lead fractures. On (b)(6) 2012 the pain was said to radiate to ear when the device stimulates and it was stated that the patient had discomfort when lifting her left arm. When the device was disabled the discomfort was gone. It was also indicated that the magnet had become more painful recently. Additionally it was noted that the patient had been experiencing an increase in seizure frequency. It was indicated that the patient usually experiencing 4-5 seizures per month when sleepy, however she had started experiencing 2-3 per month during the day as well as an increase in staring spells. The patient was referred for and underwent a full revision on (b)(6) 2012. A review of available programming history for the patient's generator was performed and diagnostic results in (b)(6) 2012 were within normal limits. Attempts for additional information and product return are in progress.
 
Event Description
Additional information was received which indicated that the voice alteration was occurring with stimulation, there were no change in medication, and the increased impedance was seen on the vns device diagnostics, but there were no visible lead fractures in x-rays. There was no patient manipulation or trauma that might have caused the lead impedance. After the full revision the patient's seizures are now gone. The patient's settings on (b)(6) 2013 are output current= 0. 25 ma/ frequency= 15 hz/ pulse width= 130 usec/on time= 30 sec/off time= 3 min / magnet output current= 0. 5 ma/ on time= 60 sec/ pulse width= 250 usec. The device history report for the 302-20 sn (b)(4) was reviewed. No unresolved non conformances were found.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
An implant card was received on (b)(6) 2013 indicating that the reason for the replacement was due to an adverse event. The impedance from the date of surgery was not provided. Per the hospital's policy the hospital will not return explanted devices without a signed consent form and the patient, however the physician's will not ask for the signed release; therefore the product will not be returned. Attempts for additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2897410


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:16:28 AM
Model Number 102
Event Date 09/15/2014
Event Type  Injury   
Event Description
Additional information was received that product analysis was completed on the lead. A coil break was identified in both the positive and negative lead coils. Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) occurred at the coil ends. Secondary fractures were observed in at least two strands of the quadfilar coils. The negative coil shows what appears to be wear (flat surfaces) resulting in reduction of the strand diameter. Although not conclusive the appearance of the lead break location is consistent with patient manipulation of the implanted device, a ¿twiddler¿. The patient had reported painful stimulation for months and the identified coil breaks may confirm this to be a contributing factor. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead. The report issue found with the lead was reported on medwatch 1644487-2014-02836.
 
Event Description
Additional clinic notes dated (b)(6) 2014 were received stating that the patient experienced wound dehiscence following the explant surgery on (b)(6) 2014. Patient's stitches were taken out and replaced with steri-strips. The patient's chest incision was reported to be open with yellow drainage from it. Patient was provided with antibiotics and was noted to be seeing the surgeon in a few days.
 
Event Description
It was initially reported that the patient had their vns explanted. After the explant, the patient picked at the incision and opened the pocket. There was nothing implanted in the patient at that time of the incision being picked open.
 
Manufacturer Narrative
Evaluation not related to event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4147147


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:17:05 AM
Model Number 302-20
Event Date 04/18/2011
Event Type  Malfunction   
Event Description
It was reported that a physician received high impedance on a patient's device after performing an unknown diagnostic test on (b)(6) 2011. The patient had been having break through seizures for 2 weeks whose pre-vns baseline comparison was unknown. Furthermore, the patient was having erratic stimulation in the neck area. The device was not disabled, and there had been no trauma or manipulation reported. Last known diagnostics were performed on (b)(6) 2009 and results were within normal limits. The patient's clinical information was received. On (b)(6) 2011, the doctor noted, "since last visit, she was doing extremely well until about three weeks ago. She also notes that her vns has been irregularly going off and at times can be painful. 1. 25 ma, 20 hz, 250 microsec, 30 secs, 60 secs, and 1. 25 ma, 30 secs, and 500 microsecs" and also "she had a recent, what sounds as of a recent breakthrough seizures that i suspect may have been secondary to either tramadol use, change in diet, or perhaps vagal nerve stimulator malfunction. Her vns showed a limited output status and a lead impedance was very high with a dcdc converter code of seven. " follow-up from the physician indicated that x-rays had not been taken of the patient and the patient "was seizure free, now had a seizure. " the patient subsequently underwent a full revision surgery. Attempts for further information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2118888


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:17:49 AM
Model Number 105
Device Problems Energy output to patient tissue incorrect; Inappropriate shock; Device displays error message
Event Date 06/12/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was having a lot of trouble with the battery. The patient reported that she was seen by the physician two weeks prior at which time the generator battery showed as "dead". The patient also reported that the physician lowered the device settings. The patient reported that she feels that she is being electrocuted constantly which began approximately a week and a half prior. The patient placed the magnet over the generator to disable stimulation; however, reported that she was still able to feel stimulation. The patient's neurologist wants to replace the generator due to the patient complaining of erratic stimulation. The patient was seen by the surgeon and it was reported that device diagnostics were within normal limits and the device was not at end of service. It was reported that the pain is limited to the patient's chest. The patient's generator was programmed off which did not resolve the patient's pain. The patient indicated that when she presses on the lead at the generator site the patient resolves. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the cause of the electrocution sensation is unknown since the event occurs without device stimulation. It was reported that the patient was scheduled for vns replacement. It was reported that the patient feels the shocking when she presses on the lead and this resolves the pain. Clinic notes dated (b)(6) 2015 note that the patient is having problems with the vns shocking her non-stop. Clinic notes dated (b)(6) 2105 note that the vns is still shocking the patient on the lowest setting. It was noted that the plan is to move the generator to the left scapular area. Surgery is planned, but has not occurred to date.
 
Event Description
The surgeon reported that the patient picked through the skin to access the lead and cut the lead. It was reported that the surgeon will not likely see the patient again.
 
Event Description
It was reported that the patient was scheduled for surgery, but later reported that the surgery had been cancelled and postponed until further notice due to the drug abuse by the patient. Clinic notes dated (b)(6) 2015 note that the patient was see in the emergency department and when no neurologists were available the patient cut the protruding lead wire out herself. The patient noted since first noticing the wire she was being shocked 24/7. It was reported that due to the patient's non-compliance the surgeon will no longer see the patient. The patient will need to be seen by another surgeon. The patient continues to complain of painful stimulation. Clinic notes dated (b)(6) 2016 note that the physician called the patient to explain why he was uncomfortable redoing the vns. The patient had positive drug screens within a week and failed to have a third done a month later. The patient dug into the electrodes under her chest wall skin, pulled the electrode out and cut it off. The patient continued to complain of shocking in the neck and the left side of her chest, even when the generator was programmed off. The surgeon indicated that he does not feel she will be happy after replacing the unit and electrodes, even if the generator is relocated to her suprascapular area where she can no longer dig at the electrodes.
 
Event Description
The patient was scheduled for surgery; however, was unable to undergo surgery due to testing positive for meth and marijuana during pre-operative testing and anesthesia cannot be done. It was reported that is it unknown whether or not the surgeon will reschedule the surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949640


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:19:19 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2016
Event Type  Injury   
Event Description
Patient reported to her that she is having extreme pain in the neck with stimulation that causes her to "tear-up" in pain. Due to the pain, the patient wants the vns explanted. Follow-up by the tc revealed that the patient was seen and the output current was turned down to previous settings and the discomfort was resolved. System diagnostics were performed and were within normal parameters. Patient again reported pain and is undergoing explant due to pain and need for mri. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8140664


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:19:57 AM
Model Number 103
Event Date 08/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, the patient reported that she was experiencing a change in seizure pattern in which she was having new seizure types and nocturnal seizures. It is unknown what the relationship of the change in seizure pattern is to vns therapy. In addition, it was reported that the patient went to the hospital the month prior due to concern about her neck bulging with stimulation. The emergency room physician ordered a ct scan of the neck. Per the patient, the emergency room physician stated that it appears the lead is 'on the main vein. ' the patient was instructed to temporarily stop stimulation using the magnet and see the primary vns physician with ct scan results. Per the patient, the vns physician disabled the device and stated that he thought the device was on high settings. The physician recommended the patient follow up with her surgeon; however, the patient does not have the resources to do so at this time. In addition, the patient has also reported experiencing a pain in the neck area, extreme voice hoarseness with stimulation, painful stimulation, difficulty breathing with stimulation, and loss of gross mobility with much of stimulation. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2887104


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:20:38 AM
Model Number 103
Event Date 09/22/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing pain in the neck believed to be due to the implant procedure. The patient wanted to have stimulation enabled one week after surgery against manufacturer recommendations. The patient experienced painful stimulation at the vns generator site that radiates up to the left ear. This pain had been improving with the use of several medications including lidocaine injections, fentanyl patches and neurontin until the patient had a seizure and now the pain has worsened. The surgeon is considering using botox to alleviate the pain. The patient was then reported as having been hospitalized after having 4 seizures, but the neurologist attributes these to a change in medication. Patient's seizures were doing well with vns therapy prior to the medication change. It was also noted that the lead in the patient's neck was "vibrating" with stimulation. A nurse at the hospital had informed the physician that the generator could be seen vibrating inside the chest wall as well. The "vibration" is likely referring to muscle spasm, but no other information is known at this time. The neurologist also reported that while hospitalized, the patient experienced ventricular tachycardia. At this time, the physician attributes the arrhythmia to vns. The patient does not have a history of any heart conditions. Additional information received indicates that the patient is no longer hospitalized and is continuing vns therapy. No interventions are planned at this time. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936628


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:21:11 AM
Model Number 302-20
Event Date 06/23/2010
Event Type  Injury   
Event Description
The pt recently had surgery for routine generator replacement, and during surgery, the surgeon cut the lead in error and therefore had to implant a new lead as well. The surgeon uses a single incision implant technique. The pt was seen by the neurologist for the first follow up appointment since surgery, and when the device was programmed on to "the lowest setting", the pt experienced intolerable coughing and painful stimulation in the neck and was not able to tolerate any stimulation. The surgeon was notified of the events, and it was noted by the surgeon that it is possible that based on these side effects, that the lead may be implanted on the wrong structure, possibly the phrenic nerve, rather than the vagus nerve. The pt is scheduled for surgery to have the lead replaced by a new surgeon, which is scheduled to occur on (b)(6)2010. Per the neurologist, diagnostic testing was performed which revealed normal device function; however, the specific results were not provided. In addition,the neurologist noted the device has been programmed off at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1801204



Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:21:53 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 04/14/2018
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency room due to feeling constant pain at her generator site for an hour, which she believed to be continuous stimulation from the device, and she was also experiencing constant tingling in her arm. The physician stated that there were no reported traumatic events prior to the constant pain. The physician was educated on how to use the magnet to disable the device until it could be communicated with. It was reported later in the same day that the patient was feeling painful stimulation every 5-7 minutes. The patient had reportedly seen her neurologist and described her pain, but nothing was changed and the pain got worse so the patient went to the emergency room. The hospital staff called the next day to report that the patient was still having continuous stimulation, but they had not been using the magnet to disable the device as instructed. A company representative was able to communicate with the patient's device, and system diagnostics were within normal limits. The patient stated that she felt the stimulation when diagnostics were performed. The neurologist had come in the night before and programmed the device off. Since the device was programmed off. The painful stimulation resolved immediately after the device being programmed off. The patient had generator replacement surgery. The device has not been received to date. No further relevant information has been received to date.
 
Event Description
The generator was received. Analysis has not been approved to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7504920


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:22:30 AM
Model Number 102
Event Date 01/01/2007
Event Type  Injury   
Event Description
It was reported by the mother of the vns pt that the pt began experiencing sleep apnea, ambulation difficulties, painful stimulation in the chest, dizziness, flushing in the face, dyspepsia, and increase in seizures above baseline about 3-4 years ago but was unsure of their relationship to vns. Attempts to further info from the pt's physician have been unsuccessful to date. No device failure is suspected. It has been noted that surgery to replace the pt's generator prophylactically is possible.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2052676


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:23:07 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 01/18/2018
Event Type  Injury   
Event Description
It was reported that a patient was experiencing a painful and localized, shocking sensation around her clavicle when device diagnostics are performed. The patient did not have painful stimulation at normal mode or magnet mode stimulation. At a subsequent office visit, the patient experienced the same painful stimulation during diagnostics. The company representative indicated that when diagnostics were run at 2ma, the patient felt the painful shock and immediately threw down the programming wand in response. When the device was temporarily disabled and the diagnostics were run at 1ma, the patient did not feel pain. The patient felt pain again when settings were turned back up to 2ma. Diagnostics run at 1ma indicated that the device was functioning within normal limits. X-rays were reviewed indicating no obvious causes for the painful stimulation during diagnostics. The connector pin appeared to be fully inserted and no obvious fractures or sharp angles were noted in the leads, though the presence of microfractures could not be ruled out. Programming data was also reviewed, and based on the data available, there were no noted malfunctions or anomalies. Multiple faulted diagnostics were noted, but were expected as the patient had reported throwing the programming wand in reaction to painful stimulation, likely breaking off communication near the end of the diagnostics. The current delivered at each diagnostic was also reviewed and were found to match expected values, indicating no malfunctions in how the diagnostics were run. No apparent differences were noted in comparing the diagnostics run at higher and lower settings either. The neurologist had conducted an emu and only found non-epileptic events which he believed unrelated to vns. It was indicated that the patient did not have any body architecture changes, such as weight change or trauma to the device area. The patient scheduled for surgery to replace the device. No surgery has occurred to date. No additional relevant information was received to date.
 
Event Description
The patient's device was replaced. During the surgery, the surgeon examined the lead throughout the chest pocket and resected scar tissue to have a better visual, and did not find any abnormalities with the lead. The lead pin was also confirmed to be fully inserted. After replacing the generator, system diagnostics were run with the generator off, indicating the vns was functioning within normal limits. The generator was programmed on to the patient's previous settings per the surgeon's request, and diagnostics were run again, indicating no abnormalities or malfunction. The explanted device was returned for product analysis. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7413161


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:24:14 AM
Model Number 302-20
Event Date 01/19/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.
 
Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.
 
Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.
 
Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.
 
Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.
 
Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:25:04 AM
Model Number 302-20
Event Date 05/07/2010
Event Type  Malfunction   
Event Description
On (b)(4) 2013 it was reported that the vns patient was continuing to have issues with shortness of breath, choking, twitching, and painful stimulation. It was reported that it was "surges felt periodically from chest area up to neck causing severe coughing episodes and pain". It was also reported that the patient's seizures are doing worse and the patient is doing poorly. The reporter stated that these issues are not constant but randomly occur sometimes with stimulation. It was stated that they have discussed this with the physician but he cannot find anything wrong with the device but that they know something is not right with the device and described "it's like there's a short in the lead". The reporter indicated that they hope the patient will get referred for replacement. It was stated that the physician has tried to make adjustments to the settings, but the patient's events have not improved or resolved. The physician later reported no causal or contributory programming or medication changes precede the onset of the adverse events. The physician stated that the patient may have a broken lead or abnormal settings. The increase in seizures were back to pre-vns baseline levels. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures. Clinic notes were received dated (b)(6)2012 which indicate that the patient has been experiencing an increase in seizure activity and increased number of flurries during the day. It was stated that the patient is not swiping the vns magnet 3x/day. Previously it had been reported on (b)(6) 2012 that the vns patient is experiencing shortness of breath, occasional spasms in the neck with pain, and the patient believes stimulation is going off when it shouldn't. The patient stated that the events all began with the last battery replacement in 2010. System diagnostics performed on (b)(6) 2012 show the device to be functioning properly with output=ok/lead impedance=ok/dcdc=2/eri=no. The patient further clarified that "when it sporadically goes off, i fell like it's a magnet swipe". The physician believes the events are due to vns stimulation. The physician lowered the patient's pulse width and the patient was scheduled for follow-up the following day to see if any of the symptoms resolved. Further follow-up after the patient's appointment revealed that the physician is just going to give it time to see if the events resolve. The patient stated that the events are sporadic. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2013 when product analysis was completed on the explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications; there were no anomalies found with the pulse generator.
 
Event Description
On (b)(4) 2013, it was reported that the vns patient underwent generator replacement that day. The explanted generator was received for product analysis on (b)(4) 2013. It was stated that the patient had some issues with vns, that the vns wasn¿t quite working very well prior to surgery. Product analysis is underway on the generator and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3028963


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:25:42 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 10/30/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported in mfr. Report #1644487-2018-00463 that the patient was experiencing pain at her chest, but the cause was unknown. The patient had full revision surgery, and it was identified that the generator was not secured to the fascia, which allowed for the device to migration. This information provides evidence that the pain/painful stimulation at the generator site may have been related to the migration. The physician believed that the generator was never secured by the implanting surgeon. The facility discards explanted product, so no evaluation could be performed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7537555



Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:26:14 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 06/01/2016
Event Type  Injury   
Event Description
It was reported that the system diagnostics taken prior to the replacement surgery were within normal limits. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient experienced an increase in seizures. The treating physician increased the parameters at that time; however, the patient experienced painful stimulation and coughing at the higher settings. The physician decreased the settings in response to the side effects, but the patient had an increase in seizures again. It was decided to replace the entire vns system. The full replacement was completed, and the battery of the explanted generator was reportedly not depleted. The explanted products were discarded following surgery and are not expected to return to the manufacturer. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252762


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:26:48 AM
Model Number 302-20
Event Date 01/01/2009
Event Type  Injury   
Event Description
It was initially reported that the patient was experiencing painful muscle spasms during stimulation in the upper limb. Recent diagnostics performed indicate that diagnostics were within normal limits. The patient was also said to not have had efficacy with the therapy. The site believes that there is a malfunction of the device, and it is expected that the patient will have her system replaced. It was later noted that high impedance was observed, but no diagnostics performed were provided in relation to normal mode diagnostics performed when initially report on patient painful stimulation and muscle spasms. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1513594



Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:27:28 AM
Model Number 302-20
Event Date 01/01/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
A vns patient implanted for depression had their device disabled reported by the patient's wife related to painful stimulation and then turned back on at low dose. The patient's vns treating physician reported that they did not have painful stimulation, but that had a history of anxiety and the stimulation would cause the patient to have more anxiety about it, preceding the stimulation about to go off. The patient's device was eventually completely disabled as they did not have a vns following physician to program it. The patient had their vns system explanted as they needed to have an mri performed and no longer needed the therapy. Diagnostics were reported to be within normal limits at the time of their device being disabled. Additional information was attained that the patient had vocal cord paralysis. No further information has been received about that at this time. Their explanted products were returned for analysis. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The lead assembly was returned for analysis note that since a significant portion of the lead (including the electrode array portion) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2783635



Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:28:00 AM
Model Number 103
Event Date 09/01/2011
Event Type  Injury   
Event Description
It was reported that the patient had a drop attack approximately two months prior to the report after being seizure free for some time. Since the drop attack, the patient has experienced a notable increase in seizures and has been hospitalized three times in the month prior to the report. The patient stated she was experiencing painful stimulation occasionally during stimulation on times, particularly when the patient turns her neck. Since the first drop attack, the patient also began to experience nausea, vomiting, and headaches. Systems and normal mode diagnostics tests show normal device function. The patient was referred for prophylactic generator replacement and surgery has occurred. Follow-up with the physician by a manufacturer representative found that the patient has not had any further adverse events since generator replacement. The patient was reported as "doing very well. " attempts for additional information and the return of the explanted generator have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2355170


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:28:50 AM
Model Number 103
Event Date 07/04/2011
Event Type  Malfunction   
Event Description
Further information reveals the patient has a consult for the painful stimulation issue and a decision will be made on how to proceed. Attempts for further information have been unsuccessful to date.
 
Event Description
Decoder spreadsheet analysis was performed for the patient's vns programming history. A review of patient programming data revealed that on (b)(6) 2011 the initial interrogation of the device resulted in a measured battery voltage of 2. 849v, indicating that a 25% battery status indicator was displayed to the user during this interrogation (e. G. 25% remaining is displayed at measured voltages of 2. 85v with demipulse generators). All subsequent communication operations resulted in a measured voltage of 2. 68v at the same programmed settings, based on charge accumulation this would have resulted in the expected 100% status indicator. Based on this data, it is possible that battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life. The manufacturer addressed this issue with demipulse generators by adding a 0. 5v offset to measured battery voltage during the first 7. 5% of battery consumption to mitigate the potential for artificially low voltage measurements during this period. The fact that the voltage measurement of 2. 894v was received at 9. 560% of consumption may indicate that battery impedance for this particular generator was longer than most (e. G. An outlier). Based on all subsequent programming data the device appears to be functioning as intended.
 
Manufacturer Narrative
Analysis of programming history. The battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life.
 
Event Description
Further manufacturer investigation revealed that the root cause of the observed battery voltage behavior has been determined to be the result of either an extended duration of the reduced conductivity (i. E. High battery impedance) experienced by cfx batteries during the beginning of life (bol) or a minute internal short that managed to "burn" itself out resulting in the observed voltage rebound following 10% of discharge (e. G. Consumption). No change to risk has occurred as a result of this investigation, which continues to be "low. " change request numbers (b)(4) were created as a result of this investigation. (b)(4) proposes that the duration of the 0. 5v offset, implemented by the firmware for model 103/104/105/106 generators be extended from 7. 5% to 15% of consumption within 11. X programming software in order to mitigate such events in the future. (b)(4) proposes that this issue be mitigated either through the firmware (as the device is still under development) or through the programming software as well.
 
Event Description
It was reported that the pt started feeling painful stimulation at generator site a few weeks prior. Pt's current setting are 2. 5/30/500/30/5 magnet 30/60/500. Diagnostics were performed and results were within normal limits, 2595 ohms, ifi: no. The green light showing battery consumption was showing half full and the physician does not think this is correct. Based on pt's current settings, the pt's device should last about 4 years and half green light means the battery has 25% to 50% remaining battery life which is not expected. X-rays of the pt's device were taken and reviewed by the mfr. No anomalies were seen on the x-rays. The physician ran diagnostics with pt's head turned different ways. When the head was turned to the right, the pt did not feel painful stimulation, but when the head was turned to the left, the pt felt the painful stimulation. Diagnostics in all positions were ok. The physician lowered the settings and the pain resolved. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245770


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:29:34 AM
Model Number 304-20
Event Date 09/24/2014
Event Type  Injury   
Event Description
On 5/17/16 the physician reported that the patient did have a portion of their vagus nerve removed and then stitched back together again on (b)(6) 2014 during the full revision surgery that day.
 
Event Description
On (b)(6) 2016 the physician indicated that the patient's chocking sensation is from misfiring of the vns. He said that the memory issues are not applicable. All diagnostics were reported to be within normal limits with the last one performed on (b)(6) 2016. The physician turned off the patient's vns and the patient is considering having it removed and probably not replaced. The patient does not have a medical history of these events prior to vns. The only event preceding the onset of the chocking/painful stimulation is replacement of the vns. It was previously reported that the patient underwent a full revision on (b)(6) 2014 due to issue following a mammogram. The patient is still having discomfort in the neck with stimulation, so the physician indicated that he would like contact information for a vns surgeon for another opinion as the previous surgeon stated he would not do another revision for the patient. It was reported that a system diagnostics test had not been performed after the recent complaint of painful stimulation. Additional information was requested from the physician but no further information was received regarding whether diagnostics were performed since the replacement. On (b)(6) 2016 the patient's mother reported that the patient has been experiencing painful stimulation as well as profound breathing issues since the generator revision. The breathing issues are described as a strong choking sensation leading to gasping and can last up to 30 seconds at a time. The patient then reported that this issue typically presents when she turns her head to the left or the right and that it has happened "thousands of times" so she is used to the effects. She also is experiencing memory issues. The patient stated that she is now having an increase in seizures since her device was turned off on (b)(6) 2016. She said that at this time, she wants her system replaced because of the shocking and not wanting to have the stimulation turned back on. The patient noted that the magnet is still programmed on. She then indicated that she never had a problem with the previous system and when it was turned on following replacement, she started to feel shocking that was more over the generator site in the shoulder. The issues were also indicated as not occurring with stimulation on-times but always happened and resolved when the generator was programmed off. The patient said that her phrenic nerve is being stimulated per her neurologist, but it wasn't clear how he determined this. She indicated that when the magnet was swiped the day after it was painful, which is why she doesn't want to turn it back on. The patient stated that there is no room on the nerve because the surgeon removed part of her vagus nerve and stitched it back together, which she was insistent that this occurred as the surgeon told her this. The patient said that the old system was completely removed according to the x-rays. On (b)(6) 2016, a physician reported that the patient was hospitalized due to the increased in seizures. He said the primary reason for disablement was painful stimulation, shocking in her neck that occurred when she turned her head.
 
Manufacturer Narrative

Manufacturer Narrative
Inadvertently reported incorrect age on initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5498371


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:30:26 AM
Model Number 103
Event Date 05/01/2012
Event Type  Injury   
Event Description
The device has been discarded and will therefore not be returned to the manufacturer.
 
Event Description
Follow up with the physician found that the physician did not believe the increased seizure frequency, duration, intensity, painful stimulation, and metallic taste in the mouth prior to gtc seizures were related to vns prior to the patient's revision surgery. It was stated that we were following up because the patient indicated she believed the events were related; however, the physician replied that although he cannot know for sure, he does not suspect the events to be related to vns. Clinic notes were received which indicate the patient's surgery date was (b)(6) 2013. Additional orders were for the nurse to arrange pre-operative pain consultation due to the patient's pain medications. Per (b)(6) 2013 clinic notes, the patient stated that she has been having discomfort at the vns site for the past two weeks, which was described as "shock-like". The patient reported increase in seizures, but continued on her medications. The operative report states that it was found the vns was no longer functioning due to a low battery so it was determined at this point that the patient would benefit from replacement of the device.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 were received which note that since the vns implant, the patient occasionally feels a metallic taste prior to her generalized tonic-clonic seizures that lasts for no more than a few seconds. Recently the patient was admitted to an epilepsy monitoring unit for evaluation given her frequent breakthrough seizures, to identify which type of seizures and events she was having given her prior history of nonepileptic events. A levetiracetan level upon admission was very low or undetectable and her lamotrigine level was quite low as well. This, along with the significant improvement in the eeg background the second day after being given medications, caused the physician to suspect, per the notes, that the patient was missing her antiepileptic medication due to noncompliance or forgetfulness. The patient reported that her seizure control was worse again, as she had around three to four grand tonic-clonic (gtc) seizures since the last visit. For about two and a half years after vns implant, the patient was almost seizure free of the gtc seizures. Throughout this time the patient has had frequent absence and myoclonic seizures. The patient also suspects she may be having seizures in her sleep because she wakes up feeling very tired and feels her mind is in a ¿fog¿ sometimes. The patient claims she has been taking medication regularly and denies any changes to her doses, recent illnesses, or other potential triggers. However, it was noted that the patient¿s pain doctor had increased the dose of her oxycodone medication. The patient¿s husband stated that the patient has been under a lot of stress lately, which is a very powerful trigger to her seizures. Further down the notes, the physician states that the patient¿s ¿seizures have always been refractory to different aeds, which could be in part due to the co-existence of psychogenic nonepileptic events, possible non-compliance with aeds based on the history she provided and the findings found in her most recent emu (very low levels upon admission, improvement in the eeg/seizures with the continuation of her home dosages of aeds), although she denies that, but mostly it is due to the medically refractory nature of her epilepsy , causing failure of multiple aeds and vns in controlling her seizures. ¿ the patient preferred to make no changes to her aeds or vns settings during this visit. On (b)(6) 2013, clinic notes indicate that the patient¿s seizures ¿continued to be frequent. ¿ the patient has had several absence and myoclonic seizures daily, and gtcs almost on a monthly basis, except that she had no gtcs in may. She has been taking her ant-seizures medications regularly. The patient¿s device was seen to be at ifi (intensified follow up condition) indicating a low battery per the physician. The physician stated that he would refer the patient for a replacement and advised the patient to increase her medication dosage in the meantime. It was later reported by the patient on (b)(6) 2013 that her battery is almost dead and she is now experiencing painful stimulation, like needles sticking in the left side of her neck, for the last month. The patient stated that she was seizure free until (b)(6) 2012 and that since then, her seizures have returned with greater frequency and intensity than before being placed with vns.
 
Event Description
It was reported that surgery was scheduled for (b)(6) 2013 and later confirmed that surgery occurred on this date. Attempts for additional information have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3230110


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:31:10 AM
Model Number 300-20
Event Date 05/10/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that the patient underwent a full revision surgery that day. The explanted lead and generator were returned for product analysis on (b)(4) 2013. Product analysis is underway and has not yet been completed. The physician¿s assistant reported that no x-rays were taken and that there was no report in the physician¿s notes of where in the body the painful stimulation was felt. No further information was provided.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death.
 
Event Description
Generator analysis was approved on (b)(4) 2013. The generator was explanted/returned for prophylactic reasons. The generator septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Pa of the lead was approved on (b)(4) 2013. An analysis was performed on the returned lead portions. During the visual analysis of the returned 212 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 33 mm and 35 mm from the connector bifurcation. Scanning electron microscopy was performed on the coil break found at 33 mm and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. Scanning electron microscopy was performed on the coil break found at 35 mm and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and (+) marked connector inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. For the observed (-) unmarked connector inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the reported allegation. The abraded openings observed on the outer and (+) marked connector inner tubing sections have the potential for contributing to the painful stimulation allegation.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient has been experiencing painful stimulation for the last couple of weeks that has been off and on; one day it will occur and the next it wouldn¿t. When the patient came into the office on the previous friday, high lead impedance was seen on diagnostics; output=limit/lead impedance=high. The patient has been getting efficacy from the therapy so the physician was hesitant on disabling the device, but stated he would call her in for the disablement. The physician did ask the patient if there had been any specific trauma/fall recently, but the only thing noted was that she uses the treadmill for exercise. The physician also noted that this patient is new to his office so it is unclear when she was last evaluated. The patient was referred for surgery. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Clinic notes dated (b)(6) 2013 indicated that the patient was having significantly more pain and hoarseness. The patient¿s vns was disabled that day. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3156500


Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:31:54 AM
Model Number 103
Event Date 10/01/2011
Event Type  Malfunction   
Event Description
Additional information was received that indicated that the product analysis was completed on the generator. Results of diagnostic testing and monitoring indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative

Event Description
Additional information was received regarding the patient. A response was received from the physician, but did not have any information about the increase in seizures. The patient reported "shooting pain" into her chest that was occurring intermittently. The generator was programmed to 0 ma and later had the magnet placed over the generator to ensure it was disabled, but the pain still occurred with both adjustments. X-rays were taken but there were no lead breaks or damage to the lead seen. The generator was turned back on and she could feel stimulation and said it felt the same as the pain she experiencing with the generator turned off. There was no trauma or manipulation to the area. The patient had a generator replacement and the generator was returned to the manufacturer for evaluation. Product analysis is planned but has not occurred to date.
 
Event Description
It was initially reported in clinic notes that the patient has been having an increase in seizure frequency, unknown if above or below pre-vns baseline. It is unclear if this is related to vns since the physician was discussing all the stressors in the patient life when it was mentioned. It was also reported that the patient was experiencing shocking pain that does no correlate with the stimulation cycles. The painful stimulation is in her left chest and neck. Turning the generator to an output of 0 ma did not stop the pain but placing the magnet over the generator reported to stop the pain. X-rays were taken that did not show any lead breaks or kinks in the lead. The x-rays were not provided to the manufacturer for evaluation. Diagnostics were within normal limits. The patient was sent to a surgeon for evaluation. It is unknown what the plan forward will be in regards to the painful stimulation. (b)(4) attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2375484



Title: Re: Painful Stimulation
Post by: dennis100 on July 02, 2018, 11:32:34 AM
Model Number 103
Event Date 01/09/2010
Event Type  Injury   
Event Description
It was initially reported that a vns patient was experiencing painful stimulation in her chest and would feel pain and vibration in her neck at the electrode site with stimulation. The patient's current settings were 0. 25/20/250/30/5 and diagnostics gave an impedance value of 3696 ohms, 10 years to eos. The physician tried to increase the patient's output current but was unable to do so due to tolerability issues. The patient denied any trauma prior to the pain but stated she did fall after the onset of the pain. The patient's device was later programmed off due to the pain. The patient was referred to a surgeon, however, he believed that the device is functioning fine and even with the device programmed off, the patient is still complaining of pain. He believes the patient is making the event up, however, the patient was scheduled for device explant. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1782826


Title: Re: Painful Stimulation
Post by: dennis100 on July 04, 2018, 12:23:00 AM
Model Number 300-20
Event Date 01/01/2005
Event Type  Injury   
Event Description
It was reported that the vns patient had been experiencing painful stimulation which required device disablement several times for long periods of time in the past nine years. When the device was programmed back on, the patient would experience intolerable painful stimulation. It was noted that the patient¿s lead may have migrated to an area that is more sensitive to the patient. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have not been returned to date.
 
Event Description
It was reported that the patient describers her discomfort as ¿feels like someone is taking their thumb and pushing in on my windpipe¿. She never deviated from this description for all these years. It was noted that at times when the physician would attempt to reprogram, the discomfort would be mild for a period of time but never completely resolved. She could never tolerate higher settings due to this discomfort and would periodically request vns to be programmed off. The patient has denied any discomfort with the newly placed generator/lead. It was indicated that the patient¿s explanted devices were discarded and will not be returning for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4276131


Title: Re: Painful Stimulation
Post by: dennis100 on July 04, 2018, 12:23:38 AM
Model Number 102
Event Date 04/01/2009
Event Type  Injury   
Event Description
It was initially reported by the physician that patient was experiencing painful stimulation at the generator site for the past three months. Patient went to the er several times for the pain. It was stated that the pain resolves when the device is turned off. Diagnostics results showed everything working within normal limits. It was also stated that the patient is scheduled for generator replacement surgery. Good faith attempts to obtain additional information has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1805132


Title: Re: Painful Stimulation
Post by: dennis100 on July 05, 2018, 07:44:57 AM
Model Number 103
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was reported that the vns patient experienced a sudden onset of painful stimulation in the neck with magnet mode stimulation. Follow up with the treating physician revealed that there were no causal or contributory programming changes or trauma that preceded the onset of the event. Recent diagnostic testing done on the device has revealed normal device function. X-rays were taken and sent to manufacturer for review. Review of x-rays revealed no anomalies that could be contributing to the reported event. The physician opted to decrease the device settings when the event initially began, which did appear to provide some relief initially. However, the patient had contacted the physician's office several days later, experiencing severe dysphagia, and the physician programmed the normal mode output current off at that time. The patient requested that the magnet mode stimulation remain programmed on, as she uses the stimulation for anxiety. Good faith attempts to obtain additional information are currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1851127


Title: Re: Painful Stimulation
Post by: dennis100 on July 06, 2018, 10:37:49 AM
Model Number 304-20
Device Problem Fracture
Event Date 05/17/2018
Event Type  Malfunction   
Event Description
It was reported that during interrogation of the patient's vns, high impedance was observed. The vns generator was at an intensified follow-up indicator, or ifi, = no condition. There was no known trauma to the area. The patient reported that stimulation did not feel right, which was confirmed to not be a report of painful stimulation. The vns was programmed off. The physician performed positional diagnostic testing and the high impedance was not resolved. The patient was referred for x-rays. The x-rays have not been reviewed by the manufacturer to date. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7572218


Title: Re: Painful Stimulation
Post by: dennis100 on July 06, 2018, 10:38:22 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received that the patient was experiencing pain in the left neck up to the ear with vns stimulation that was described as a burning sensation. The patient has concurrent ear problems that are being treated by the pcp, but the patient noted this burning as independent of the ear problems. It was also noted that the patient's generator had migrated, which created tension on the vns lead, resulting in protrusion, a lead pulling sensation, and discomfort. The patient was referred for vns replacement surgery. Follow up with the physician's office revealed that the intervention was for both the patient's comfort and to preclude serious injury. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7572226


Title: Re: Painful Stimulation
Post by: dennis100 on July 06, 2018, 10:38:56 AM
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
A research article comprised of data from a hospital's registry of all vns patients implanted between 2000 and 2013 reported several adverse events. This report captures the adverse events associated with the generator that are reported throughout the article. Five patients had their device removed due to postoperative infection. One patient had the device removed due to stimulation related pain. The eight deaths mentioned in the article are reported on mfr. Report # 1644487-2018-00979. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7575393


Title: Re: Painful Stimulation
Post by: dennis100 on July 06, 2018, 10:39:31 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 05/27/2018
Event Type  Injury   
Event Description
A patient began experiencing painful stimulation, prompting her to go to the er. The patient's device was programmed off due to the painful stimulation, and the pain resolved. The patient's device was then programmed on to low settings, but the patient began experiencing severe pain again in the neck and ear. Diagnostics were performed and returned results within the normal limits. The patient's device was programmed off again and referred the patient for surgery. A company representative reported that x-rays were taken of the patient's neck, and the physician did not identify any issues with the visible part of the vns. X-rays have not been evaluated by the manufacturer to date. The patient attended a surgical consult. During the appointment, the surgeon programmed the vns back on, and the patient did not exhibit symptoms of painful stimulation during the appointment. Per the patient, she did not experience any trauma to the device preceding the painful stimulation, but the patient reported that her large dogs jumped on her chest frequently near her vns implant. No additional relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7627365


Title: Re: Painful Stimulation
Post by: dennis100 on July 06, 2018, 10:40:11 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 05/21/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a physician that a vns patient¿s device was still firing even though the magnet was reportedly used to disable the device. The magnet was placed over the scar on the patient's chest, but the generator could not be felt. The physician reported that he could still see the device firing, which was determined by the patient clenching her teeth. The patient had multiple seizures during this time, which were attributed to the pain caused by the stimulation. It was reported that the seizures got worse and more frequent when the magnet was placed over the generator and that the patient had a neck muscle spasm during stimulations. The patient's device was communicated with the next day, which showed that the device was delivering therapy properly and that there had been no magnet activations during the times that the physician and patient stated that the magnet was used. The magnet was taped over the generator, and then the magnet activation was recorded properly. The physician reported that the generator was placed deep in the patient but could still be palpated, which could have caused the magnet to not activate. Follow-up was then received the next day reporting that, even with the magnet taped in place, the patient had neck and face spasms and tremors in the patient¿s cheeks during vns stimulation. Immediately following the symptoms that lasted up to 20 seconds, the patient went into a tonic seizure lasting 20-40 seconds. The patient's device was then programmed off. The patient was then referred for replacement of the device. Further follow-up indicated that the increase in seizures was not worse than before vns, but the device had been off for a week and the patient's seizures were back to one a day. The increase in seizures was stated not to be caused by vns therapy. The patient felt like the magnet didn't inhibit stimulation. The muscle spams, painful stimulation and increase in seizures resolved after the device was disabled, but the patient was still experiencing a subdermal burning sensation around the generator site. The patient had generator replacement surgery due to the painful stimulation. Diagnostics were within normal limits prior to surgery, and the surgeon found no visible anomalies with the devices prior to explant. The generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7594908


Title: Re: Painful Stimulation
Post by: dennis100 on July 06, 2018, 10:40:47 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 11/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient is experiencing muscle spasms with vns stimulation. When the device stimulates, patient's muscle by the neck twitches. All of the diagnostics were within normal limits. Patient underwent parathyroid surgery and since then, the patient has had bulging of the muscle over the left side of his neck with vns stimulation. Since reducing the output current , the bulging was reported to be tolerable. Patient underwent lead revision surgery due to painful stimulation in the muscle. The explanted lead was received. Analysis is underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7574456


Title: Re: Painful Stimulation
Post by: dennis100 on July 06, 2018, 10:41:24 AM
Model Number 104
Device Problem Energy output to patient tissue incorrect
Event Date 05/02/2018
Event Type  Malfunction   
Event Description
It was reported by the company representative that she followed up to check a patient's device. (upon physician's request). The patient had recently been replaced and the new generator set to the same settings as the old generator. The patient experienced no issues post replacement. Upon interrogation, she observed a pop-up message upon interrogation that asked her to confirm settings. The patient responded very poorly when she accepted the settings. The patient began to cough profusely, shake and cry. The representative believed that the nonverbal patient was in pain. She said that the pain was definitely related to stimulation. The patient had to be turned all the way down until 0. 25 ma output current from 2. 75 ma until he could tolerate the settings. Per the company or support specialist's data, system diagnostics were within normal limits while the generator was in the pocket but before it was closed. No further interrogation or diagnostics were taken that day. Review of the internal data of the generator from the date that the company representative noticed the adverse events, it was determined that the patient's generator had become pulse-disabled due to eos-yes sometime within a day after the or support specialist performed system diagnostics mid-surgery. It is suspected that the patient's generator was hit with some sort of electrosurgerical tool or other electrostatic discharge during the last part of surgery. This causes the generator's voltage to drop below eos-yes threshold. Afterwards, the generator's voltage rebounds to expected voltage. Likely the patient reacted poorly to being set to 2. 75 ma because his generator had been off for the 6 days post-surgically and had lost tolerance to high stimulation. It's important to note that the company or support specialist didn't know whether electrocautery was used, but that the company representative indicated that the surgeon was well-versed in the vns and knew not to use electrosurgical instruments after the generator was in the field. Operative notes from the patient's surgery was reviewed, and there was no evidence that electrosurgery was used after the vns was in the field. However, it was noted that the patient's pocket was extended after the final system diagnostics were run. Previously a photon blade was used to make a cut. It is unclear whether the photon blade was used to extend the pocket. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7575640


Title: Re: Painful Stimulation
Post by: dennis100 on July 07, 2018, 04:35:14 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Information was received that the patient was experiencing pain was experiencing pain in the neck that was reportedly constant and worsened with stimulation. The device's settings were lowered due to the pain and the patient was referred for pain management. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7567558


Title: Re: Painful Stimulation
Post by: dennis100 on July 07, 2018, 04:35:50 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 05/24/2018
Event Type  Injury   
Event Description
It was reported that the patient was feeling "electrical jolts" and recurrent pain at the vns site. Clinic notes received for the referral indicate that patient has recurrent left chest pain most likely related to vns placement as well as on occasion "feeling electrical jolts" suggestive of vns dysfunction/malfunction. It was reported that the electrical jolt occurs with stimulation on occasion but not every single time of stimulation. There is no pattern on when it occurs or with certain specific body movements. Surgical exploratory surgery was planned in regard to probable replacement of vagal nerve stimulator in view of chest pain as well as "electrical jolts" to preclude a serious injury but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7609529


Title: Re: Painful Stimulation
Post by: dennis100 on July 11, 2018, 08:01:09 AM
Model Number 302-20
Event Date 08/04/2010
Event Type  Malfunction   
Event Description
It was reported that a generator and lead were explanted due to unknown reason. Information from the explanting facility indicated the lead was explanted due to default but no further information was provided. Further follow-up by a company representative with the treating neurologist indicated the patient had a lead break as high lead impedance (7/limit/high) was received during a diagnostic test and the patient suddenly suffered pain. No patient manipulation or trauma was reported to have contributed to the high lead impedance and the neurologist believed the pain was caused by a broken lead which affected the surrounding areas. Moreover, no x-rays were taken by the site. The explanted generator and lead were returned to the manufacturer and underwent product analysis. Product analysis of the generator revealed the pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. At the moment, the lead still remains in product analysis.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1854560


Title: Re: Painful Stimulation
Post by: dennis100 on July 11, 2018, 08:01:48 AM
Model Number 102
Event Date 02/17/2010
Event Type  Injury   
Event Description
A review of clinic notes dated (b)(6) 2012 found that the patient went to the emergency room the prior week with records from the emergency room dated (b)(6) 2012 showing that she had an increased frequency of seizures. The emergency room records also noted that the patient's white blood cell count in the urine was high suggesting a mild infection. The clinic notes continued to state that the patient had continued to have a change in her pattern of seizures as well described by her husband. The patient's husband stated that the patient seems to have a twisting movement with shaking in the right arm. The patient had one of these seizures during the appointment, and the physician noted that she appeared to be able to move to her husband and that it appears that the patient is seeking comfort from her husband. After the patient's vns was interrogated, an attempt was made to increase the pulsewidth from 250usec to 500usec, but the patient had significant changes in her voice and felt as if there was a sharp, stabbing pain in her neck when the stimulator turned on. Because of this, the stimulator was reversed and the settings were adjusted so that only minor change was made. According to the physician, the battery appeared to be satisfactory and the plan for the future was to adjust the patient's medication. Attempts have been made to get more information; however, they have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2816907


Title: Re: Painful Stimulation
Post by: dennis100 on July 11, 2018, 08:02:23 AM
Model Number 105
Event Date 01/01/2010
Event Type  Malfunction   
Event Description
During the evaluation of data from a clinical investigational device (model 106 aspiresr generator) used in a (b)(4) study, cyberonics identified a hardware design issue that can cause a portion of the stimulation output to be redirected from the intended path. Like the investigational device, the same circuit configuration is also present within the model 105 aspirehc generator which is a commercially marketed device. (refer to manufacturer report number 1644487-2011-02121 for the model 106 event). As a result of this issue, the stimulation current actually delivered to the vagus nerve can be less than what is programmed by the physician. This diversion of stimulation current can potentially lead to the following pt effects: delivery of stimulation current that is less than the magnitude required for effective therapy. Presence of neck pain, inflammation and/or swelling/edema at the lead electrode location in the neck; and/or pt perception of unusual stimulation or muscle twitching between the pulse generator and the lead electrodes implanted in the neck. The magnitude of the diverted current and its consequences depends on the pt's programmed parameters settings and physiology, tending to manifest only as the pt's programmed parameters (output current, pulse width, frequency, and on time) reach higher parameters. No pt injury has been reported as a result of this particular event. Cyberonics will be sending recommendations on programming to treating physicians who have pt's implanted with the model 105 generator. Cyberonics recommends that physicians continue their practice of titrating programming parameters for pts implanted with an aspirehc generator to achieve appropriate clinical outcomes, paying particular attention to reports of: lack or loss of efficacy. Pain, inflammation, swelling/edema in the neck area; and/or pt perception of stimulation or muscle twitching in the area surrounding the implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266742


Title: Re: Painful Stimulation
Post by: dennis100 on July 12, 2018, 01:27:28 AM
Model Number 103
Event Date 02/27/2009
Event Type  Injury   
Event Description
The patient reported that after the device was replaced in 2008 she had problems including increased headaches, jaw and neck pain anytime they increased her settings. The patient's device was then disabled on (b)(6) 2011 and ultimately explanted due to these adverse events. The explant date is unknown. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6124054


Title: Re: Painful Stimulation
Post by: dennis100 on July 12, 2018, 01:28:01 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing laryngeal problems after vns stimulation began. It was stated that voice alteration began about three months after surgery and persisted after stimulation was turned off. An ent evaluation concluded laryngeal immobility, "meaning a recurrent damage". It was suspected that the problems were due to stimulation, and not surgery. Follow up from the physician's office provided a timeline of events. The vns device was implanted with ok diagnostics. Two weeks later, the device was titrated up to 0. 25ma. About three weeks after this titration, the patient was titrated up to 0. 5ma. Since this titration, there was a report of pain at the generator site. The vns was checked and was found to be ok. A week later, it was reported that the patient was vomiting with intense pain radiating along the neck, and the vns was turned off as a result. Voice alteration was confirmed to have been noted in mid (b)(6) and to have persisted after the device was turned off. The device was checked in mid (b)(6) and confirmed disablement. No device malfunction or impedance issue was noted from this visit. An ent assessment then found vocal cord paralysis. The physician believed the events were due to vns stimulation, and planned to have the device explanted. No surgery has occurred to date. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650798


Title: Re: Painful Stimulation
Post by: dennis100 on July 12, 2018, 01:28:33 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing laryngeal problems after vns stimulation began. It was stated that voice alteration began about three months after surgery and persisted after stimulation was turned off. An ent evaluation concluded laryngeal immobility, "meaning a recurrent damage". It was suspected that the problems were due to stimulation, and not surgery. Follow up from the physician's office provided a timeline of events. The vns device was implanted with ok diagnostics. Two weeks later, the device was titrated up to 0. 25ma. About three weeks after this titration, the patient was titrated up to 0. 5ma. Since this titration, there was a report of pain at the generator site. The vns was checked and was found to be ok. A week later, it was reported that the patient was vomiting with intense pain radiating along the neck, and the vns was turned off as a result. Voice alteration was confirmed to have been noted in mid (b)(6) and to have persisted after the device was turned off. The device was checked in mid (b)(6) and confirmed disablement. No device malfunction or impedance issue was noted from this visit. An ent assessment then found vocal cord paralysis. The physician believed the events were due to vns stimulation, and planned to have the device explanted. No surgery has occurred to date. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650798


Title: Re: Painful Stimulation
Post by: dennis100 on July 12, 2018, 01:29:07 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing laryngeal problems after vns stimulation began. It was stated that voice alteration began about three months after surgery and persisted after stimulation was turned off. An ent evaluation concluded laryngeal immobility, "meaning a recurrent damage". It was suspected that the problems were due to stimulation, and not surgery. Follow up from the physician's office provided a timeline of events. The vns device was implanted with ok diagnostics. Two weeks later, the device was titrated up to 0. 25ma. About three weeks after this titration, the patient was titrated up to 0. 5ma. Since this titration, there was a report of pain at the generator site. The vns was checked and was found to be ok. A week later, it was reported that the patient was vomiting with intense pain radiating along the neck, and the vns was turned off as a result. Voice alteration was confirmed to have been noted in mid (b)(6) and to have persisted after the device was turned off. The device was checked in mid (b)(6) and confirmed disablement. No device malfunction or impedance issue was noted from this visit. An ent assessment then found vocal cord paralysis. The physician believed the events were due to vns stimulation, and planned to have the device explanted. No surgery has occurred to date. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650798


Title: Re: Painful Stimulation
Post by: dennis100 on July 12, 2018, 01:30:09 AM
Model Number 103
Event Date 10/01/2012
Event Type  Malfunction   
Event Description
A vns patient's caregiver reported that the patient was having "a lot of problems" since her last cluster that started (b)(6) 2012, which included one grand mal seizure. The patient and caregiver reportedly talked to the treating vns physician on (b)(4) 2012. The caregiver indicated that he was "pretty sure that the vns device is causing problems and may be malfunctioning somehow". The device was reportedly disabled for periods of time on (b)(6) 2012, and the patient feels much better with the device disabled. The caregiver was leaving the vns magnet taped over the device to keep the device disabled. The caregiver was planning on having the patient evaluated by the treating physician to perform diagnostic tests. Attempts for additional information from the treating physician have been unsuccessful to date.
 
Event Description
Additional information was received indicating the patient was seen by the physician again on (b)(6) 2013, and the patient/spouse and physician elected to turn the device on to low settings at 0. 25ma. All is reportedly well with the patient at this time and the patient will continued to be monitored.
 
Manufacturer Narrative
Age at time of event, corrected data: additional information received indicates the event date was around (b)(4) 2012, and therefore, the initial report inadvertently reported the age incorrectly. Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not list that intervention was taken. Date of event, corrected data: additional information received indicates the event date was around (b)(4) 2012, and therefore, the initial report inadvertently reported the date incorrectly.
 
Event Description
The patient had an appointment with the treating vns physician on (b)(6) 2013, and the company representative attended the appointment. The clinic notes for the office visit were received and reviewed. The patient's device was turned off on (b)(6) 2012, but the magnet output current was left at 1. 0ma so she could still swipe the magnet when she feels a seizure coming on. The interval month was met with a lessening in frequency and intensity of partial epilepsy. The patient has utilized this feature, per the clinic notes. The device was turned off because of tachycardia arrhythmia and epigastric pain and pyrosis which was felt potentially to be aggravated by the vns. The patient was wearing an monitor from the cardiologist, and the arrhythmia reportedly stopped after the device was turned off. She did not have any more episodes. The epigastric pain and pyrosis is believed to have begun around the same period of time as the arrhythmia. The physician does not believe the device is malfunctioning, as diagnostics are within normal limits. However, the physician noted that it is of interest that the patient has not had any cardiac sinus tachyarrhythmia or epigastric pain/pyrosis since the device normal output current has been turned off. The physician notes there is a questionable relationship of these events to vns therapy, and the epigastric pain/pyrosis is suspicious for vagotonia. At this time, the plan is to keep the device turned off (except magnet mode) and monitor the patient. Previously on (b)(6) 2012, the physician mentioned that the patient had a high pulse rate at 140 bpm at a previous dosing session (unknown date) but later dropped to 106 bpm. The physician did not think the issue was related to the vns at the time, but did refer the patient to cardiologist for evaluation. The physician noted at that time that nothing was found.
 
Event Description
Additional information was received from the patient indicating that she was taken to emergency room in (b)(6) 2012 due to tachycardia experienced during vns stimulation. She denied any reoccurrence of tachycardia since vns was "turned down. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2899181


Title: Re: Painful Stimulation
Post by: dennis100 on July 12, 2018, 01:30:53 AM
Event


Title: Re: Painful Stimulation
Post by: dennis100 on July 13, 2018, 02:40:15 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 05/15/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing some complications from her vns device and was referred for evaluation by the surgeon. The patient had acute spasmatic pain in the left neck and coughing lasting seconds whenever her magnet was swiped. However, the patient also experienced this 6-8 times per day spontaneously. The physician stated that there was no abnormality with the lead and that he suspected potential glossopharyngeal neuralgia. The physician prescribed gabapentin for the left neck paroxysmal pain. No surgery has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7596790


Title: Re: Painful Stimulation
Post by: dennis100 on July 20, 2018, 12:49:15 AM
Model Number 302-20
Event Date 01/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Conclusions: device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient was scheduled for surgery (unrelated to vns) and in preparation for the surgical procedure, the surgeon was programming the device off. Upon interrogation of the device, a high lead impedance warning message appeared. As a result, the surgeon opted to revise the lead and pulse generator since the patient was already undergoing a surgical procedure. Additional information was received revealing that the patient had sustained trauma to the chest site while playing volleyball. It is unknown when this trauma occurred. In addition, the patient's mother also reported that over the past 4-5 months, the patient had been experiencing painful and intolerable stimulation. The explanted lead and generator have been returned to manufacturer where analysis is underway. Good faith attempts to obtain additional information from the treating physician are also underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1854037


Title: Re: Painful Stimulation
Post by: dennis100 on July 20, 2018, 12:50:21 AM
Model Number 102
Device Problem No Information
Event Date 06/09/2015
Event Type  Injury   
Event Description
It was reported that the patient woke up with a lump around the generator and was experiencing painful stimulation. The device was programmed off and x-rays were ordered. It was later reported that the patient had a knot over the left neck area and will need to be seen by the surgeon. Clinic notes dated (b)(6) 2015 note that the patient started noticing a knot in the neck the day prior and that the generator was programmed off. It was also reported that the patient was experiencing confusion. No known surgical interventions have been performed. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Further follow-up revealed that the generator implant site was slightly raised. The confusion resolved when the generator was programmed off. There was no patient manipulation, programming or medication changes, or trauma that is believed to have caused the mass and the painful stimulation. X-rays were performed on (b)(6) 2015 which did not identify any adverse vns findings. It was reported that the patient has not yet been seen by the surgeon. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient was seen by the surgeon who believed the device should be reactivated as there was nothing found wrong with the vns. The physician believes that the vns has been helpful for the patient; however, the surgeon is sending the patient for resective surgery consult. The patient reported that the device is fine, but is nearing end of service. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4893039


Title: Re: Painful Stimulation
Post by: dennis100 on July 25, 2018, 06:02:00 AM
Model Number 103
Event Date 10/25/2010
Event Type  Injury   
Event Description
Reporter indicated that the vns pt had been admitted to the hospital because he was in pain. The reporter stated the pain appeared to be occurring with stimulation. Diagnostics are normal as per the physician. The physician has been informed of possible ways to alleviate the painful stimulation. Further attempts for info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1909984


Title: Re: Painful Stimulation
Post by: dennis100 on July 25, 2018, 06:02:35 AM
Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Manufacturer Narrative
Event description, corrected data: previously submitted mdr inadvertently omitted information received during follow-up. This report is being submitted to correct this information.

Event Description
Information was received that the patient was seen on (b)(6) 2013 for consult. The notes indicated that the patient¿s pain in the chest was not consistent with vns. It was stated that the (b)(6) event was a recurrent infection ((b)(6)), but it is unknown when this started as this information was provided by the patient. There was no documentation was available regarding the ¿heart problems¿; however, it was documented that the patient was negative for murmurs or gallops. No additional information or x-rays were available. Attempts for product return have been unsuccessful. An implant card indicated that the patient was explanted due to painful stimulation.

Event Description
On (b)(6) 2013, this patient underwent generator revision. The product has not been returned to date.

Event Description
On (b)(6) 2013, it was reported that this patient's device has shifted due to weight loss beginning in 2011. This was not causing the patient pain that began four days prior. For the past month, the patient had been observing a lump over the generator site, and since then, it has tripled in size. There was no manipulation/trauma and no medication changes or programming changes. The patient stated that she was last seen two months prior by her vns physician, and her device was found to be functioning properly. Additional information was received indicating that the a little over a month ago, a quarter-sized nodule was noticed near her generator. Now the area is swollen from the left side of her sternum to her arm pit, approximately the size of a hand. The outline of the generator is visible. The area is painful and bruising. There is no drainage or opening in the incision area, and there was no trauma to the area. Vns had controlled her seizures as she has gone from 15 per day to 2 to 3 per month. Clarification was given that the generator migrates from mid-left ribs to under the arm pit settings and diagnostics from (b)(6) 2013 were provided. The patient was referred for prophylactic replacement and pocket revision additional information was received that there may be a disc in the patient's neck that is out of place. (the left side of her neck had been swollen for several months, and she has limited movement on her left side. ) this is not related to vns. It was also suggested that the patient had heart problems, and the patient is a (b)(6) carrier. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3069093


Title: Re: Painful Stimulation
Post by: dennis100 on July 25, 2018, 06:03:10 AM
Model Number 102
Event Date 09/08/2010
Event Type  Injury   
Event Description
Reporter indicated a vns pt was hospitalized for evaluation of vns generator migration and painful stimulation that was occurring in the pt's left arm and chest at the generator site. The vns was to be disabled. The pt has had no trauma and does not manipulate the vns. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1869526


Title: Re: Painful Stimulation
Post by: dennis100 on July 26, 2018, 10:23:21 AM
Model


Title: Re: Painful Stimulation
Post by: dennis100 on July 26, 2018, 10:24:08 AM
Model Number 102R
Event Date 11/27/2011
Event Type  Malfunction   
Event Description
Additional information received revealed that during revision surgery, the generator site was opened and the header of the generator had separated from the can. The lead itself appeared to be intact. With the generator header separation, lead impedance could not be assessed so a full revision was performed where the lead and generator were explanted and replaced. The explanted products have been returned to the manufacturer and product analysis is currently being performed. The dhr for the generator was reviewed and no non-conformances or other adverse conditions were noted in the generator's dhr.
 
Event Description
Product analysis of the explanted lead and generator has been completed. Note that a large portion of the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. The septa of the explanted generator were not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation" and "stimulation to unintended site"). A window was cut into the pulse generator case to access the feed-thru output connections on the substrate. Bench test connectors were attached to the negative and positive feed-thru wires, at the substrate, to perform a final electrical test. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. It is very likely that the identified, "detachment of component(s) header", occurred while the generator was implanted, and is related to patient trauma. Other than the header observation, there were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no non-conformance or other adverse conditions with the generator prior to shipment. Brand name, corrected data: initial report indicated the lead was the suspect device however new information received indicates the issue was most likely caused by the detachment of the generator header. Type of device, name, corrected data: initial report indicated the lead was the suspect device however new information received indicates the issue was most likely caused by the detachment of the generator header. Model #, serial #, lot#, expiration date, corrected data: initial report indicated the lead was the suspect device therefore the lead model number, serial number, lot number, and expiration date were provided however new information received indicates the issue was most likely caused by the detachment of the generator header. Manufacturer date, corrected data: initial report indicated the lead was the suspect device therefore the lead manufacturer date was provided however new information received indicates the issue was most likely caused by the detachment of the generator header.
 
Event Description
It was reported on (b)(6) 2011 that a vns patient walked into a door and the edge of the door hit the patient in the chest close to the generator site. Immediately following the hit, the patient began to feel stimulation more intensely in his neck and continued to feel the stimulation however the intensity lessened over time. Systems diagnostics were performed which resulted in ok/ok/1/no but normal mode diagnostics resulted in 7/limit/high. The device was programmed off and the patient was referred for x-rays. The patient's output current is 2. 75 ma. On (b)(6) 2011, systems and normal mode diagnostics were repeated which resulted in 7/limit/high/no. The patient was scheduled for a surgical consult and x-rays were sent to the manufacturer for review. A review of the x-rays did not show any anomalies however it was noted that in a certain portion of the lead, the lead was twisted onto itself suggesting some sort of patient manipulation or trauma. Clinic notes were received dated (b)(6) 2011 where the device was found to be programmed to 2. 75/30/500/30/3/3/500/30. Systems diagnostics resulted in ok/ok/1/no and normal mode diagnostics resulted in 7/limit/high/no. The device was programmed to 0 ma due to the high lead impedance and the patient's aeds were adjusted to compensate for the patient not receiving vns therapy. The notes indicate that following the trauma to the generator site, the patient felt discomfort in the throat with device stimulation. He also has an increase in his cough reflex. The patient had reportedly tolerated his settings until the trauma to the generator site and using the magnet to temporarily disable the device did not help. The discomfort occurred for 24 to 36 hours but has slightly lessened in intensity. If the patient was setting up and leaning forward, the discomfort was not as bad. The patient weighs (b)(6). Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2389370


Title: Re: Painful Stimulation
Post by: dennis100 on July 26, 2018, 10:25:08 AM
Model Number 302-20
Device Problems Fracture; No Information
Event Date 02/19/2014
Event Type  Injury   
Event Description
It was later reported by the patient mother that the symptoms of vomiting, gas, and weight loss have continued since the device was programmed off. However, she also stated the symptoms have improved some. The patient mother stated she is still concerned about the weight loss and was directly attributing the issues to the presence of the device and that she wanted the device removed. The patient mother did explain that they had not yet been seen by a gi specialist. It was noted by the patient current physician that he was referred to a gi specialist and she does not believe the gi issues are related to vns as the patient had been programmed off for months.
 
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that this vns patient¿s device was disabled due to vomiting on (b)(6) 2014. It was previously reported recently had device settings turned back up and vomiting, pain, and stomach issues returned. In addition to reporting the device disablement, the physician stated that the events were occurring continuous, not just with stimulation, and were possibly related to vns; however, the patient had not been evaluated by a gastroenterologist. Interventions included disabling the device. The patient was reportedly experiencing pain in the throat and chest. On (b)(6) 2010, this vns patient caregiver reported that the patient had discomfort in the neck and chest region with stimulation. He also experienced voice alteration, dyspepsia, and difficulty sleeping with stimulation. The patient did not experience any adverse events when the settings were low. Follow-up at the time showed that there were no reports of trauma or manipulation; however, device settings were changed on (b)(6) 2010 where the output current was increased from 1. 50 to 1. 75 ma, and the signal frequency was increased from 25 to 30 hz. The patient did not have a history of sleep disturbances or dyspepsia prior to vns. The sleep disturbances and dyspepsia were related to device stimulation. The physician stated that the settings were lowered but then increased because the patient felt the device was not as efficacious at lower settings. In the past, the patient complained of pain, voice alteration, and emesis (if he already had concurrent nausea) during stimulation. He also complained of pain, too frequent stimulation, and that device stimulation would wake him up at night. There were no casual or contributory factors that preceded the onset of any of the events.
 
Event Description
It was noted during a periodic review of the programming history database that high impedance was noted on the patient's device on (b)(6) 2014. It was noted the patient's vns generator was programmed off on (b)(6) 2014. The high impedance found may be related to the previously reported events of sleep disturbances, dyspepsia, vomiting, pain, voice alteration, and the perception of an increase in frequency of stimulation.
 
Event Description
Additional information was received showing the physician still did not believe the gi related issues were associated with vns. However, it was noted that the other issues (voice alteration, sleep disturbances, painful stimulation and pain in the chest, neck, throat, and altered perception of stimulation were related to the high lead impedance that first occurred years ago. The patient was referred for replacement when the issues related to the high impedance first began (around (b)(6) 2014); however, the patient was a no-show to the appointment with the surgeon. The patient's device had been programmed off at that time. It was explained they later tried to titrate the patient's settings up again, unaware of the high lead impedance, which led to the continuation of the reported adverse events. The patient was programmed off again due to the return of the vns related adverse events. The patient had been referred for vns removal; however no known surgical interventions have occurred to date.
 
Event Description
It was further noted the surgery will be taking place due to patient comfort. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3728867


Title: Re: Painful Stimulation
Post by: dennis100 on July 27, 2018, 10:42:18 AM
Model Number 1000
Device Problem No Known Device Problem
Event Date 05/10/2018
Event Type  Injury   
Event Description
It was reported that a patient was implanted in (b)(6) 2018 and his device was not turned on until recently due to scheduling issues. The patient was programmed to 0. 25ma. The patient returned today complaining of burning at the generator site. The patient was sent for x-rays, and the device was disabled. Ap and lateral x-rays of the neck and chest were available that displayed complete view of the neck and chest. Based on the images provided, the feedthrough wires appeared intact at the connector pins, and the generator was placed in the upper left chest, as expected. However, based on the angle of the image, the connector pin does not appear to be fully inserted past the connector block. The lead was observed in the patient¿s neck and was routed toward the patient¿s left chest. A strain relief bend and loop are present and placed per labeling. Two tie downs are present. Both tie downs appear to be securing the strain relief loop per labeling but no tie down appears to be securing the bend. No obvious fractures or sharp angles were found in the images. Note that a portion of the lead was routed behind the generator so it could not be assessed. Based on the images provided, the patient¿s painful stimulation may be related to incomplete lead pin insertion. Note that the presence of micro-fractures could not be ruled out. Patient was referred to surgery for consult. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7567346


Title: Re: Painful Stimulation
Post by: dennis100 on July 27, 2018, 10:43:09 AM
Model Number 103
Event Date 07/12/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was referred for surgery. The neurologist believed that there was an issue with the patient¿s lead. The patient¿s device was tested and system diagnostic results showed normal device function at the time. The neurologist stated that the patient¿s device showed an ifi condition and that the patient was no longer feeling the same intensity from stimulation. Further follow-up revealed that the patient had a surgical consult on (b)(6) 2014. The surgeon stated that generator and lead replacement was needed and that the patient¿s device was ¿dead. ¿ the patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Event Description
It was reported that diagnostics were normal. A full replacement of the vns system was performed by the surgeon on (b)(6) 2014. During surgery, the surgeon noticed that the lead wire was sutured to the fascia in the chest, rather than suturing the generator to the fascia as indicated in labeling. There was also a kink in the lead wire in the chest area, but no specific lead damage was observed. The surgeon wondered if perhaps the suturing of the lead wire to the chest was causing the patient painful stimulation in the chest area and clinical symptoms, or whether it was due to generator migration. It was also noted that the neurologist thought the patient's device reached ifi = yes quickly, but based on the estimated battery life per labeling at the provided settings in (b)(6) 2013, there is no evidence to suggest premature depletion. The caregiver reported that manipulations or intense movements was not an issue with this patient. The patient's pain has resolved since full revision surgery.
 
Event Description
It was initially reported on (b)(6) 2013 via a (b)(4) message that the patient was having breathing problems during deep sleep since vns implantation. A video was posted of the patient's sleeping issue. The patient's caregiver reports that she is certain that these problems started with vns implant and have continued to get worse as settings increase. Later on (b)(6) 2013, the caregiver reported that she has brought up the sleeping issue concern with the patient's vns neurologist and primary care physician (pcp), but the physician did not seem concerned and said it was "normal," but she feels that this is not. The caregiver said that she understands that there are warnings for patients with pre-existing issues and being evaluated prior to vns for things like this, but she felt that the patient does not have any physical issues that would cause her to have a pre-existing condition that would be exacerbated by the vns therapy. She did confirm that the patient has not had a sleep study done since so far her pcp did not think it was needed and also has not referred her to an ent. The caregiver then went on to explain that during the episodes, the patient's oxygen levels are dropping into the 80s, especially more recently and was not an issue in the past. The issue only occurs during deep sleep, is not position dependent or due to an illness like a cold, is present when breathing through mouth or nose, or if the patient is lying flat or elevated. The patient had generator replacement on (b)(6) 2012, and the caregiver reported that this issue was present with the patient's previous generator implanted on (b)(6) 2009. (the sleeping issues with the previous generator are captured in mfg report number: 1644487-2013-01308. ) however, the issue has worsened since generator replacement in 2012. She said that as far as she knew there had not been any attempts to alleviate the issue with settings adjustments, however when the patient's output current was lowered (settings unknown) for a few days the patient had increase in her seizure frequency, so the patient's settings were increased again. That patient is stilling having about 20+ seizures every 24-hours and has several seizure-types due to a traumatic brain injury several years ago, which appears to have several focal points in her brain, so her treatment options are limited. The patient was started on a new medication about a year ago. The caregiver does not feel that cpap is an option due to the patient's seizures which have been violent and would likely cause the cpap to be damaged within a few days. The caregiver was suggested to discuss these issues with the physician for further discussions and suggestions. Follow-up with the treating vns neurologist was performed which revealed that the patient was evaluated on (b)(6) 2013. She reported that she was not aware of the patient's breathing troubles and lower oxygen levels (below 80) until the vns manufacturer contacted her office. The patient/caregiver had not reported this to her until her appointment on (b)(6) 2013. The caregiver brought in the video of the patient sleeping to show the physician. The physician reported that the breathing troubles appear to be related to stimulation, so she lowered the output current and pulse width. She further indicated that it is "clear that the patient gets gassy during stimulation. " she reported that if this does not resolve the issue, she plans on lowering the stimulation further. She stated that when the patient/caregiver disabled the device with the vns magnet, the issues resolved so it is "obviously" related to vns. The physician lowered the output current to 2. 5ma and pulse width to 250usec. However, the patient did not want the settings lowered, but the physician elected to turn down the settings to see if this helps the breathing troubles. No additional information was provided by the physician as she was not previously aware of the breathing issues during sleep. Attempts for the product information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3102380


Title: Re: Painful Stimulation
Post by: dennis100 on July 27, 2018, 10:44:14 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 02/22/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient experienced fainting and stimulation throughout the chest when the vns was stimulating. The physician programmed the vns generator off and the symptoms resolved. However, it was reported that during an mri, the patient felt stimulation during an mri and loss consciousness, hitting his head and breaking his ankle. Follow up with the company representative revealed that the patient's magnet output current had not been disabled. The patient reported the stimulation has uncomfortable/painful. The vns was then fully disabled. It was reported that the diagnostics were within normal limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7350087


Title: Re: Painful Stimulation
Post by: dennis100 on July 27, 2018, 10:45:02 AM
Model Number 304-20
Event Date 06/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, this patient reported that she was experiencing pain just above the generator site (related to the previous chest pain) and that she had been to the er numerous times for this discomfort. The pains reportedly began one week prior. The patient also indicated that this was in addition to the breathing problems and chest pains that began with vns implant. When the patient was at the hospital, x-rays were taken with no noted issues, and there was no infection. The patient was given pain medication. The patient noted that the device was previously turned off. This morning the settings were turned down, and the issues did seem to improve. Attempts for additional information have been unsuccessful.
 
Event Description
On (b)(4) 2013, it was reported that this patient wanted her device removed. The patient reported that she developed a blot clot in the left neck. She was informed by her surgeon that the she bled quite a bit in surgery and had to be transfused intraoperatively. Three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking. She reported that she saw a pulmonologist who performed a bronchoscopy and informed her that her left vocal cord is almost completely paralyzed and that he could see the lead next to the vocal cord. The patient was last seen on (b)(6) 2013 at which time her settings were adjusted. (increased settings have not affected her chest pain and shortness of breath adversely: it was no worse and no better. ) attempts for information have been unsuccessful. Surgery is likely and will be captured in mfr report #1644487-2013-01510. The patient had earlier reported that two days after her system was implanted she went to the hospital because she could not breathe or swallow. The patient was turned on one month later. The patient indicated that the swallowing issue was only occurring a couple of times per week and not necessarily coinciding with stimulation on times. The breathing issue occurred all of the time and was worse with stimulation. The patient also experienced painful magnet stimulation at the electrode site (magnet output current: 1. 0 ma). The patient also had incidents of pain at the generator site for the past two to three months. The patient did not experience any trauma. At the hospital, her vitals were noted to be fine and everything was okay. The patient¿s physician was unable to provide information as to the cause of the events. The patient also reported that a ct performed after surgery showed a blood clot at the lead site. Follow-up at a patient appointment in september showed that the pulsewidth and frequency were too high. Once the settings were adjusted, the patient was fine. Follow-up with the surgeon¿s office showed that the patient was seen for implant and again in (b)(6) for post-op follow-up and one more time in (b)(6), at which time she reported the pain and swallowing; however, these were determined to be only the result of the patient¿s settings. At the follow-up appointments, the patient was healing well without any complications. Follow-up with the neurologist showed that the patient was doing well and was seen in (b)(6)with no complaints. The patient was doing well with seizure control. The relationship of the blood clot to vns was unknown. The patient was on clonazepam, lamictal, keppra, lamotrigine, haproen, and vimpat at the time of the event. No causal or contributory medication changes precede the onset of the thrombosis. To the physician¿s knowledge, the patient did not have a medical history of thrombosis, and there were no pre/co existing medical conditions which may have contributed to the event. No medical interventions were taken. The patient was last seen on (b)(6) 2012, and reported no new symptoms or issues.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was hospitalized for several days due to shortness of breath. The patient was admitted to the hospital on (b)(6) 2014. The patient reported experiencing pain at her generator site while hospitalized but states that the pain had since resolved. The patient was also having seizures frequently. While hospitalized, the patient¿s device was found to be disabled. The neurologist at the hospital stated that the patient was suffering from depression and was taking too many aeds. Further follow-up revealed that the patient was seen by her following neurologist. The patient reported that her device had been disabled for two months prior to the office visit and that she was experiencing pain. The neurologist did not believe the pain was related to vns as the pain was not occurring at the patient¿s implant sites. After her office visit, the patient went to the emergency room due to a seizure on the bus that caused facial lacerations.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122977


Title: Re: Painful Stimulation
Post by: dennis100 on July 27, 2018, 10:45:40 AM
Model Number 304-20
Event Date 11/15/2012
Event Type  Injury   
Event Description
On (b)(6) 2012 the surgeon reported that the patient was seen that day and has vocal cord paralysis. The patient recently underwent a full revision surgery on (b)(6) 2012 and on (b)(6) 2012 was turned back on the previous settings by the neurologist. The device was disabled at the (b)(6) 2012 appointment with the surgeon and the patient was in tears and could not talk during stimulation times. There was painful stimulation in her neck and the patient was crying and bent over during the on-times. The patient was going to return in two weeks for an ent workup regarding her left vocal cord paralysis. (b)(4) attempts for additional information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2871669


Title: Re: Painful Stimulation
Post by: dennis100 on July 28, 2018, 08:23:12 AM
Model Number 102
Event Date 07/01/2010
Event Type  Injury   
Event Description
It was reported that the pt had a stress test, and ever since then, the pt has been "tailspinning". The pt is now having an increase in depression, suicidal ideations, and pain during device stimulation. The physician adjusted the pt's setting to address the painful stimulation, but the depression has continued. The relationship to pre-vns baseline depression levels is unk. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1908113


Title: Re: Painful Stimulation
Post by: dennis100 on July 28, 2018, 08:23:52 AM
Model Number 103
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported by the pt that when she was walking into a casino, she experienced a painful stimulation in her chest area. There were no believed security detectors when she entered the door. The pain was said to have eventually went away and then over the weekend after she got home she began experiencing painful stimulation every min. Her husband took her to er at one facility and was later transferred to another er facility. The pt was disabled at that time and told to f/u with her treating neurologist. The pt later requested that her pcp refer her for explant of the device due to the painful stimulation she was experiencing. Two weeks prior to the report, the pt had an increase in her settings, but the pain didn't show up until a few days prior to the report. There has been no known trauma or manipulation to the device. The pt did go through airport security and was patted down at that time. A search performed in the mfr's programming history database indicates that the last known diagnostics performed on (b)(6) 2010 were within normal limits. During the explant surgery, the surgeon indicated that the leads were twisted due to pt manipulation. It appeared that the pt flipped generator over and over again. The lead was straight, then twisted, then straight again. The explanted lead portions and pulse generator have been returned to the mfr, but has yet to be completed on the pulse generator. Note that a large portion of the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete eval could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1908004


Title: Re: Painful Stimulation
Post by: dennis100 on July 31, 2018, 03:45:18 AM
Model Number 300-20
Event Date 07/30/1998
Event Type  Injury   
Event Description
Reporter indicated that a vns pt has had painful stimulation in the throat since the vns was implanted on (b)(6) 1998. Vns setting changes have not helped alleviate the painful stimulation, and the reporter has recommended the pt have vns lead and generator replacement due to the painful stimulation. Surgery is likely, but a surgery date has not been set.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1892642


Title: Re: Painful Stimulation
Post by: dennis100 on August 02, 2018, 01:46:49 AM
Model Number 102
Device Problem Device operates differently than expected
Event Date 11/01/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4). Additional manufacturer narrative and/or corrected data : the previously submitted mdr inadvertently did not provide the udi# of the suspect device.
 
Event Description
It was reported that the vns patient has had adverse events ever since she was implanted. It was reported that patient has had earache and inflamed tonsils, especially on the left side, as well as terrible lethargy. It was reported that the device output current was gradually increased but the patient then complained of severe earache and pain in her tonsil, the output current was then decreased to 0. 50ma which relieved patient's pain tremendously. It was reported that the patient was treated for tonsillitis with earache, which treatment was inefficacious. Patient is planned for a week long in hospital tests at the beginning of march 2016. Additional information was received that patient has had episode of tonsillitis before vns implant, but not tinnitus. The pain started when the stimulation was switched on. The earache occurs when the device stimulates and continues. The patient was treated for tonsillitis because the tonsil was inflamed, but it was not necessarily diagnosed as tonsillitis. When the stimulation was switched on, the doctor could actually see it affecting the tonsil on the left. It was reported that device diagnostic test gave normal results.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5446723


Title: Re: Painful Stimulation
Post by: dennis100 on August 02, 2018, 01:47:25 AM
Model Number 103
Event Date 11/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician at the hospital that the pt was experiencing painful stimulation at the electrode site. Device was checked and confirmed to be functioning within normal limits. After lowering the settings, the pt was doing fine. Follow up with the treating physician revealed that the device was turned off as pt's pain was not resolved after reducing the vns settings. Pt did well initially but the event came back. The pt requested to have the device turned off as he could not tolerate the pain and he was referred to the surgeon for a possible revision surgery. Per physician, the pain was quite serious for the pt and therefore, he had to refer the pt for a revision of vns. Surgery has not been planned at the moment but it will likely take place. The pain occurs with vns stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943832


Title: Re: Painful Stimulation
Post by: dennis100 on August 03, 2018, 01:12:25 AM
Model Number 302-20
Event Date 07/05/2009
Event Type  Injury   
Event Description
It was reported in (b)(6) 2009 that the vns pt began experiencing coughing and pain in the jaw during stimulation on times. At the time of the onset of the events, there had been no preceding setting changes that took place prior to the onset of the coughing and painful stimulation, and no reports of pt trauma. Diagnostic testing following the onset of the events revealed normal device function. The device settings had been unchanged since (b)(6) 2009. The pt was seen by the treating physician for follow up following the onset of the events, where the output current was decreased from 1. 75ma to 0. 5ma and the events had significantly improved; however, the pt did begin experiencing an increase in seizure vigor, and per the physician this was a result of having lowered the vns device setting intentionally. The pt was seen by a surgeon in (b)(6) 2009, where diagnostic testing revealed normal device function, and the setting was kept at a low output current. The surgeon advised that they could wait on any surgical interventions at that time, and see how the pt responds with respect to seizure control at the lower settings. The physician had noted that the interventions taken up to this point were for pt comfort, and not to preclude a serious injury. Additional info was received in 12/2010, via receipt of a document from the hospital containing vns implant info, which revealed that the pt had surgery in (b)(6) 2010 where only the lead was replaced. On the documentation received, it was noted that the reason for replacement of the lead was due to "neuropathic pain from stimulation of left nerve. " the documentation provided was hand written and due to poor handwriting, the additional writing on the form was not clear. Good faith attempts with both the surgeon and the treating physician to obtain additional info on the current status of the pt, as well as what was observed during surgery have been made, however, no further info has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1947542


Title: Re: Painful Stimulation
Post by: dennis100 on August 03, 2018, 03:19:55 AM
Model Number 102
Event Date 10/27/2010
Event Type  Injury   
Event Description
It was reported that the pt felt she had not had efficacy with vns and had possibly even had a slight worsening in seizures since vns was implanted. The pt has always been set to very low settings due to painful stimulation and intolerable hoarseness. The pt's device has been turned off and she may have it removed. No surgery has occurred to date. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1933757


Title: Re: Painful Stimulation
Post by: dennis100 on August 05, 2018, 02:13:56 AM
Model Number 302-20
Event Date 09/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a serious injury.
 
Event Description
It was initially reported by the surgeon that he saw the pt in his office for painful stimulation at the electrode site. He performed diagnostics and noticed high lead impedance. He took the pt into surgery as a result and observed a lead fracture in the operating room, so he decided to go ahead and replace the lead. He stated that the last good diagnostics results were obtained about 6 months ago. The pt was referred to him by the treating physician who stated that the impedance said high and they wanted the pt to be checked by him. X-rays were taken but it did not show anything. Copies of x-rays are not available for manufacturer review. No pt manipulation or trauma occurred that might have contributed to the onset of events. Explanted lead was discarded by the hospital; therefore, not available for manufacturer review.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1921929


Title: Re: Painful Stimulation
Post by: dennis100 on August 05, 2018, 02:14:33 AM
Model Number 302-20
Event Date 07/05/2009
Event Type  Injury   
Event Description
It was reported in (b)(6) 2009 that the vns pt began experiencing coughing and pain in the jaw during stimulation on times. At the time of the onset of the events, there had been no preceding setting changes that took place prior to the onset of the coughing and painful stimulation, and no reports of pt trauma. Diagnostic testing following the onset of the events revealed normal device function. The device settings had been unchanged since (b)(6) 2009. The pt was seen by the treating physician for follow up following the onset of the events, where the output current was decreased from 1. 75ma to 0. 5ma and the events had significantly improved; however, the pt did begin experiencing an increase in seizure vigor, and per the physician this was a result of having lowered the vns device setting intentionally. The pt was seen by a surgeon in (b)(6) 2009, where diagnostic testing revealed normal device function, and the setting was kept at a low output current. The surgeon advised that they could wait on any surgical interventions at that time, and see how the pt responds with respect to seizure control at the lower settings. The physician had noted that the interventions taken up to this point were for pt comfort, and not to preclude a serious injury. Additional info was received in 12/2010, via receipt of a document from the hospital containing vns implant info, which revealed that the pt had surgery in (b)(6) 2010 where only the lead was replaced. On the documentation received, it was noted that the reason for replacement of the lead was due to "neuropathic pain from stimulation of left nerve. " the documentation provided was hand written and due to poor handwriting, the additional writing on the form was not clear. Good faith attempts with both the surgeon and the treating physician to obtain additional info on the current status of the pt, as well as what was observed during surgery have been made, however, no further info has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1947542


Title: Re: Painful Stimulation
Post by: dennis100 on August 05, 2018, 02:15:09 AM
Model Number 302-20
Event Date 10/01/2009
Event Type  Injury   
Event Description
It was reported by a psychiatrist that a vns patient experienced pain going up the left side of the neck and down into the left shoulder with stimulation. Patient's current settings were 1. 75/20/500/30/5 and treating psychiatrist stated that diagnostics were all ok (no specifics) and have been in the past. The patient denies any trauma to the area. Additional information was received from the patient indicating that she is still experiencing painful stimulation only when her head is turned to the left. Patient stated that when her head is straight there is no pain. The patient stated she would like to see a surgeon to see if he can offer any solutions to the reported pain. However, at the time no interventions have been scheduled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919376


Title: Re: Painful Stimulation
Post by: dennis100 on August 06, 2018, 02:23:44 AM
Model Number 102
Event Date 09/23/2008
Event Type  Injury   
Event Description
It was reported that a vns patient's device was programmed off due to painful stimulation at the generator site. The patient experienced an increase in depression while the vns device remained off. Further interventions were to program the patient's vns on, but the depression stage continued after vns was programmed on. At the moment it is unknown what triggered the patient's increase in depression and pre-vns depression levels are unknown. Additional information was received from the office of the treating psychiatrist asking for a company representative to be present at the patient's next office visit and ensure vns was working correctly. Further information was received from a company representative indicating she was present at the patient's most current office visit. Patient's current settings were 0. 75/30/500/14/10 magnet 0. Normal mode diagnostics results ok/ok dcdc:2 eos:no and system diagnostics were within normal limits dcdc:2 eos:no. The patient was seen at another follow-up appointment and patient settings were changed (decreased pw to 250 from 500) which helped the patient with the reported pain. The patient still continued to cough at these settings, but it would not cause the bronchial spasms that she had been experiencing before from the vns (patient pre-vns diagnosed with asthma). Good faith attempts to obtain additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1924673


Title: Re: Painful Stimulation
Post by: dennis100 on August 06, 2018, 02:24:17 AM
Model Number 102
Event Date 10/01/2010
Event Type  Malfunction   
Event Description
It was initially reported by the pt's mother that the pt has an increase in seizures above baseline that began (b)(6) 2010. Pt is also experiencing painful stimulation since the device settings were increased. Physician has adjusted the pt medication doses. Mother stated that the magnet does help with seizures as she no longer passes out with seizures when it is used. Good faith attempts to gain more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1937783


Title: Re: Painful Stimulation
Post by: dennis100 on August 06, 2018, 02:24:52 AM
Model Number 102
Event Date 11/01/2010
Event Type  Injury   
Event Description
It was initially reported by the surgeon's nurse that the patient has been scheduled for a full revision surgery due to unknown reason. Follow up with the surgeon revealed that the patient was experiencing neck pain with vns stimulation approximately for 5 minutes. Patient was unable to swallow or talk during this time. Patient also had one episode of pain around her generator. Diagnostics showed everything working within normal; however, the treating physician felt it was necessary to replace the device. They suspected an intermittent dysfunction of vns system. The surgery was to prevent a serious injury as the pain was intense. No medication changes or trauma contributed to the onset of the event. Additional information received stated that the patient underwent a full revision surgery. Good faith attempts to obtain explanted products for analysis has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1917817



Title: Re: Painful Stimulation
Post by: dennis100 on August 07, 2018, 01:15:14 AM
Model Number 103
Event Date 11/30/2010
Event Type  Malfunction   
Event Description
It was initially reported by the physician that an error message was received with diagnostics were run on the pt. A company representative came to the site to troubleshoot the issue. The warning message and result were duplicated by the company representative on her programming system. A generator reset was perform and appeared to correct the issue. The patient's previously programmed parameter cause painful stimulation, hoarseness and tingling which it has not done before. Pt was programmed to lower output current to allow them to adjust to stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956837


Title: Re: Painful Stimulation
Post by: dennis100 on August 07, 2018, 01:16:01 AM
Event Date 12/07/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated a vns patient was hospitalized due to having painful stimulation in the neck. No known trauma occurred. The patient was hospitalized to preclude a serious injury per the reporter. The vns was disabled, but the patient continued to report, she felt painful stimulation and was observed to have voice alteration with the reported stimulation. The patient had the vns settings increased slightly three days prior to the painful stimulation occurring. The patient later had generator replacement surgery only due to the painful stimulation; the original lead was not replaced. Since the surgery, the patient's new vns generator has been turned on and the patient is no longer experiencing any painful stimulation. Attempts for return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953644


Title: Re: Painful Stimulation
Post by: dennis100 on August 07, 2018, 01:21:31 PM
Device Problem No Known Device Problem
Event Date 05/25/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from an er physician that a vns patient was in the emergency room (er) presenting with seizures and was coughing rhythmically. The physician stated that the parents put the magnet over the stimulator and that stopped the seizures. She thought that it might be the generator that might be causing the coughing and wanted to have it checked. The company representative went to the er at request of the physician. The patient stated it feels like the device is going off continuously and giving painful stim in the throat. The physician thought the coughing was related to the stimulation. He indicated that the physician thinks it may attention seeking as when the magnet is removed from the generator, the patient coughs and reports difficulty breathing from the coughing. The patient was worried that if the magnet was used to inhibit stimulation her seizures may increase. The next day, the patient had been moved to a new room and didn't seem to be having the issues reported earlier. The magnet was not being used at that time. It was reported that when the magnet is in place she seems to be ok. Then she seizes, the magnet moves off, and cough reflex starts again. She stated that they think the settings may be too high. The company representative was requested to turn off the device. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7617895


Title: Re: Painful Stimulation
Post by: dennis100 on August 08, 2018, 12:49:11 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 09/01/2016
Event Type  Injury   
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on follow-up report #2.
 
Event Description
It was reported that a vns patient was experiencing painful and erratic stimulation for about three months prior to an appointment on (b)(6) 2016. She stated that her autostimulations were going off "constantly and painful" at times, particularly at night. The provider changed device settings comfort measures. The device was then disabled. It was later provided that explant surgery was scheduled. No known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on the initial report.
 
Event Description
Follow-up from the provider indicated the reason for explant was that the patient did not think the vns helped.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6953908


Title: Re: Painful Stimulation
Post by: dennis100 on August 08, 2018, 12:49:50 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 03/09/2018
Event Type  Injury   
Event Description
The patient had generator explant surgery. The device was received, but analysis has not been approved to date.
 
Event Description
It was reported that the patient experienced painful stimulation when she was near an mri machine and afterwards as well, even though her device was programmed off (normal and magnet modes). The patient's device was communicated with after the mri, and it was confirmed that the output currents were set to 0ma. A generator reset was performed to make sure it was disabled, but the patient still felt stimulations and had voice alterations. Programming data from the generator was reviewed, which showed that there were multiple magnet activations on the date of the mri, most with 0 to 1 second between activations. However, since the magnet mode output current was programmed off, no stimulation was delivered. The therapy time recorded by the generator did not show any unexpected stimulation time. The only increase in stimulation time was from a system diagnostic test being performed, which is expected as the device delivers a short stimulation during the test. Therefore, the data showed that the device was not delivering stimulation to the patient. The physician and patient decided to have the device explanted to prevent the patient from feeling any more stimulation. No further relevant information has been received and no surgery has occurred to date.
 
Event Description
Analysis on the generator was approved. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7400487


Title: Re: Painful Stimulation
Post by: dennis100 on August 08, 2018, 11:43:48 AM
Model Number 103
Event Date 01/07/2011
Event Type  Injury   
Event Description
It was reported by a nurse that a vns pt had an increase in seizures above pre-vns baseline. The treating nurse believes that the increase in seizures is due to loss of therapy. There has been many medication and programming changes for pt's seizure control. Additionally, pt complained about painful stimulation which did not resolve with settings adjustment. Placing a magnet over the generator to disable the device; however, alleviated the pain in neck. There has been no trauma or manipulation to the vns generator and lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1993856


Title: Re: Painful Stimulation
Post by: dennis100 on August 08, 2018, 11:44:19 AM
Model Number 302-20
Event Date 07/19/2010
Event Type  Injury   
Event Description
It was reported by an epileptologist that a vns pt experienced intermittent pain in the chest generator area and electrode site due to unk reason. The epileptologist indicated the pain was not always associated with stimulation and current diagnostics were within normal limits (no specifics). The epileptologist reduced the pt's settings from 1. 75 ma to 1ma, in turn this reduced the pt's pain. Moreover, f/u from a company rep with the epileptologist revealed the pt is doing well and was not complaining of pain or any migration. The epileptologist does not believe the pt's device migrated as there might have been a complaint from the pt regarding the event. Additional information was rec'd from a company rep indicating the pt continued to have painful stimulation at the neck site and now felt like there was a knot there. The pt's epileptologist was now referring the pt to the surgeon for possible full revision. At the moment, it is unk if medical intervention is being taken for the reported painful stimulation as good faith attempts to the treating epileptologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000313


Title: Re: Painful Stimulation
Post by: dennis100 on August 09, 2018, 05:35:23 AM
Model Number 102
Event Date 01/31/2011
Event Type  Injury   
Event Description
It was reported by an emergency room (er) physician that a vns pt was having painful stimulation in her neck and felt that the device was stimulating too often. Later info from the pt's physician, however, indicated that the pt had a manic episode - during the episode the pt had visited the er multiple times, and all of the reported events were due to her psychiatric problems with the manic episode. The physician stated that none of the events were caused or even related to vns whatsoever, but solely a part of her mental disease. The pt's device was "off for right now" and the physician indicated that "he did check it", and no problems with the device were reported (no specifics available). The physician indicated that the vns was not shut off to preclude a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2039473


Title: Re: Painful Stimulation
Post by: dennis100 on August 09, 2018, 05:35:54 AM
Model Number 304-20
Event Date 04/03/2014
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient was in a car accident on (b)(6) 2014 and sustained a neck injury. The patient had neck pain and immediately had a seizure following the car accident. The patient had been seizure free for nearly a year prior to the car accident. The patient¿s device settings were increased during an office visit on (b)(6) 2014. The patient¿s neck pain worsened with stimulation. The patient began having head and ear pain. The patient also began experiencing voice hoarseness, occasional drooling, and head tilting with stimulation. (the patient pulled her neck toward her chest during device on-times. ) x-rays were taken and were reported by the physician to be unremarkable. The patient¿s device settings were decreased during an office visit on (b)(6) 2014. The patient subsequently had four generalized convulsions within 24 hours. The patient¿s device settings were increased during an office visit on (b)(6) 2014 and the patient was able to tolerate her adjusted device settings. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
New information changes the suspect device.
 
Manufacturer Narrative

Event Description
Additional information was received stating that, despite normal diagnostic results, the vns patient¿s lead was replaced due to the patient¿s increase in seizures following the motor vehicle accident. Furthermore, it was reported that the patient did not have a history of acid reflux. The reported acid reflux is believed to be related not to stimulation but to the patient¿s psychosomatic issues. Lead replacement surgery occurred prior to the onset of the acid reflux.
 
Event Description
It was reported that the patient's symptoms resolved after lead replacement surgery.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014. The patient¿s generator was not replaced. The explanted lead has not been returned to date. Further follow-up revealed that the patient¿s device was tested during an office visit on (b)(6) 014 and diagnostic results showed normal device function. The patient was concerned that there was a potential relationship between vns and the patient¿s acid reflux. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Corrected data: this date on follow-up mfr. Report #03 inadvertently reported the incorrect year. The date should have been reported as 07/28/2014. The report was not a late submission.
 
Manufacturer Narrative
The previously submitted mdr inadvertently did not include information regarding the reason for lead replacement surgery and the patient¿s acid reflux. The previously submitted mdr inadvertently did not include that no device failure is believed to have occurred as diagnostic results showed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854244


Title: Re: Painful Stimulation
Post by: dennis100 on August 09, 2018, 05:36:26 AM
Model Number 102
Event Date 02/07/2011
Event Type  Injury   
Event Description
It was reported by a neurosurgeon that a vns patient's device was explanted due to erratic and painful stimulation, however, the patient would like to be re-implanted. Good faith attempts to obtain more information and retrieve the devices for product analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026023


Title: Re: Painful Stimulation
Post by: dennis100 on August 09, 2018, 05:36:58 AM
Model Number 101
Event Date 02/01/2011
Event Type  Injury   
Event Description
It was reported by a neurologist via clinic notes that a vns pt was having painful stimulation in neck and jaw since 2009 with vns stimulation for 30 seconds every 5 minutes. The pain in her neck and jaw were resolved with the vns device being turned off. The pt suffered from a possible trauma while she was playing "body block" with her grandson. She took number of x-rays before where no abnormalities were observed. The x-ray report states that the generator was placed in left chest and the lead, which extends into the left lower neck, as visualized, appears stable in alignment and is intact. Single lateral view of the neck demonstrates the lead out of the chest into the left lower neck. The visualized leads appear intact, this report was found in clinic notes as the x-rays images were not returned to the manufacturer. The physician referred the pt for a full revision suspecting a lead problem where the surgery took place. Good faith attempts to get the generator and lead back for product analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2017496


Title: Re: Painful Stimulation
Post by: dennis100 on August 10, 2018, 04:12:11 AM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/19/2018
Event Type  Injury   
Event Description
It was reported by the physician that the patient was experiencing painful stimulation in the neck where the electrodes were located. The patient's settings were subsequently turned down and the patient was referred for a full revision surgery. Diagnostics were not performed at the patient's appointment. The patient's device was subsequently disabled later in the day. It was later reported that the patient was also having erratic stimulation. No additional relevant information has been received to date. No surgical intervention has been known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7721758


Title: Re: Painful Stimulation
Post by: dennis100 on August 11, 2018, 01:20:33 AM
Model Number 304-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 06/25/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for a lead revision due to a lead fracture. It was later reported that the lead revision was also due to painful stimulation in the neck area. The lead was replaced. The explanted device has not been received for analysis to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7707636


Title: Re: Painful Stimulation
Post by: dennis100 on August 11, 2018, 01:21:04 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/25/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received by the manufacturer that the patient was in a motor vehicle accident and the vns generator migrated. The patient reported feeling the generator slipping under her arm. The patient reported having headaches that were constant and had worsened overall. The patient continued to utilize her vns for all symptoms, but it was stated that this had not helped with her headaches. The patient reported at an appointment a year following the accident that she felt a shocking pain in her neck. The patient reported that she could feel a wire and continue to complain regarding the generator slipping under her arm and causing constant pain. The patient stated that she feels shocks, which are causing more headaches. The diagnostics were reported as within normal limits. The patient was referred for full vns replacement surgery to address the migration and the painful stimulation. The physician stated that the intervention was to preclude serious injury. The patient underwent replacement surgery. The patient reported following the vns replacement surgery, the patient still feels painful stimulation despite the vns not being programmed on. The physician believed that this may be due to a pinched nerve. The patient was in a motor vehicle accident previously and had neck and back surgery in the past. The physician planned to allow the patient to heal prior to programming the vns back on. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
During attempts at product return, it was revealed that the facility does not return explanted products without a patient signed release and will not return explanted devices to the manufacturer.
 
Manufacturer Narrative
Patient problem :(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7686856


Title: Re: Painful Stimulation
Post by: dennis100 on August 13, 2018, 01:11:58 AM
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was reported in a scientific article that a vns pt experienced severe neck pain synchronous with the duty cycle resistant to alteration of parameters and requiring lead revision. Good faith attempts to obtain add'l info have been unsuccessful to date.
 
Manufacturer Narrative
Article citation: elliot, robert, a. Morsi, a. Silverberg, c. Carlson, e. Geller, o. Devinsky and w. Doyle. "vagus nerve stimulation in 436 consecutive patients with treatment-resistant epilepsy: long-term outcomes and predictors of response. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2020352


Title: Re: Painful Stimulation
Post by: dennis100 on August 13, 2018, 01:12:28 AM
Model Number 250
Event Date 08/19/2009
Event Type  Malfunction   
Event Description
It was reported that a pt was having painful stimulation at the neck and generator site whenever she tried to use her magnet to disable the device. The physician reviewed the pt's settings and found that the magnet output current was set to 1. 0 ma when it should have been set to 0 ma. Review of the pt's programming history by the physician who reported the event revealed that a faulted diagnostic test occurred on (b)(6) 2009 and all the settings were corrected however the magnet output current was left at 1. 0 ma when it should have been 0 ma. The physician stated that she believed the test was interrupted because it is run at higher settings than what the pt is programmed to and the pt experienced pain when the test was being performed. The physician was reminded of the importance of performing final interrogations to ensure all of the settings are correct including magnet settings. Good faith attempts to obtain current programming and device diagnostic info have been unsuccessful to date therefore the programming anomaly cannot be confirmed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092178


Title: Re: Painful Stimulation
Post by: dennis100 on August 13, 2018, 01:13:08 AM
Model Number 302-20
Event Date 01/01/2009
Event Type  Injury   
Event Description
It was reported that the pt was very sensitive to stimulation and was feeling pain during stimulation. The pt was not able to tolerate stimulation at 0. 50ma, so the device was disabled for several months. The pt was then set to 0. 25ma in (b)(6) 2010 and was able to tolerate the stimulation as she could not feel it. Diagnostics were not able to be performed at this time. The pt was later programmed to 0. 75ma and able to feel the stimulation. X-rays were received by the mfr for review, which revealed no anomalies. Later, it was indicated that it was very difficult from the very beginning to increase the output current, due to pt's sensitivity. The physician tried for a year and a half to raise the output and managed to do so up to 0. 5ma with the pulsewidth at 250 and 130. The stimulator was stopped (b)(6) 2010 and started again in (b)(6) 2010. The pt was said to be feeling the painful stimulation since being turned on and the physician confirmed that is believed to be related to the vns therapy. There is no known pt manipulation or trauma that occurred that is believed to have caused/contributed to the painful stimulation. No programming changes were taken as the pt was already at low settings. The pt later had vns lead revision surgery due to the painful stimulation. At the time of surgery, the surgeon noted that the electrodes were placed a little too low on the nerve in his opinion. The pt is doing much better since surgery and is currently having a new vns titrated up. The explanted lead was returned to the mfr, but no anomalies were noted with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2075905


Title: Re: Painful Stimulation
Post by: dennis100 on August 17, 2018, 06:33:22 AM
Model Number 103
Event Date 03/28/2011
Event Type  Injury   
Event Description
It was reported that the pt was experiencing painful and erratic stimulation in the neck. Pt says pain is at the generator site and up the lead to the neck, and is erratic and not just with stimulation. The physician programmed the pt's device off and took x-rays of the device. X-rays were not sent to the mfr for review. The physician feels that the generator has moved because he could not feel it in the past and can now clearly palpate the generator. Later info reveals that the generator had slipped into the armpit area. No trauma or manipulation has occurred. The pt was also experiencing an increase in seizures after the device was turned off due to loss of therapy. The pt underwent surgery to revise the generator pocket and secure the generator down. Diagnostics were all normal. The lead was also revised during surgery due to fluid being seen in the tubing (addressed in medwatch # 1644487-2011-01083). Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2096033


Title: Re: Painful Stimulation
Post by: dennis100 on August 17, 2018, 06:33:55 AM
Model Number MODEL 250
Event Date 04/19/2011
Event Type  Malfunction   
Event Description
It was reported that the patient was experiencing an increase in seizures with an unknown relationship to the pre-vns baseline and was experiencing painful stimulation underneath his armpit. Diagnostics taken indicated normal device function; however, the generator was at or near end of service. A rough battery life calculation was performed using dates from 10/09/2002 to 12/27/2006 that confirmed that the generator was likely at end of service. Upon interrogation of the patient's vns, it was found that a faulted diagnostics test had likely occurred, resulting in a change in the patient's settings. The physician indicated that the increase in seizures was likely a result of the decrease in settings. The patient's generator has been replaced due to end of service. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102253


Title: Re: Painful Stimulation
Post by: dennis100 on August 17, 2018, 06:34:33 AM
Model Number 102
Event Date 04/21/2011
Event Type  Malfunction   
Event Description
It was reported that the pt was scheduled for prophylactic generator replacement. During surgery, it was noted that there was high impedence present with the old generator. Once the lead pin was cleaned and a new generator was attached, diagnostics were within normal limits. The surgeon noted that the lead pin area was "a little messy" which may have been causing the high impedance. The pt had complained of painful stimulation at the generator site, and after surgery, the pt no longer had pain with stimulation. Explanted generator was returned to the mfr, but analysis is pending. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102360


Title: Re: Painful Stimulation
Post by: dennis100 on August 17, 2018, 06:35:09 AM
Model Number 250
Event Date 05/03/2010
Event Type  Malfunction   
Event Description
A review of the patient's programming history was performed on (b)(6) 2012. During this review it was observed that a faulted system diagnostic test first occurred on (b)(6) 2010, which resulted in a change to the patient's settings. The off time was left at 60 minutes and the magnet was left at 1. 0ma. It was previously reported by the physician that on (b)(6) 2010, the patient's off time was 5 minutes, however review of the available history indicates that the off time was 60 minutes as it had not previously been corrected. Additionally 3 faulted test occurred on (b)(6) 2011, which resulted in a change to the patient's setting. Again, the patient left at un-intended settings as the off time was left at 60minutes. The off time was not corrected until (b)(6) 2011. The magnet appears to have been intentionally enabled.
 
Event Description
It was initially reported that a patient was having painful stimulation, although the pain was not present with every stimulation. System diagnostics revealed proper device function at this time and the patient's settings were said to be 2 ma/20 hz/250 microsec/30 sec/5 min. Furthermore, when a company representative followed up with the site diagnostics on (b)(6) 2010 showed all systems to be properly functioning. It was on this date that the doctor described receiving an error message, but the exact detail on the message was not known at this time. The representative met with the patient and doctor and found the patient's settings to be 1 ma/20 hz/500 microsec/30 sec/60min. System diagnostic testing on this day showed proper device function. It was explained to the doctor that these settings indicated a faulted diagnostic test. Attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative
Method: analysis of programming history (if applicable).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102227


Title: Re: Painful Stimulation
Post by: dennis100 on August 17, 2018, 06:35:43 AM
Model Number 302-20
Event Date 04/19/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2011 the vns patient reported that her device was "leaking" because she is experiencing pain in her neck during stimulation. The patient said that the neck pain is non-debilitating. The patient is also experiencing a cough. The physician's nurse reported that the patient was seen on (b)(6) 2011 because of the neck pain during stimulation that she was feeling. The physician was worried that there may be a device malfunction, that the device may be leaking or a lead may be loose, so they referred her to another physician for a second opinion. The nurse reported that they decreased her output current to 3. 0ma. No other diagnostics or programmed settings were provided. The patient will be back to see the physician in (b)(6) 2011. Additional information was requested from the physician that the patient was referred to for a second opinion; however no further information has been received thus far. If additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2100459


Title: Re: Painful Stimulation
Post by: dennis100 on August 19, 2018, 01:18:26 AM
Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was initially reported by a neurologist that a vns pt was being referred for surgery due to end of service (eos). The pt was referred to surgeon whom found the device was not at eos. The pt was averaging one to two seizures per day which was less than his history of five to six per day. The pt's family reported that pt's seizures had progressively gotten worse. So, the treating neurologist adjusted his vns programming settings to 3/20/250/60/0. 3 and magnet settings 3. 25/500/60. This adjustment still did not bring pt seizures under control. Mfr received add'l info in form of clinic notes that on (b)(6) 2011, pt was seen by the neurologist and the pt was having more breakthrough seizures above pre-vns baseline. The magnet swipe also did not have any relief of clinic response but causing headache and pain in the neck area which was related to vns stimulation. There was no report of trauma or manipulation to the vns device. The programming settings were modified again to 3/25/500/0. 3/60 and magnet mode 3. 25/500/60. The pt's medications were also adjusted to address the poor seizure control. Per the physician, the pt was receiving 65% efficacy prior to increase seizure. On (b)(6) 2011, the physician found that the vns device was showing eos. A revision surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2083052


Title: Re: Painful Stimulation
Post by: dennis100 on August 19, 2018, 01:18:58 AM
Model Number 300-20
Event Date 01/01/2011
Event Type  Malfunction   
Event Description
It was reported by a physician that the patient was referred for explant due to painful stimulation in the neck region, which occurred every 3 minutes. The patient's current settings were 2. 5 ma/20 hz/250 microsec/30 sec/3 min. System diagnostic were within normal limits, but with a dcdc code of 0. The patient's past programming history was reviewed and it was noted that the dcdc code had been 1 or 2 previously; therefore, the patient was scheduled for a revision due to a potential short circuit. There was no report of manipulation or trauma. X-rays were not going to be taken. The patient underwent a full revision - the generator was returned for product analysis, but the lead was not returned.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2094902


Title: Re: Painful Stimulation
Post by: dennis100 on August 20, 2018, 03:24:57 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Event Description
It was reported that a patient was to have her device replaced due to pain at the site. Clinic notes were received indicating that patient has had severe left neck pain, dysphagia and hoarseness with stimulation. The device had been turned off and the patient had experienced an improvement of symptoms since having the device off. It was indicated the patient previously had a left thyroid lobectomy. It was noted from a recent office visit that the patient felt pain in her neck and throat that radiated into her jaw and left face. The patient had difficulty swallowing and had been eating less as a result. She stated she had been to the er at least once for the pain. The device output was lowered, and the patient still felt pain. Both output and magnet current were turned off. Diagnostics indicated no issues and battery life ok. The physician plans to have the battery replaced and possibly lead revised. From follow up with the neurologist, it was stated that the patient had not experienced any trauma to the site or other events that may have led to the adverse events. No surgery has occurred to date. No other additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7709600


Title: Re: Painful Stimulation
Post by: dennis100 on August 22, 2018, 07:00:52 AM
Model Number 103
Event Date 10/20/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient developed an infection. The patient had an allergic reaction to the surgical glue used during the procedure at the neck incision site. Following the implant procedure, the patient also experienced numbness on the side of her face and left arm. When the patient¿s device was tested, the patient subsequently experienced pain in her neck and head and was unable to breathe or speak during stimulation on-times during the test. The patient¿s device was disabled. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Additional information was received that the patient's device was turned on during (b)(6) 2014 and that the patient is doing well. Patient also experiences pinching sensation in her chest during stimulation and when she lies down. Patient's pain when turning her head was reported to be better and was attributed to be due to patient having a bulging disc.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300491


Title: Re: Painful Stimulation
Post by: dennis100 on August 22, 2018, 07:01:29 AM
Model Number 101
Event Date 01/01/2005
Event Type  Injury   
Manufacturer Narrative
Correction: it was inadvertently reported previously that the seizures began in 2006, but they actually appear to have begun sometime in 2005. Correction: the seizures previously mentioned in 2011 are not applicable to this event as they occurred with a different generator and were reported under medwatch #1644487-2011-01619.
 
Event Description
It was reported via clinic notes, that the pt had experienced several increases in seizures over the past few years and pain with stimulation. The pt's output current was decreased to 2. 75 ma. It was also noted that the pt had surgery for excision of an acoustic neuroma and some of the seizures began after this surgery in 2011. It was also noted that many of the seizures appear to be caused by stress and cannot be controlled with vns or medications. Attempts for further info have been unsuccessful to date.
 
Event Description
It was inadvertently reported previously that the seizures began in 2006, but they actually appear to have begun sometime in 2005 per clinic notes. Also, the seizures previously mentioned in 2011 are not applicable to this event as they occurred with a different generator and were reported under medwatch #1644487-2011-01619.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2201796


Title: Re: Painful Stimulation
Post by: dennis100 on August 26, 2018, 01:40:28 AM
Model Number 300-20
Event Date 05/09/2011
Event Type  Malfunction   
Event Description
It was reported that the patient's device was showing high impedance and the patient was feeling intermittent pain during stimulation. Patient was seen by a surgeon, but no revision surgery is scheduled to date. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2187458


Title: Re: Painful Stimulation
Post by: dennis100 on August 27, 2018, 08:40:09 AM
Model Number 102
Event Date 05/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that the pt was experiencing painful stimulation in left jaw and neck which diminishes over time if she places magnet over the device. When she removes the magnet, event comes back intensely. It was stated that the event began a month ago and has gotten progressively worse. Pt was also experiencing cough with stimulation. Physician stated diagnostics showed everything working within normal limits. X-rays were taken and reviewed by mfr. There were no anomalies identified in the visualized portion of the pt's vns device which could have contributed to the reported painful stimulation. Pt underwent a full revision surgery due to the events she was experiencing. Good faith attempts to obtain explanted products for analysis has been unsuccessful till date.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1772673


Title: Re: Painful Stimulation
Post by: dennis100 on August 27, 2018, 08:40:44 AM
Model Number 302-20
Event Date 02/28/2011
Event Type  Malfunction   
Event Description
It was reported that the vns patient was experiencing painful stimulation in her abdomen. The patient's generator was implanted in the abdomen due to her small size. Diagnostics of the vns were performed at the patient's next visit that indicated high impedance. The physician was advised to disable the patient's vns; however, the physician chose to leave the stimulation enabled. It was noted that the patient has grown 7 inches since her initial vns implant. Surgery to replace the patient's vns lead and generator has occurred. When the lead was explanted, the lead was noted to be fractured. Attempts for the return of the explanted lead and generator have been unsuccessful to date. Attempts for further information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2118871


Title: Re: Painful Stimulation
Post by: dennis100 on September 02, 2018, 01:15:03 AM
Model Number 102
Event Date 01/25/2013
Event Type  Injury   
Event Description
Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. It was reported that the surgeon did not proceed with a full generator and lead revision and that the generator was replaced prophylactically. The new generator was placed back on the patient's right side due to the patient's pacemaker on the left side; however, a new pocket was created. The surgeon coiled and placed the lead in a pocket near the generator. It was reported that the surgeon feels that the patient's pain will no longer be an issue now that the lead has more flexibility, with less pulling across the patient's chest. The generator was programmed back to on at lower settings than previous and the patient did not experience any pain from the device stimulation. An implant card was received confirming that the generator was replaced prophylactically on (b)(6) 2013. The lead impedance with the new generator and old lead was "ok". Attempts to have the generator returned to device manufacturer are underway; however, the device has not been received to date.
 
Event Description
The generator was discarded by the explanting facility and will not be returned to device manufacturer for analysis.
 
Manufacturer Narrative

Event Description
Reporter indicated that the patient was experiencing painful and erratic stimulation across her chest where the lead is located and also across her neck and down the left side of her chest and arm. It was also reported to also occur at times when she turns her neck too far in certain positions. It was reported that the patient's painful stimulation was a gradual increase over time and did not start immediately. The physician indicated in notes that the vns may be broken. The patient's device was programmed off and the pain resolved. The magnet mode stimulation was left on and the patient indicated that the pain still occurred when the magnet was used. It was reported that the patient was to follow-up with physician to see if lowering device settings would resolve the pain or if surgery was required. Device diagnostics were performed and were within normal limits. X-rays were taken and sent to device manufacturer for review. There were no gross lead fractures that were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. Further follow-up revealed that the patient has been scheduled for system replacement; however, surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972914


Title: Re: Painful Stimulation
Post by: dennis100 on September 03, 2018, 01:45:51 PM
Model Number 302-20
Event Date 04/20/2011
Event Type  Malfunction   
Event Description
It was reported that the vns patient would be having her generator replaced due to end of service. Information was later received from the patient indicating that her heads were also replaced because they were "bad. " operative notes received from the surgeon's office noted that the patient had been experiencing painful stimulation down her left arm and upon examination of the lead during surgery found that there was a break in the insulation. This was the anomaly that prompted the lead replacement and was described ass a "break in the electrode insulation with fluid bubbles inside the electrode sheath. " the site believes that the painful stimulation is related to be opening in the insulation as per the notes. Diagnostics following surgery were normal. The explanted lead was returned and underwent analysis. The opening in the insulation was not confirmed and no anomalies were found however the electrode portion of the lead was not returned.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2199025


Title: Re: Painful Stimulation
Post by: dennis100 on September 04, 2018, 08:37:23 AM
Model Number 103
Event Date 07/12/2006
Event Type  No Answer Provided   
Event Description
On (b)(6) 2011, a vns pt reported that she was experiencing painful stimulation and that it feels as though her breast is being "shocked". She said that she has had painful stimulation since the original implant on (b)(6) 2006. She had a battery replacement on (b)(6) 2011 and she is still experiencing the painful stimulation. The pt reported that the pain used to radiate down her arm but it is not as bad now. She said that the physician ran diagnostics but did not see any problems. As far as efficacy, she reported that she has not had a seizure in four years with vns. The physician's nurse later reported that the pt is having a breast reductions surgery at this time and after that procedure they are going to look into the pt's painful stimulation. The nurse reported that they were not going to provide any further information. Good faith attempts for product information from the implanting hospital were made but no information has been received to date. If additional information is received, it will be reported.
 
Event Description
Additional information was received on (b)(6) 2011 when the implanting hospital provided the patient's generator product information. On (b)(6) 2011, the vns patient reported that a surgeon had scheduled her for breast reduction surgery on (b)(6) 2011 but that on (b)(6) 2011, the surgeon backed out of the surgery. The surgeon told the patient that he was worried that he might damage the vns device and had no assurance that insurance would replace it and could not subject the patient to seizures. The patient reported that he did not allow another colleague to review the case and stated that she should seek a university setting. The patient reported that she wants a breast reduction because there is tension on the vns device that is causing pain even after the device was moved in (b)(6) 2011.
 
Manufacturer Narrative
Initial mdr inadvertently listed wrong product.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2228172


Title: Re: Painful Stimulation
Post by: dennis100 on September 04, 2018, 08:37:59 AM
Model Number 103
Event Date 06/10/2011
Event Type  Injury   
Event Description
Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported that the pt had experienced a breakthrough "major motor seizure" and required medication to sleep due to painful stimulation in her neck. It was noted that the pt recently stopped taking cymbalta which may have been masking the pain or decreasing her awareness of the stimulation as per the physician. X-rays were taken to evaluate for any anomalies that may have been causing the pain however a manufacturer review of the x-rays showed no anomalies. Diagnostics of the vns system suggests no issues. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2167114


Title: Re: Painful Stimulation
Post by: dennis100 on September 04, 2018, 08:38:38 AM
Model Number 102
Event Date 06/01/2011
Event Type  Injury   
Event Description
It was initially reported that the pt began experiencing painful stimulation, continuous stimulation and that her device migrated after passing through an airport metal detector. The pt's mother was concerned and called the paramedics and was planning on taking the pt to the er. There was no reported trauma or pt manipulation. Good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2160609


Title: Re: Painful Stimulation
Post by: dennis100 on September 05, 2018, 08:23:13 AM
Event Date 07/01/2011
Event Type  Injury   
Event Description
It was reported by a company representative that a physician mentioned that he was a pt who suffers from painful stimulation with low output currents and that he is thinking about explanting the device. Physician stated that this pt reacts sensible to all changes of this therapeutic scheme, including medications. The company representative offered the physician assistance regarding all these problems, suggested additional parameter changes to optimize outcome and minimize side effects. Additional info was received from the company representative indicating that the reporting physician was not providing any further detail regarding the pt and the event for the moment. Good faith attempts from additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2235066


Title: Re: Painful Stimulation
Post by: dennis100 on September 06, 2018, 01:42:32 AM
Model Number 302-20
Event Date 07/22/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by the physician that the pt had a high lead impedance, and the pt was stated to have "intermittent somewhat painful stimulation". Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2248025


Title: Re: Painful Stimulation
Post by: dennis100 on September 06, 2018, 01:43:48 AM
Model Number 302-30
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported that the pt had gone through a metal detector and was swiped with the wand multiple times while going through a security check point. She woke up the following day with pain at the electrode site and went to see her physician. Diagnostics were within normal limits and there was nothing found wrong. The pain has continued and the pt has been referred for a surgical eval. Good faith attempts for more info have been unsuccessful to date.
 
Event Description
Reporter indicated the patient was seen in the office on (b)(6) 2012. The vns settings were adjusted which resolved the painful stimulation in the chest and neck, and the patient was having no discomfort by the end of the visit. The vns is reported to be working properly. The vns had previously been disabled temporarily in 2011 due to the painful stimulation.
 
Event Description
Additional information was received that indicated that the patient is not going to have surgery at this time. Diagnostics were run at a recent appointment and were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2229149


Title: Re: Painful Stimulation
Post by: dennis100 on September 06, 2018, 01:44:42 AM
Model Number 302-20
Event Date 04/28/2011
Event Type  Malfunction   
Event Description
It was reported that the vns patient had been experiencing painful stimulation in her neck and her vns generator indicated 4 months left on her vns battery. It was believed that the painful stimulation may have been related to the battery nearing depletion; however, the painful stimulation persisted following vns generator replacement. The explanted generator was returned and no anomalies were found with the performance of the generator. Additional information was later received indicating the patient was being referred for lead replacement because a lead fracture was suspected. A manufacturer representative at the lead replacement surgery discovered that the patient had previously fractured her clavicle prior to the generator replacement and needed to have a plate placed on her left clavicle. The physician believes the placement of the plate damaged the leads. X-rays taken show that the screws of the plate are in the lead path; however, these x-rays have not been forwarded to the manufacturer for review. Lead impedance was normal following the generator replacement as per the physician. The vns lead has been replaced and diagnostics following replacement are normal. Attempts for the return of the explanted lead have been unsuccessful to date. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2241440


Title: Re: Painful Stimulation
Post by: dennis100 on September 07, 2018, 11:26:27 AM
Model Number 102
Event Date 05/04/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient was experiencing pain in their chest with stimulation. The patient said the pain is sharp and is at the incision location of the generator site. The patient was also reported to be experiencing sleep apnea. The patient was recently evaluated by an ear, nose, and throat physician who discovered that the patient has paralysis of the left vocal cord in the median position which is causing the patient dyspnea and coughing. The patient says that the vns does help with seizures and that if the vns is off she will have grand mal seizures. A 14-system review of the patient's systems was done by the physician and the patient was found to have asthma. The patient's settings were output=2. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=3ma/magnet on time=60sec/magnet pulse width=130usec. The physician reported that if the patient's symptoms persist, it may be necessary to explore and possibly replace the generator as she gets benefit from a functioning system. Clinic notes dated (b)(6) 2011 report that the patient has had an increase in seizure frequency over the past few months. The patient has also noticed an increased pain in her left chest in the area of the generator pocket. Diagnostics were performed which revealed no malfunction; specifics were not provided. The physician reported that given the patient's pain in her chest, as well as decreased efficacy within the past 3 months, he is referring the patient for prophylactic battery replacement. Additional clinic notes were received from the physician dated (b)(6) 2011 which revealed that the patient was having an increase in spells. The patient went to the epilepsy monitoring unit and these were non-epileptic. The patient also feels that her asthma has worsened. The patient's settings were output=2. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=3ma/magnet on time=60sec/magnet pulse width=130usec. A battery life calculation was performed with the patient's programming history and it revealed negative years until eri = yes. The patient went for battery replacement surgery on (b)(6) 2011. The manufacture's consultant reported that she has the explanted generator and will be sending it back for product analysis but it has not yet been received. When additional information has been received, it will be reported.
 
Event Description
Additional information was received on (b)(6) 2011 when the explanted generator was returned for product analysis that was completed on (b)(6) 2011. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits.
 
Event Description
Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits. The manufacturer's consultant reported that she made good faith attempts to obtain additional information from the physician concerning the patient's adverse events. The physician reported that the patient is doing well after the generator replacement and that all the patient's issues have resolved except for her pre-existing conditions.
 
Event Description
Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits.
 
Manufacturer Narrative
(b)(6). The aware date as well as the date that the implant card was received should have been listed as (b)(6) 2011.
 
Manufacturer Narrative
The aware date as well as the date that the implant card was received should have been listed as (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2212668


Title: Re: Painful Stimulation
Post by: dennis100 on September 07, 2018, 11:27:01 AM
Model Number 303-30
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 07/08/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The doctor reported that this patient has high lead impedance. The patient went to the er due to a shock like feeling in his neck, stated to be painful stimulation. The patient stated that they turned their head to the left and heard a pop and this is when the painful stimulation began. The generator has been disabled. The lead wires looked more bulging on the skin now compared to when the patient was implanted. X-rays were reviewed by the facility stating that the device looked in-tact. The patient followed up with their neurologist where the neurologist could feel that the wires were fractured in the patient¿s neck, and the patient felt as though the wires were poking him under the skin. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7738760


Title: Re: Painful Stimulation
Post by: dennis100 on September 07, 2018, 11:27:32 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/27/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing pain in the neck and chest when swiping the magnet. The device's settings were lowered due to the painful stimulation. It was reported that this did not resolve the pain which persisted after adjustment, and the patient was referred for surgery for the painful stimulation and discomfort. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7832642


Title: Re: Painful Stimulation
Post by: dennis100 on September 09, 2018, 01:17:11 AM
Model Number 102
Event Date 08/22/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2011, indicating that the pain that the patient was experiencing was attributed to the generator movement in the chest.
 
Event Description
Attempts for additional information regarding the patient's reported pain and migration have been unsuccessful to date.
 
Event Description
It was initially reported that the patient was complaining of pain and twitching in his arm, occurring with stimulation. Additional information was received indicating that the patient was experiencing electrical stimulations in the chest area. Diagnostics were performed and reported to be within normal limits, however no specifics were provided. X-rays were also performed but it is unclear if they will be sent to the manufacturer for review. The patient's device was not disabled, as the patient's neurologist felt that the vns was successfully controlling the patient's seizures. The patient was however referred to a surgeon for possible full revision. Surgery took place on (b)(6) 2011. During the procedure, the lead wire was found to be intact; however the generator was loose in the chest. The old generator was removed and a new generator was securely implanted. The explanted generator has not yet been returned to the manufacturer for analysis. On (b)(6) 2011, it was reported by the patient's surgeon's office that the patient has developed an infection at his generator site, following the replacement surgery. This will be reported under mdr number: 1644487-2011-02286.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266994


Title: Re: Painful Stimulation
Post by: dennis100 on September 09, 2018, 01:17:58 AM
Model Number 302-20
Event Date 07/06/2011
Event Type  Malfunction   
Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the explanted generator. The device performed according to functional specifications and no elective replacement indicator (eri) flags were observed during testing. The device was continuously monitored for 25. 75 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Product analysis on the lead was completed on (b)(4) 2012. A portion of the lead assembly body including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. What appeared to be remnants of dried body fluids were observed inside the outer and inner silicone tubes, in some areas. For the observed fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2011, a vns treating physician reported that the vns pt was experiencing pain from pulsations and contractions on the left side of his neck for a few hours. The pt went to the hospital and x-rays were taken. The physician reported that he noticed a lead fracture in the pt's x-rays; however, the x-rays were not sent to the mfr for review. The physician placed the magnet over the generator and the pt's pain stopped. The physician said that he has not performed diagnostic tests to confirm a lead break because he doesn't want the pt to start having pain in his neck again. The pt's generator was disabled and he was referred for full revision surgery. The pt's programming history was reviewed and the last system diagnostic test listed was from the date of implant, (b)(6) 2006, which revealed output=ok/ lead impedance = ok/ dcdc = 2/ eri = no. Add'l info was requested from the physician, but he reported that they will not fill out any requests for further info. He did say that they could send the pt's medical records, but none have been received to date by the mfr. Although surgery is likely, it has not yet been scheduled. When further info is received, it will be reported.
 
Event Description
Additional information was received on (b)(4) 2011, when it was discovered that the patient was scheduled for a full revision surgery on (b)(6) 2011. The surgery took place that day and the explanted lead and generator were returned for product analysis on (b)(4) 2011, that has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2199433


Title: Re: Painful Stimulation
Post by: dennis100 on September 09, 2018, 01:18:54 AM
Model Number 300-30
Event Date 07/08/2011
Event Type  Malfunction   
Event Description
Additional information was received on (b)(4) 2011, when product analysis was completed on the explanted lead. The green negative electrode, a portion of the white positive and green negative electrode quadfilar coils, and a portion of the anchor tether helical were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 8 mm portion the end of the white positive electrode quadfilar coil appeared to be melted. Scanning electron microscopy was performed and the area was identified as having the appearance of being melted, with re-solidified material. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surface, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool during the explant of this lead. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion of the device; however since portions of the lead were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. What appeared to be remnants of dried body fluids were observed inside the inner silicone tubes, in some areas. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress. Puncture marks were observed on the inner silicone tubes, past the electrode bifurcation. The marks penetrated the insulation and the quadfilar coils appeared to be kinked. Tool marks were observed on the marked connector inner silicone tubing. The marks penetrated the insulation and three of the marked quadfilar coil strands appeared to have been cut in half. The gouge and puncture marks appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. The torn appearance of the electrode bifurcation and kinked quadfilar coil most likely occurred due to manipulation of the lead during the explant procedure. Product analysis on the explanted generator was completed on (b)(4) 2011. The device performed according to functional specifications and no eri flags were observed during testing. The device was continuously monitored for 26. 5 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The consultant reported that he would meet with the physician in september 2011 and would find out how the patient is doing since the full revision surgery. When additional information is received, it will be reported.
 
Event Description
On (b)(6) 2011, a vns treating physician reported that he saw the vns pt on (b)(6) 2011 and the pt was complaining of painful stimulation in the chest area, above the clavicle. The physician did evoked potential monitoring and noticed a break down of skin where the pt was complaining of pain. It appeared that stimulation was stopping at the clavicle where the skin was breaking down. The physician had three sets of x-ray taken and fluoroscopy performed all of which will not be sent to the mfr for review. The physician reported that the x-ray did not show any lead breaks. The pt's device was disabled and the painful stimulation resolved. The pt was then scheduled for a full revision surgery. The pt is a swimmer and does do butterfly stroke, but no trauma or manipulation was reported. The physician believes that the lead is frayed and did not want to perform any diagnostics because the pt was in pain. The consultant requested that diagnostics then be performed prior to surgery when the pt is under anesthesia. The consultant was unable to attend the pt's full revision surgery on (b)(6) 2011; therefore, the operating room circulating nurse reported that she would have either the neuro-tech who normally does the vns programming in the operating room to call the consultant once the system and normal mode diagnostics were run prior to the pt's revision surgery. The consultant never received a call so it was unk at this time whether diagnostics were indeed performed. The consultant is scheduled to meet with the surgeon at a later date. The lead impedance was reported to be ok after the surgery. The explanted product was returned for product analysis on (b)(6) 2011, which has not yet been completed. The pt's programming history was reviewed which revealed that the pt's last system diagnostic test was performed on november 10, 2010 which showed output = ok/lead impedance = ok/dcdc = 1/eri = no. The pt's settings on (b)(6) 2010 were output - 2ma/frequency = 20 hz/pulse width = 250 usec/on time - 21 sec/off time = 3 min/magnet output = 2. 75 ma/magnet pulse width = 250 usec/magnet on time = 60 sec. A battery life calculation was performed with the programming history available which revealed 6. 91 years until eri = yes. When add'l info is received, it will be reported.
 
Manufacturer Narrative
Method: analysis of programming history.
 
Event Description
The patient's father wrote a book describing the patient's epilepsy. The book described the painful stimulation that occurred in (b)(6) 2011. The book reported the electrical charge was leaving the stimulator properly. It was stopping right where [the patient] was feeling the shock. There was also a description of a red mark on the shoulder, near where the painful stimulation was occurring. The red mark on his shoulder was described as directly over the path of the wire that was hooked up to his stimulator. The patient's physician reportedly turned the device off due to the painful stimulation.
 
Event Description
On (b)(6) 2011, additional information was received when the physician reported that the patient has been doing well with no painful stimulation since replacement surgery.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2201312


Title: Re: Painful Stimulation
Post by: dennis100 on September 09, 2018, 01:20:10 AM
Model Number 102R
Event Date 08/17/2011
Event Type  Injury   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the pt was experiencing painful stimulation in his ear and neck. The pt's vns was reportedly lowered and the pain resolved initially however the pt reported later that he was still experiencing pain. X-rays have been taken and sent to the manufacturer for review. No anomalies of the lead that could be the cause of the painful stimulation were observed. Vns diagnostics were not taken at the pt's office visit. Surgery to replace the pt's vns generator has occurred. The explanted generator has been returned and is currently undergoing analysis. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276539


Title: Re: Painful Stimulation
Post by: dennis100 on September 09, 2018, 01:20:51 AM
Model Number 102
Event Date 09/01/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
 
Event Description
Good faith attempts for more information have been unsuccessful to date.
 
Event Description
It was initially reported that the patient was experiencing intermittent painful stimulation. The patient had some swelling and redness on her chest. The patient was on her way to the emergency room at the time of the report. The patient had not been disabled but disablement was likely. Last diagnostics at the time of the report were within normal limits. No further information know regarding these events, when more information is known it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2262660


Title: Re: Painful Stimulation
Post by: dennis100 on September 09, 2018, 01:22:26 AM
Model Number 103
Event Date 07/11/2011
Event Type  Injury   
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns patient experienced bradycardia after battery replacement surgery that day. The medical professionals in the operating room determined that the bradycardia was related to normal mode stimulation of the vns. The bradycardia occurred during the cycles of stimulation which led to 4 events of arrhythmia. System diagnostics performed during surgery showed output = ok/lead impedance = ok/impedance value = 1394/eri = no. The patient was given robinul and oxygen and the bradycardia subsided. The patient has a history of hypertension and pre-existing medical conditions of seizure disorder, asthma, and diabetes. The patient's heart rate and blood pressure prior to the bradycardia was 77 bpm and 180/83 respectively. During the bradycardia event the heart rate and blood pressure were 36 bpm and 110/70. The event did not occur intraoperatively; the event occurred in the recovery room after implant that day. The patient also perceived some pain with stimulation. There were no triggers or traumatic events other than surgery. The patient was not taking any medications; just general anesthesia. The patient is not currently programmed on and the arrhythmia event has not recurred. If additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196485


Title: Re: Painful Stimulation
Post by: dennis100 on September 10, 2018, 08:12:46 AM
Model Number 304-20
Event Date 08/26/2011
Event Type  Malfunction   
Event Description
Additional information was received regarding the patient. X-rays are not going to be provided to the manufacturer. There was no known manipulation or trauma also no causal or contributory programming or medication changes precede the onset of the high impedance. Product analysis has been completed on the lead. A break was identified in the positive coil. Also, abraded openings in the outer silicone tubing and an abraded opening in the inner silicone tubing of the positive coil were identified. Scanning electron microscopy images of the positive coil broken ends show that pitting or electro-etching conditions have occurred in at least one strand at the break location. The broken strands of the quadfilar coil show appearance of a stress-induced fracture (due to rotational forces). Also, the early stages of secondary breaks were identified in the vicinity of the broken strands. Other than the above mentioned observations and typical wear and explant related observations, no additional anomalies were identified within the returned lead portions.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient was experiencing painful stimulation. X-rays were taken (no provided to the manufacturer) that were reported to show the lead had become disconnected from the generator. The patient had their lead replaced and it has been returned to the manufacturer for evaluation. Product analysis is plan but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2251471


Title: Re: Painful Stimulation
Post by: dennis100 on September 10, 2018, 08:13:31 AM
Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was reported that the pt was experiencing painful stimulation in her throat. The pt was referred to a surgeon and had vns explanted on (b)(6) 2011. It is unk why is was decided to explant the device. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2249065


Title: Re: Painful Stimulation
Post by: dennis100 on September 10, 2018, 08:14:11 AM
Model Number 103
Event Date 08/19/2011
Event Type  Injury   
Event Description
It was reported that the patient had a vns generator revision because he was experiencing painful stimulation. It appears that the neurologist also referred the patient for a vns lead revision based on the painful stimulation however the surgeon stated that he chose not to because the vns system diagnostics were normal and the painful stimulation appeared only to have occurred when the patient's output current was set to 3. 0ma. The generator was also reportedly at end of life however based on the known settings, it is unlikely that the generator has reached end of service. The explanted vns generator has been received and is currently undergoing analysis. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2257026


Title: Re: Painful Stimulation
Post by: dennis100 on September 11, 2018, 02:58:49 AM
Model Number 300-20
Event Date 10/04/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2011, clinic notes were received from the vns treating physician. Clinic notes dated (b)(6) 2011 revealed that high impedance was discovered. A system diagnostics test performed showed output=limit/lead impedance=high/dcdc=7/eri=no. The patient's settings were output=1. 75ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=2. 0ma/magnet on time=60sec/magnet pulse width=500usec. The physician referred the patient for x-rays and for lead revision surgery. Also on (b)(6) 2011, the manufacturer's consultant reported that the vns patient had been experiencing painful stimulation prior to the high impedance being discovered. The patient's programming history was reviewed and a battery life calculation was performed which revealed 2. 46 years until eri=yes. Attempts have been made for additional information from the physician, but no further information has been received to date. Although surgery is likely, it has not yet occurred.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2011, additional information was received when it was discovered that the vns patient's family has decided not to replace the patient's vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2303433


Title: Re: Painful Stimulation
Post by: dennis100 on September 11, 2018, 02:59:40 AM
Model Number 103
Event Date 04/28/2011
Event Type  Injury   
Event Description
Clinic notes were received on (b)(6) 2015 which provided additional information. There was neck pain in (b)(6) 2011 which was attributed to inadvertent swipe of magnet and then continued for 2 days. It was noted that on (b)(6) 2011 there was improvement of pain symptoms (generator was replaced on (b)(6) 2011). It was noted on (b)(6) 2011 that there were no seizures and the patient was tolerating vns well.
 
Event Description
It was reported that the pt was being referred for vns generator replacement because the pt had been experiencing painful stimulation in her neck for some time and the physician felt that "nerve damage" may have occurred. The pt's stimulation had been turned down previously to reduce the pain; however, the pt experienced breakthrough seizures as a result. Attempts for further information have been unsuccessful to date. Surgery to replace the pt's generator has occurred. Attempts for the return of the pt's generator are in progress.
 
Event Description
Additional information was received indicating that the explanted vns generator was discarded following replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2314806


Title: Re: Painful Stimulation
Post by: dennis100 on September 11, 2018, 03:00:18 AM
Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned as a result of operational context, but did not cause or contribute to a death or serious injury.
 
Event Description
The implant card was received which confirmed the generator and lead replacement on (b)(6) 2013. An analysis was performed on the returned lead portion and the reported lead fracture was not confirmed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated allegations. During the product analysis there were no anomalies found with the pulse generator. The generator performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially from the neurologist that on (b)(6) 2013 the patient was leaning down and his head on a cabinet, fell, and neck went down. Since that time, he had a pulsing sensation and pain in the left neck area. These symptoms were not present before he hit head. He reports that he has had good seizure control with vns and has not noticed an increase in seizures since the pain started although neck pain is intense. However, when the patient moved next a certain way, he felt better. Due to the trauma to neck, the lead was now protruding and the patient experiences the pulsing sensation/pain during stimulation on times. Before the accident, no lead could be seen. Diagnostics performed by the company representative on this date were within normal limits. The device was left on at lower settings because the patient did not want seizures to return. The patient was referred for a/p and lateral x-rays. X-rays were taken but a copy will not be returned to the manufacturer. Due to the patient¿s benefit with vns therapy, he was referred for generator and lead revision surgery for patient comfort and not to preclude a serious injury. The patient had full revision surgery on (b)(6) 2013, and during the surgery, the surgeon saw a lead fracture but he had to cut the lead to remove everything. There was movement noted when the device stimulated. The prior coils were left intact on the nerve. The explanted devices were received by the manufacturer on (b)(6) 2013. However, product analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2968752


Title: Re: Painful Stimulation
Post by: dennis100 on September 11, 2018, 03:01:31 AM
Model Number 102
Event Date 07/06/2011
Event Type  Injury   
Manufacturer Narrative
 
Event Description
An implant card was received to the manufacturer indicating the patient had vns generator replacement surgery performed on (b)(6) 2012 due to end of service. The explanted vns generator was discarded by the hospital.
 
Event Description
Reporter indicated to the manufacturer via clinical notes received that a patient was having difficulty tolerating vns stimulation and was having increased seizures. Lamictal medication was increased and the seizures improved. It is not known what to attribute the seizure increase too, or what the level of the seizure increase is compared to pre-vns baseline levels. The patient has not had any generalized seizures, only partial onset seizures. The vns generator was also reported to be at end of service, but it was unclear if the increased seizures were felt to be related to the vns end of service. The patient also had botox injections due to the painful vns stimulation without relief. It is unknown if the botox injections were performed for patient comfort or to preclude a serious injury. The vns is set to low settings. Surgery to replace the vns generator is not planned until (b)(6) 2011 at the patient's request.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2302041


Title: Re: Painful Stimulation
Post by: dennis100 on September 12, 2018, 02:43:57 AM
Model Number 103
Event Date 11/13/2010
Event Type  Injury   
Event Description
Reporter indicated vns revision surgery was tentatively planned for (b)(6) 2012. The patient later had vns generator and lead replacement surgery performed on (b)(6) 2012. The explanted generator has been returned and is pending analysis. The explanted lead was discarded by the hospital.
 
Event Description
Manufacturer follow-up with the surgeon's office revealed the patient has scheduled and cancelled her surgical consult appointment for the vns generator migration and pain three times. Due to the multiple cancellations, the surgeon's office will no longer see the patient for a surgical consult. All attempts to the reporter for additional information have been unsuccessful to date.
 
Event Description
Reporter indicated a patient was being referred for a surgical consult due to the vns generator migrating in the chest and causing pain. Attempts for further information are in progress. Surgery to reposition or replace the generator appears likely. The patient previously had generator repositioning surgery on (b)(6) 2011 due to migration; the surgery was done for patient comfort only and not to preclude a serious injury.
 
Event Description
Product analysis was completed on the returned vns generator. No anomalies were identified, and the generator performed per specifications.
 
Event Description
Reporter indicated the patient presented to the office on (b)(6) 2012 complaining of painful stimulation on her left side and when lying down. Vns diagnostics were reported as ok, and the vns output current is set to 0. 5ma. The patient then reported to the manufacturer on (b)(6) 2012 that she was having pain in her neck and chest. Before the pain started, the patient had been in a physical domestic dispute, and was assaulted. There is also swelling at the generator site per the patient. The patient was referred back to her treating physicians, who were also notified of the events by the manufacturer. The patient has been referred for vns lead and generator revision surgery, but a consult has not occurred to date.
 
Event Description
Reporter indicated the patient was seen in clinic on (b)(6) 2011 and vns diagnostics were normal and the patient is doing well at this time. Surgical intervention is no longer planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2288147


Title: Re: Painful Stimulation
Post by: dennis100 on September 12, 2018, 02:44:30 AM
Model Number 102
Event Date 05/04/2011
Event Type  Injury   
Event Description
Reporter indicated a patient's vns generator had migrated upward in the chest, and the patient would massage the generator back down into the correct position. The patient was also experiencing painful stimulation in her neck and in her chest at the generator site. The vns hz setting was decreased as an intervention for the painful stimulation. The patient had no known trauma. Surgery to reposition or remove the vns appears likely, but has not been scheduled to date.
 
Manufacturer Narrative
 
Event Description
Manufacturer follow-up with the vns implanting surgeon revealed a non-absorbable suture was used to secure the generator to the fascia during implant of the vns on (b)(6) 2011, which is recommended per manufacturer labeling. Reporter indicated surgery is not planned at this time. The vns has been disabled and the patient will be monitored for the next 3-6 months for seizure activity and the need for surgery will be reassessed at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2292738


Title: Re: Painful Stimulation
Post by: dennis100 on September 12, 2018, 02:45:37 AM
Model Number 102
Event Date 02/22/2011
Event Type  Malfunction   
Event Description
The reporter indicated that the patient had no trauma or events that led up to the pain, burning, itching, and "random firing of the vns. " surgery to replace the vns appears likely and is tentatively scheduled for (b)(6) 2013. Attempts for additional information are in progress.
 
Event Description
Reporter indicated that vns generator replacement surgery is still planned. The vns generator is to be replaced for patient comfort and to preclude a serious injury.
 
Manufacturer Narrative
Event is both a serious injury and a product problem. Overall reportability of event is a malfunction. Manufacturer reviewed x-rays of implanted device. This code was inadvertently omitted form the initial mdr report. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. This code was inadvertently omitted form the initial mdr report.
 
Manufacturer Narrative
 
Event Description
Reporter indicated a vns patient was having painful, erratic stimulation in the neck and chest. Vns settings were lowered and the painful stimulation improved. The patient had no known trauma. Current vns diagnostics cannot be performed as the patient cannot tolerate the 1ma output current necessary to complete the test. X-rays were reviewed by the manufacturer and no obvious anomalies were identified. A vns generator battery estimate performed yielded approximately 7. 97 years remaining. Vns generator replacement appears likely, but has not been scheduled to date. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient had vns generator replacement surgery performed on (b)(6) 2013. Preoperative vns diagnostics indicated normal device function. It was the opinion of the current surgeon that the original implanting surgeon ¿probably had the coils a little close to the laryngeal nerve¿. The explanted generator was received back to the manufacturer on (b)(4) 2013 and is pending analysis.
 
Event Description
Reporter indicated the patient presented at clinic on (b)(6) 2013 with pain, burning, itching and "random firing of the vns. " surgery to replace the vns appears likely. Attempts for additional information are in progress.
 
Event Description
Analysis was completed on the returned vns generator. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
Reporter indicated the patient's vns generator replacement surgery was on hold due to insurance issues, but surgery is still planned. Although vns diagnostics are within normal limits, the reporter feels there may be a "problem with the generator" and that the patient may benefit from having generator replacement surgery performed prophylactically.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2299589


Title: Re: Painful Stimulation
Post by: dennis100 on September 12, 2018, 02:46:31 AM
Model Number 304-20
Event Date 07/01/2011
Event Type  Malfunction   
Event Description
It was reported that the patient had an or date for exploration of a vns revision. The revision took place on (b)(6) 2011. Additional information was received from the patient's surgeon's office on (b)(6) 2011, indicating that the patient underwent a lead revision on (b)(6) 2011, due to painful stimulation. The physician suspected that there was a device malfunction. The patient's generator had previously been disabled because the patient was complaining of painful muscle spasms in the neck. During the revision surgery, a cervical dissection of the patient's 10th cranial nerve was also performed. No diagnostics were provided and there were no specifics available regarding the type of lead malfunction which may have been occurring. The patient's generator was turned back on during a follow up visit on (b)(6) 2011. While following up with the surgeon's office, it was also indicated that, since the patient,s recent revision, the patient is experiencing vocal cord paralysis. This will be reported under medwatch number: 1644487-2011-02436 attempts for additional information and product return have been unsuccessful to date.
 
Event Description
Additional information was received from the patient's neurologist indicating that the suspected lead issue was causing the muscle spasms. There was no believed trauma or manipulation that caused the lead issue. Diagnostic results were not provided, and there were no details on the suspected type of device issue; high impedance, low impedance, leads fracture, etc. The explanted products have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2292977


Title: Re: Painful Stimulation
Post by: dennis100 on September 13, 2018, 02:11:07 AM
Model Number 102
Event Date 08/11/2011
Event Type  Injury   
Event Description
Additional information was received that they have tried to increase the patient's settings but she developed ringing in her ears. The patient reported that her vns has been moving. About a year ago she was run over by a horse and has had issues with vns since. She was in the hospital for concussion. It was reported her lead was ok. She was seen by a surgeon and the generator for the device has become dislodged from the subclavicular area into her left breast. This is causing tension on the implant wires and the device is quite painful within her breast. She feels the device is still functional and she can feel when it activates with temporary hoarseness. Fiberoptic laryngoscopy shows normal true vocal fold movement. She does have some baseline hoarseness and she does smoke. Her seizures have been under much better control with the device. If the patient has surgery they will attempt to create a new pocket higher on the chest and secure the implant to the pectoralis fascia. At this time surgery is not scheduled.
 
Event Description
The patient's generator was confirmed to have migrated during revision surgery. The suture attaching the generator in the pocket had become dislodged likely when the patient fell off their horse. The product analysis was completed on the patient's explanted lead. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the explanted generator. Although the reported allegation of "painful stimulation", "increased seizures", and "pain" cannot be evaluated in the laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, addressing the allegations of "painful stimulation" and "pain". In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
It was reported that the patient was feeling a "shocking feeling" in chest near generator when sleeping on side. Per patient, a horse fell on her, and she had an x-ray in (b)(6) 2010. Further information reveals that the patient also has pain in her neck and chest below the neck and has experienced an increase in seizures recently. Per reporter, the lead was checked awhile ago and everything was okay. The patient later went to the er due to the pain and she feels her generator is moving around. Attempts for further information have been unsuccessful to date.
 
Event Description
Additional information was received from the patient. She reported that diagnostics had been run on her vns since her horse accident. She reported that one time they were inconclusive and then the next time they were fine. She also mentioned that sometimes she has a pain with stimulation and then at times the magnet doesn't always work and she has to swipe it twice. The patient had a prophylactic replacement of their lead and generator. Their explanted products were returned for analysis and they are pending completion. The patient's voice alteration was a preexisting condition, but she still had it with vns stimulation as well.
 
Event Description
Further information reveals that the patient has fibromyalgia and other problems, so her personality changes quite a bit and she blames things. The patient also had an ear infection that has been treated. Recent diagnostic tests were normal and ok (system and normal mode). Her vns settings have been the same since she's had it, once it reached a therapeutic dose. Nothing has changed with her other than her other non-vns related issues. There has not actually been an increase in seizures, she just had one. She said she has not had any seizures in 6 months, and this seizure was believed to be due to the ear infection and sickness. It is unknown whether chest pain is due to stimulation. The patient taped the magnet over her chest for days and had no stimulation, but said she still had the pain occasionally. The physicians do not know what the pain is from, possibly anxiety. It is unknown what kind of suture was used to secure the generator. The patient had previously indicated that a horse fell on her, but diagnostics were normal after that event. No patient manipulation of device has occurred. No interventions have been taken.
 
Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2353195


Title: Re: Painful Stimulation
Post by: dennis100 on September 13, 2018, 02:11:45 AM
Model Number 102
Event Date 09/01/2011
Event Type  Injury   
Event Description
Further information indicates that the patient has recently turned her device off a few times with her magnet due to painful stimulation. Clinic notes from (b)(6) 2011 were received indicating that the patient's pain in neck and seizures were worse, though the patient has been doing well overall with vns. Per notes, the physician increased the output and pulse width and was to reassess in 3 months. It also noted that the patient wakes up with bifrontal headaches which have been worse for the past 6-7 months.
 
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing an increase in seizures and also reported an increase in migraines. The patient had a surgical consult for possible generator replacement. The patient has had great efficacy with vns (is off seizure medications and no longer uses a wheelchair) and does not want the battery to deplete. The patient is also feeling pain at the generator site with stimulation and feels like the generator is vibrating. The patient was seen by a surgeon and the generator was determined to be operating fine. Exact diagnostic results not given. X-rays were taken of the device, but have not been sent to manufacturer for review. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2275285


Title: Re: Painful Stimulation
Post by: dennis100 on September 13, 2018, 02:12:23 AM
Model Number 300-20
Event Date 09/09/2011
Event Type  Malfunction   
Event Description
Reporter indicated that vns high lead impedance readings were obtained for a patient at an office visit. No trauma or device manipulation had occurred. The vns was not disabled, but the reporter was made aware of the manufacturer's recommendation to disable the vns when high lead impedance is noted. The patient is also experiencing painful stimulation at the vns generator site. Surgery to replace the vns lead and generator appears likely. Attempts for further information are in progress.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
All attempts to the reporter for additional information have been unsuccessful to date.
 
Event Description
Reporter indicated the patient had vns generator and lead replacement surgery performed. A lead fracture was not observed during the surgery. The explanted generator and lead were discarded by the hospital.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2277640


Title: Re: Painful Stimulation
Post by: dennis100 on September 13, 2018, 02:13:11 AM
Model Number 103
Event Date 02/23/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received indicating that the patient's painful stimulation started following her generator being programmed back on in (b)(6) 2011. During stimulation, the patient experienced pain in left side of neck that proceeded to back of her head. She also noted more pain during magnet activation. She does; however, have seizure control. The patient's settings were provided and diagnostics were also run with ok results, however, no specifics were provided. The physician then lowered the patient's signal frequency to 20hz and pulse width to 250usec. The patient's magnet mode pulse width was also adjusted to 250usec. Diagnostics were repeated and tested ok. The patient was able to tolerate both normal stimulation and magnet stimulation following these adjustments and stated it was much better. The patient also complained of chest discomfort at generator site which the physician felt it was due to scar tissue and not stimulation related. The change in patient settings was performed for patient comfort, and no other interventions are planned at this time.
 
Event Description
It was reported that the patient was experiencing constant burning at her generator site as well as a shooting pain into the back of her head, hot flashes, and trouble breathing when her device would go off. This started following her recent replacement in (b)(6) 2011. The patient was told that this may be due to a lack of fatty tissue and possible scarring. The patient has been referred for a generator, and possible lead replacement. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2351767


Title: Re: Painful Stimulation
Post by: dennis100 on September 13, 2018, 02:14:03 AM
Model Number 103
Event Date 10/28/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when the patient reported that she is having bradycardia episodes when her vns goes off. The patient stated that she has an appointment with her cardiologist that day. She states she has a pacemaker, but in the conversation she says that her heart rate goes down to 20 beats per minute and she starts to feel worse. According to the patient she experience dizziness, nausea and ringing in her ears when her heart rate gets so low.
 
Event Description
On (b)(6) 2011, a vns patient reported that she had a seizure on (b)(6) 2011 and fell on her face and broke her nose. She stated that her vns settings had been increased on (b)(6) 2011. While in the hospital having surgery on her nose, the patient was hooked up to the heart monitor. It was discovered that every five minutes when the vns device stimulated, the heart monitor would alarm and her heart would skip two beats. The patient reported that she is also experiencing some shortness of breath. The patient was scheduled to see her neurologist on (b)(6) 2011. The neurologist later reported that the patient's arrhythmia (heart skipping 2 beats) was first noticed on (b)(6) 2011 and was related to the vns stimulation. The neurologist decreased the patient's settings as the arrhythmia event appeared to have occurred after the programmed settings were increased and a holter monitor was used. The patient does not have a medical history of arrhythmia prior to this event. The neurologist reported that it is unknown if the arrhythmia event has recurred, they are in the process of evaluating this. Good faith attempts were made to the patient's implanting hospital for the lead product information but no further information has been received to date. On (b)(6) 2011, the vns patient reported that she is experiencing a slow heart rate as well as the heart rate skipping with stimulation. The patient reported that after the neurologist increased her settings on (b)(6) 2011, she also experienced coughing and painful stimulation. After 10-14 days the events stopped and the patient said she could tolerate settings. The patient stated that after her seizure on (b)(6) 2011, she had another one on (b)(6) 2011. She stated that she saw a physician on (b)(6) 2011 and was referred to an ear nose and throat surgeon on (b)(6) 2011 to operate and repair her nose. On (b)(6) 2011, she had the surgery and during pre-op, she was hooked up to the heart monitor which revealed a slow heart rate and that every five minutes , her heart skipped two beats. The ear nose and throat surgeon informed her to go back to the neurologist to have the settings decreased. The patient's settings were decreased but the patient's heart was still skipping and at half rate according to the holter monitor. The patient was referred to a cardiologist and stated she is going to have a pacemaker implanted. The patient also reported that prior to vns, she did not have any pre-existing heart conditions. The patient further divulged that she has been now diagnosed with a/v stage 2 heart disease and claimed that her heart is only beating 24 beats/minute. On (b)(6) 2011, the patient had a pacemaker implanted. Prior to surgery the patient's output was decreased to 1. 75ma and the patient's heart rate was in the 50's bpm, at 1. 5ma the patient's heart rate was in the 60 bpm (so within normal limits), then at 2. 25ma, the patient's heart rate was in the 40's bpm, and lastly at 2. 5ma, the patient's heart rate showed 40 bpm. The patient's device was then turned off and the patient did not experience bradycardia. The surgeon implanted the pacemaker with the vns disabled through the entire procedure and the patient did not experience bradycardia. After the pacemaker was implanted, the vns was programmed back on. The patient was set to varying settings and the pacemaker was observed to be pacing indicating a decrease in the patient's heart rate. The pacemaker was able to keep the patient's heart rate within normal limits when the vns stimulated. With the patient turned to an output of 2. 0ma, the patient's heart rate was in the mid 60's-68bpm. System diagnostics were performed which showed output=ok/lead impedance=ok/impedance=2834ohms/ifi=no. The patient was programmed to output=2ma/frequency=20hz/pulse width=130usec/on time=21sec/off time=5min/magnet output=2. 25ma/frequency=60hz/pulse width=130usec. The patient wants her device at a higher output current because this is where she reaches efficacy.
 
Event Description
On (b)(6) 2014 it was discovered that this event was reported in a duplicate report; on mfr. Report # 1644487-2014-01642.
 
Event Description
Additional information was received on november 29, 2011 when the patient provided further information that her heart missed two beats every 5 minutes. The patient said that since she has had the pacemaker implanted everything is fine. The patient said that vns has been great for her and she still wants it implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2347665


Title: Re: Painful Stimulation
Post by: dennis100 on September 14, 2018, 08:21:56 AM
Model Number 302-20
Event Date 10/21/2011
Event Type  Malfunction   
Event Description
During a prophylactic vns generator replacement surgery, fluid was noted to be in the vns lead body by the reporter. The lead was not explanted and vns diagnostics were within normal limits with the new generator and resident lead. The patient was also experiencing a shocking sensation and painful vns stimulation. Follow up with the patient's treating neurologist revealed it was not known anatomically where the painful vns stimulation was occurring, but this had resolved since the generator was replaced and the vns is working properly. The painful stimulation was felt to be related to the vns. Manufacturer review of the device history record for the lead documents the lead met all quality testing requirements prior to distribution.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2337297


Title: Re: Painful Stimulation
Post by: dennis100 on September 14, 2018, 08:22:36 AM
Model Number 103
Event Date 10/04/2011
Event Type  Malfunction   
Event Description
It was reported that the pt's vns indicated high impedance during a routine office visit. The pt reported that he had been experiencing an increase in seizures below the pre-vns baseline seizure frequency and having sharp pains in his neck that began around the same time. No trauma or manipulation was reported. No x-rays were taken. The pt's generator was not disabled but the pt was referred for surgery. During surgery, high impedance was not observed and the surgeon opted to just replace the pt's generator. Diagnostics following generator replacement were normal with an impedance value of about 3000 ohms. Per hosp policy, the site does not normally return the generator. Add'l info was received from a mfr rep indicating that the pt's pain was located in the chest and associated with vns stimulation. The pt has reportedly not had any issues following surgery. Attempts for further programming history have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2380274


Title: Re: Painful Stimulation
Post by: dennis100 on September 14, 2018, 08:24:48 AM
Model Number 302-20
Event Date 08/24/2011
Event Type  Malfunction   
Event Description
Reporter indicated a vns patient was experiencing painful "stinging" stimulation in the neck that would cause headaches. The patient was referred for a surgical consult for the painful stimulation, but surgery is not planned at this time. The vns diagnostics history is reported to be currently a dcdc code = 0, indicating low impedance. As the low impedance is occurring in conjunction with the painful stimulation, a short circuit condition of the lead may be occurring. Review of previous vns diagnostics history shows a dcdc code = 3 in 2007. As this has currently dropped to a dcdc code = 0, a short circuit condition is suspected. Attempts for additional information are in progress.
 
Event Description
Reporter indicated the patient had vns generator replacement surgery performed on (b)(6) 2012. An implant card was also received to the manufacturer indicating diagnostics with the new vns generator and resident lead were within normal limits. The generator was returned on (b)(6) 2012 and product analysis is pending.
 
Event Description
Reporter indicated the patient was seen in clinic on (b)(6) 2012. Systems and normal mode diagnostics were within normal limits. The patient's painful stimulation in the neck resolved with a decrease in the output current from 1. 25ma to 1. 0ma. In addition, the patient has voice alteration with stimulation, indicating the intended therapy is likely being delivered. No surgery to replace the vns generator or lead is planned at this time; the family may wish to replace the generator later this year.
 
Manufacturer Narrative
Type of report, corrected data: the initial mdr report inadvertently omitted the 30-day report designation.
 
Event Description
Reporter indicated to the manufacturer that it is unknown on which vns diagnostics test the high lead impedance was obtained (systems or normal mode diagnostics). The patient had no known trauma and does not manipulate the vns. X-rays were not performed.
 
Event Description
All further attempts to the reporter for additional information have been unsuccessful to date. Per the patient's caregiver, the patient is to have additional vns diagnostics testing performed before seeing the surgeon again, but this has not occurred to date. In addition, the patient had seen a new neurologist in (b)(6) 2011. Lamictal medication was increased and the vns settings were changed, which resolved the painful vns stimulation and pain. It is still unknown if the dcdc = 0 result originally reported was received on a systems or normal mode diagnostics test. No surgery date has been scheduled to date.
 
Event Description
Analysis of the vns generator was completed. No anomalies were noted, and the generator performed per specifications. The generator was not at end of service.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2342431


Title: Re: Painful Stimulation
Post by: dennis100 on September 14, 2018, 08:25:51 AM
Model Number 102
Event Date 11/14/2008
Event Type  Malfunction   
Event Description
On (b)(6) 2011, a vns implanting surgeon reported that the vns patient had been experiencing painful stimulation since 2007 and that her device had been disabled. The patient reported that she wanted the generator replaced. The surgeon reported that he thinks a new generator would not cause the painful stimulation as it would not be malfunctioning. It was discovered that previously in (b)(6) 2008 the patient had complained to her vns treating physician about painful stimulation even at an output of 0. 25ma since she was implanted. The patient's device was disabled in (b)(6) 2008 per patient request due to the discomfort. The patient at that time reported that she had wanted the device to be explanted but then later decided to leave it implanted. Good faith attempts were made for additional information about the patient's painful stimulation but no further information was received. On (b)(6) 2011, the manufacturer's consultant reported that the patient is having a prophylactic battery replacement that day because the surgeon feels that since the patient is having painful stimulation, it would resolve with generator replacement and with moving the generator from the axilla to the subclavicle. He also stated that on (b)(6) 2011 the patient's device was programmed back on and that the patient was not complaining of painful stimulation. A battery life calculation was performed with the programming history available which revealed 8. 22years until eri=yes. Good faith attempts will be made for the return of the explanted product for product analysis.
 
Manufacturer Narrative

Event Description
Additional information was received as an implant card confirming the generator replacement. Attempts for return of the explanted generator have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2331436


Title: Re: Painful Stimulation
Post by: dennis100 on September 14, 2018, 08:26:52 AM
Model Number 302-20
Event Date 10/13/2011
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2011, when product analysis was completed on the explanted generator. Product analysis revealed that the generator was at end of service and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator. The septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #1 inadvertently did not include product analysis results for the generator.
 
Event Description
On (b)(6) 2011, the vns patient's caregiver reported that the patient during the patient's battery replacement on (b)(6) 2011, due to end of service, the surgeon noticed that the lead was broken and that there was water in it. The caregiver reported that the surgeon said that this may have caused the generator to short and to stop working effectively. The surgeon then replaced the lead along with the generator. The manufacturer's consultant reported that prior to surgery, she had tried to interrogate the patient's generator, but it was at end of service and therefore could not be interrogated nor could diagnostics be performed. The surgeon reported that no x-rays were taken prior to the patient's surgery. It is unknown if patient manipulation or trauma occurred that is believed to have caused or contributed to the lead fracture and fluid leak. The surgeon reported that the patient's generator was at end of service and therefore could not be interrogated. The surgeon also stated that the patient's family reported that the patient had been complaining of neck pain with stimulation. The generator and lead were returned for product analysis on (b)(6) 2011, that has not yet been completed.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(6) 2011, when product analysis was completed on the explanted lead. A hole appeared to have been cut out of the outer silicone tubing. This hole could have provided the leakage path for the fluid leak allegation by the surgeon, but fluid was not present during the product analysis. The hole found on the outer silicone tubing and the incision mark appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. An abraded opening of the positive inner tubing was observed near the anchor tether that product analysis discerned could be due to wear. No other obvious anomalies were noted except for the half set of setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, another set of setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was indeed present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. What appeared to be remnants of dried body fluids were observed inside the inner silicone tubes, in some areas, but there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. However, product analysis reported that it is possible that the abraded positive inner tubing opening near the anchor tether may have contributed to the painful stimulation allegation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2324408


Title: Re: Painful Stimulation
Post by: dennis100 on September 15, 2018, 01:54:24 AM
Model Number 102
Event Date 10/01/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the patient¿s vns was explanted. It was unknown when and where the surgery occurred; therefore, product return attempts cannot be made. Good faith attempts to the physician for further information were unsuccessful.
 
Event Description
It was reported that a patient's device could not be interrogated. The wand was repositioned several times and the programming system worked successfully on other patients a few days prior to this appointment however communication could not be established with this patient's device. The physician stated the last time the device was checked was about a year ago. The patient could feel stimulation in the neck and was having voice alteration with magnet stimulation. There was no increase in seizure activity. The patient was reporting some painful stimulation in the chest area over the past few weeks which led to the appointment. The wand battery was checked and was verified to be sufficient and the handheld device was not plugged into the wall. All cable connections were verified to be secure however the physician would obtain various warning messages indicating that communication with the patient's device could not be established. The physician was unsure as to whether or not the patient's device was at end of service and wanted to have the device checked again. It was suggested to the physician that the device be checked soon so there are no breaks in the patient's therapy if the device is at end of service. A battery life calculation was performed using the patient's programming history available in the manufacturer's programming history database which indicated the device was at or nearing end of service. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2316948


Title: Re: Painful Stimulation
Post by: dennis100 on September 15, 2018, 01:55:28 AM
Model Number 303-30
Event Date 09/15/2011
Event Type  Malfunction   
Event Description
Reporter indicated the patient's painful vns stimulation was experienced at the chest wall location. The patient had no known trauma and did not manipulate the vns. Vns diagnostics tests prior to explant of the device were within normal limits per the reporter. In addition, x-rays of the vns did not indicate any adverse findings or fractures. The reason for the explant of the vns was due to lack of efficacy per the reporter.
 
Manufacturer Narrative
Suspect medical device, corrected data: the incorrect lot number was inadvertently reported on the initial mdr report. The correct lot number is provided.
 
Event Description
All attempts for further information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
Reporter indicated a patient had their vns generator and lead removed due to "shocking" sensations, lack of efficacy, and suspected damage to the vns lead due to a mri being performed. No new vns devices were implanted. The explanted devices will not be returned per hospital policy. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2317767


Title: Re: Painful Stimulation
Post by: dennis100 on September 15, 2018, 01:56:48 AM
Model Number 302-20
Event Date 12/01/2011
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2012, when the explanted lead and generator were returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.
 
Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator. Product analysis of the lead was completed on (b)(6) 2012. During the visual analysis the electrode coil appeared to be broken near the electrode bifurcation area. Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The coil showed characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
On (b)(6) 2011, a physician reported that the vns patient has high impedance. The physician reported that they discovered the high impedance from a recent report from the patient's psychiatrist. The patient has also been experiencing painful stimulation in her chest described as almost a shocking sensation. The patient also reported that she feels that her generator has migrated and the patient's depression has worsened. The physician did not know the relationship of the increase in depression to pre-vns baseline levels. No interventions had been planned at that point. The patient's settings were disabled that day but were previously at output=0. 25ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=5min/magnet=0ma. The system diagnostics showed output=limit/lead impedance=high/dcdc=7/eri=no. X-rays were received by the manufacturer on (b)(6) 2011. Based on the x-rays received, the cause of the high lead impedance could not be identified. The lead pin appeared to be fully inserted into the connector block, and there did not appear to be any sharp angles or discontinuities in the visible portions of the lead. However, an unpronounced lead discontinuity cannot be ruled out. A battery life calculation was performed which showed 7. 32 years until elective replacement indicator (eri) shows yes. Although surgery is likely, it has not yet occurred. Additional information has been requested from the physician but no further information has been received to date.
 
Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the vns patient was scheduled for a full revision surgery. The surgery took place on (b)(6) 2012. The leads were replaced due to high impedance, but the generator was replaced for prophylactic reasons. Attempts were made for the return of the explanted lead and generator but they have not yet been received.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2391601


Title: Re: Painful Stimulation
Post by: dennis100 on September 15, 2018, 01:58:07 AM
Model Number 102
Event Date 10/18/2011
Event Type  Injury   
Event Description
It was reported by the patient's mother that things have gone "downhill" since the patient saw the physician on (b)(6) 2011 to have titration performed. She stated that her son was implanted a couple of months ago and has been set to a very low output current since implant. On (b)(6) 2011, the physician changed the output current to 1 ma (which was a large jump according to the patient's mother). She stated that her son expressed to the physician how much pain he was in and said he didn't want to go that high yet, but the physician told him that she could not turn it down. The patient's mother thinks that the physician might have turned his output current back down to 0. 75 ma or 0. 5 ma but isn't sure. No history is currently available to confirm the patient's settings. Since the visit, the patient has been in intense pain during stimulation. In addition, the mother reported that the patient also has a flutter in his heart and his heart rate changes with the stimulation. Patient has experienced an increase in seizures that is above pre-vns baseline levels and the patient has become very angry since the setting change. The patient's mother went on to say that the patient has become so angry that he has had suicidal thoughts. She clarified that this was only once and that they were monitoring him closely and he seems to not have considered that anymore. The patient had an appointment on (b)(6) 2011 and has reportedly been doing very well since that appointment when the settings were changed. Attempts for further information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
Further information received from the physician indicates that at the visit on (b)(6) 2011, the patient had "normal settings" and was at 0. 5 ma. Per physician, the increased seizures were back to pre-vns baseline levels and could be due to a "combination of factors". Patient has intractable epilepsy. The patient had an increase before vns placement and the vns was at low settings. Patient also reports stress and sleep changes which may have contributed to the seizures. Per physician, the patient did not report suicidal thoughts at the last visit, but did report anger and mood changes. The relationship of the level of suicidal thoughts to pre-vns baseline levels is unknown. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the pain. The cognitive changes have multifactorial causes, per physician. The patient is frustrated that the seizures are not controlled and the primary care physician has made medication changes. No known causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. The patient has been treated for depression in the past by a different physician. The patient's settings were adjusted on (b)(6) 2011 visit and is scheduled for follow-up with physician. The patient was not diagnosed with arrhythmia and no cardiac testing was performed, but the patient reported that his "heart hurt" and felt palpitations. The patient has no history of cardiac issues. Physician does not believe the possible arrhythmia is related to vns, but is unable to rule it out. The event occurred following an increase in depression and seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341562


Title: Re: Painful Stimulation
Post by: dennis100 on September 16, 2018, 03:38:58 AM
Model Number 300-20
Event Date 12/01/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Good faith attempts for product return have been unsuccessful to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that product analysis was completed on the generator and lead. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found with the generator. One of the connector pins was returned without the connector boot. The unmarked connector pin and coil appear to have been extracted/exposed from the connector boot and pushed back in to the connector boot as indicated by the portion of the coil and pin partially exposed. Based on the appearance of the lead portions, it is believed that this was most likely caused during the explant procedure. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no product-related anomalies were identified within the returned lead portion.
 
Event Description
Additional information was received that there was no reported trauma or manipulation. There were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the event. The patient had their lead and generator replacement. Good faith attempt for product return are in process.
 
Event Description
It was initially reported that the patient had low impedance at a recent diagnostics (dcdc-0). The patient has always had lower dcdc codes of 0 and 1 so it was unclear if there was normal or an indication of a problem. For the week prior to the initial report the patient reported feeling painful stimulation and an increase in seizures. The physician feels that there is an issue with the lead. The patient was temporally disabled and the symptom resolved. X-rays were taken and were sent to the manufacturer for evaluation. Based on the x-rays received there was no anomaly visualized that could have been contributing to the low impedance and clinical symptoms. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. A full revision is planned, but has not occurred to date. Good faith attempts for more information have been unsuccessful to date.
 
Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. Product analysis is planned, but has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2384345


Title: Re: Painful Stimulation
Post by: dennis100 on September 16, 2018, 03:40:30 AM
Model Number 102
Event Date 12/06/2011
Event Type  Injury   
Event Description
It was reported by the pt's caregiver that the pt has been having seizures, about baseline or a little fewer. However, some of the seizures are more intense and result in the pt falling out of the chair. The neurologist reportedly attempted to turn the magnet mode up on (b)(6) 2011 which caused severe choking and coughing. He then turned his magnet mode down, but the pt was still having painful stimulation. Pt has multiple co-morbities has pseudo-seizures. However, the pt's neurologist feels that he sees an area of seizure activity per eeg. Attempts for add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2391314


Title: Re: Painful Stimulation
Post by: dennis100 on September 17, 2018, 11:57:32 AM
Model Number MODEL 250
Event Date 09/06/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported the vns patient's vns had been previously disabled due to lack of efficacy and was now requesting that the vns be explanted. The physician checked the device during the office visit, confirmed it was previously turned off, and referred the patient to a surgeon for removal. The patient left the office but came back later that afternoon complaining of painful stimulation. The device was checked and it was found that the patient's stimulation had inadvertently been turned on due to a likely faulted system diagnostics test. It is likely that the physician did not perform a final interrogation to check that the patient's vns was still. The patient's vns was disabled once more and the pain resolved. Attempts for the product information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2775090


Title: Re: Painful Stimulation
Post by: dennis100 on September 18, 2018, 08:53:54 AM
Model Number 105
Event Date 11/15/2011
Event Type  Injury   
Event Description
It was reported that the patient was feeling painful stimulation at his generator site following having his stimulation enabled after initial implant. Vns diagnostics are normal as per the physician however no specifics were provided. No trauma or manipulation was believed to have occurred. The physician attempted to reduce the patient's settings to alleviate the painful stimulation however this did not appear to resolve the issue. The physician then referred the patient for prophylactic generator replacement which has occurred. The explanted generator has been returned and is currently undergoing analysis. Attempts for further information have been unsuccessful to date.
 
Event Description
Additional information was received as an implant card indicating that the reason for replacement was due to "neck pain with stimulation. " the lead impedance as noted on the implant card was (b)(6); ok. (b)(6); follow-up was received from the physician indicating that the patient's painful stimulation was first documented on (b)(6) 2011 and had been occurring for a few weeks prior to that. The patient also noted a sensation of 'jumping' in her neck at the same time. Several programming changes had been occurring at two week intervals prior to the documentation of the painful stimulation. No trauma or manipulation was believed to have occurred. The physician noted that several changes in the programmed settings were attempted prior to the referral for replacement. Diagnostics were noted as normal a few days prior to replacement. The patient's painful stimulation has reportedly resolved since replacement. Analysis of the patient's generator has been completed. The generator performed to specifications and no anomalies were found.
 
Manufacturer Narrative

Event Description
Additional information was received as a returned product form that indicated that the generator was replaced due to painful stimulation in the neck. There was no note of painful stimulation in the chest as originally reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2375241


Title: Re: Painful Stimulation
Post by: dennis100 on September 19, 2018, 01:36:25 PM
Model Number 102
Event Date 01/05/2012
Event Type  Injury   
Manufacturer Narrative
The initial report inadvertently reported that product return attempts were unsuccessful to date when it was good faith attempts for more information have been unsuccessful to date.
 
Event Description
Good faith attempts for additional information have been unsuccessful to date.
 
Event Description
It was initially reported that the patient had painful stimulation over its chest and next that lasted for 8 minutes and occurred twice. Caregiver taped magnet over generator and after removing magnet pain was gone and the patient felt back to normal. The caregiver was concerned that the patient may have had a heart attack. The patient went to see their physician and there were no issues found. There was no reported manipulation or trauma and there are not interventions planned. Good faith attempts for product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2430420


Title: Re: Painful Stimulation
Post by: dennis100 on September 19, 2018, 01:37:28 PM
Model Number 300-20
Device Problem Mechanical Problem
Event Date 11/07/2011
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Analysis of programming history. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the patient is scheduled to have the device removed. No known surgery has occurred to-date.
 
Event Description
Additional information was received on (b)(6) 2011, when it was discovered that the patient had a surgery consultation on (b)(6) 2011. The patient's device was disabled because the patient was still feeling painful stimulation in the chest area. Although surgery is likely, it has not yet occurred.
 
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that the vns patient was seen by them yesterday and a high impedance warning message came up when the patient was interrogated. The physician turned the patient up from an output of 1. 5 ma to 2. 5 ma and the patient was complaining of feeling painful stimulation in the neck at the electrodes. He turned the patient back down to 1. 5 ma and the patient no longer felt any painful stimulation. The manufacturer's consultant visited the physician's office and the patient came in again for evaluation. The patient's generator was interrogated again and the high impedance warning message was again received. A system diagnostics test was performed which showed lead impedance=high/impedance value >10,000ohms/ifi=no. The patient is still receiving stimulation however and is at output = 1. 5ma/frequency = 30hz/pulse width = 250usec/on time = 30sec/off time = 3min/magnet output = 1. 5ma/magnet on time = 60sec/magnet pulse width = 500usec. They know the patient is still getting some stimulation since the patient's voice fluctuates with stimulation; this is normal for the patient. The manufacturer's consultant stated that x-rays would be taken and sent to the manufacturer for review. The patient was reported not to be feeling any pain whatsoever. The physician decided to leave the patient programmed on despite the manufacturer's recommendation to turn it off. The patient is being referred for revision surgery. It was also reported that the patient wants to have brain surgery independent of vns. The patient's x-rays were received by the manufacturer and during the x-ray review, whether the lead wires were intact at the connector pin could only be confirmed for one of the lead pins, the other was unable to be assessed due to poor contrast of the x-ray image. The lead pins could be visualized past the connector blocks and therefore appeared to be fully inserted. Based on the x-ray received, no gross lead discontinuities or sharp angles appear to be present. However, an unpronounced lead fracture cannot be ruled out. Using the battery longevity tables, with the patient's settings the patient has about 10 years left until end of service with his battery. Although revision surgery is likely, it has not yet occurred.
 
Event Description
It was later reported by a medical professional that the patient experiences periodic neck pain when his dbs device is turned on. The dbs was turned off and symptoms resolved. It was stated the patient elected not to revise the device. No known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the physician¿s office was received (b)(6) 2016 and provided that the vns was still programmed off. The pain was not suspected to be due to the vns, but pain was experienced on the same side as the vns when the dbs goes off. It was decided to remove the device due to the continued complaint from the patient, even though vns was not expected to have been causing the pain. The generator and the entire lead were removed on (b)(6) 2016, and it was stated the patient has not complained regarding the pain since explant. The explanted generator and lead was received for analysis, which is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the generator. The device output signal was monitored while placed in a simulated body temperature environment. Results showed no signs of variation in the output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The diagnostics were as expected for the programmed parameters. A comprehensive electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 989 volts and was not at end-of-service. The downloaded data revealed that 23. 935% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed for the returned lead. Abraded openings were noted on the outer silicone tubing. The reported lead fracture was not verified within the returned lead portion. Note that since a portion of the lead including the electrode array was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2355453


Title: Re: Painful Stimulation
Post by: dennis100 on September 19, 2018, 01:38:29 PM
Model Number 302-20
Event Date 01/11/2012
Event Type  Malfunction   
Event Description
The generator and lead were received by the manufacturer on (b)(4) 2012. However, product analysis has not been completed to date. The return product form was received which provided the reason for generator and lead replacement surgery due to lead discontinuity with eri=no. The implant card was also received which confirmed the date of surgery as (b)(6) 2012, and it also reported the reason for generator and lead replacement surgery due to lead discontinuity.
 
Manufacturer Narrative
Date of event, corrected data: the initial report inadvertently reported the incorrect aware date.
 
Event Description
A company representative reported that high impedance was observed during systems diagnostics. The pt had experienced painful stimulation at the generator site and face. The representative reported that the pt's symptoms were all characteristic of high impedance, and no diagnostics had been performed in some time. The pt's pain went away when the generator was disabled after the high impedance was observed. The pt was involved in a car accident a couple of years ago, but it is unk if this may have contributed to the high impedance. The pt's lead was replaced in 2009, and during surgery, the lead was reportedly dropped on the floor. The surgeon electively chose to implant the dropped lead after cleaning in a betadine or saline solution, per the company representative. No x-rays are being taken. It is unclear if systems diagnostics were okay following surgery, as there are no records of the pt's programming/diagnostic history available. The pt was referred to a surgeon for lead revision. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis for the generator and lead was completed. The generator performed according to functional specifications. No abnormal performance or any other type of adverse conditions were found. A portion of the electrode array portion including the electrodes was not returned for analysis, so an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Event Description
It was reported on (b)(6) 2012, that the patient had a surgical consult the following week for full vns replacement surgery. The patient then had generator and lead replacement surgery on (b)(6) 2012. Although product return is expected, the generator and lead have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2439929


Title: Re: Painful Stimulation
Post by: dennis100 on September 21, 2018, 02:07:20 PM
Model Number 102
Event Date 07/25/2011
Event Type  Injury   
Event Description
Additional information was received from the patient's treating neurologist indicating that the patient's device was initially programmed off in 2008 due to painful stimulation. In (b)(6) 2011, the patient first reported feeling the vns stimulate, despite being turned off. When the device was interrogated it was determined that the magnet had been left on to 1. 5ma, but diagnostics were within normal limits. The magnet mode current was disabled that day. There were no causal or contributory programming or medication changes that preceded the onset of the event. Manipulation and trauma were also no suspected. The physician indicated that the patient was still experiencing these sensations when the device was programmed off, but when the magnet was taped over the device, it helped. The patient did not experience these issues pre-vns.
 
Event Description
Review of available programming history revealed that the patient was disabled on (b)(6) 2007. It is unclear from the available history if the patient was re-enabled after that date.
 
Event Description
Additional information was received that the patient had a generator and lead replacement. Product analysis was completed on the lead and still is in process for the generator. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Event Description
It was reported through clinic notes received on (b)(6) 2011 that the patient was experiencing a choking sensation when she eats and trouble breathing and pain across her chest when the device stimulates. The patient indicated that she has this sensation about once a week. The patient is being scheduled for replacement because of this. The physician indicated; however that the device output and magnet mode currents are presently set to 0. 0ma. The physician indicated that the patient needed the device removed regardless of whether it was stimulating or just causing irritation. Explant is likely; however has not occurred to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the generator. Although the negative septum appears to be split, there is no evidence of dried body fluids, corrosion in the connector block and there is no evidence of dried body fluids in the lead cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Analysis in the pa lab determined that the generator had reached an end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414917


Title: Re: Painful Stimulation
Post by: dennis100 on September 21, 2018, 02:08:35 PM
Model Number 102
Event Date 12/20/2011
Event Type  Injury   
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns patient wants his device explanted due to painful stimulation in his chest just above the generator. The patient is not currently seeing a psychiatrist for his vns and consulted directly with the surgeon for the removal of his vns. The surgeon does not know when the pain first started and was not able to provide any further information. A battery life calculation was performed with the programming history available which revealed 2. 9 years until the elective replacement indicator (eri) shows yes. The explant surgery took place on (b)(6) 2011 and the explanted lead and generator were returned for product analysis on (b)(6) 2012 that has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2413731


Title: Re: Painful Stimulation
Post by: dennis100 on September 21, 2018, 02:09:27 PM
Model Number 102R
Event Date 12/14/2011
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital due to pain in the shoulder and neck that the physician and family attributes to vns. The vns was turned off and the pain seemed to stop once vns is off. Per physician, the pain begins once the vns stimulates, but lasts a little longer than the 30 second on time. The physician later decided to turn the vns back on to 0. 25 ma and the patient said this was more 'tolerable'. The patient then underwent generator replacement surgery as the generator had been implanted for some time. During surgery, the surgeon noted that upon removing the lead pins, the positive pin wasn't flush; and didn't appear fully inserted. Also, clear fluid came out of the generator receptacle when the positive pin was completely removed. It was also noted that the pin did not appear fully inserted in the x-rays, per surgeon. However, pre-operative diagnostics were within normal limits.
 
Event Description
Further information reveals that no patient manipulation or trauma occurred that is believed to have caused or contributed to the painful stimulation. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. The only intervention taken was the generator replacement and the physician indicated that the pain has resolved since the generator replacement surgery. Attempts for product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414487


Title: Re: Painful Stimulation
Post by: dennis100 on September 23, 2018, 04:49:14 AM
Model Number 102
Event Date 12/01/2010
Event Type  Injury   
Event Description
It was initially reported that the patient was being referred for vns removal. Clinic notes were later received that indicated that the patient was having painful stimulation and was being referred to a surgeon for discussion of removal of her vns. (b)(4) attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received that indicated that the patient felt that the vns was defective due to the patient experiencing painful stimulation for over a year. The patient was disabled on (b)(6) 2011. The patient was referred for explant for patient comfort and because the patient needed an mri. There were no contributory settings or medication changes that preceded the painful stimulation. There also was no manipulation or trauma that was believed to cause or contribute to the painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2404368


Title: Re: Painful Stimulation
Post by: dennis100 on September 26, 2018, 05:42:47 AM
Model Number 300-20
Event Date 01/01/2009
Event Type  Injury   
Event Description
On (b)(6) 2012 the vns treating neurologist reported that the vns pt's parents think that the pt is being electrocuted by the device. The physician stated that she is not certain that there is anything wrong with the device because they tried disabling the device and the "electrocution" was still occurring. The parents were concerned that even though the device is disabled, it was still electrocuting the pt and therefore they are planning on having the leads disconnected from the generator to see if these episodes resolve. The physician stated that they had to cancel the surgery because the pt developed an intrapulmonary infection, completely unrelated to vns. Although surgery is likely, it has not yet occurred. The pt's mother previously reported that the vns pt was experiencing pain at the electrode site that was random. The pain did not resolve if the vns was disabled with the magnet. The mother said the pt was usually exerting herself when the pain occurred. There were no problems with the regular vns stimulations. The mother was advised to f/u with the neurologist and surgeon. The pt was to be having a prophylactic generator replacement soon due to length of implant. F/u with the neurologist's office revealed the mother had not reported the neck pain to them at a recent visit on (b)(6) 2011 or on the visit on (b)(6) 2011. Vns systems and normal mode diagnostics were performed on the (b)(6) 2011 visit and were charted "ok, eos = no. " it was not known if there was any trauma or device manipulation occurring. As the pt/mother had not reported the pain event to the office, the office could not comment on the cause of the neck pain. The mother later reported that the pt had generator replacement surgery performed on (b)(6) 2011 and when the vns was activated the same neck pain was occurring. The mother was advised to again f/u with the neurologist's office. All attempts to the neurologist for further info have been unsuccessful to date. F/u with the surgeon revealed diagnostics were within normal limits at the battery replacement surgery. All attempts for the return of the explanted generator have been unsuccessful to date. The pt's father previously reported that the pt had been experiencing add'l adverse events; that the pt panics, doesn't feel well, turns pale white, starts coughing and gagging, and has pain. These events are followed by a headache. Within 15 minutes of these events, the pt is asleep. The pt's dad reported that this first began 1. 5 years ago, and at first was a very infrequent event. It had slowly started occuring more frequently. They believed this had to do with her generator battery due to the length of the implant, so they got it replaced. The pt's dad explains that the pt's device was replaced on (b)(6) 2011. Now, even after the device has been replaced, the pt is still experiencing these events. The father stated that since the device was replaced on (b)(6) 2011, this event has occurred 3 times. It doesn't occur every time the device stimulates, but when it does happen, they will use the magnet to disable the device. The pt's dad also mentioned that after the replacement of the device on (b)(6) 2011, the new device was not programmed on to deliver therapy for 1 week after the surgery, but the pt still experienced this event during this time. The dad said that diagnostics have been done many times before, and show results within normal limits. The father said that they do not want to turn the device off because the pt's condition is controlled very well with vns therapy. The physician previously reported that the pt's neck pain is not attributed to vns. Settings for the original generator were output =. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 21 sec/off time = 3 min/magnet output = 1 ma/magnet pulse width = 250 usec/magnet on time = 60 sec. The new generator after the battery replacement surgery was programmed on to output =. 5 ma/frequency = 20 hz/pulse width = 250 usec/on time = 7 sec/off time = 3 min/magnet output =. 75 ma/magnet pulse width = 250 usec/magnet on time = 30 sec on (b)(6) 2011. The physician stated that programming changes and medication changes are not felt to be related to the symptoms. Sys diagnostic results performed on (b)(6) 2011 showed output = ok/lead impedance = ok/dcdc = 2/eri = no at different head positions. X-rays were received and reviewed. No anomalies were noted however the entire lead could not be seen in the x-ray images as a portion of the lead was coiled behind the generator. There were no lead discontinuities or sharp angles observed in the visible portions of the lead body, however a fracture or microfracture cannot be ruled out. The physician later reported that it is unk what the cause of the pt's anxiety, feeling poorly, turning white, coughing, gagging, and headache are attributed to. The physician did not know if it is related to vns stimulation. No causal or contributory programming or medication changes preceded the onset of the events. The physician reported that they are working on the issues with the pt, but what they were doing was not provided.
 
Event Description
Additional information was received on (b)(4) 2012, when the patient's father reported that the patient has been disabled due to painful stimulation and the patient has been referred to a surgeon. Even after being disabled, the patient's father claims that the patient is still experiencing this painful stimulation and the father thinks that even with the device disabled it is still discharging current and causing painful stimulation. The neurologist does not think this is the case, but after trying to explain this to the patient's father, it appeared that the only way to appease him would be to disconnect the generator from the lead to see if there was any improvement. The surgeon stated that disconnected the generator from the lead but left both the lead and generator still implanted in the patient. The surgeon wanted to leave the device implanted but not connected as he thinks the patient will eventually want the device connected again.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465243


Title: Re: Painful Stimulation
Post by: dennis100 on September 27, 2018, 10:21:47 AM
Model Number 102
Event Date 12/15/2011
Event Type  Injury   
Event Description
It was reported that the patient underwent prophylactic generator replacement. Reporter indicated that pre-operative diagnostics were good with eri = no and the lead looked good on inspection. Explanted generator was returned to the manufacturer, but analysis is pending.
 
Event Description
It was reported that the patient was referred for revision surgery for an unknown reason. Further information reveals that the patient was having painful stimulation in her throat and voice changes and thinks there is something wrong with her device. The patient wanted the device relocated which the physician felt was okay since it had been implanted for over 6 years. Diagnostics performed were good (exact results not given) and her settings were lowered to help with the pain. Follow-up with the physician reveals that no patient manipulation or trauma occurred that is believed to have caused or contributed to the events. No causal or contributory programming or medication changes preceded the onset of the events. Revision surgery is planned, but has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2012 when product analysis was completed on the explanted generator. The septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator. A battery life calculation was performed which showed 1. 79 years until the elective replacement indicator shows as yes. The last system diagnostics from (b)(6), 2008 showed the device to be functioning properly with output=ok/lead impedance=ok/dcdc=0/eri=no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2458675


Title: Re: Painful Stimulation
Post by: dennis100 on September 27, 2018, 10:22:38 AM
Model Number 302-20
Event Date 01/09/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the lead impedance after the patient's full revision surgery on (b)(6), 2012 was reported to be within normal limits. The implant card from the surgery stated that the reason for the revision was a lead discontinuity; however follow-up with the surgeon revealed that no lead discontinuity was seen during surgery. The neurologist had previously reported that he had suspected a lead break due to the patient's painful stimulation although diagnostic results had shown the device to be functioning properly.
 
Event Description
On (b)(6) 2012 a vns treating physician reported that the vns patient felt painful stimulation in the neck and chest area. The patient was previously set at 1. 5/30/500/30/3. The diagnostics showed ok/ok/2260 ohms. He also ordered x-ray but did not find anything unusual about the lead but he suspected a lead fracture somewhere. When he lowered the patient to 0. 75 ma and 250 us pulsewidth the patient was feeling ok. The physician said the patient did not have any medication changes prior to the onset of the event. He also said patient did not report any trauma or manipulation of the device to him. The physician's nurse reported that the patient was experiencing an electrical shock for a couple of weeks. The physician performed diagnostics which showed results within normal limits. X-rays were ordered and the physician stated that no abnormalities were observed. The physician's nurse later reported that the patient was seen a couple of weeks ago because he started to feel a shocking sensation and high degree of pain during stimulation around the chest area. The physician turned the device off and the pain was gone. The nurse stated that before last week's visit, the patient wasn't seen since november 2011 where diagnostics back then were within normal limits as well as last week's visit. The patient was referred for a full revision surgery due to the painful stimulation. Although surgery is likely, it has not yet occurred.
 
Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the vns patient had a full revision surgery that day. The hospital discarded the explanted lead and generator after the surgery therefore product analysis cannot be performed on the devices.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2453229


Title: Re: Painful Stimulation
Post by: dennis100 on September 29, 2018, 04:31:44 AM
Model Number 302-20
Event Date 08/01/2011
Event Type  Injury   
Event Description
On (b)(6) 2012, a vns treating neurologist's nurse reported that the vns patient was seen the week prior complaining that she had painful stimulation in her jaw. The physician lowered the patient's settings and had an x-ray performed which revealed that the clips or coil had made its way up to another nerve and therefore was stimulating where it should not have. The patient's device was disabled. The patient was referred for surgery to have a full revision. The manufacturer's consultant reported that the painful stimulation was first noticed in (b)(6) 2011 and the physician lowered the patient's settings which helped for a while. However, the pain then got worse so they disabled her deice and sent her for x-rays in (b)(6) 2012. No trauma to the lead was reported. No diagnostics had been performed because of the patient's painful stimulation in the neck area. The manufacturer's consultant reported that the surgeon did additional scans on the patient's neck and did not find anything out of the ordinary in regards to the placement of the helical coils of the lead, and as a result, there are no surgical plans for the patient at this time. No migration of the leads was observed. A normal mode diagnostics test performed on (b)(6) 2012 showed results within normal limits and a dcdc code of 2. Since the device has been disabled, the patient's pain has resolved but she stated she would like the device turned back on as it was helping with her depression. The consultant stated that the physicians still don't know why the pain was occurring. The surgeon recommended that the patient have a full revision surgery based upon the patient's painful stimulation and the x-rays. The generator replacement will be due to the age of the device; therefore, for prophylactic reasons. X-rays were received by the manufacturer and based on the x-ray images provided, the cause of the patient's painful stimulation could not be determined. Since a portion of the lead and generator was not visible in the x-ray, analysis could not be performed on these portions a battery life calculation was performed with the programming history available which showed 2. 86 years until elective replacement indicator (eri)=yes. Although surgery is likely, it has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2444409


Title: Re: Painful Stimulation
Post by: dennis100 on October 01, 2018, 02:29:56 AM
Model Number 103
Event Date 01/05/2012
Event Type  Malfunction   
Event Description
Surgery for vns replacement was scheduled for (b)(6) 2013, but was cancelled. A new surgery date has not been set.
 
Event Description
Additional information was received stating that the vns patient was scheduled for generator and lead replacement surgery. No known interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(6) 2014. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. No obstructions were observed in the header lead cavity or the connector blocks. In addition, the in-line cavity go gauge test passed and a bench lead inserted completely passed the negative connector block (lab conditions). A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Reporter indicated a patient had high lead impedance readings with vns diagnostics testing at an office visit. The vns was disabled, and the patient was referred for x-rays and a surgical consult. The patient had no known trauma and does not manipulate the vns. The x-rays will not be forwarded to the manufacturer. The patient had vns generator replacement surgery performed previously on (b)(6) 2011, and vns diagnostics were ok at the time of surgery. Surgery to revise the vns is likely, but has not occurred to date.
 
Event Description
Additional information was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to high impedance. Pre-operative diagnostic results showed high impedance. The replacement generator was tested with the patient¿s existing lead and diagnostic results showed lead impedance within normal limits. The generator was returned to the manufacturer where analysis if currently underway.
 
Event Description
Reporter indicated the patient experienced painful stimulation with the vns prior to disabling the vns. No specific trauma occurred, but the patient does sometimes fall with seizures. Vns replacement is still likely, but has not occurred to date. The vns remains disabled.
 
Manufacturer Narrative
Brand name; corrected data: additional information indicates that the suspect device is the generator. Type of device, name; corrected data: additional information indicates that the suspect device is the generator. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator. Date of implant; corrected data: additional information indicates that the suspect device is the generator. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434846


Title: Re: Painful Stimulation
Post by: dennis100 on October 01, 2018, 02:30:56 AM
Model Number 302-20
Event Date 01/27/2012
Event Type  Malfunction   
Manufacturer Narrative
(conclusions) - device failure is suspected, but did not cause or contribute to a serious injury.
 
Event Description
A vns physician reported that during a clinic visit a patient was complaining of neck pain at the electrode site with stimulation that began approximately two weeks prior. The pain was reportedly worse the previous night causing the patient to visit the neurologist. The neurologist took x-rays, cat scan and did an ultrasound of the area which were all normal. The patient denies any trauma to the site, but indicated that he recently started working out. The patient's device was turned off. Clinic notes dated (b)(6) 2012 were received which indicated that the patient had a sudden pulsing sensation in the throat two days prior with a subsequent burning sensation and painful stimulation in the left, lateral neck where the vns lead is. The physician stated in the notes that he suspected a stretching injury to the vagus nerve or surrounding soft tissue. During this clinic visit, the patient's settings were decreased, and after fifteen minutes, the patient did not have improvement with the irritation. However, after another twenty minutes of waiting, there was reportedly no abnormal feeling anymore. It was noted that if the patient is no longer having irritation, the settings will be increased. In the notes dated (b)(6) 2012, it was noted that the patient was awakened by the "shocking sensation to the left neck. " the physician noted that he was unsure of the lead integrity. However, the x-rays did not show any anomalies. Diagnostics were later performed on (b)(6) 2012, and the company representative reported the diagnostics showered high lead impedance. The device was subsequently disabled, and the patient was referred for surgical consult. No trauma is suspected to have caused the high impedance, and there were no medical changes prior tot he event. Since the x-rays reportedly did not show any anomalies, it is not believed that a copy is being sent to the manufacturer for review. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2012. The implant card was received by the manufacturer which confirmed that the patient had generator and lead replacement surgery on (b)(6) 2012. It reported that the generator was replaced prophylactically, and the lead was replaced due to the high lead impedance. The generator and lead were discarded by the hospital, so product analysis cannot be completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2455372


Title: Re: Painful Stimulation
Post by: dennis100 on October 01, 2018, 02:32:21 AM
Model Number 103
Event Date 02/22/2012
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
Analysis of the patient's explanted vns generator has been completed. The generator performed to specifications and no anomalies were found. Review of the generator source code found that the last impedance value taken prior to the generator being disabled was normal at 3029 ohms.
 
Event Description
It was reported by the vns patient that she felt the vns was stimulating erratically and she was experiencing painful stimulation in her neck when she turned her head to the right. The physician took x-rays which were forwarded to the manufacturer for review. Review of the x-rays found no anomalies. No gross lead fractures or sharp angles could be visualized. Vns diagnostics were within normal limits, however no specifics were available. The patient's device was disabled and she stated she was still experiencing the adverse events. No medication or programming changes preceded the onset of the pain. No trauma or manipulation is believed to have occurred. The patient also stated her neck hurts at the electrode site when she lies down. The patient requested to have her device replaced. Follow-up with the site found that the physician is not sure what the events are related to. Surgery to replace the patient's vns is likely.
 
Event Description
Additional information was received indicating that the patient's generator has been replaced. An implant card was received that indicated the reason for replacement was "erratic stim. " the explanted generator has been returned and is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2511973


Title: Re: Painful Stimulation
Post by: dennis100 on October 01, 2018, 02:33:20 AM
Model Number 302-20
Event Date 02/28/2012
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was initially reported that the patient was experiencing painful stimulation. The last to interrogation prior to the reported have impedance of 9000 ohm and 60000 ohms. (b)(4) attempts for more information have been unsuccessful to date.
 
Event Description
Additional information was provided that at a recent appointment both system and normal mode diagnostics were run and were within normal limits. The physician will monitor the patient closely. No further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2502194


Title: Re: Painful Stimulation
Post by: dennis100 on October 02, 2018, 12:54:25 AM
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/21/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by the patient that he was experiencing vocal cord paralysis and damage to his nerve as a result of the replacement surgery due to high impedance and painful stimulation, which is reported in mfg. Report #1644487-2017-03370. Follow up with the implanting surgeon revealed that the patient had reported feeling an intense shock in his neck and the patient became hoarse after that episode. It was reported that the patient was examined after the incident and vocal cord paralysis was documented. It was unclear when the shock in the patient's neck and hoarseness occurred. The patient had medicalization laryngoplasty in order to improve vocal function, which the surgeon stated was for the patient's comfort. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6793004


Title: Re: Painful Stimulation
Post by: dennis100 on October 02, 2018, 12:55:16 AM
Model Number 302-20
Event Date 04/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated a patient had vns lead and generator replacement surgery performed on (b)(6) 2012 due to painful stimulation. The patient had an mri in the past that may have damaged the left vagus nerve per the reporter. The new vns lead was implanted on the right vagus nerve. The reporter and the surgeon were both aware of the manufacturer's labeling regarding not implanting the vns lead on the right vagus nerve. Attempts for further information and return of the explanted devices are in progress.
 
Event Description
The explanted vns generator and lead were returned for analysis on (b)(6) 2013. Paperwork returned with the explants indicated the vns was replaced due to "lesion in nerve by mri". The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the lead. Note that since a small portion of the lead assembly (body), including the electrode array section, was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. In the pa lab, the generator output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. All attempts to the reporter for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2916436


Title: Re: Painful Stimulation
Post by: dennis100 on October 02, 2018, 12:55:57 AM
Model Number 302-20
Event Date 04/25/2008
Event Type  Injury   
Event Description
Reporter indicated that a pt protrusion of the lead body, increased seizures, pain and painful stimulation secondary to a bad cold where she experienced severe coughing, sneezing, and vomiting. The pt underwent surgery and the pt's vagus nerve was found to be bent at an angle and attached to the jugular vein. The surgeon provided more strain relief in the neck and straightened the nerve. The pt's generator was also replaced prophylactically.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1051741


Title: Re: Painful Stimulation
Post by: dennis100 on October 02, 2018, 12:57:01 AM
Model Number 304-20
Event Date 09/28/2011
Event Type  Injury   
Event Description
It was reported by a physician that vns patient had the nerve injured (cut) during vns surgery, after that, patient has experienced a high sensibility to stimulation which is an intolerable feeling to the patient. The patient doesn't want to continue vns therapy and wants vns system removed. Removal surgery is still pending.
 
Event Description
Additional information was received from the area representative indicating the patient underwent removal surgery as expected and the device would not be returned to the manufacturer for analysis. Moreover, information from the treating physician indicating the patient's seizures were the same or probably worse since the patient's device was programmed off on (b)(6) 2011, 2 months after the reported incident. At the moment good faith attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2465829


Title: Re: Painful Stimulation
Post by: dennis100 on October 02, 2018, 12:58:02 AM
Event Type  Malfunction   
Event Description
It was reported by a patient that he had experienced "irregular stimulation" and painful stimulation with his vns device. The patient reported that the generator (unknown when implanted and reportedly explanted in (b)(6) 2016) caused him to have painful stimulation in the left neck and armpit, and the "irregular stimulation" to his vagus nerve caused his body to "forget how to breathe" while sleeping. The patient also reported that he had to then start using oxygen at night to make sure his body continues to breathe while he sleeps. Reportedly, the neurologist informed the patient that the irregular stimulation from the generator caused his nerve to become dependent on the stimulation to remember to breathe, so the neurologist continues to suggest that the patient be re-implanted with vns. However, the patient refused to be re-implanted after the third generator was explanted. The patient kept the third generator after explant, and the lead was left implanted. The patient also reported that vns did help reduce his seizures, but he has stress-induced grand mal seizures which were exacerbated by the painful stimulation and distress over having "defective vns devices. " he tried to hurt himself as well because of the painful stimulation and distress. No further relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
The patient reported that his third generator malfunctioned and shocked his jaw and teeth to the point where he had to get dentures. He reported that he could not get the lead removed where he lived due to the damage on his nerve from stimulation. Neither of the patient's previous surgeons were aware of a third generator being implanted. Attempts for further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6031775


Title: Re: Painful Stimulation
Post by: dennis100 on October 03, 2018, 03:42:39 AM
Model Number 300-20
Event Date 07/17/2011
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2012. The implant card confirmed the date of surgery and indicated the reason for replacement as battery depletion with neos=yes and lead discontinuity. The explanted products were received by the manufacturer on (b)(6) 2012, however product analysis has not been completed to date.
 
Event Description
A physician reported on (b)(6) 2012 that upon interrogation of a patient's model 104 generator, the physician received a warning about low output. The patient's output current was at 1. 0ma, so the company representative instructed the physician to turn the output current up to 1. 5ma. Normal mode diagnostics at 1. 5ma were performed and showed low output current, and then systems diagnostics were performed and showed high lead impedance. On the patient's previous visit on (b)(6) 2012, all diagnostics were reportedly okay. No patient trauma is suspected to have contributed to the high impedance. The patient did pick up a (b)(6) child in (b)(6), and the child wiggled around. The physician was unsure if this may have caused the high impedance. The physician does not suspect that fibrosis would cause the high impedance. The patient has not experienced an increase in seizures. The physician is requesting x-rays be taken of the patient's vns, but it is unclear if the x-rays will actually be taken. Therefore, the x-rays have not been received to date. The physician elected to keep the device programmed on because the patient is doing fine, and he did not want to stop therapy. Although surgery is likely, it has not occurred to date. No additional information was provided.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays received by the manufacturer, no gross lead discontinuities visualized.
 
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect date of the event, so the patient age was reported incorrectly. Date of event, corrected data: the initial report inadvertently reported the incorrect date of the event. With the additional information received, the patient's symptoms began around (b)(6) 2011 and the impedance began to increase as first captured on this day.
 
Event Description
It was reported on (b)(6) 2012, that the patient had x-rays taken in (b)(6). The ap and lateral cervical spine x-rays were later received by the manufacturer on (b)(6) 2012. The radiology report was also received which reported that the leads appeared to be radiographically intact. Due to only neck images being taken, the generator cannot be visualized, and thus, resulting commentary on pin insertion and feed-thru wires being intact cannot be assessed. The electrodes appear to be in alignment. There are no gross lead discontinuities or sharp angles present. However, resulting commentary on the area in the chest that is not visible cannot be assessed. In addition, the presence of an unpronounced lead discontinuity or discontinuity in the portion of the lead not seen in the provided x-rays cannot be ruled out. Therefore, there is no indication from the x-rays that would reveal the cause of the high impedance. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
Additional clinic notes were received for the upcoming surgery which has not occurred to date. The notes dated (b)(6) 2011, does not indicate any vns abnormalities or patient adverse events. The vns settings were changed, and there were plans to titrate the settings higher. On the next visit on (b)(6) 2011, it was reported that the patient was "doing somewhat worse since the last visit. " the husband reported that her seizures were slightly worse. He reported a total of eight bigger seizures in the past two months. Her milder, atypical absence episodes are just as long but less intense. There were no recent other changes in the patient's medical history. The patient's vns settings were still titrated up to prior settings, the output currents were increased on (b)(6) 2012. The patient was doing about the same on the (b)(6) 2011, visit. The notes indicated the patient was now reporting about 15-20 seizures in the last 10 weeks on (b)(6) 2012, and the patient was not satisfied with her seizure control. The vns settings were titrated up again. In the notes dated (b)(6) 2012, the patient reported 3 tonic-clonic seizures and four smaller seizures since the last visit. She reported improvement with the vns increase and no side effects, and she was somewhat satisfied with her seizure control at that point. She was doing better since the last visit. An increase in output current was attempted but the patient experienced coughing, so the pulse width was decreased. However, the device indicated high lead impedance from system diagnostics. The physician planned to leave the output current at 1. 0 ma with increased pulse width to 750usec. Attempts for additional information from the physician have been unsuccessful to date. Review of the diagnostic history revealed that a > 25% impedance occurred on (b)(6) 2011.
 
Event Description
The patient reported that she "does not like the magnet because it hurts. " however, the company representative followed up with the physician's office. The clinic notes were provided to him to review, and there was no mention of the patient experiencing pain with the magnet in the notes. In addition, there did not seem to be a recent change in magnet settings. Attempts for additional information from the physician's office were unsuccessful.
 
Event Description
The clinic notes and cover sheet were received from the patient's physician's office. It reported that the patient has been referred for surgical follow up regarding the "lead issues" and the fact that the leads have been implanted for about 12 years. Although surgery is likely, it has not occurred to date.
 
Event Description
Product analysis of the generator and lead was completed. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. During analysis of the explanted lead, an abraded opening in the outer tubing was observed as well as dried body tissue on the positive electrode ribbon. Note that a portion of the lead assembly (body) was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 87 mm portion pitting was observed on the surface of the marked connector pin. The front portion of the connector boot appeared to be detached from the connector pin. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the marked connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. Of note, suture indentations were observed on the outer silicone tubing. Manufacturer labeling indicates to not use sutures on the lead body. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. During the visual analysis, the (+) white electrode ribbon appeared to be embedded in remnants of dried body tissue. This condition may have prevented the electrode ribbon from coming in contact with the vagus nerve; therefore, contributing to the reported allegations. Other than observed pitting on the marked connector pin and tissue-covered (+) white electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations.
 
Event Description
Follow up with the physician was performed which revealed that the patient's increased seizures were believed to be due to loss of vns therapy. The patient experienced coughing with attempted increase in vns settings. The increase in the patient's seizures in 2011, were still below pre-vns baseline levels, and there were no clear causal factors for the increased seizures. The patient experienced painful stimulation during vns programming changes on (b)(6) 2012. To prevent morbidity from seizures, the patient's background medication dosing was adjusted while waiting to address the vns issue, per the physician. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2493494


Title: Re: Painful Stimulation
Post by: dennis100 on October 03, 2018, 03:43:51 AM
Model Number 302-20
Event Date 02/01/2012
Event Type  Malfunction   
Event Description
Additional information was received from the physician on (b)(6) 2012. An x-ray assessment performed by the site was provided and indicated that no fractures were observed. This however cannot be confirmed as the x-rays have not been sent to the manufacturer. It was indicated that the patient was complaining of headaches, stomach pains, tingling in her neck and chest with vibrating in her voice. She was also complaining of being shocked with headaches. The patient's settings were provided. No additional information was provided.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported to the manufacturer that the patient had high impedance on a system diagnostics test performed on (b)(6) 2012. It was indicated that the last acceptable diagnostics for this patient were performed in (b)(6), however no specific results were provided. The physician indicated that there was no trauma or manipulation to the device. The patient's device was disabled, and it was indicated that the patient would be sent for x-rays which would be provided to the manufacturer for review. The x-rays have not yet been received. The physician also noted that the patient had been experiencing headaches with stimulation and also painful stimulation at neck region for about (b)(6) prior to this report of high impedance. The patient was referred for and underwent a full revision on (b)(6) 2012. The explanted products will not be returned as the hospital's policy requires the hospital to keep explanted products for 7 years. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2482832


Title: Re: Painful Stimulation
Post by: dennis100 on October 03, 2018, 03:44:51 AM
Model Number 300-20
Event Date 02/22/2012
Event Type  Malfunction   
Event Description
It was reported by a vns treating physician that he had a patient with high lead impedance/ limit on system and normal mode diagnostics. The patient is being sent for a full revision surgery as soon as possible. There was no trauma to the neck or chest prior to their high impedance being attained. The patient did report painful stimulation and reported that in recent months she has felt some discomfort with the stimulation. It seems to be stronger than it was. (b)(4) attempts are underway to obtain further details.
 
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a patient death or serious injury.
 
Event Description
The patient had full revision surgery. A lead break was not visible in the operating room. The old lead was attached to a new generator and the patient still had high lead impedance therefore their lead and generator was replaced. The explanted lead is not being returned for analysis as it was discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2495302


Title: Re: Painful Stimulation
Post by: dennis100 on October 04, 2018, 04:18:56 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
Follow up with the surgeon's office revealed that the surgical intervention was for the patient's comfort.
 
Event Description
The explanted generator and lead were received by the manufacturer. Analysis on the lead was approved. Note that since the lead¿s electrodes were not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. Analysis on the generator has not been approved to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing painful stimulation and pressure in the chest, shortness of breath, and left arm pain. The diagnostics were found to be within normal limits. It stated that the patient was experiencing cardiac pain symptoms, but the physician did not think they were related to the vns. The vns parameters were programmed at various settings in an attempt to replicate the pain described by the patient. The patient was referred for a complete cardiac checkup with a holter monitor in order to rule out any relationship between his chest pain and vns. The patient requested removal as he had found the generator uncomfortable and the area was sore due to being bumped regularly when playing with his children. The patient underwent vns explantation surgery. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
Generator product analysis was completed. The reported pain, painful stimulation, and dyspnea could not be evaluated in the product analysis, or pa, lab. However, proper functionality of the generator was verified in the pa lab. The septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids, which addresses the allegations of pain and painful stimulation. The generator was placed in a simulated body temperature environment and the output signal was monitored for more than 24 hours. No signs of variation in the signal were observed and diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no performance of other adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544133


Title: Re: Painful Stimulation
Post by: dennis100 on October 05, 2018, 12:43:46 PM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/05/2018
Event Type  Injury   
Event Description
Additional information was received that the patient was seen by the surgeon who stated the pain was most likely related to a muscle strain so no surgery was scheduled and the patient was referred back to the neurologist.
 
Manufacturer Narrative

Event Description
It was reported that the patient presented in the er with painful stimulation. The pain was stated to be at the neck site for the patient. The patient's device showed that diagnostics were fine. The patient seems to have pain that is associated with magnet stimulation. The device was turned off until the patient can see the neurologist. The patient was then referred for replacement due to battery depletion and because of the new pain at left chest and left neck as the physician was worrisome for lead dysfunction. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7842396


Title: Re: Painful Stimulation
Post by: dennis100 on October 05, 2018, 12:44:46 PM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/16/2018
Event Type  Injury   
Event Description
It was reported that a vns patient was experiencing painful stimulation in the neck associated with the vns firing. The patient stated it started that day at 10:30 to 11:00 and is sharp and intense pain. She states the pain is more "powerful than the typical sensation she fee ls when her vns current is on. She states the pain lasts longer than the 30 sec on time duration and occurs frequently at intermittent times. She states the pain is localized to her neck, where she typically feels her vns fire. The symptoms lowered after the pulse width was lowered from 500 to 250. She denies any radiating pain or chest pain. She denied any falls, hits, or trauma to her chest or neck. Diagnostics were within normal limits, however the physician is still concerned for a lead break given the acute onset and severity of the symptoms. The patient was referred for prophylactic replacement. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative
 
Event Description
An implant card was received indicating the patient's prophylactic replacement surgery occurred. It was indicated that the device would not be available for return. No explanted device was returned to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7511501


Title: Re: Painful Stimulation
Post by: dennis100 on October 06, 2018, 05:53:13 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/13/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Following a full revision surgery, patient stayed at the outpatient clinic overnight due to pain and vomiting. Vns was turned on after surgery and the patient also complained of tooth pain associated with stimulation cycle. The patient's device settings were later adjusted. The autostimulation feature was turned off and then the normal current was lowered and the patient reported feeling better. Per the surgeon, the pain was in the neck area and the lead revision and stimulation may have contributed to the pain. The vomiting is probably related to anesthesia per surgeon.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7856852


Title: Re: Painful Stimulation
Post by: dennis100 on October 06, 2018, 05:53:49 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported to a company representative that a vns patient was experiencing painful stimulation 5-10 times per day. Impedance values were reported to be good. The patient reports tension of the lead in the neck, but no pain or impedance changes with lateral rotation. The patient was referred for x-rays and referred to neurosurgery. It was later reported that generator replacement surgery occurred. The explant facility does not return devices to the manufacturer. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7867487


Title: Re: Painful Stimulation
Post by: dennis100 on October 06, 2018, 05:54:25 AM
Model Number 304-30
Device Problem Fracture
Event Type  Malfunction   
Event Description
It was reported that a patient had an emergency surgery to explant a lead that was stated per the stepdad to be internally burning him. It was unknown if there was trauma to the site, if devices were explanted, diagnostics, or who the surgeon was. A call was received confirming that both the generator and lead were explanted due to painful stimulation, exposed lead wires and "drainage" from the exposed wires. The devices were to be shipped back for analysis. Surgical operation notes were received indicating pus, an infection at the electrode site and "exposed, infected" devices, however it was stated per the patient's physician that nothing had happened to the lead or generator and that the patient had also been sent to "infectious disease" who had clarified that there was no infection seen. Impedance measurements from march 2018 showed ok impedance, within normal limits. The physician stated the patient had been doing well with vns and was looking to have the patient re-implanted with vns. The devices were returned for analysis, however analysis has not been completed to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7883963


Title: Re: Painful Stimulation
Post by: dennis100 on October 06, 2018, 05:55:14 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2016
Event Type  Injury   
Event Description
Further information was received that the surgeon intended to perform surgical intervention for the lead when the generator needed to be replaced since at this time, the generator was still functional. No further relevant information has been received to date.
 
Event Description
Incoming information was received indicating the patient's device was to be upgraded and the patient was referred for surgery. Follow up with the patient stated that generator replacement was needed due to low battery. It was stated that the surgeon would also take a look at her lead as she reported that the lead was "all clumped up under her neck" and that when she turns her head to the right, she can see the wiring under the skin. She stated she could see the "clump" without turning her head. The patient also reported that her generator had migrated and the surgeon stated that when the generator was replaced, he would ensure the device was better secured in the pocket. It was further stated that the patient has near constant ear and toothache believed to be with stimulation and attributed to vns as she had seen both a dentist and ent. She reported a scratchy voice that worsens with stimulation and makes her feel like she has to gasp for air to continue conversations. It was noted that the patient otherwise has been doing well with vns and sees decrease in seizures with the device. The replacement surgery occurred. It was stated that the leads were not revised as they tested to be functioning within normal limits. Post-operation diagnostics showed the devices were functioning as intended. No device was expected for return per the hospital policies. No additional relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing painful stimulation at her jaw. The patient also had pain in her neck and jaw which made it difficult to move. Therefore the patient was being referred for a possible lead revision due to the pain. Because of these symptoms the patient was experiencing issues with depression. No additional relevant information has been received. No surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6914216


Title: Re: Painful Stimulation
Post by: dennis100 on October 06, 2018, 05:55:53 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/27/2018
Event Type  Injury   
Event Description
It was reported that the patient was having painful stimulation after surgery. It was also reported that the patient was turning purple and coughing with every stimulation like they were choking. The physician subsequently turned the output and magnet currents down as well as turn the off time down from 0. 8 minutes to 3. 0 minutes. Information was received from the physician's office the doctor thinks the patient's settings were too high. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7899101


Title: Re: Painful Stimulation
Post by: dennis100 on October 07, 2018, 03:26:28 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Injury   
Event Description
It was reported that a patient with ring chromosome 20 was implanted with vns and within the past 2 months the patient was playing with a personal tablet and that the tablet would trigger strong seizures when he got closer to the tablet and was switching it on. The patient allegedly receives stimulation when playing with the tablet despite the magnet output current being disabled. The painful stimulation is at the location of the generator. The physician decided to disable the device as he was annoyed with the unpredictable stimulation and painful stimulation. It is reported that nothing happened to the patient since device disablement and the physician decided to program the vns back on. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7897586


Title: Re: Painful Stimulation
Post by: dennis100 on October 08, 2018, 01:52:24 PM
Event Date 03/20/2012
Event Type  Injury   
Event Description
Reporter indicated a patient had the vns lead "extended" surgically due to experiencing painful stimulation in the face when the head was turned. The reporter declined to provide any additional information at the time of the initial report, and all attempts to the reporter for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2513878


Title: Re: Painful Stimulation
Post by: dennis100 on October 09, 2018, 01:12:26 PM
Model Number 102
Event Date 12/29/2003
Event Type  Injury   
Event Description
Additional information was received that the physician will not be providing any additional information.
 
Event Description
It was initially reported that the patient was being referred for a generator replacement and lead evaluation. It was reported that the patient unable to tolerate therapeutic settings. The patient was having throat irritation, painful stimulation and tinnitus. It is unclear if the surgery is directly related to these events but the want the notes were written it may be. Surgery is likely but has not occurred to date. Good faith attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
Additional information was received that the patient had a generator replacement. The generator was disposed of at the hospital so it will not be returned to the manufacturer for evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2517254


Title: Re: Painful Stimulation
Post by: dennis100 on October 09, 2018, 01:13:28 PM
Model Number 302-20
Event Date 07/29/2011
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: the correct event date for the high lead impedance is provided. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated the painful stimulation was felt to be related to a "short-circuit" of the vns. X-rays were taken but were not forwarded to the manufacturer. The high lead impedance was first noted on (b)(6) 2011, and the patient had reported feeling electrical shock sensations in her neck when turning her head to the left for the previous month. Vns diagnostics were last within normal limits in (b)(6) 2010. Analysis of the explanted vns generator and lead was completed. No anomalies were identified with the vns generator and the generator performed per specifications. During the lead visual analysis of the returned 35mm lead portion, the green (-) electrode quadfilar coil appeared to be broken approximately 12mm from the distal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged and pitted which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure is suspected.
 
Event Description
Reporter indicated a patient was noted to have high lead impedance with vns diagnostics in (b)(6) 2011. The patient was also experiencing painful vns stimulation in her shoulder. The vns was disabled, but no other interventions were done as the patient was pregnant at the time. The patient does have a history of falling with her seizures. The patient delivered her baby in (b)(6) 2012 and surgical replacement of the vns lead and generator occurred on (b)(6) 2012. Diagnostics with the new generator and resident lead still indicated high lead impedance, ruling out a lead pin issue and making a lead fracture more likely. Diagnostics with the new lead and new generator were within normal limits. However, during explant of the resident lead, the jugular vein was nicked which required a vascular surgeon to assist with the repair. The new vns system was left disabled. The explanted generator and lead have been returned and are pending analysis. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2513252


Title: Re: Painful Stimulation
Post by: dennis100 on October 09, 2018, 01:14:32 PM
Model Number MODEL 250
Event Date 08/20/2012
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6), 2012 it was reported that on (b)(6), 2012 the patient had his vns checked and when the wand was against the device and diagnostics were performed, it transmitted two times of the programmed output. The patient stated that he doubled over, stopped breathing, and his heart stopped for about a minute. While driving home the patient stated that it did it again and at home one other time before he returned to the physician who had it fixed and re-programmed the patient to the correct settings. The patient noted that he had his magnet taped over his device until he was able to see his physician again to get the settings corrected. The physician later clarified that the patient is very sensitive to parameter changes and when the physician performed the system diagnostics, which runs at higher settings than the patient is used to, the patient immediately had painful stimulation and reacted badly so the physician aborted the test. Instead of stopping the test by pressing cancel on the screen, he removed the wand from the patient's generator. The physician did not do a final interrogation prior to the patient leaving the clinic visit. Later that day the patient returned reporting that his vns wasn't set to the correct settings and when the physician interrogate the patient, the patient was set to output=1ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=60min which are the settings that the system diagnostics test runs at. The physician then corrected the patient's settings by programming the patient back down to an output of 0. 5ma and adjusted the other settings appropriately, settings not provided. The physician also stated that the patient only felt painful stimulation, there was no asystole or syncope experienced by the patient during the visit and the physician feels that the reports were likely exaggerated by the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2746524


Title: Re: Painful Stimulation
Post by: dennis100 on October 09, 2018, 01:16:36 PM
Model Number 104
Event Date 10/04/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
No further information has been attained after good faith attempts have been made.
 
Event Description
It was reported that the patient continues to have left shoulder pain with stimulation. The patient¿s caregiver would like to have the patient¿s lead replaced. She reports that the patient saw the surgeon a year ago about the pain and other events, and the surgeon reported to them that the patient did not need replacement.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.
 
Event Description
Additional information was received from a company representative indicating the patient was to undergo surgery as a piece of a foreign object was detected under the patient's shoulder area and believed to be associated with initial vns surgery. Moreover, the patient was reported to have an increase in seizures. Interventions taken were to increase the medication doses. At the moment, attempts to obtain further information regarding the foreign object have been unsuccessful to date.
 
Event Description
It was reported by a patient's mother that the vns patient had recently undergone generator replacement surgery and since then, the patient has experienced an increase in seizures, started having cardiac issues, and constant left shoulder pain. The patient's mother did not know if the reported increase in seizures was above pre-vns baseline, but did mention the patient underwent medication and parameter changes to reduce the seizure frequency. At the moment the relationship of the reported cardiac issue, pain, and increase in seizures to vns therapy is unknown as good faith attempts to obtain further information from the treating epileptologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2540783


Title: Re: Painful Stimulation
Post by: dennis100 on October 10, 2018, 03:11:36 AM
Model Number 300-20
Event Date 03/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient denies having any pain with the device programmed off and there has not been any seizure activity either. The patient feels that the medications he is taking are controlling the seizures and he did not want to have his vns replaced at this time.
 
Event Description
It was reported on (b)(6) 2012, that a vns patient thought his device was malfunctioning as it was sending electrical impulses to other parts of his body. The patient elaborated by saying he has been experiencing abdominal cramping, chest pain and should pain that was occurring every 5 minutes so he believed it as occurring with stimulation. The patient was also experiencing a shocking pain down his left arm and abdomen. When the patient met with his physician, he described the issues as a sharp pain in the left neck area, and sometimes it affects the left upper extremity, causing it to twitch, almost like a shock. At other times the pain is a funny sensation also in the right upper abdomen going to the right side of the abdomen. This lasts for about 30 seconds and occur every 3-5 days. Overall the pain is not and symptoms are not as severe, but they are still recurring, and strangely they do not occur every rhythmic beat with different time periods in between. The patient has not had any new weakness or numbness. No bowel or bladder changes. No trauma that could explain the symptoms. The patient does not have much of neck pain follow up with the physician revealed that the pain as subsided and the vns settings were lowered. The physician stated that the chest pain, should pain, and abdominal cramping were all related to vns however he did not indicate the relationship. There was no trauma or manipulation prior to the onset of any of the events nor was there any causal or contributory programming or medication changes. The physician will be programming the device off as a result of the reported events. The patient does not have a medical history of chest pain, shoulder pain, or abdominal cramping. When asked if there were any suspected device issues the physician responded "lead break?" however there were no diagnostic results available that indicated a device issue. X-rays were taken and sent to the manufacturer for review however no cause for the patient's adverse events was found. Additionally, no lead break or sharp angles were observed. The patient is going to be referred for revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2565708


Title: Re: Painful Stimulation
Post by: dennis100 on October 10, 2018, 03:12:58 AM
Model Number 103
Event Date 01/27/2012
Event Type  Injury   
Event Description
Clinic notes were received on (b)(6) 2012 from, a physician's office. The notes covered the patient's physician visit from (b)(6) 2011 to (b)(6) 2012. The patient was implanted on (b)(6) 2011, at which time the device was not programmed on. On (b)(6) 2011, notes reported pain at the surgical site, hoarse voice, and "multiple grand mal seizures after vns. " the vns incision lines looked good, were both healing well, without tenderness. The neck incision had surrounding swelling. On (b)(6) 2012, notes state that the patient's hoarse voice was gone, there was no more pain at the vns site, and no change in frequency. The notes indicate that the patient's device was turned on, and the patient did not feel anything. No settings are provided for this date, and initial interrogation at the next appointment indicates normal mode and magnet output currents were 0 ma. On (b)(6) 2012, the patient reported an increase in seizures and duration, along with aggression. The notes report that the magnet did seem to stop the seizures and make them shorter; however, settings from this date indicate that the device was programmed off until this appointment. The patient experienced painful magnet mode stimulation for the first magnet activation. On (b)(6) 2012, it was stated that the patient felt he had an upper respiratory infection the previous week. The patient turned during sleep and "felt spinal cord electricity," a lack of consciousness for 30 minutes, and then numbness throughout his head, which continued. There was now a change in seizures: the patient had a warning and then an out of body experience. He was unable to use the magnet during this time. The patient's aggression was reported to be less, he did not have any more headaches, but he did have neck pain. On (b)(6) 2012, notes reported that the seizures did decreased but have recently reoccurred. The patient occasionally coughed with vns but had no serious ill effects. The patient did experience coughing and choking during magnet stimulation; however, the magnet did abort seizures well. The patient's vns was adjusted, and the physician ensured that the patient tolerated both normal mode and magnet stimulation. On (b)(6) 2012, the patient was seen for increased blood pressure and a check of the patient's vns after the patient held a shocking dog collar while the collar was charging. The patient's vns settings were altered. This event is captured in mfr. Report # 1644487-2012-01066. On (b)(6) 2012, notes report that the patient was having the same amount of seizures (4/day) and no issues since turning the stimulator back on from the collar incident. On this date, the patient's settings were adjusted. On (b)(6) 2012, the patient was seen again for marked aggression, agitation, and an increase in grand mal seizures since the adjusted settings the previous day. The magnet did not seem to stop the seizures. The patient's mother taped the magnet over the patient's vns to disable the device, and all symptoms stopped. The patient's settings were reduced to (b)(6) 2012 settings. On (b)(6) 2012, the patient was reported to have a bad mood, irritable, snapping, and having more seizures. He was saying things he wouldn't have in the past and demonstrating almost manic-depressive type behavior. The patient became violent, hit his parents, screamed, held his head, demonstrated symptoms like a grand mal seizure, and later bit his finger. The patient was not able to perceive normal mode or magnet stimulation. The patient's mother felt that things were going well with vns at first, but felt as though the seizures were never really controlled. The patient's normal mode output current was programmed off, and the magnet was programmed to a higher output current that resulted in a cough lasting less than 5 seconds. Follow up with the nurse practitioner revealed the following information: the patient's increase in seizures was below his pre-vns baseline. The patient was treated by his primary care physician for the upper respiratory infection; however, the nurse practitioner did not think that the infection was related to vns. When asked about the change in seizure reported on (b)(6) 2012, no additional information regarding the change in seizures was available; however, the change was attributed to anxiety. The patient's anxiety was caused by vns: the presence of the device and the surgery. The nurse practitioner believes that the vns causes the patient anxiety. The anxiety, in turn, propagates more seizures. The patient was placed on medication to assist with the anxiety and sleep. There are discrepancies between the settings from appointment-to-appointment that may be due to recording errors. Attempts to obtain the physician's flashcard to review the patient's complete programming history are underway.
 
Manufacturer Narrative

Event Description
On (b)(4) 2012, a copy of the physician's flashcard was received. The patient's programming history was reviewed. The programming history provided spanned (b)(6), 2012.
 
Manufacturer Narrative
Analysis of programming history. Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr reported incorrect settings for (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, and (b)(6) 2012. Additional information was received providing correct settings for these dates. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2584000


Title: Re: Painful Stimulation
Post by: dennis100 on October 10, 2018, 03:14:13 AM
Model Number 302-20
Event Date 10/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but cannot be confirmed as the device remains implanted in the patient and analysis is not possible at this time.
 
Event Description
It was initially reported on (b)(6) 2012, that a patient presented high lead impedance on systems diagnostics (7/limit/high/no) during a routine office visit. The patient had some chest pain with stimulation that began a few weeks prior to the office visit. There were no reports of trauma or manipulation. The patient was no longer able to feel stimulation in her neck. The last acceptable diagnostics were (b)(6) 2011, on systems that resulted in ok/ok/2/no and ok/ok/4/no on normal mode. The patient's current settings are 2. 25/30/750/21/3/0/750/60. The patient began to experience an increase in depression since december however it is below baseline levels and the physician believes it is due to the high lead impedance. There were no recent changes in settings, medications, or lifestyle. X-rays were taken and sent to the manufacturer for review. No lead discontinuity was found however there was a portion of the lead is behind the generator and continuity in that portion of the lead cannot be assessed. Clinic notes were received dated (b)(6) 2012, where it was noted that the patient had gradually increasing depression from (b)(6) 2011. Adjustments to the patient's medications were being made at the same time so the patient was not alarmed however the patient began to notice her depression worsening with an increase in manic episodes with rushed thoughts and speech along with a mild spending spree. The patient also had one episode of self-mutilation were she cut her left forearm however there were no current thoughts of self-harm. The self-mutilation is part of the patient's depression as well as the mania. When the depression is worse, these events are more pronounced. The patient does have a history or mania as well as self-harm prior to being implanted with vns. The patient was referred to a surgeon for an appointment on (b)(6) 2012, for evaluation prior to lead replacement. It is unknown when/if revision surgery will occur at this time. In notes dated (b)(6) 2012, it stated that the patient had some mild discomfort in her left chest and no longer had pain in her throat with device stimulation. The chest pain was described as sharp and would increase whenever the physician's assistant pressed on the generator. The device was programmed off on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2536485


Title: Re: Painful Stimulation
Post by: dennis100 on October 10, 2018, 03:17:03 AM
Model Number 103
Event Date 03/27/2012
Event Type  Malfunction   
Event Description
Additional information was received from the physician. The patient is at low settings (0. 5ma) and is being titrated up slowly. Diagnostics were recently performed, and the results were within normal limits. The patient is reportedly doing "really well. " with the vns helping the patient so much since replacement, the benefit is counteracting the side effects of the patient's medications. It is unclear if the patient exhibited any of the clinical symptoms for which the mother alleged following surgery. The patient is more active since replacement. No additional information was provided for the physician.
 
Event Description
A vns patient's caregiver reported that after the patient's generator and lead replacement surgery on (b)(6) 2012, she had some concerns. The surgery went well, and the patient even improved. The patient's vns settings were programmed following surgery which resulted in pain for the patient. In addition since then, the patient has still been having seizures. The patient reportedly "had more intense seizures with longer duration. " the patient was seen on (b)(6) 2012, for a post-operative appointment with the neurologist. It was reported that everything was okay with the patient. In addition, the surgeon reported that everything was fine following surgery. There was a lot of scarring around the nerve, so the electrodes were not removed from the nerve. The new electrodes were placed above the previously residing electrodes. The patient was experiencing painful stimulation due to his settings being set to 3. 25 ma following surgery, which was believed to be related to the settings being titrated too quickly. Attempts for additional information from the physician have been unsuccessful to date.
 
Manufacturer Narrative
Adverse event or product problem, corrected data: the initial report inadvertently did not include the malfunction in addition to the serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2589085


Title: Re: Painful Stimulation
Post by: dennis100 on October 10, 2018, 03:18:27 AM
Model Number MODEL 250
Event Date 11/21/2010
Event Type  Malfunction   
Manufacturer Narrative
Relevant tests, corrected data: vns diagnostics test per the clinic notes dated (b)(6) 2012, were inadvertently omitted from the initial mdr report. The diagnostics indicate proper device function of the vns generator.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
All attempts to the reporter for additional information have been unsuccessful to date.
 
Event Description
During manufacturer review of a patient's vns programming history, it was observed a faulted systems diagnostics test occurred on (b)(6) 2010, which changed the vns settings. The settings were all corrected, but the off time was programmed back to 30 minutes, not 3 minutes as was the previous off setting prior to the faulted test. It was unknown if the 30 minutes off was intended as the off time; however, this is not an efficacious setting. Clinic notes dated (b)(6) 2012, were later received to the manufacturer on (b)(6) 2012, indicating the patient was having increased seizures, painful vns stimulation in the throat, and the patient felt the vns was not stimulating regularly. Settings at the (b)(6) 2012 office visit note the off time was still 30 minutes. The increased seizures were attributed to a medication dosage error per the notes. However, the off time of 30 minutes may have been a factor as this is not an efficacious setting for vns therapy. Attempts for additional information and vns programming history are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2558957


Title: Re: Painful Stimulation
Post by: dennis100 on October 10, 2018, 03:19:49 AM
Model Number 103
Event Date 02/08/2012
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported through clinic notes dated (b)(6) 2012 and received on (b)(6) 2012 that the patient presented to the er with painful stimulation and seizures. The physician was questioning the function of the generator indicating that it was possibly malfunctioning. The patient also reported having seizures about every other day when pre-vns the patient was having seizures daily to every other day; however the physician indicated that some of the seizures may be non-epileptic and questioned the patient's compliance to medications. Diagnostics were not provided and attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received that the patient wanted to be referred to a surgeon to have their device explanted because it was shocking her and she just wanted it out. No surgery date has been planned at this time.
 
Event Description
Additional information was received on (b)(6) 2012 from the patient's treating neurologist. He indicated that the device was working well with no suspected malfunction. The patient was experiencing the pain at the base of her neck and there was no suspected trauma or manipulation to the device. There were also no causal or contributory programming or medication changes. It was indicated that the patient's issues may have been related to protrusion of the device. Diagnostic results and programming history for the patient's device were not provided and no additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2540011


Title: Re: Painful Stimulation
Post by: dennis100 on October 11, 2018, 06:50:31 AM
Model Number 302-20
Event Date 05/25/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012 it was originally reported by a nurse practitioner that the vns patient was scheduled for a full revision surgery as the patient (non-verbal) was experiencing pain near the electrode site. The patient was seen on (b)(6) 2012 and the pain was timed as the patient winces with the pain, and it was found to be associated with stimulation. Normal mode and system diagnostics were run and were within normal limits; system dcdc=2, normal mode dcdc=3. The patient's current settings are: output=1. 5ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 8min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. Based on just the physical symptoms, the doctor has decided to move forward with a full revision for the patient. No x-rays have been done and will not be done. No setting changes, medication changes, or trauma had occurred prior to the patient's pain. The doctor is aware that the diagnostics show that the device is functioning as intended, but wants to move forward with the full revision in hopes that it will resolve the patient's pain. The reason for the replacement is prophylactic based on the age and the patient's settings. On (b)(6) 2012 the patient had a full revision surgery. Diagnostics were within normal limits prior to surgery and in surgery. Although the revision was because of painful stimulation, the surgery was for patient comfort and not a serious injury. Prior to surgery, the surgeon stated that he thought the helices may have slipped off the vagus nerve but during surgery he noticed that they had not. Everything looked fine when he dissected to the vagus nerve. As vns had been a great success for the patient, the parents and surgeon decided to replace the entire system as vns was the only thing that worked for the patient and they didn't want to lose efficacy. X-rays were taken in the operating room and looked normal. After surgery the patient was going to be programmed to output current of output=1ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 8min/magnet output=1. 25ma/magnet on time=60sec/magnet pulse width=250usec. The explanted lead and generator were returned for product analysis on (b)(6) 2012. The returned product form reported that the patient's system was replaced due to "stimulation causing patient pain and drops". The manufacturer's consultant clarified that these drops were actually a reaction to the painful stimulation. Product analysis of the leads was completed on (b)(6) 2012. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. The positive coil appears to be retracted against the connector ring. The positive coil tubing appears to be torn open at the ring/backfill interface. Further inspection of the lead verified that the inner silicone tubing of the positive coil appears to be torn open at the ring/backfill interface. Based on the appearance of the lead it is believed that this condition was most likely caused by forces exerted on the lead during manipulation of the lead. However, the exact point in time of when this occurred is unknown. The outer silicone tubing is cut at approximately 28. 7cm from boot. The inner silicone tubing of the lead coils is cut/torn in the vicinity of the outer tubing end. A portion of the lead coils is exposed at the end of the returned lead portion. The lead assembly has remnants of what appears to be body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Product analysis of the generator was completed on (b)(6) 2012. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2630367


Title: Re: Painful Stimulation
Post by: dennis100 on October 11, 2018, 06:51:23 AM
Model Number 302-20
Event Date 05/01/2012
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
On (b)(6) 2012, a vns patient reported that she had been experiencing a shocking in the front of her chest and left shoulder for some time but was not specific on when the issue first started. The patient noted that x-rays were taken and nothing was seen as told to her by the physician. The patient stated that a few months ago she had an accident, after the start of the painful stimulation, which caused her device to "not lay down" so she had it removed on (b)(6) 2012. She further stated that she was then informed by the surgeon that the wire by the generator was "hanging loose and tangled with a wire sticking out. " the patient clarified what she meant was that when the surgeon opened her up, he noticed the wire sticking out of the lead body. Good faith attempts were made to the physician for further information but no additional information was received. Attempts are underway for the return of the explanted lead and generator to the manufacturer for product analysis, but the products have not been received to date.
 
Event Description
Additional information was received on (b)(6) 2012,when it was discovered that the explanted products had been discarded by the hospital and therefore could not be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2627468


Title: Re: Painful Stimulation
Post by: dennis100 on October 11, 2018, 06:52:07 AM
Model Number 103
Event Date 05/24/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(4) 2012, indicating that the explanted products were discarded. It was also confirmed that the generator and most of the lead were removed during the surgery. The electrodes however remained on the nerve.
 
Manufacturer Narrative
 
Event Description
It was reported by the patient that he was experiencing some pain and swelling in his left face that was making it difficult to eat and chew. The patient indicated that he wished to have his device explanted. The patient was then scheduled for a consult with a surgeon to have the device removed. Follow up with a nurse at the patient's treating neurologist's office revealed that the patient has been in pain for a while and that the device has been off for about a year. She indicated that she has not seen the patient since his consult with the surgeon, but she has spoken with him and he seems happy to have the device taken out. She indicated that they are unsure is this is just the patient, or if the device may have been implanted incorrectly, but she indicated that the patient does seem to be in legitimate discomfort. She was not able to provide any additional information. The patient had previously reported issues with pain, pain with stimulation, and voice alterations, starting following a lead replacement in (b)(6) 2011, however at the time these were thought to be mild and no interventions were taken. Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(4) 2012, indicating that the patient had a vns removal surgery (b)(6) days prior on (b)(6) 2012. It is unclear at this time if only the generator was removed or if the lead was removed also. Attempts for product return and additional information are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2616944


Title: Re: Painful Stimulation
Post by: dennis100 on October 11, 2018, 06:52:54 AM
Model Number 302-20
Event Date 03/30/2012
Event Type  Malfunction   
Event Description
Reporter indicated a patient had vns generator replacement surgery for battery depletion, and lead replacement due to a suspected abraded insulation issue. No lead anomalies were visualized in the surgery, but the patient was experiencing painful stimulation and tightness in the chest area which was felt to be attributed to a breach in the lead insulation or possible fracture. The explanted devices will not be returned by the hospital per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2614896


Title: Re: Painful Stimulation
Post by: dennis100 on October 12, 2018, 04:47:16 PM
Model Number 102
Event Date 06/08/2012
Event Type  Injury   
Event Description
The patient reported that as far as she knows the vns system is functioning properly and the device is not at end of service.
 
Event Description
An implant card was received for the patient's generator replacement surgery on (b)(6) 2012. It reported the reason for replacement as "prophylactic reasons. " lead impedance was okay following surgery.
 
Manufacturer Narrative

Manufacturer Narrative
Describe event or problem, corrected data: this information is relevant for the conclusion coding. There is no device malfunction suspected, and diagnostics are suspected to be okay as reported by the patient.
 
Event Description
It was reported through clinic notes dated (b)(6) 2012; received on (b)(4) 2012, that the patient had been waking in the morning with sore muscles and a bitten tongue. The physician indicated in the notes that this is strongly suggestive of breakthrough nocturnal seizures; however he indicated that the seizures were not confirmed. At the appointment, the patient's generator was interrogated and the off time was lowered to 3 minutes. The generator was also said to be not at end of service. The patient also reported on (b)(6) 2012, that she had been experiencing whole body twitching at night in her sleep for about the last 2-3 weeks. She also mentioned that she had experienced a bad seizure the (b)(6) prior to her call, but stated that this was below her pre-vns seizure frequency. Since that seizure she reported pain from her generator site going to the neck site which occurs with stimulation every 3 min. Per the patient the pain began (b)(6) nights ago it feels like sensitivity. She states she especially feels it if she lays down on her left side. She also says that if she swipes her magnet then she feels the sensation in her throat. The patient was referred for and underwent a generator replacement on (b)(6) 2012. Attempts for additional information and product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2675781


Title: Re: Painful Stimulation
Post by: dennis100 on October 12, 2018, 04:48:05 PM
Model Number 302-20
Event Date 06/16/2012
Event Type  Malfunction   
Event Description
The patient's explanted products were returned for analysis. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. An analysis was performed on the returned lead portions. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The incision mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device failure is suspected.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned for analysis but did not cause or contribute to a death.
 
Event Description
Additional information was received on (b)(6) 2012, indicating that the patient underwent a full revision on (b)(6) 2012. The explanted products will not be returned as the hospital does not return items to the manufacturer. An implant card that was received following surgery, indicated that lead impedance was ok following surgery and that the devices were explanted due to damage caused by a fall.
 
Event Description
It was reported that the patient had been experiencing lead protrusion, a choking sensation during stimulation in her throat, along with an increase in seizures (below pre-vns baseline levels) and painful stimulation in the neck area which started occurring after the patient dropped a 50 lb rock on her chest on (b)(6) 2012. The patient said that her magnet activations were also more intense than the normal mode stimulation. The patient was seen for a follow up visit on (b)(6) 2012 and system diagnostics were performed causing pain. The diagnostic results indicated high lead impedance. The physician believes that the recent trauma has caused all the recent issues and is sending her for a full revision, including a prophylactic generator replacement. The patient had previously been seen one week prior to the accident, and at that time diagnostics were within normal limits. The device was disabled and x-rays were not performed. Revision is likely but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2673601


Title: Re: Painful Stimulation
Post by: dennis100 on October 13, 2018, 05:02:12 AM
Model Number 302-20
Event Date 06/06/2012
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Additional information was received the patient found a new surgeon and is presuming surgery. Surgery is likely but has not occurred to date. The patient had her generator turned off as she felt her symptoms have been getting worse. Diagnostics still indicated high impedance.
 
Event Description
On (b)(6) 2012, programming history from the physician's flashcard was received with history from one date: (b)(6) 2012. A battery life calculation was performed with results of 5. 78 years to eri = yes. Follow up was conducted with the physician on (b)(6) 2012. The physician stated that the patient and physician have decided to leave the device programmed on, and no other interventions would be taken at this time. Surgery may still occur but has not taken place to date.
 
Event Description
Additional information received revealed that the patient had both the generator and lead were explanted and replaced.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer. No gross lead discontinuities visualized. Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was attained that the patient has yet to undergo full revision surgery and the surgeon that they would have been going to has retired. At this time a new surgeon has not been located for the patient.
 
Event Description
On (b)(4) 2013, additional information was received indicating that the patient was reporting that she was feeling a "humming" in her vocal cords when she lays down. The event began two months prior, and the patient stated that it was positional. The frequency increased when the patient is lying down, but it is not noticed when standing up. The event is occurring with stimulation. Diagnostics still indicated high impedance.
 
Event Description
On (b)(6) 2012, a physician reported that diagnostics for this vns patient indicated high impedance. The physician stated that today was his first appointment with this patient. The patient's device was interrogated, and the settings were provided. It was stated that the pulsewidth was 250 usec and not 500 usec because the patient could not tolerate the higher pulsewidth due to painful stimulation at the electrode site. At the patient's current settings, the patient did not experience painful stimulation. The physician stated that he ran normal mode and system diagnostics on this date. Both diagnostics indicated high impedance. The physician stated that the patient did not feel a change in stimulation; therefore, he was unsure if he was going to program the device off as the patient was doing very well. The physician stated that the patient saw a chiropractor about six months ago. The chiropractor was manipulating her neck, but as far as the patient knows, the chiropractor did not manipulate the device or press it in anyway. The physician stated that the patient's previous psychiatrist likely interrogated the device after the event but probably did not run diagnostics. The physician was uncertain about the relationship between the patient's chiropractic experience and the high impedance. The physician stated that x-rays would be ordered and sent to the manufacturer for review. On (b)(6) 2012, the patient provided her programming and diagnostic history and requested a battery life calculation. Correspondence with the physician for a copy of his flashcard is underway. On (b)(6) 2012, follow up with the physician revealed the following information. The patient is doing very well with the exception of some shortness of breath. He stated that this was not a significant event. The patient did not notice a change in stimulation since the high impedance event. The physician believes the patient's device was last interrogated two to three years ago. When asked about the painful stimulation, the physician stated that the patient was not currently experiencing painful stimulation. On (b)(6) 2012, ap and lateral images were provided for the neck and chest. The lead connector pin appeared to be completely inserted into the generator connector block, and the generator feed-through wires appeared to be intact. The lead wires at the connector pin appear to be intact. A portion of the lead body is behind the generator; therefore, as the entire lead could not be assessed, continuity in the obstructed portion of the lead cannot be confirmed. No obvious lead discontinuities were visible. Attempts for additional information are underway. Replacement surgery is likely but has not occurred to date.
 
Event Description
Additional information received revealed that the explanted lead and generator will not be returned for analysis, as they were destroyed by the explanting facility per the hospital's protocol.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2637706


Title: Re: Painful Stimulation
Post by: dennis100 on October 13, 2018, 05:02:56 AM
Model Number 302-20
Event Date 06/19/2012
Event Type  Injury   
Event Description
On (b)(4) 2012, the operative report was received from the patient's surgery on (b)(6) 2012. It was discovered that the patient only underwent a lead replacement not a full revision that day. The report stated that the patient had left ear pain with stimulation during the last year. The patient had a generator replacement on (b)(6) 2012, but the patient still had persistent left ear pain with stimulation. It was then decided that the patient needed prophylactic lead revision for patient comfort. During surgery the surgeon noticed extensive scar tissue around the leads and the surrounding jugular vein making dissection difficult. The generator was left implanted as it was just implanted in march. The generator was connected to the new leads and impedance was within limits. It was initially reported on (b)(6) 2011, by the physician that the vns patient is complaining of painful stimulation in the left side of his neck radiating up into the left ear. The patient's settings were a pulse width of 350usec and frequency of 20 hz. The last time diagnostics were performed they were within normal limits; specifics not provided. The manufacturer's consultant reported during a clinical visit with the patient on (b)(6) 2012, that the patient's current settings were output=0. 5ma/frequency=20hz/pulse width=250usec/on time=7min/off time=1. 1min/magnet output=1ma/magnet on time=60sec/magnet pulse width=250usec. A system diagnostics test showed results within normal limits; dcdc=3/eos=no. A normal mode diagnostics test was not performed. The pain is located in the left ear with stimulation which began in (b)(6) 2011. No trauma or manipulation occurred that is believed to have caused or contributed to the painful stimulation. There also has been no change in settings. The physician tried decreasing the patient's settings to try and help with the painful stimulation but the patient continued to feel the pain. The patient was having prophylactic generator replacement and a possible prophylactic lead revision surgery (if battery replacement doesn't improved the patient's pain). The surgery was for patient comfort. The patient was experiencing an increase in seizures, below pre-vns baseline levels, due to the lowering of vns settings.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when the patient underwent full revision surgery. The products could not be returned for product analysis as they were discarded by the hospital. Attempts for additional information from the physician have been unsuccessful to date.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient was scheduled for a generator and lead revision surgery. The lead revision was originally scheduled for prophylactic reasons. The patient was admitted to the hospital on (b)(6) 2012 for multiple seizures. The surgeon's office was unable to provide any additional information. On (b)(6) 2012, the neurologist's nurse practitioner reported that the patient was admitted to the icu on (b)(6) 2012 because, he had 25 seizures in 12 hours. The patient then had 9 more seizures while being admitted. The patient was discharged on (b)(6) 2012 and is being medically managed with iv medications and an adjustment of his po medications. The physician thinks that these seizures have been so uncontrolled and may be related to vns, which is why the patient will be undergoing a full revision instead of just a lead replacement. The nurse did not know the relationship of the increase in seizures to pre-vns baseline levels. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2650180


Title: Re: Painful Stimulation
Post by: dennis100 on October 13, 2018, 05:03:37 AM
Model Number 302-20
Event Date 06/07/2012
Event Type  Malfunction   
Event Description
Reporter indicated a patient was having painful vns stimulation in the neck which was felt to be due to a possible lead microfracture. Vns device diagnostics are within normal limits and do not indicate a device malfunction. The vns was disabled on (b)(6) 2012. The patient has not had any known trauma or recent changes in vns programmed settings. The patient has been doing neck stretching exercises which may be contributing to the painful stimulation per the reporter. The patient may be referred for surgery, but this has not occurred to date. The plan of care for the patient is to observe clinically with the vns disabled for now, and possibly seek vns revision surgery.
 
Manufacturer Narrative
 
Event Description
Analysis of the generator and lead was completed. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. A significant portion of the lead (including the lead's electrodes) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Event Description
Reporter indicated via a manufacturer's implant card that the patient had vns lead and generator replacement surgery on (b)(6) 2013 due to a lead discontinuity. The explanted lead and generator have been returned and are pending analysis.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2646561


Title: Re: Painful Stimulation
Post by: dennis100 on October 13, 2018, 05:04:24 AM
Model Number 102
Event Date 06/13/2012
Event Type  Injury   
Manufacturer Narrative
Initial reporter, corrected data: the initial mdr report inadvertently listed the incorrect initial reporter. The correct reporter and occupation are provided.
 
Event Description
Reporter indicated the patient was having some left pectoral pain, but this was not considered a serious injury. It was felt the generator had migrated over the previous 3-4 weeks. The patient had generator replacement surgery performed on (b)(6) 2012. Attempts for return of the explanted generator have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
Additional manufacturer follow up with the hospital revealed the explanted vns generator was discarded after the surgery.
 
Event Description
Reporter indicated a patient was experiencing migration of the vns generator into the left axilla, along with painful vns stimulation in the chest. The migration occurred approximately (b)(6) 2012. The patient has also reported the vns lead was migrating, but the reporter confirmed only the generator was migrating. It was also reported the generator was at end of service. However, a battery estimate performed yielded 4 years remaining, indicating end of service is unlikely. The patient had no trauma and did not manipulate the vns. The vns generator was secured with a non-absorbable suture at the initial implant surgery on (b)(6) 2007. Surgery to replace the vns generator is tentatively planned for (b)(6) 2012. Attempts for further information are in progress.
 
Event Description
A manufacturer's implant card was received from the reporter indicating that vns device diagnostics were within normal limits with the resident lead and new vns generator at the (b)(6) 2012 surgery. The implant card indicated the generator was replaced for prophylactic reasons.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2648409


Title: Re: Painful Stimulation
Post by: dennis100 on October 14, 2018, 12:30:37 PM
Model Number 300-20
Event Date 12/22/2011
Event Type  Injury   
Event Description
Reporter indicated the patient had the vns explanted at the family's request on (b)(6) 2012. The explanted devices will not be returned per hospital policy.
 
Event Description
Reporter indicated a vns patient was experiencing lead protrusion in the neck, and that this was very painful. Additionally, performing vns systems diagnostics caused the patient to have painful stimulation, dyspnea, and coughing. The vns was disabled, and the patient was sent for a surgical referral and x-rays. Although surgery is likely, it has not occurred to date. Attempts for further information are in progress.
 
Event Description
All attempts to the reporter for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2493185


Title: Re: Painful Stimulation
Post by: dennis100 on October 14, 2018, 12:31:19 PM
Model Number 302-20
Event Date 07/26/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated that during vns generator replacement surgery for reported generator end of service, it was noted the lead was fractured. A new vns lead and generator was implanted. The lead was discarded at the surgery. The vns generator was returned for analysis and no anomalies were identified. The generator was not at end of service. Attempts for additional information are in progress.
 
Manufacturer Narrative
Describe event or problem, corrected data: information regarding the patient's painful stimulation was inadvertently omitted from mdr report #1. Date of event, corrected data: the initial mdr report inadvertently reported the incorrect event date. The correct date is provided.
 
Event Description
Reporter indicated that at the surgical consult on (b)(6) 2012, the patient reported she was having painful stimulation in her neck and left arm which was described as a shocking sensation. Vns generator replacement was planned as it was felt the generator was nearing end of service and the patient was having painful stimulation. The painful stimulation may be related to the lead fracture, but this was not certain.
 
Event Description
Reporter stated x-rays were done prior to the surgery and no anomalies were noted. The patient had no known trauma and does not manipulate the vns. The patient was seen in surgical consult on (b)(6) 2012 and the vns was reported to be working properly at that time, but diagnostics were not charted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2715879


Title: Re: Painful Stimulation
Post by: dennis100 on October 14, 2018, 12:39:42 PM
Model Number 101
Event Date 01/01/2011
Event Type  Injury   
Event Description
Additional information was received that the generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
Additional information was received that product analysis is complete on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. There was no abnormal performance or any other type of adverse condition found with the generator.
 
Event Description
It was initially reported that the patient was having a change in seizures and painful stimulation. The patient had a prophylactic generator replacement. Good faith attempts for product return are in process. The patient began having an increase in seizures (b)(6) 2011 believed to be related to a depleting battery. The patient had their topomax dose increased which helped a little. The patient was also having painful stimulation in the neck. Diagnostics were all ok. It was decided that due to the seizure increase and the painful stimulation, a prophylactic generator replacement would be best. The level of the seizure increase was unknown as compared to baseline. The patient has partial complex seizures and non-epileptic stress events. The patient is doing well currently. No further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2592710


Title: Re: Painful Stimulation
Post by: dennis100 on October 15, 2018, 11:55:18 AM
Model Number 103
Event Date 07/21/2012
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the vns patient was scheduled for surgery on (b)(6) 2013. It was reported that the patient had pain around the generator and left neck and the device was turned off due to the pain. The patient had surgery on (b)(6) 2013 and only the generator was replaced. It was reported that the generator was first replaced and then an impedance value of 3960ohms was observed, which is within normal limits, and therefore the surgeon did not want to replace the leads. The explanted generator could not be returned to the manufacturer for product analysis according to the hospital. Review of manufacturing records confirmed both the generator and lead met specifications prior to distribution.
 
Event Description
Additional information was received on (b)(6) 2013 when product analysis was completed on the explanted generator. The pulse generator diagnostics were as expected for the programmed parameters. No obstructions were observed in the header lead cavity or connector blocks. In addition, the in-line cavity go gauge test passed. A bench lead inserted completely passed the negative connector block and was secured with the returned setscrew. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 977 volts, shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed both lead and generator met specifications prior to distribution. Brand name; common device name; model #, serial #, lot #, expiration date; device manufacture date; corrected data: additional information was received which changes the product from what was initially reported on initial report.
 
Event Description
On (b)(6) 2012 it was reported that 5 days ago the patient stopped being able to feel normal mode stimulation. The patient has also been experiencing an intermittent pain in the neck over the past 5 days. The patient denied any falls or trauma to the neck/chest. The patient saw her physician and the physician reported that a system diagnostics test showed high impedance with an impedance value 10,000ohms. The physician disabled the device and referred that patient for surgery. It was unclear if x-rays were going to be taken but they would not be sent to the manufacturer for review. The physician later reported that he believes the pain is related to vns and is likely due to a leak of stimulation. The physician further indicated that the patient is 6 months pregnant. Clinic notes were received from the (b)(6) 2012 clinic visit which reported that the patient has a sharp pain in the nerve that started the night before and was constant. There is a possible lead fracture. The device was disabled due to the pain. The patient's settings prior to this was output=0. 5ma/frequency=25hz/pulse width=130usec/on time=30sec/off time=3min/magnet output=1ma/magnet on time=60sec/magnet pulse width=250usec. It was also reported in clinic notes dated (b)(6) 2012 that the patient has depression. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the explanted generator would be returned to the manufacturer for product analysis. It was stated that the generator had been replaced due high impedance and that the lead was not replaced. The explanted generator however, has not been received by the manufacturer to date.
 
Event Description
On (b)(4) 2013 the patient's explanted generator was received for product analysis. Product analysis is still underway and has not yet been completed. The manufacturer's consultant reported that the patient continues to have painful stimulation in the neck despite generator replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2705439


Title: Re: Painful Stimulation
Post by: dennis100 on October 15, 2018, 11:56:22 AM
Model Number 300-20
Event Date 07/21/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated a patient was experiencing painful, erratic stimulation in the neck that was occurring every 2-3 minutes. The patient had no known trauma. The reporter was unable to interrogate the vns generator as it is believed to be depleted. The generator was interrogated one month prior and at that time indicated the generator was at end of service (eri = yes). The reporter does not believe there is an issue with the vns programming wand, as the patient's vns generator is at end of service. It is felt the generator being depleted in the reason the wand is unable to communicate with the vns. The reporter stated the vns may be explanted due to the patient's painful stimulation event. Attempts for further information are in progress.
 
Event Description
Reporter indicated the plan of care was to explant the vns. Explant of the generator occurred on (b)(6) 2012; the lead was not explanted. No new devices were implanted. The hospital discarded the generator. The patient had no changes in medications. The patient had also been seizure-free for several years, and had brain surgery after the vns was implanted. It was clarified that the generator was unable to be interrogated, and was not disabled but was at end of service and the patient no longer had any pain. The reporter confirmed the vns programming system was working properly, ruling out any issue with the programming system. A battery life estimate performed by the manufacturer yielded -0. 55 years remaining, indicating end of service was very likely.
 
Event Description
Additional vns programing history was received and a new battery file estimate was performed, which resulted in -1. 36 years remaining.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2707636


Title: Re: Painful Stimulation
Post by: dennis100 on October 15, 2018, 11:57:11 AM
Model Number MODEL 250
Event Date 07/17/2012
Event Type  Malfunction   
Manufacturer Narrative
Analysis of setting provided by site.
 
Event Description
A vns programming physician reported that he performed a system diagnostic test and when he did the patient complained that she felt a horrible pain up her neck at the lead site and has continued to feel the same pain every hour since that time. The patient's device had been programmed off prior to the testing. The test is performed at 1ma. The physician did not perform a final interrogation to make sure that patient was still turned off before she left the office. The patient was so upset that she would not allow him to get the programming wand near her. The patient returned to clinic and it was determined that their device had been left programmed on and they were receiving therapy at 1ma once an hour. The patient was programmed to 1/20/500/30/60. This is from a faulted system diagnostic test. The patient's device was set to 0 ma. Teaching was provided as to the cause of the event and how to prevent in the future.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2702257


Title: Re: Painful Stimulation
Post by: dennis100 on October 16, 2018, 03:14:08 PM
Model Number 102
Event Date 07/19/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2012, a vns treating physician reported that the vns patient was feeling sporadic stimulation and a tightening sensation. The patient went to the er on the evening of (b)(6), 2012 to have their vns checked and the neurologist on call disabled the device. The physician ran a system diagnostics test on (b)(6), 2012 and everything was within normal limits. The patient is being referred for prophylactic replacement. The physician later reported that the events were first observed on (b)(6), 2012. No causal or contributory programming or medication changes preceded the onset of the events. No patient manipulation or trauma occurred that is believed to have caused or contributed to the events. The physician stated that he believes the sporadic stimulation and tightening sensation are related to vns and occur with stimulation. The physician further indicated that the patient feels the tightening sensation/painful stimulation in the neck. The physician plans to replace the patient's generator as an intervention. The patient was scheduled for a battery replacement on (b)(6), 2012 and during surgery the surgeon accidently cut the lead. The battery was not replaced and the patient was re-scheduled for a complete revision surgery. Although surgery is likely, it has not occurred to date. A battery life calculation was performed which showed 1. 87 years remaining until eri=yes.
 
Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation"). A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis of the lead was completed on (b)(6) 2012. A large portion of the lead assembly body, including the electrodes, was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The ends of the outer/inner silicone tubes and quadfilar coils appeared to be cut. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the one and a half sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. There was no alleged or observed malfunction with the returned portion of the lead. What appeared to be remnants of dried body fluids were observed inside the outer and inner silicone tubes. No obvious path other than the cut ends made during the explant process. No observed product related anomalies were observed with the single returned lead portion; however a lead coil cut was observed.
 
Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the patient underwent a revision surgery that day. On (b)(6) 2012, the patient's generator had been explanted and the surgeon accidently cut the lead in the process. At this point the surgeon decided to not implant a generator and closed the patient up. On (b)(6) 2012, the patient returned for surgery and a new lead and generator were implanted at this time. The generator had been replaced for prophylactic reasons. The explanted lead and generator were returned for product analysis on (b)(6) 2012. The lead impedance after surgery was noted to be within normal limits. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2692931


Title: Re: Painful Stimulation
Post by: dennis100 on October 18, 2018, 02:33:41 AM
Model Number 302-20
Event Date 08/23/2012
Event Type  Malfunction   
Event Description
An implant card was received by the manufacturer on (b)(4) 2012 which revealed that the patient had lead replacement surgery on (b)(6) 2012 due to "lead discontinuity. " the explanted lead was received by the manufacturer on (b)(4) 2012. However, product analysis has not been completed to date.
 
Event Description
Additional information was received indicating that the physician performed both normal mode and system diagnostics which resulted in okay results. They were perplexed because the diagnostics are okay but the x-rays show a partial lead break (which the physician and company representative also observed). A/p and lateral x-ray images of the chest and neck dated (b)(6) 2012 were also received by the manufacturer. The generator placement appears lower than normal in the left chest. Without images from immediately following implant surgery in (b)(6) 2010, it is difficult to assess whether the generator has migrated. The connector pin appears to be fully inserted inside the connector block, and the lead wires appear to be intact at the connector pin. The filter feed-through wires also appear intact. No portion of the lead appears to be located behind the generator. The electrodes were visualized in the neck and appear to be in the proper orientation. Unlike the previous images dated (b)(6) 2012, there do not appear to be any lead fractures in the chest area above the generator. No gross discontinuities or sharp angles are visualized in the images provided. However, a micro-fracture or unpronounced lead discontinuity cannot be ruled. It appears that there was likely an artifact in the images dated (b)(6) 2012 that made it appear as though there were two partial lead fractures in the chest area. Based on the x-ray images provided, no anomalies can be observed to account for the reported pain and potential generator migration. It can be noted that these are adverse events and not device malfunctions, and therefore, they are not expected to be observed on an x-ray. No gross lead discontinuities or sharp angles could be visualized, however an unpronounced lead discontinuity cannot be ruled out. No anomalies were identified that could account for the adverse event. The physician believes inadequate strain relief in the neck may be contributing to the patient's pain in the neck. She only gets the painful stimulation when she turns her head to the right. They believe the generator has migrated which may be pulling on the leads from the two tie-downs due to poor strain relief. The patient has received good efficacy from vns therapy. The physician believes the way to resolve this is to fix the strain relief, however, no interventions have been planned to date. Although surgery is likely, it has not occurred to date.
 
Event Description
The return product form indicates that the reason for lead replacement on (b)(6) 2012 was due to lead discontiuity. Product analysis on the explant lead has not been completed to date. The generator was not replaced.
 
Manufacturer Narrative
Device available for evaluation, corrected data:the supplemental report #2 inadvertently did not include the date in which the lead suspect device was received by the manufacturer.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis on the returned lead assembly was completed. The lead was returned in three portions. The connector pin, connector ring, and lead's electrodes were not returned for evaluation. The reported high impedance and lead discontinuity allegations were not verified within the returned lead portions. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portions.
 
Event Description
Patient reported on (b)(6) 2012 that she is doing well.
 
Manufacturer Narrative
Conclusion, corrected data: the supplemental report #4 inadvertently reported the incorrect conclusion code. No device failure is suspected. No device malfunction is suspected, and the (b)(6) 2012 x-rays did not show a lead fracture, so the event is coded as confirmed invalid. In addition, normal mode and system diagnostics were reportedly within normal limits.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
X-rays were received on (b)(6) 2012, by the manufacturer, and the radiology report indicated that the patient was experiencing neck pain. Review of the ap and lateral chest and neck x-rays, dated (b)(6) 2012 revealed that the generator can be visualized in the left chest and it appears to be in a normal orientation. The lead pin appears fully inserted into the connector block. The filter feedthru wires appear intact and the lead wires appear intact at the connector pin. The lead wire does not appear to be located behind the generator. The electrodes were visualized in the neck and appear in the proper orientation. There appears to be two partial lead fractures in the chest area above the generator. No additional gross discontinuities or sharp angles in the images provided are visualized. Based on the x-rays received, there are two partial lead fractures present in the chest area which may be contributing to the pain. Follow up with the company representative revealed that the patient's pain was thought to be the same pain the patient experienced before in the neck and shoulder area in 2011 due to generator migration and patient trauma from a car accident (before the physician was aware that there appears to be two partial lead breaks). The physician believed the pain may be related to the generator migration or potentially scar tissue at the electrode site which may be making the strain relief less prominent during neck movement. However now, the pain occurs during stimulation and when she turns her head ot the right or left. The plan is to discuss this with her on the next visit and evaluate if surgery may be needed. The physician suspects that the strain relief may or may not be present anymore due to scar tissue or it may be pulling the lead wire back into the neck area. The physician reported that all diagnostics are within normal limits, and he does not think there is a lead break but only associated with the strain relief. It could have had more of a strain relief and then when the generator migrated, caused a less prominent strain relief. If the pain is still present and it is decided to pursue surgery, the physician and company representative indicated that he would suggest to open up the pocket and neck, move the generator higher in the pocket, capture the lead wire and make a proper loop/strain relief. The physician did not know when the patient will be seen next and does not know how much dysfunction the pain is causing her. The pain does not occur every time during stimulation and is not constant, but only when she turns her neck. The device had not been turned off to date as of (b)(4) 2012. Attempts for additional information have been unsuccessful to date thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2754445


Title: Re: Painful Stimulation
Post by: dennis100 on October 18, 2018, 02:34:47 AM
Model Number 101
Event Date 08/07/2012
Event Type  Malfunction   
Event Description
The patient reported on (b)(6) 2012 that he was having issues with his vns device. He felt that it was malfunctioning and causing him to have seizures. The patient reported 4 grand mal seizures. He also indicated that he tried to disable the generator with the magnet however it would not shut off. The patient had previously reported erratic stimulation and constant pain at the electrode site, which started around (b)(6) 2012. He went to the er for this on (b)(6) 2012, however no interventions were performed at that time. It is unknown if diagnostics have been run on the generator to date as the patient does not currently have a treating neurologist. Attempts for additional information are underway.
 
Manufacturer Narrative
 
Event Description
A voluntary medwatch report, number (b)(4), was received on (b)(6) 2012. The report mentioned that the patient was experiencing painful stimulation. Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received from the treating physician. There was no manipulation or trauma that was believed to have caused or contributed to the patient's pain of erratic stimulation, however it was noted that programming and/or medication changes were believed to have contributed to the erratic stimulation. The physician did not believe that the patient's seizures were related to vns and he indicated that the patient did not experience an increase in seizures the physician was unable to provide any programming history, however he did indicate that interventions were performed and that the patient had pain when checking the diagnostics. It is unclear at this time what the interventions were. Additionally the physician indicated that the patient did not experience any adverse events as a result of the magnet not inhibiting stimulation, however he was unsure why the magnet did not disable the device. The patient has reported that he wanted a generator replacement. Revision has not occurred to date. 

Event Description
Additional information was received on (b)(6) 2012 indicating that the patient had been seen by a neurologist and had his device disabled from (b)(6) 2012 until (b)(6) 2012 to alleviate the patient's pain. On (b)(6) 2012, the device was re-enabled to 0. 25ma. No additional information has been provided to date and no interventions are planned as the patient has relocated.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
Additional information was received on (b)(6) 2013 with the patient's current settings. Attempts to increase in the output current were made, but elicited a painful response from the patient: the patient grabbed at his own neck. X-rays were taken and provided for review. The generator was not visualized in the images provided and therefore could not be assessed. The lead in the location of the generator could also not be assessed. The electrode placement appeared normal. The lead was seen routed down toward the left chest. There did not appear to be any lead discontinuities or sharp angles in the lead portion that was able to be visualized. Based on the x-ray images provided, no anomalies were observed that could be contributing to the reported event. Note that a portion of the lead as well as the entire vns generator could not be visualized in the images provided. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2763228


Title: Re: Painful Stimulation
Post by: dennis100 on October 18, 2018, 02:35:38 AM
Model Number 302-20
Event Date 09/17/2012
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed during a clinic visit on (b)(6) 2012, on a system diagnostic test, so the device was turned off. The patient was seizure-free before vns was placed and has continued to be seizure free, so there are no plans for the patient to have a revision at this time. Although revision may occur in the future, surgery has not occurred to date. The patient presented in the clinic on (b)(6) 2012, and the magnet current was changed to 1. 0ma at that time because the patient was complaining of a shocking sensation. Diagnostics on (b)(6) 2012 resulted in okay results. No causal or contributory programming or medication changes preceded the onset of the shocking sensation. No patient manipulation or trauma occurred that is believed to have caused/contributed to the shocking sensation, and it only occurs with normal mode stimulation. The patient feels it in the neck area, with no specific area in the neck mentioned. Since the device was turned off on (b)(6) 2012, due to high impedance, the painful stimulation has ceased. X-rays of the patient's vns system have not been taken.
 
Event Description
Additional information was recieved indicating the patient is being referred to neurosurgery for explant. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2760938


Title: Re: Painful Stimulation
Post by: dennis100 on October 18, 2018, 02:36:42 AM
Model Number 102
Event Date 03/01/2012
Event Type  Malfunction   
Event Description
Reporter indicated that since she had intentionally lost weight approximately six months ago, her vns was causing muscle twitching and painful stimulation. The reporter currently does not feel the vns stimulation in her neck but at the clavicle, and reported that her depression has increased since the events began. A vns battery life estimate performed by the manufacturer resulted in approximately 3. 30 years remaining, indicating generator end of service is unlikely. Attempts for further information from the treating psychiatrist are in progress.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Manufacturer follow up with the treating psychiatrist revealed the patient's vns is operating properly. The patient has not been seen since (b)(6) 2012 due to financial issues. The patient is on several medications for her depression. The patient's depression does fluctuate due to outside personal stressors, and the reported increased depression is not felt to be due to the vns. The vns has been helpful for the patient. The reporter also later indicated to the manufacturer that the vns was also felt to be helpful for her depression.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2763617


Title: Re: Painful Stimulation
Post by: dennis100 on October 19, 2018, 11:46:34 AM
Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
It was reported that the patient's vns was explanted on (b)(6) 2015 due to the patient not wanting vns any longer and feeling that vns did not help her. Both the generator and majority of the lead was explanted. On (b)(6) 2015, the patient was doing well after explant. The nurse reported that the patient has a lot of psychiatric issues, so the patient thought vns was causing a lot of the problems. However, the nurse does not think that vns necessarily was and that it was likely more psych-related. The explanted devices have not been received by the manufacturer for analysis to date. Clinic notes dated (b)(6) 2015 reported that the presented to the clinic on (b)(6) 2014 with complaints of left shoulder and chest being "inflamed. " she was advised to go to nearest er for evaluation but the patient declined. At that time, the patient was still wanting the vns settings to be adjusted. The neurologist assessed that since the patient had non-epileptic seizures, there was no plan to revise the vns. However, due to the patient's complaints, the decision was made to explant the vns. The patient reported redness and warmth over the left chest intermittently and typically applied an icepack to the area to relieve the symptoms. The patient stated that she had symptoms related to the vns when it is on, including throat tightness and right shoulder pain. However although the device was off, the patient still complained of difficulty swallowing at times with right arm pain and swelling. Therefore at that time, the surgeon assessed that the events very likely may have not been related to vns.
 
Manufacturer Narrative

Manufacturer Narrative

Event Description
Analysis was completed on the explanted products. In the pa lab, the device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Analysis in the analysis lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Event Description
Additional information was received stating that the vns patient¿s swollen generator site was causing the patient to experience painful stimulation. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
On (b)(6) 2014, it was reported that the generator site is "extremely" swollen (described as the size of a pocket with four generators inside), which has been like this for about a year. It was confirmed that the swelling was not normal. The patient also reports periodic swelling at the incision site in the neck. Normal mode diagnostics were performed with showed dcdc = 3. It was noted that the patient recently had an mri and it was not turned off during the procedure. At this time, the patient would like it resolved since she is getting efficacy and would prefer to not have the device explanted. Surgery is likely, but has not occurred to date.
 
Event Description
It was reported that the patient's the device was previously turned off due to painful stimulation. Explant may occur due to reasons unrelated to vns therapy. However, no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3627213


Title: Re: Painful Stimulation
Post by: dennis100 on October 19, 2018, 11:47:46 AM
Event Date 08/15/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On (b)(6) 2012, a physician's assistant reported that she had seen a patient who reported painful stimulation and normal diagnostics; however, a small fracture was present. No additional information was available. Follow up with the physician's assistant was performed. It was stated that the patient identity, condition, adverse events, or any other information was unknown. No additional information was available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2745267


Title: Re: Painful Stimulation
Post by: dennis100 on October 20, 2018, 12:38:39 PM
Model Number 303-20
Event Date 08/15/2012
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Full revision surgery occurred on (b)(6) 2016. It was reported by the company representative who attended the surgery that pre-operative diagnostics showed high impedance again. The explanted devices have been received by the manufacturer, where analysis is underway but has not been completed to-date.
 
Event Description
The surgeon reported to the company representative that the x-ray did not indicate a problem with electrodes/lead. In addition, the lead pin appeared to be fully inserted into the connector block of the generator, per the surgeon. The representative completed a lead (systems) diagnostic test while the patient was at physician's office and the results were within normal parameters. The neurologist was notified, and the patient will not be scheduled for surgery at this time. Attempts are in progress for copy of the neurologist's programming/diagnostic history for the patient to determine if high lead impedance was in fact observed on a system diagnostic test. Ap and lateral chest and neck x-ray images for dated (b)(6) 2012 were received by the manufacturer. The generator can be visualized in the left chest, and the placement appears normal. With the angle of the chest x-ray images, it is unable to be assessed whether the connector pin appears to be fully inserted inside the connector block. The lead wires appear to be intact at the connector pin, and the feedthru wires appear intact. The lead is routed upwards to the left side of the neck. The electrodes are visualized in the neck and appear to be in alignment. There are no gross lead discontinuities or sharp angles present. A portion of the lead appears to be located behind the generator, so continuity in the lead in that area cannot be assessed. Based on the x-rays images received, there are no gross lead fractures or sharp angles that can be visualized. However, the presence of an unpronounced lead discontinuity cannot be ruled out. The cause of the high impedance cannot be determined with the images provided.
 
Event Description
Additional information was received indicating that chest and neck x-rays were ordered, but the physician is waiting for the patient to come back to have them taken. The physician turned the device to 0ma the date the high impedance was first observed on (b)(6) 2011. The physician explained the options to the patient (full revision surgery or no replacement, etc. ), and the patient stated that she would have the x-rays taken and then evaluate the situation. It is unknown if trauma or manipulation may have contributed to the high impedance. No additional information was known or provided. Although surgery may occur, it has not occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contributed to a death or serious injury.
 
Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #1 inadvertently reported the date the high impedance was first observed incorrectly.
 
Event Description
The date the high impedance was first observed was (b)(6) 2012 as reported in the initial report. The neurologist reviewed x-rays for the patient and there was no apparent lead problem found, but the patient still complained of painful stimulation. Therefore, the device was remained turned off at that time. The patient is being referred for surgical consult for possible full revision surgery. Attempts for additional information have been unsuccessful to date.
 
Event Description
A copy of the treating neurologist's flashcard was received and reviewed for the patient's programming/diagnostic history. It was observed that a system diagnostic test was performed by the neurologist on (b)(6) 2012 which resulted in high lead impedance. The neurologist reportedly observed the high lead impedance again since (b)(6) 2012 (unknown date). It was reported on (b)(6) 2012 that the patient is reportedly at low settings and is not experiencing painful stimulation or adverse side effects and seizures are pretty well controlled.
 
Event Description
It was reported that high lead impedance was observed on the patient's device on (b)(6) 2012, and the neurologist is referring the patient for generator and lead replacement surgery as a result. The generator was turned off, and x-rays were ordered. However, attempts for additional information and return of the x-rays have been unsuccessful to date. Although surgery is likely, it has not occurred to date.
 
Event Description
Analysis was completed for the generator 02/08/2017. An end-of-service warning message was verified, associated with the output being disabled by the pulse generator, as a result of electrocautery use during explant. Various electrical loads and results of diagnostic tests demonstrated accurate resistance measurements in all instances. Electrical evaluation showed that the generator performed according to functional specifications. The battery measured 3. 048 volts and does not show an end-of-service condition. The downloaded data revealed that 23. 787% of the battery had been consumed. Other than the noted end-of-service event (due to electrocautery during explant), there were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed for the returned lead portion. Note that the electrodes were not returned for analysis and a complete evaluation could not be performed on the entire lead product. The lead pin appeared fully inserted into the header, as-received. The slice marks and incision marks found on the outer silicone tubing and the cut ends that were made during the explant process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed and no discontinuities were identified. There was no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the high impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2738017


Title: Re: Painful Stimulation
Post by: dennis100 on October 20, 2018, 12:39:39 PM
Model Number 300-20
Event Date 06/15/2012
Event Type  Injury   
Event Description
The patient's explanted generator was returned and analysis completed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
The patient had their generator replaced on (b)(6) 2012. Thus far the explanted generator has not been returned for analysis.
 
Event Description
A site reported that they had a vns patient who is experiencing neck pain with stimulation which has been occurring for the past 2 months. The patient was last seen in (b)(6), and the diagnostics were ok then, and today when diagnostics were run, the results were all ok. There have been no setting changes recently, nor were there any changes in (b)(6). The patient reported it was a sharp pain, like a knife. It is happening sporadically and patient is cognitively impaired so couldn't say if the pain is related to stimulation or not. As a result, the physician swiped the generator with the magnet and elicited the same pain so knew it was related to stimulation. The patient normally has a high tolerance for pain so if he's feeling such pain, then they think there must be something wrong. The patient is currently programmed to: 2. 50 ma, 20 pulse width, 250 signal frequency, 30 seconds on time and five minutes off time. There had not been any manipulation or trauma that may have contributed to this event. It was reported that they would be programming the patient's device off and referring for full revision surgery. The site took x-rays, but they were not sent to the manufacturer for review. At this time no surgery date has been set.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2739455


Title: Re: Painful Stimulation
Post by: dennis100 on October 20, 2018, 12:40:28 PM
Model Number 103
Event Date 08/15/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's explanted product has not been returned at this time. It needed to go to risk management. It is unknown if it will be returned.
 
Event Description
A vns programming physician reported that he had a vns patient who was having painful stimulation in the chest and throat area. The event was reported to have started after they had a mammogram performed. The patient's pain is just during stimulation on times only. It was reported that their device had different timings. It was reported to their physician that their friend documented that the patient has had stimulation times of 7, 19, and 30 seconds. It did not happen every time. The patient is programmed to 2. 5/20/130/7/3. 0 and 2. 5/30/130. The patient was at 3. 5 before the mammogram but could not tolerate this so their output current was lowered to 2. 5ma. The diagnostic results were around 2900 ohms each time the diagnostics were performed. Four tests were performed with the patient's neck in different orientations which all resulted in 2900-3000 ohms. The patient has a port o cath on the left hand side of their chest so the implant is actually on the right hand side but connected to the left vagus nerve. With the patient's lowered therapy she started to have seizures and were attributed to the lowering of their therapy in relation to their pain event. The patient was sent to surgery with the intentions of a full revision. The patient only had a battery change under local anesthesia and with the device programmed off they were still experiencing some pain. It is questioned if this was a psychological issue. The patient did just have surgery so some pain would be expected around this time. The explanted product is being returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2739814


Title: Re: Painful Stimulation
Post by: dennis100 on October 25, 2018, 03:18:55 AM
Model Number 302-20
Event Date 10/03/2012
Event Type  Injury   
Event Description
On (b)(6) 2012 it was reported that the vns b patient is in the emergency room due to electrical shocks in her chest; pain from vns. The patient was referred for a revision surgery due to the painful stimulation. It was later reported that the painful stimulation was first observed on (b)(6) 2012. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. No patient manipulation or trauma occurred that is believed to have caused/contributed to the painful stimulation. It was reported that both system and normal mode diagnostic tests were performed which showed the device to be functioning properly as they came back "ok. " the device is currently programmed off. The revision surgery is for patient comfort. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient was seen that day by a vns treating physician and the patient's mother had informed the physician that the device had been disabled in october because the device was at near end of service and the patient was having painful stimulation in her neck and had been referred for a full revision surgery because he believed that something may be wrong with her lead. No diagnostics were performed on the (b)(6) 2013 visit because the device was disabled and they did not want to bring the painful stimulation back with diagnostics. The physician's rational in referring the patient for a full revision was because the battery was depleted anyways and he believed something was wrong with the lead which was causing the painful stimulation. Clinic notes dated (b)(6) 2013 were received which indicated that the vns battery is depleted causing an increase in seizures. The patient was referred for a full revision surgery. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Brand name; common device name; model #, serial #, lot #, expiration date; device manufacture date; corrected data: additional information was received which changes the product that the initial report was submitted on.
 
Event Description
Additional information was received on (b)(4) 2013 when clinic notes were received. The clinic notes dated (b)(6) 2012 indicated that the patient has had no chest pain, cough, or throat irritation. The vns appears to be in place without surrounding redness, swelling, increased warmth, or tenderness. The clinic notes state that the patient's headache resolved with change in vns settings and patient not able to tolerate >1. 0ma output current. The patient's last seizure was on (b)(6) 2011 with no recurrence. The clinic notes dated (b)(6) 2012 indicate that for the last 4 days, the patient complains of intermittent pain starting on the right side of the chest along the vns and radiating into the right side of the neck that is severe and occurring on a frequent basis. The patient states that it is every five minutes and on for 21 seconds. The patient has had no recurrent seizures. No obvious injuries or neck injuries. Her x-rays were reported as unremarkable and no obvious notable break along the wires to suggest a short. The physician stated that the left-sided chest and neck pain are most likely related to the vns. The patient's vns was interrogated and appeared to be working "essentially unremarkable. " the lead impedance was ok with no signs of end of service and a dcdc of 2. The patient's device was disabled and the patient was referred for surgery. Although surgery is likely, it has not occurred to date. It was later reported that the patient has clinical depression and symptoms are worsening as well as seizures. The patient's device had been disabled in the er prior to this.
 
Manufacturer Narrative

Event Description
On (b)(6) 2013 the patient underwent generator replacement. It was reported that the lead was fine. The explanted generator could not be returned to the manufacturer as the hospital does not return explanted products.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2808655


Title: Re: Painful Stimulation
Post by: dennis100 on October 26, 2018, 11:03:25 AM
Model Number 101
Event Date 01/10/2012
Event Type  Injury   
Event Description
Pt with painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2809416


Title: Re: Painful Stimulation
Post by: dennis100 on October 27, 2018, 01:13:10 AM
Model Number MODEL 250
Event Date 07/24/2012
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2012, and the patient was identified. It was indicated that the patient was seen in their office on (b)(6) 2012. At that time it was noted that the patient's off time was changed to 60minutes and the pulse width was 500usec. The patient had been reporting voice alteration with stimulation, as well as pain in her neck with stimulation since her last appointment in (b)(6). At the appointment in (b)(6), the physician realized that a faulted system's diagnostic test had occurred and corrected the patient's settings. The patient's correct settings were provided by the physician.
 
Manufacturer Narrative
Report source - corrected data: the "report source" was inadvertently omitted from follow-up report 2. The correct report sources were health care professional and company representative. Date received by manufacturer - corrected data: the "date received by manufacturer" was inadvertently omitted from follow-up report 2. The correct date was (b)(6) 2013.
 
Manufacturer Narrative
Analysis of programming history.
 
Manufacturer Narrative
 
Event Description
Reporter indicated a patient's vns settings were changed to unintended settings following a faulted systems diagnostics test. A final interrogation was not performed. The settings were later corrected, but it is not known when the faulted diagnostics occurred, or when the settings were corrected. Attempts for additional information are in progress.
 
Event Description
Programming history from the date of the event was received. The patient's generator was interrogated on (b)(6) 2012, at intended settings. A system diagnostic test was then performed which failed. Per the available programming history, a final interrogation of the generator was performed which identified that the patient's settings had changed, however, they were not corrected. On (b)(6) 2012, the patient's generator was again interrogated as the un-intended settings and corrected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2798027


Title: Re: Painful Stimulation
Post by: dennis100 on October 30, 2018, 12:52:50 AM
Model Number 103
Event Date 11/22/2010
Event Type  Injury   
Event Description
It was reported by the patient that he was having an increase in his seizures. The patient indicated that he was at the lowest settings due to coughing and a choking sensation during stimulation at higher settings. He did not feel that the device was working as he has not been able to tolerate increased settings since his generator replacement in 2010. Clinic notes were also received for this patient, which indicate that the patient has pain with stimulation when the settings are increased and also experienced an intense cough. The clinic note also mentions that the generator was interrogated on (b)(6) 2012 and "full diagnostics" were run and everything was ok.
 
Manufacturer Narrative
 
Manufacturer Narrative
Type of reportable event; corrected data: inadvertently listed event as a malfunction instead of a serious injury on the initial report.
 
Event Description
Clinic notes dated (b)(6) 2014 note that since the addition of keppra the patient has had no breakthrough seizures and his last seizure was on (b)(6) 2014 prior to increasing the keppra dose. It is noted that the patient is not able to tolerate the increased vns settings due to severe coughing and difficulty catching breath despite multiple attempts. It was noted that the patient experiences seizures with sleep deprivation.
 
Event Description
Additional information was received on (b)(6) 2012 indicating that the patient continues to have increased seizures and the physician has added a fourth medication. The generator settings can still not be increased due to discomfort. The patient was sent for a ct of the neck which showed that the device was intact. A piece of a lead wire from a previously explanted lead was observed in the neck. The surgeon indicated that they may try to remove this piece to see if that helps with the patient issues. At a follow up appointment on (b)(6) 2012, diagnostics were performed and the impedance value was within normal limits (3544 ohms). The physician was able to adjust the patient's setting slightly, by increasing the output current and decreasing the pulse width, exact settings not provided. The physician noted that she would try to titrate the patient further prior to referring him for revision.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2772418


Title: Re: Painful Stimulation
Post by: dennis100 on October 31, 2018, 01:54:21 AM
Model Number 302-20
Event Date 04/01/2011
Event Type  Injury   
Event Description
Additional information was received that the patient did not have any trauma. Their dcdc code still remains at a 2. The patient will be seen for followup again.
 
Event Description
A vns surgeon reported to our country manager in (b)(6) that their patient presented in clinic with a complaint of the electrode site being painful upon stimulation, the device was switched off approx 9 months ago, their physician believes the issue maybe the electrode placement. One screen shot was received for review which is inconclusive. One tie down was noted. At least an ap and lateral view is needed to determine if an electrode is detached or misplaced if it is not obvious. Good faith attempts were made for further details about the reported event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2850763


Title: Re: Painful Stimulation
Post by: dennis100 on November 01, 2018, 02:58:09 AM
Model Number 102
Event Date 09/01/2012
Event Type  Injury   
Event Description
Information was received that a vns patient had their generator replaced. Per the patient's mother about a month ago the patient experienced painful stimulation in the left neck which the mother described as the vns device "misfiring. " the patient presented to (b)(6) hospital where er physicians were unable to stop stimulation when the magnet was placed over the device. The mother states the device was located in a difficult to access place and was approximately six years old. Per mom, the er physicians did not understand why they could not stop stimulation with magnet placement, and had to get a programmer to turn off the device. Per mom, after the vns was turned off, the family flew to (b)(6) where established physicians reimplanted the vns on (b)(6) 2012. Their mother reported that their voice was hoarse for 2 ½ weeks after the painful stimulation episode , but is resolved now. The surgeon's office reported that the patient reported painful stimulation in the throat area that resolved with the vns being programmed off and felt surgery needed to investigate the pain event. Their device was not at eos and diagnostics were reported in the or to be within normal limits. Product analysis was completed on the returned generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. No eri flags were identified during the analysis. Although the reported allegation of "painful stimulation" cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. The septum was cored. However, no evidence of bodily fluid remnants were observed in the header septum cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation"). Magnet activations performed at the bench (at a distance of one-inch, spacer block, from generator); demonstrate the appropriate magnet output for the programmed settings. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Additionally, the generator output was disabled using a magnet at a distance of one inch using a spacer block with no observed anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2846784


Title: Re: Painful Stimulation
Post by: dennis100 on November 02, 2018, 08:40:52 AM
Model Number 102
Event Date 03/12/2009
Event Type  Injury   
Event Description
Rptr indicated that the pt was having muscle spasms and pain with stimulation. Setting changes were made, and the pt's treating physician reported the pt's pain had resolved. Additionally, it was reported the pt was having seizures. It is unk if the pt's seizures are over their pre vns seizure rate, and it is unclear if the events are seizures. Reported that pt had been having pseudo seizures and the treating physician had not witnessed any of the pt seizures to know if actual seizure events or pseudo seizures. Their medications were titrated and the pt is not due to be seen again until later date in 2009. The pt, it was reported was scared to use their magnet to abort their seizures related to painful stimulation with magnet activations and this may have possibly contributed to the increase in pt seizure rate. Setting titrations were made to make the pt's magnetic activation tolerable for the pt.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1394777


Title: Re: Painful Stimulation
Post by: dennis100 on November 03, 2018, 12:39:51 AM
Model Number 102
Event Date 09/01/2012
Event Type  Malfunction   
Event Description
Reporter indicated that the patient was having problems since a motorcycle accident in (b)(6) 2012. The patient was in the office on (b)(6) 2012 stating that he was feeling like he was having continuous stimulation after magnet swipes. The physician disabled the generator for a while then turned the generator back on during an office visit on (b)(6) 2012. Patient is now saying he has painful stimulation in his neck any time the vns is titrated up or he uses his magnet. The patient indicated that the pain typically goes away after a while. The patient's current settings were provided, however diagnostics were not available. The physician reported that patient is also having an increase in seizures above his pre-vns baseline since the generator was turned back on. There were some medication changes during that time, but he does not know what the increase in seizures is attributed to. Attempts for additional information, including diagnostic results have been unsuccessful to date.
 
Event Description
Reporter indicated the patient had prophylactic generator replacement surgery performed on (b)(6) 2013. The seizures have improved since the surgery. Attempts for additional information and return of the explanted vns generator are in progress.
 
Manufacturer Narrative

Event Description
The explanted generator has been returned and is pending analysis.
 
Event Description
Product analysis of the generator was completed. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The elective-replacement-indicator (eri) was observed prior to decontamination, but was not duplicated in the pa lab. There were no performance or any other type of adverse conditions found with the pulse generator. The patient is currently doing very well with his seizure control and his seizures have improved since replacement. The painful stimulation has also resolved, but the patient is not yet back to his original vns settings as he is still being titrated. As the seizures are stable, settings will likely stay where they are for now. The events of continuous stimulation, painful stimulation, and increased seizures began after the patient was in a motorcycle accident in (b)(6) 2012 and this was the event that precipitated the patient's adverse events. Diagnostics are currently ok. The seizures were just increased in general, and the types were not specified, but the seizures have improved since replacement. The cause of the events are felt to be likely due to the accident the patient had.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2882949


Title: Re: Painful Stimulation
Post by: dennis100 on November 03, 2018, 12:40:43 AM
Model Number 302-20
Event Date 10/24/2008
Event Type  Injury   
Event Description
It was reported by a physician's office that the patient had repositioning surgery for the lead in (b)(6) 2008 due to migration of the electrodes. It was indicated that the patient was experiencing painful stimulation in the neck so the revision was performed. It was indicated that absorbable sutures were used during the initial implant. Attempts for additional information are in progress.
 
Event Description
Reporter indicated the patient's pain was not related to the vns, but the cause was not specified. It was felt to possibly be due to vns stimulation. It was unknown if any contributory programming or medication changes preceded the onset of the pain. It is possible there was patient trauma and manipulation of the vns. The lead repositioning surgery was not performed to preclude a serious injury. The lead tie-downs were secured with non-absorbable suture.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2882636


Title: Re: Painful Stimulation
Post by: dennis100 on November 04, 2018, 01:52:40 AM
Model Number 102
Event Date 10/01/2012
Event Type  Injury   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross discontinuities visualized.
 
Event Description
A vns physician reported to our local distributor in (b)(4) that there was a patient having pain in her neck that had been more intense recently and is taking pain medication to relieve the pain. He did not have any additional information but stated that x-rays and ultrasounds have been performed. This pain is similar to the pain that she feels every time she is adjusted with new parameters, but more intense. Her last adjust was in (b)(6) 2012. To relieve the pain, the patient is taking ketoprofen orally. The radiography and ultrasound taken don't show any abnormality. The patient's treating physician feels the event is related to stimulation. It is occurring with stimulation and more intense with the use of the magnet. No trauma or patient manipulation has been reported prior to the onset of the event. The event started after the patient's last programming change about 45 days ago. Their physician introduced lamotrigine to the patient medication regime. The pain occurs during stimulation on-times. On (b)(6) 2012, the physician reduced the intensity of the stimulation, from 1. 75ma to 1. 5 ma. Then prescribed ketoprofen. On (b)(6) 2012, the physician lowered the frequency from 30 to 25 hz. The pulse width was already setup at 250's. On (b)(6) 2012 the physician reported that the patient was relieved from the pain in the neck, however, the physician is concerned about the seizure control because the frequency of seizures has increased. It was reported by their treating physician that it was likely that their seizure increase might been due to the intense pain that she felt. X-rays were received for review. The generator was seen in the left chest. The continuity of the filter feedthru wires and whether the lead pin was fully inserted into the connector block were unable to be assessed due to the angle of the x-ray. A portion of the lead appears to be present behind the generator. No break was observed in the lead; however, a portion of the lead is behind the generator and cannot be assessed. The electrodes were observed in the neck and appear to be in proper alignment. A strain relief bend is present and per labeling as there is at least 1-cm of lead routed parallel to the nerve prior to the onset of a 3-cm bend. However, there is no strain relief loop. There are two tie-downs present; however, they are not placed lateral to the anchor tether. The lead is seen routed down toward the generator. Based on the x-ray images provided, the cause of the neck pain cannot be determined. However of note, there was not adequate strain relief present in the loop. There were no lead breaks found, but the presence of additional micro-fractures in the lead cannot be ruled out. No further interventions have been taken at this time.
 
Event Description
Seizures reported as below baseline rate of pre-vns but above baseline rate before lowering down vns intensity from 1. 75 to 1. 5. A battery life estimation was performed and their battery is noted to have an estimate of years remaining until eri=yes: 2. 59. No further information attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2873232


Title: Re: Painful Stimulation
Post by: dennis100 on November 05, 2018, 11:27:50 AM
Model Number 103
Event Date 10/15/2012
Event Type  Malfunction   
Event Description
A vns treating physician reported that one of his patient's was seen and complained that since (b)(6), she has been experiencing painful stimulation in her ear with magnet mode stimulation. A system diagnostic test performed was within normal limits. Their pain was reported as a mild pain, so any intervention he would be taking would be for her comfort. The patient came into clinic programmed to 0. 25/30/130/30/5 magnet 0. 5/60/500. The patient lives a few hours away, so they decided to go ahead with titration and increase her output current. The patient left the office programmed to 0. 5/30/130/30/5 magnet 0. 75/60/500. The patient did not report any trauma and none of her medications have recently changed. The patient was seen again on (b)(6) 2012 and was still experiencing painful stimulation with magnet mode stimulation. The patient came into the office programmed to 0. 5/30/130/30/5 magnet 0. 75/60/500 and left programmed to 0. 75/30/130/30/5 magnet 1/60/500. All diagnostics that were run were reported to be within normal limits. It also noted that the patient has had a slight increase in seizures over the past month, which they think may be related to the stress from the pain. The patient's increase in seizures is above her pre-vns baseline, but they will not be taking any intervention. Further programming changes may be made at the patient's next office visit.
 
Manufacturer Narrative
 
Event Description
Additional information was received that the patient was seen in clinic. The patient reported further increased seizure activity and said that she is still feeling an excruciating pain with magnet mode stimulation like she was before. The last time the patient was in the office, her settings were changed to 0. 75/30/130/30/5 magnet 1/60/130. Upon interrogation today, the patient was still programmed to those settings and all diagnostics were within normal limits. Programming changes were going to be made. The patient's magnet output current was going to be lowered.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2869407


Title: Re: Painful Stimulation
Post by: dennis100 on November 08, 2018, 01:37:13 AM
Model Number 103
Event Type  Injury   
Event Description
It was reported that a vns patient had 50 seizures in one day but it was unknown what day they was. It is unknown if that is over the patient's prevns rate. It was reported that the vns just did not help with the patient's seizures and she found it significantly annoying. Therefore, she wanted to have it removed. The patient also had pain with stimulation. Good faith attempts are underway for further details surrounding their events.
 
Manufacturer Narrative

Event Description
Good faith attempts have been made and no further information has been attained about the patient's reported events. Their explanted generator was discarded therefore will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2901469


Title: Re: Painful Stimulation
Post by: dennis100 on November 09, 2018, 03:00:25 AM
Model Number 300-20
Event Date 11/01/2012
Event Type  Malfunction   
Manufacturer Narrative
The event date on follow-up report 1 was inadvertently not updated with the new date as provided by the physician.
 
Event Description
Additional information was received indicating that the painful stimulation started after an appointment in (b)(6) 2012 and was first reported to the md at the follow up appointment on (b)(6) 2012, the date the end of service was observed. Diagnostics were provided from (b)(6) 2012 and were within normal limits. It was again noted on (b)(6) 2012 that end of service was observed during interrogation. X-rays were performed but have not been sent to the manufacturer for review. There was no suspected manipulation or trauma that had occurred and it was noted that the painful stimulation was believed to be related to the lead impedance. Product analysis on the lead and generator has since been completed. An analysis was performed on the returned lead portions. Note that the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. Analysis of the generator was completed and an eri=yes condition was observed. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to a 'partially depleted battery' condition. The septa were not cored and there was no evidence of dried body fluid or corrosion observed in the connector block areas, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. No abnormal performance or any other type of adverse condition was found with the generator.
 
Event Description
It was initially reported that the patient had been experiencing painful stimulation in the left neck. The patient had been referred for a generator revision, however the neurologist believed that there may be an issue with the lead as well, due to the pain. Additional information was received on (b)(4) 2012 indicating that diagnostics which were performed confirmed high impedance in the system. The patient underwent a full revision on (b)(6) 2012 and the products have since been returned for analysis. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Only a small portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2892664


Title: Re: Painful Stimulation
Post by: dennis100 on November 09, 2018, 03:01:15 AM
Model Number 302-20
Device Problem High impedance
Event Date 10/03/2018
Event Type  Malfunction   
Event Description
Patient reported experiencing painful stimulation and had taped a magnet over the device overnight to avoid this pain. Upon interrogation, high impedance was observed. Diagnostics were performed and the generator was not near end of service. X-rays were reviewed. The generator placement appeared to be normal in the left axillary chest area. A small portion of the lead pin is visible past the connector block and the feed-through wires appear to be intact. However, lead wire connectivity at the connector pin could not be assessed due to the quality and angle of the x-ray images. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. Based on the images provided, there is no obvious cause for the reported events. Patient was referred for surgery, but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8010867


Title: Re: Painful Stimulation
Post by: dennis100 on November 09, 2018, 03:01:55 AM
Model Number 103
Event Date 10/03/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated that since the patient's vns generator was replaced on (b)(6) 2012, the patient's increased seizures, painful stimulation, and erratic stimulation have resolved.
 
Event Description
Reporter indicated a vns patient was having painful stimulation in the neck since (b)(6) 2012. The vns settings were lowered, and diagnostics indicated normal device function. It was later reported the patient was having increased seizures, and was having painful and erratic vns stimulation. The patient was later referred for vns generator replacement surgery due to the painful stimulation and increased seizures, and surgery occurred on (b)(6) 2012. The explanted generator will not be returned as the hospital does not return explanted devices. All attempts to the reporter for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2893030


Title: Re: Painful Stimulation
Post by: dennis100 on November 10, 2018, 03:26:40 AM
Model Number 302-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 05/09/2018
Event Type  Malfunction   
Event Description
It was initially reported that this patient¿s device was disabled. Clinic notes were received and indicated that this patient¿s vns device was found to have a lead fracture and high impedance. X-rays were performed and showed no obvious areas of lead fracture; but it was stated that micro fractures cannot be completely excluded. The patient has pain when swiping the magnet and elected to have their vns removed. Per the neurologist¿s office, the cause of the patient¿s painful stimulation with the magnet swipe was unknown. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7960733


Title: Re: Painful Stimulation
Post by: dennis100 on November 10, 2018, 03:27:20 AM
Model Number 304-20
Device Problem Mechanical Problem
Event Date 09/01/2018
Event Type  Malfunction   
Event Description
During attempts at product return, it was revealed that the explanting facility, historically, discards all explanted devices.
 
Event Description
It was reported that the patient underwent vns lead replacement surgery due to severe neck pain and side effects. The surgeon noted fluid in the lead tubing, but no visible breaks were observed. Follow up with the company representative revealed that the vns had been programmed off a few weeks prior to the surgery due to pain. Diagnostics were reported as within normal limits. It was stated that the patient had been fine and then suddenly presented with bruising on the neck and pain with stimulation. The patient's mother reported that could not identify a single event that could have lead to the observed issues, but that the patient did have violent type seizures, where she falls to the ground, etc. The surgeon reported a lot of scare tissue around the lead in the neck that usually comes from bleeding. The diagnostics prior to surgery were within normal limits. The explanted lead has not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8008797


Title: Re: Painful Stimulation
Post by: dennis100 on November 10, 2018, 03:27:53 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/07/2018
Event Type  Injury   
Event Description
It was reported that the patient was feeling painful, erratic stimulation throughout the left side of her neck where the lead is located. The lead was previously not visible, but was reported to now be protruding against the patient's neck. It was reported that the patient had lost some weight. Lead impedance was reported to be normal with multiple diagnostics being performed. It was also stated that the patient was unable to sleep due to the stimulation. It was reported that the physician had ordered x-rays; however, these have not been reviewed by the manufacturer to date. The patient's device was later disabled, and the patient was referred to a surgeon for surgery. The neurologist reported that the erratic stimulation was believed to be related to a possibly disconnected lead, and that the cause of the protrusion was not known. The neurologist indicated that the surgical consult was not due to or to preclude a serious injury. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7949664


Title: Re: Painful Stimulation
Post by: dennis100 on November 11, 2018, 02:46:08 AM
Model Number MODEL 250
Event Date 11/28/2007
Event Type  Malfunction   
Event Description
It was initially reported that the patient experienced painful stimulation when the physician ran a systems diagnostics test and he aborted the test. The patient reported he continued to have painful stimulation after he left the appointment. Review of the programming history for the patient revealed that the system diagnostics that was run lead to the patient to have their setting changed as it was no able to complete. There was no final interrogation and the patient left the appointment at unintentional settings which led to the painful stimulation that he experienced after the appointment. The patient returned at a later appointment and the settings were corrected.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972674


Title: Re: Painful Stimulation
Post by: dennis100 on November 12, 2018, 08:04:03 AM
Model Number 103
Event Date 01/17/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 it was reported by the physician that the patient is being treated for cancer and a port was "installed" today in her left neck for the cancer treatment. After the procedure, the patient reported a stinging sensation each time the vns stimulation occurred. It was stated that this stinging sensation was not painful; however, it did not occur prior to the port procedure. It was stated that the patient would be seen the following week for diagnostic testing and to possibly order x-rays. The physician and patient were informed that they can temporarily disable the device using the magnet if needed. Attempts for additional information have been unsuccessful. No additional information has been provided. It is unknown what the cause of the cancer is nor its relationship to vns.
 
Event Description
Follow up with the physician's office found that there was no association between the cancer and vns. The cancer was located in the right breast. The port was placed to help with medication for the cancer. Besides the port, the patient is being followed by an oncologist for interventions. The patient has a medical history of breast cancer. No causal or contributory programming or medication chnages proceeded the onset of the singing sensation in the neck from after the port was placed. No patient manipulation or trauma occurred which is believed to have caused or contributed to the stinging sensation. It was stated that a recent evaluation showed that the patient's device was functioning well and that the stinging sensation symptoms resolved. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2964829


Title: Re: Painful Stimulation
Post by: dennis100 on November 12, 2018, 08:08:48 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2008
Event Type  Injury   
Event Description
A patient reported that his vns device had been removed prior due to painful stimulation and voice alteration. The patient's explant had previously been reported and was due to unknown reasons. The generator was returned for product analysis and verified that the generator performed according to all functional specifications and was able to adequately provide the intended therapy while placed in a simulated body environment. A review of the manufacturing records and diagnostic history also indicated proper device functionality. Follow-up was performed with the explanting facility, but no further relevant information was able to be received. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6394773


Title: Re: Painful Stimulation
Post by: dennis100 on November 13, 2018, 07:13:28 AM
Model Number 300-20
Event Date 03/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Product analysis was completed on the returned vns generator and lead. No anomalies were noted during the generator analysis, and the generator performed per specifications. During the lead visual analysis abraded openings were observed on the outer and both inner silicone tubes. The marked connector quadfilar coil appeared to have two broken strands in the area of an abraded opening. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. With the exception of the abraded openings found on the outer and inner silicone tubes and the two broken coil strands from the marked connector quadfilar coil, the condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. The electrode array was not returned.

Manufacturer Narrative

Event Description
Reporter indicated a patient had vns lead and generator replacement surgery performed on (b)(6) 2012 due to painful stimulation. The surgery was performed for patient comfort and not to preclude a serious injury. Vns diagnostics preoperatively indicated normal device function. During explant of the vns lead, bloody fluid was noted inside the lead insulation, and it was suspected there may be a breach in the lead insulation. There was not a frank lead discontinuity seen. The explanted lead and generator have been returned and are pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2959251


Title: Re: Painful Stimulation
Post by: dennis100 on November 13, 2018, 07:14:57 AM
Model Number MODEL 250
Event Date 01/02/2013
Event Type  Malfunction   
Event Description
It was initially reported that the patient had painful stimulation in his jaw during a systems diagnostics. The patient had been programming off previously and the painful stimulation was believed to be related to the stimulation from diagnostics. The patient later contact the manufacturer and reported the intense pain in the jaw continued after the appointment and seemed to be occurring every hour. The patient followed up with the physician and it was determined that the patient was accidentally left on. The patient was then programming off again and is not having any additional intense pain but still has some residual pain in the jaw. Since the patient was reporting that the intense pain was occurring every hour there is a suspected incomplete diagnostics that may have occurred that left the patient programmed on and to an off time of 60 minutes. The physician states that the issue of pain has resolved, and was a result of the vns being programmed on for a short time but it is turned off now and the patient has completed recovered after allowing time for healing. It is still unclear if an incomplete diagnostics occurred. Good faith attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received that an incomplete diagnostic did occur and resulted in the patient being program to 1. 0 ma for a short time. The physician did not notice this change prior to the patient leaving the office and the patient left with his generator turned on.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2957665


Title: Re: Painful Stimulation
Post by: dennis100 on November 15, 2018, 08:48:53 AM
Model Number 102
Event Date 01/27/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated the patient had vns generator replacement surgery on (b)(6) 2013. The explanted vns generator will not be returned from the hospital as the hospital discards explanted devices.

Event Description
All attempts to the reporter have been unsuccessful to date. Vns replacement surgery is still currently planned, but has not occurred to date.

Event Description
Reporter indicated a vns patient was experiencing painful stimulation in the neck for the previous month. Vns device diagnostics indicated normal device function, and the vns is not at end of service. However, the patient has been referred for vns generator and possible lead replacement surgery due to the painful stimulation. Review of available vns programming history for the patient noted the patient has been on very low duty cycle settings, with 7 seconds on and 5 minutes off. The off time was also set to 10, 15, 20, 30, and 50 minutes off previously. Attempts for additional information are underway. Surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023377


Title: Re: Painful Stimulation
Post by: dennis100 on November 15, 2018, 08:49:42 AM
Model Number 300-20
Event Date 01/15/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that this vns patient was feeling painful stimulation for an unknown reason and was referred for surgery. Follow-up with the physician indicated that the patient began on (b)(6) 2103. The patient's last programming change had been on 11/26/2102. No recent patient manipulation or trauma occurred that is believed to have caused/contributed to the event. The patient's device was disabled. The patient was at the electrode site. The patient was having her vns replaced to have the discomfort reduced. X-rays were taken but have not been provided to review. The patient underwent full revision on (b)(6) 2013. An implant card received on (b)(4) 2013 reported that this was due to a lead fracture. Follow-up with the surgeon showed that x-rays were taken prior to surgery, and a lead fracture was identified. No other additional information was available. The explanted devices were discarded.

Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3018974


Title: Re: Painful Stimulation
Post by: dennis100 on November 15, 2018, 08:51:08 AM
Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2013 due to painful stimulation and the patient felt as if the device was flipping. The explanted products were received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date.

Event Description
An analysis was performed on the returned lead portions which identified observed abraded openings on the outer and inner tubing sections have the potential for contributing to the painful stimulation allegation. The abraded opening found on the outer and one inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and one of the inner silicone tubes. For the observed inner tubing fluid remnants found inside the second inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Other than the abraded openings of the outer and inner tubing, no additional obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. One set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is evidence of an abraded opening in the inner tubing, which may have contributed to the stated painful stimulation complaints. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

Manufacturer Narrative
Suspect medical device, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device manufacture date, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device failure occurred, and may have contributed to the patient's pain. Review of lead manufacturing records confirmed that all quality tests were passed prior to distribution.

Manufacturer Narrative

Event Description
It was initially reported that the patient was referred for surgery due to the device slipping. Diagnostics are fine but the patient feels pain. Clinic notes dated (b)(6) 2013 were received due to the patient being referred for surgery. The generator was disabled due to currently experiencing "pain in her neck over the scm muscle as it did once prior in 2006 when revision was needed, because the device had slipped out of place". The events in 2006 were previously reported in mfg report number: 1644487-2013-00840. It was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. It was further indicated in the notes that the patient had noted pain with vns stimulation on times for the past month described as focal pain at the electrode site. The patient's seizures are under good control, but the vns device was turned off due to "lead impedance problems and elevated dc code and pain". However, diagnostics were within normal limits. System diagnostics showed dcdc=2, and normal mode diagnostics showed dcdc=3. Additionally, the lead impedance was indicated as "ok". The physician also stated the generator is not at eos, "but we believe it is disconnected. " x-rays were ordered, and the patient was referred for vns replacement surgery due to painful stimulation which the physician indicated the pain could preclude injury. Upon follow-up with the treating physician, it was reported that they are unable to establish communication with the device currently but then it was later indicated that the device could be interrogated to show the impedance. Current x-rays do not show any obvious discontinuities, but they have not been provided to the manufacturer for review to date. The x-ray report indicates the x-rays were compared to those dated (b)(6) 2006 and there were no evidence of lead disruption or significant displacement identified. Additionally, there was no gross discontinuity involving the stimulator although evaluation was reported to be quite limited. No patient or manipulation is believed to have contributed to the events. The physician does not believe the leads are disconnected and does not believe that there is lead migration at this time. There were no causal or contributory programming or medication changes that preceded the onset of the events. After the device was turned off due to pain in the generator and lead area, the pain stopped. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027440


Title: Re: Painful Stimulation
Post by: dennis100 on November 15, 2018, 08:52:53 AM
Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 it was reported that the patient was referred for generator replacement due to "discomfort and movement". It was previously reported that the patient's vns was at end of service; but diagnostics later confirmed that the device was not at end of service. It was later clarified that the "movement" was migration of the vns generator. Clinic notes were received dated (b)(6) 2013 that state the patient is awaiting prophylactic surgery for her generator to be replaced due to discomfort and movement. The patient has a medical history of copd and went to the e. R. With difficulty breathing during a seizure on (b)(6) 2012 and to the e. R. On (b)(6) 2013. The clinic notes dated (b)(6) 2013 indicate that the patient states her magnet mode stays on after a magnet swipe and she has to hold the magnet over the generator for a few minutes so that it will go back. It was later reported that the patient first noticed the device started moving around a couple of months ago after being admitted to the hospital for west nile virus. A cat scan had been performed at that time. The patient also started experiencing a burning pain at the generator which goes up to the neck that occurred with stimulation. The patient also mentioned that the magnet stimulation is particularly painful, and mentioned that when the device is swiped, it will stay on at the magnet settings until she holds the magnet over it to disable the stimulation. The patient said, after doing so and removing the magnet, it will go back to the normal generator settings. The patient says they have tried to make changes to the parameter settings to lessen the painful stimulation but there has been no improvement. The patient said she discussed this with the implanting physician who told her the device "is probably messed up". The manufacturing records for the generator were reviewed and the device met all specifications prior to distribution. Good faith attempts for further information from the physician have been unsuccessful to date. Although surgery is likely, it has not yet occurred.

Event Description
The surgeon's office reported that it was unknown if a non-absorbable suture was used to secure the generator to the fascia during implant surgery as it was not in records.

Manufacturer Narrative

Manufacturer Narrative
Age at time of event, corrected data: the initial report reported the age incorrectly.

Event Description
On (b)(6) 2013 it was reported that the patient saw another neurologist and it was determined that she does not have epilepsy so she wants the vns removed.

Event Description
It was reported that the patient's vns device was removed on (b)(6) 2013. Attempts were made for additional information and product return; however, they were unsuccessful.

Event Description
It was reported that the explanted generator was discarded by the hospital. Therefore, analysis cannot be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3025829


Title: Re: Painful Stimulation
Post by: dennis100 on November 16, 2018, 08:38:53 AM
Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
Further follow-up revealed that the physician does not believe that the pain the patient was experiencing was related to vns therapy or stimulation. The patient underwent generator replacement surgery on (b)(6) 2013. Attempts to have the device returned to manufacturer for analysis are underway; however, the device has not been received to date.

Manufacturer Narrative

Event Description
Additional information was received that product analysis was completed on the generator and lead. Note that since a portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical, wear and explant related observations, no anomalies were identified in the returned lead portion. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. There was no dried body fluids or corrosion identified in the lead cavity or connector block area, thus eliminating the possibility of a potential unintended electrical current path through body fluids.

Event Description
The explanted generator and lead were returned on (b)(6) 2013 and are pending product analysis.

Event Description
Clinic notes dated (b)(4) 2013 indicate that the patient has been experiencing intermittent pain in the left shoulder and neck region and that it has progressed. It was noted that the pain is more frequent and more intense and that it appears to occur with vns therapy stimulation. Additionally, it was noted that the patient now involves the patient's left arm from elbow to shoulder, the patient's left breast and the left neck and ear region. The notes indicate that x-rays of the chest and neck were performed at the patient's last visit; however, no problems with the "patency of the device or wire" were noted and it was noted that the discomfort the patient was feeling was due to scar tissue. It was noted that the device diagnostics were "normal" and that the device was programmed off. The notes indicate that the patient returned approximately two hours later with a significant decrease in pain. The physician noted that the device would be left off and that the patient would be referred for lead replacement surgery as the physician noted that there may be a short in the wire. The patient has been referred for surgery; however, the surgery has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3010765


Title: Re: Painful Stimulation
Post by: dennis100 on November 16, 2018, 08:40:02 AM
Model Number MODEL 250
Event Date 12/17/2012
Event Type  Malfunction   
Event Description
It was reported that the patient was interrogated on (b)(6) 2012 and then system and normal mode diagnostic tests were performed were ran along with a final interrogation. The next day, the patient called the physician's office severe pain. On (b)(6) 2012, the patient presented back to the office and her device was interrogated and found to be at unintended parameters that were indicative of a faulted system diagnostic test. The nurse practitioner programmed the patient's parameters back to normal, and the patient was reportedly okay. The company representative confirmed that the faulted system diagnostic test on (b)(6) 2012 resulted in the programming anomaly. The representative confirmed that the final interrogation on (b)(6) 2012 showed the unintended settings but they were not corrected until (b)(6) 2012. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received from the physician's office indicating the patient's pain was in the left neck region near the vagus nerve and was associated with vns stimulation on times.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993677


Title: Re: Painful Stimulation
Post by: dennis100 on November 17, 2018, 04:55:21 AM
Model Number 103
Event Date 01/30/2013
Event Type  Injury   
Manufacturer Narrative
Adverse event or product problem, corrected data: previously submitted mdr stated that the event was reportable as a both a malfunction and an adverse event; however, this should have been reportable as an adverse event only. This report is being submitted to correct this data. Type of reportable event, corrected data: previously submitted mdr stated that the event was reportable as a malfunction; however, this should have been reportable as a serious injury. This report is being submitted to correct this data.

Event Description
Product analysis was performed. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage shows a non-ifi condition. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2013, it was reported that this vns patient's device was disabled two weeks prior due to pain at the chest. The pain resolved with the device being disabled, and the surgeon believed that there was a malfunction with the generator. The patient was referred for generator revision. It was reported that the physician did not see anything in x-rays (not provided for review) and that all diagnostics were okay. The surgeon wanted to revise the generator to see if it made a difference. X-rays were received for review. The generator is visible the upper left chest, close to the shoulder. It cannot be verified that the connector pin is fully inserted in the connector block. Feedthru wires appear intact. Lead appears to be present behind the generator. Lead wires appear intact at the connector pin. Follow-up with the surgeon and physician showed that the patient was experiencing painful stimulation (occurring with on times). The device was disabled, and the pain ceased; however, the patient experienced an increase in seizures due to loss of therapy. The surgeon stated that he intended to revise the generator because he didn't know what was wrong. He stated that diagnostics were all okay. The physician indicated that the patient experienced painful stimulation even at very low output currents and a pulsewidth of 130 usec. The generator was revised on (b)(6) 2013. The generator has not been received to date.

Manufacturer Narrative

Event Description
The generator was returned on (b)(4) 2013 and is pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3078704


Title: Re: Painful Stimulation
Post by: dennis100 on November 17, 2018, 04:56:10 AM
Model Number 302-20
Event Date 03/14/2013
Event Type  Malfunction   
Manufacturer Narrative
Review of manufacturing history records performed. Review of the generator and lead manufacturing history records confirmed that all quality tests were passed prior to distribution.

Event Description
The vns treating physician reported that on (b)(6) 2013 high impedance was observed upon performing diagnostics. The patient is a depression patient and stated she wanted to talk to her psychologist before proceeding with interventions. As a result, the device was not disabled, and x-rays have not been taken to date. The physician also stated that the patient has been experiencing painful stimulation in the neck "every now and then. " no additional information was initially provided. It was observed upon review of the patient's programming/diagnostic history available in the manufacturer's database that high impedance was observed during implant surgery on (b)(6) 2007 which was resolved during surgery via troubleshooting and prior to the end of surgery results were within normal limits upon system diagnostics. Attempts for additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3077959


Title: Re: Painful Stimulation
Post by: dennis100 on November 17, 2018, 04:57:04 AM
Model Number 102
Event Date 10/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this vns patient underwent surgery in (b)(6) 2013 to check the state of the vns system. No anomalies were found. The generator was moved to a different place inside the chest pocket. The generator was turned back on 10 days after the surgery, and it was noted that the patient did withstand an output current up to 1ma, but 1. 50ma appeared to cause painful stimulation (1. 25ma was not tested). The patient stated that painful stimulation seems to be increased or triggered in certain positions of the patient, especially when he keeps his head bent to one or other side. Review of programming history shows that the device was disabled on (b)(6) 2012 and programmed on (b)(6) 2013. Painful stimulation was initially reported in (b)(6) 2012; however, the event began in (b)(6) 2012 when the output current was at 1. 25 ma. System diagnostics showed that the lead impedance was within normal ranges, with dcdc = 3, and normal mode diagnostics returned impedance within normal ranges too, with dcdc = 5. The generator was disabled. Further information was received stating that the pain started in (b)(6) 2012. No causal or contributory programming or medication changes preceded the beginning of the painful stimulation. No trauma was noted, though the patient reported that the first painful shocks occurred after a physical effort (he raised something heavy). No other interventions were planned at that time. X-rays were provided for review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin was fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator. No acute angles or clear breaks were found in the parts of the lead that were visible. Attempts to obtain further information were unsuccessful.

Manufacturer Narrative
Review of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075477


Title: Re: Painful Stimulation
Post by: dennis100 on November 18, 2018, 09:17:02 AM
Model Number 103
Event Date 09/07/2010
Event Type  Injury   
Event Description
It was reported that a vns pt experienced painful stimulation and had his vns programmed off due to the painful stimulation. Moreover, the pt experienced a burning sensation at the site of the generator after the pt's device was programmed off. X-rays were taken and sent to the mfr. Review of x-rays indicated the generator placement appeared to be normal, and the filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. There was no lead behind the generator. No obvious lead discontinuities or acute angles were observed in other portions of the lead body that could be assessed. At the moment good faith attempts to obtain additional info from the treating nurse have been unsuccessful to date as the pt was referred for eval.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1858492


Title: Re: Painful Stimulation
Post by: dennis100 on November 19, 2018, 08:24:57 AM
Model Number 302-20
Event Date 09/05/2012
Event Type  Malfunction   
Event Description
It was reported that a vns patient presented with pain around the collarbone for two seconds at the beginning of each stimulation pulse. The physician believed there was a malfunction of the vns system. The output current was at 0. 75 ma and was decreased to 0. 25 ma. The problem resolved. System and normal mode diagnostics were within normal limits. The pain initially began on (b)(6) 2012 at which time settings were decreased and the pain resolved. Follow-up from the physician indicated that trauma cannot be ruled out, as the patient is very active in sports, but he does not believe that the painful stimulation started after a trauma. No serious injury was indicated. Attempts to obtain further information have been unsuccessful. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3054196


Title: Re: Painful Stimulation
Post by: dennis100 on November 19, 2018, 08:25:40 AM
Event Date 01/31/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated a patient was experiencing increased seizures, and the vns was disabled on (b)(6) 2013. However, the patient reported on (b)(6) 2013 that he experienced painful stimulation in the throat and back pain, and believed the reporter had not disabled the vns. The patient was also given trobalt medication as an intervention for the seizures, which decreased the seizures. The reporter feels the patient's report of painful stimulation and back pain are not related to the vns, and has referred the patient for psychiatric evaluation. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3061702


Title: Re: Painful Stimulation
Post by: dennis100 on November 20, 2018, 07:59:56 AM
Model Number 302-20
Event Date 03/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Device failure is suspected but did not cause or contribute to a death.

Event Description
On (b)(4) 2013, it was reported that x-rays were inconclusive and that the patient was referred for evoked potential testing. Attempts for results and additional information have been unsuccessful. X-rays have not been provided for review.

Event Description
On (b)(6) 2013 it was reported that the patient was seen that day by the physician and when system diagnostics were performed a dcdc of 4 was observed with high impedance and neo=no. The patient was scheduled for surgery. Although surgery is likely, it has not occurred to date. It was stated that the patient¿s vns is disabled and the patient does not want it turned on at this time because he feels painful stimulation. It was stated that fibrosis is suspected but it has not been verified. It was reported that the patient had worsening epilepsy in late 2012 that led to the discovery of a malfunction of the vns, ¿which appears to correspond to a lead problem/vns contact, fibrotic¿. It was stated that stimulation is tolerated until 0. 75ma but the patient has a severe cough from 1ma. The patient¿s mother thinks the patient has a worse clinical condition since stimulation was stopped; a problem with language/speech. Therefore the patient was re-programmed to output=0. 5ma/on time=14sec/off time=1. 1min. The physician also reported that ¿after the fight, there was a lesion of the electrode (the onset of pain was very sharp)¿.

Event Description
On (b)(6) 2103, it was reported that high impedance was seen during diagnostics on (b)(6) 2013. The patient was at rapid cycling, but the device was disabled. Follow-up showed that the patient was hit in the neck that may have contributed to the high impedance. X-rays were taken but have not been provided to date. A blc was performed with 4. 83 years remaining. Attempts for additional information have been unsuccessful.

Event Description
An implant card was received which indicates the patient underwent generator and lead replacement on (b)(6) 2013. The implant card noted the lead impedance was ok. Attempts to have the products returned for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3029714


Title: Re: Painful Stimulation
Post by: dennis100 on November 20, 2018, 08:01:04 AM
Model Number 302-20
Event Date 02/27/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated x-rays of the patient¿s vns showed a lead break. The vns has been disabled. The last known acceptable vns diagnostics results are unknown, and there were no vns programming changes or other changes prior to the painful stimulation occurring.

Event Description
Reporter indicated high lead impedance was obtained with vns systems diagnostics for a patient at an office visit. The patient was also experiencing painful stimulation in the throat since (b)(6) 2013. The reporter was advised to disable the vns. No trauma or device manipulation occurred. All attempts for additional information from the reporter have been unsuccessful to date. Surgery to replace the lead is likely, but insurance issues are preventing surgery scheduling at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3052431


Title: Re: Painful Stimulation
Post by: dennis100 on November 21, 2018, 08:05:26 AM
Model Number 102R
Event Date 05/01/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 product analysis on the explanted generator was completed. Although the septa appear cored, there was no evidence of dried body fluid or corrosion observed in the connector block areas, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. During decontamination an eri message was observed. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Event Description
On (b)(6) 2013 the explanted generator was returned for product analysis. It was stated that it had been removed due to ¿painful stimulation shocking patient¿. Product analysis is still underway and has not yet been completed.

Event Description
On (b)(6) 2013 it was reported that the vns patient has been experiencing painful stimulation in the neck which started the week prior. The patient was taken to the emergency room. The patient¿s vns was turned off sometime the week prior but the patient is still complaining of intermittent pain, not occurring all the time. Diagnostics were performed and were within normal limits; system diagnostics test: output=ok/lead impedance=ok/dcdc=2/eri=no. Additionally, x-rays were taken but the physician could not see anything that would point to a device issue. When the physician did ekg monitoring in the neck area, she said that she observed a "peak" that appeared to be a stimulation cycle, which coincided with the patient's pain at that time, despite that the device was confirmed to be programmed to 0. 00ma. It was reported that the patient underwent generator replacement on (b)(6) 2013 due to the painful stimulation. It was reported that the explanted generator would be returned for product analysis but it has not been received to date. Good faith attempts to the physician for further information have been unsuccessful. A battery life calculation was performed which showed 0. 47 years remaining until eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3132013


Title: Re: Painful Stimulation
Post by: dennis100 on November 22, 2018, 03:06:43 AM
Model Number 102
Event Date 04/16/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this patient had falls a couple of days ago which caused the device to move. The device was checked and was ¿not working. ¿ x-rays were taken which showed that the device had moved. Clinic notes dated (b)(6) 2013 indicated that this patient was seen due to a recent fall on the left side of the chest and soon after noticed that her device was displaced. The patient began to have chest pain and was uncomfortable. The patient did not experience any obvious unpleased side effects with stimulation. The device was interrogated, and settings were provided. A diagnostic test was performed in which there appeared to be a problem in output current. The output delivered was 1 ma but was expected to have 1. 75 ma but there was no evidence of impedance problems. The physician¿s impression was that the device was malfunctioning, and the patient was referred for revision. A voicemail form the patient indicated similar events. Follow-up with the physician showed that the patient was experiencing extremely painful stimulation at the generator and electrode site. The patient was previously programmed to an output current of 1. 75 ma, but the stimulation had to be reduced to 1. 0 ma to alleviate symptoms; however, reducing the output current caused the patient to have an increase in seizures due to the loss of therapy. The patient was prescribed medications to control seizures as she was previously seizure free. The patient was referred for surgery because it was believed that there was a device malfunction. Diagnostics were performed and returned within normal limits. It was also stated that there was pain due to the generator moving in the chest. Surgery is likely but has not taken place.

Event Description
An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2013. The lead impedance was marked as "ok". It was reported that the explanting facility does not returned explanted devices so the device will not be returned for analysis.

Event Description
On (b)(6) 2013, this vns patient reported that she was seen by her physician on (b)(6) 2013. The patient had a wound abscess from another surgery that prevented her from being able to undergo generator revision. The patient also stated that she had a seizures one month earlier and several emergency room visits, not related to vns. The patient stated that her seizures had been increasing for about two weeks to seizures almost every day to every other day because her device was not working. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3119262


Title: Re: Painful Stimulation
Post by: dennis100 on November 23, 2018, 08:22:38 AM
Model Number 103
Device Problem Migration or Expulsion of Device
Event Date 05/08/2015
Event Type  Injury   
Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
It was reported that a patient has neuropathy at the lead site. She reported constant pain in the neck, numbness under the chin, and a lead pulling sensation. She also reported that the device has migrated and is experiencing pain from the migration at the chest site. The patient has been referred for surgery. No known surgical interventions have occurred to date.

Event Description
Patient was implanted with vns on (b)(6) 2015. Vns was programmed on on (b)(6) 2015. Initially, the magnet was helping with her seizures. Additional information was received that the patient's vns was removed on (b)(6) 2015. It was removed due to all of patient's symptoms. Patient also had an increase in seizures above her pre-vns baseline and started having convulsions which she did not have prior to vns. Patient never reached therapeutic levels and the device was disabled on (b)(6) 2015. Clinic notes dated (b)(6) 2015 were received indicating that since the patients last visit, patient's vns has shifted down from the original placement spot. Patient has been experiencing painful sensations in the left face and under both sides of her jaw. This spreads down the front of the left side of her neck. Patient describes the pain as pins and needles. This occurs randomly and not just when the vns is stimulation and worsens considerably with magnet mode (higher output current) stimulation. Patient has difficulty with daily activity due to the generator moving around. When the magnet was swiped, significant dystonic pulling of the left face and neck was noted associated with extreme discomfort on the part of the patient. The vns was turned off as a result. Physician's assessment was that the patient's painful facial and neck sensation and dystonic motor movements of the face and neck may represent a spread of electrical current and the entire system should be removed and replaced. Patient visited the hospital on (b)(6) 2015 because of a generalized seizure and an increase in the pain patient also had a convulsion. Noted dated (b)(6) 2015 indicates that the patient's headaches are worse since the increase in vns settings. Patient feels soreness at the vns generator site. It is implanted more medially in the chest wall near the sternum, rather than the axillary area. She feels that her vns has turned and is now vertical. This is pulling on the lead in her neck. Since the surgery, the vns has rotated and dropped inferiorly, placing a weight and stretching burden on the lead attached to the vagal nerve. Patient's normal and magnet mode output current were decreased from 0. 5 ma and 0. 75 ma to 0. 25 ma and 0,5 ma respectively. The explanted products will not be returned to manufacturer unless the patient signs a release form.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5088394


Title: Re: Painful Stimulation
Post by: dennis100 on November 24, 2018, 05:10:27 AM
Model Number 103
Event Date 04/04/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, the patient reported that he was experiencing pain. Clinic notes dated (b)(6) 2013 were later received which state that the patient's seizures have never been controlled with his longest seizure free interval being two days. It was stated that the patient has several seizures per day, and that the vns worked well after it was implanted on (b)(6) 2012, until the patient had a lumber fusion in (b)(6). The notes state that as far as the patient is aware, the device was not turned off during the surgery. The patient states that his "vns is malfunctioning" as it cuts off his breath and he can feel it ¿run up (his) neck¿. It was stated that ¿when it fires, he feels like he has a frog in his throat¿. Additionally, it was stated that "it was 10 am before the vns ever went off" that morning per the patient. The notes state that when the device was placed, it helped reduce the seizure frequency from 15 - 20 per week to 10 per week as an estimate. The patient had 4 seizures the day before and two seizures so far that day per the notes. According to the clinic notes, the patient was involved in a car accident on (b)(6). The patient already had low back pain, but now there is a lot of pressure in his low back that was not there before and his back is sore. The patient has some joint pain and stiffness, and the notes state that he has a history of syncope additionally, the clinic notes state that the patient has a history of syncope and his generator will be replaced. The patient was prescribed keppra due to an increase in seizure frequency. The assessment/ plan portion of the clinic notes state "vagal nerve stimulator with malfunctioning generator". The patient has been referred to get the generator replaced. Attempts have been made for additional information; however, they have been unsuccessful. The patient was scheduled for surgery on (b)(6) 2013; however, he did not show up for this surgery. No new surgery date has been scheduled. No additional information has been provided.

Event Description
On (b)(4) 2013 it was reported that the patient was scheduled for surgery the next day. The surgery took place on (b)(6) 2013. The explanted generator has not been returned for product analysis to date. Also, it was reported that the patient¿s settings were programmed lower (output current and magnet pulse width) on (b)(6) 2013 which made the patient more comfortable.

Event Description
An implant card was received indicating the explant was due to painful and erratic stimulation. The generator was replaced and lead impedance was ok with impedance value 3108 ohms.

Event Description
It was reported that the explanting facility does not return explanted products.

Manufacturer Narrative
Inadvertently did not include the following on the initial report, "also, it was reported that the patient¿s settings were programmed lower (output current and magnet pulse width) on (b)(6) 2013 which made the patient more comfortable. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118959


Title: Re: Painful Stimulation
Post by: dennis100 on November 25, 2018, 06:19:45 AM
Model Number 302-20
Event Date 09/01/2012
Event Type  Injury   
Event Description
It was initially reported that this vns patient experiencing light-headedness and shortness of breath after a dog fell on her neck. Settings and diagnostics were all normal. X-rays were taken, but the physician did not see any abnormalities in the lead. Additional information was received that diagnostics were run on (b)(6) 2013, with the patient's neck in several different positions, and each time, the diagnostics were all ok. The patient also reported pain in the neck area during stimulation where her head was up. The device was temporarily disabled, and the pain and breathing problem improved. There was no recent settings change. The patient fell in the shower in december and the shortness of breath began after that; however, a dog also jumped on the patient's neck at in (b)(6) 2012; however, the time of this event cannot be confirmed. There was no report of dizziness on this date. The patient had not experienced this shortness of breath prior to the incidents of the dog jumping on the neck/falling in the shower. The patient was visibly uncomfortable with stimulation. The patient's settings were provided. The settings were titrated down, and the dyspnea recurred. The settings were further reduced to bearable settings. Ct images were provided for review; however, due to image quality, they could not be assessed. Surgery is likely but has not taken place.

Event Description
On (b)(4) 2013 it was reported that the patient underwent a full revision that day due a ¿lead malfunction¿. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted lead and generator were returned for product analysis on (b)(4)2013. Product analysis is still underway but has not yet been completed.

Event Description
On (b)(4) 2013 product analysis was completed on the explanted leads. Visual examination of the connector pin showed two setscrew indentations at the end tip suggesting that the lead connector was not inserted completely at one point in time. The exact point in time of when this occurred is unknown. Based on the location of one set of setscrew marks present on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator ¿+¿ and ¿¿¿ terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. The lead connector was inserted in a representative pulse generator header and no anomalies that could prevent proper insertion were identified. Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No anomalies were identified in the returned lead portion. The lead assembly has remnants of what appears to be body fluids/betadine solution inside the inner silicone tubing. No obvious point of entrance was identified other than the cut end of the returned lead portion. Product analysis on the generator showed an output pulse disabled condition due to a perceived low battery voltage; burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device explant, which may have been a contributing factor. A reset of the pulse-disabled bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3102490


Title: Re: Painful Stimulation
Post by: dennis100 on November 28, 2018, 02:23:11 AM
Model Number 102
Event Date 06/17/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the vns patient was in a car accident on (b)(6) 2012. Since the accident, the patient has had an increase in seizures; baseline levels unknown. Diagnostics were performed on (b)(6) 2013 and were within normal limits; system diagnostics test: output=ok/lead impedance=ok/dcdc=2/eri=no and normal mode diagnostics test: output=ok/lead impedance=ok/dcdc=3/eri=no. The patient¿s settings were noted to be output=1. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=3min. The cause of the increase in seizures was not clear, but the physician stated that the patient¿s settings needed to be adjusted. The patient¿s settings were increased to an output of 1. 75ma on (b)(6) 2013, but the patient had painful stimulation in the throat that was intolerable and therefore, the patient was lowered back to 1. 5ma on (b)(6) 2013. No diagnostics were performed at the previous appointment. Additionally, the patient reported that there were a few instances where the stimulation felt stronger than normal in the neck on (b)(6) 2013. The physician stated at this time he was going to increase the duty cycle to see if that helps with the recent increase in seizures. Good faith attempts for further information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3172859


Title: Re: Painful Stimulation
Post by: dennis100 on November 29, 2018, 03:04:43 AM
Model Number 102
Event Date 05/13/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Follow up with the physician's office confirmed that the surgery was not to preclude a serious injury and that the pain was in the neck. The pain was not related to vns stimulation or the vns; however, the pain was said to have resolved with the new implant. No programming or medication changes preceded the event. The nurse stated that this was all the information they had and no other information was provided. Diagnostics taken prior to surgery showed that the lead was ok and that there were no issues with the device. Product analysis of the explanted generator found that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that the patient was scheduled for a prophylactic battery replacement. On (b)(6) 2013, the physician's office reported that the patient's wife called to say that the patient is having a bad burning sensation in the neck by the leads. The patient was seen by the physician on (b)(6) 2013 and stated that he started feeling pain in his neck a couple days ago. He stated that the pain occurs all the time, but is worse with stimulation. The patient's settings from (b)(6) 2013 were provided and it was stated that the device was approaching end of service. There were no medication changes, trauma patient manipulation, or other events which preceded the pain. Diagnostics were performed with patient's head turned to the right and left to rule out any issue with patient's lead. During the process of doing diagnostics the patient's settings were reset accidently, but then reset set back to intended settings. All diagnostics done were ok with dcdc of 1 and eos no. Information was later received that the patient's surgery was pushed back to (b)(6) 2013 due to "some issues with vns stimulator". Follow up found that there were no issues with the lead and that the generator was just nearing end of service. The "issues" referred to the pain the patient was experiencing. Surgery took place on (b)(6) 2013 due to battery depletion. The generator was returned on (b)(6) 2013 and is pending product analysis. The patient has been seen twice since surgery and is experiencing no issues. The pain has resolved since the surgery. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3163298


Title: Re: Painful Stimulation
Post by: dennis100 on November 29, 2018, 03:05:55 AM
Model Number 300-30
Event Date 05/20/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that the vns patient had a prophylactic generator replacement on (b)(6) 2013. The patient reported painful stimulation was occurring prior to the replacement. The old generator was interrogated prior to removal and lead impedance was ok, with a dcdc of 0. The new generator was implanted and lead impedance was ¿ok¿ with a reading of 1500 ohms. During replacement, the current lead was observed by surgeon to have fluid inside it. X-rays were performed prior to surgery and no lead break was observed. The patient was programmed to prior settings per surgeon. It was later reported that there is an issue with the lead so the patient¿s lead will also be replaced. The patient underwent a full revision surgery on (b)(6) 2013. Device diagnostics and lead impedance were ¿ok¿. It was stated that the painful stimulation occurred in the left chest and the full revision surgery on june 10, 2013 was intervention for the painful stimulation. Attempts were made for the return of the explanted products but they have not been received to date. No further information has been received from the physician despite request for additional information.

Event Description
On (b)(4) 2013 the lead and generator that were explanted on (b)(6) 2013 due to a lead discontinuity and painful stimulation were returned for product analysis. Product analysis on these is still underway and has not yet been completed. On (b)(4) 2013 product analysis was completed on the generator that was explanted on (b)(6) 2013. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications and the product analysis lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Event Description
On (b)(6) 2013, the generator that was prophylactically explanted on (b)(6), 2013 was returned for product analysis. Product analysis is still underway and has not yet been completed.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received that product analysis was completed on the generator and lead which were explanted (b)(6) 2013 to a lead discontinuity and painful stimulation. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. An abraded opening was identified in the outer silicone tubing at the lead body. The lead assembly has remnants of what appear to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3170202


Title: Re: Painful Stimulation
Post by: dennis100 on November 29, 2018, 03:07:07 AM
Model Number 300-20
Event Date 12/01/2012
Event Type  Malfunction   
Manufacturer Narrative

Manufacturer Narrative
(b)(4). Adverse event or product problem, corrected data: previously submitted mdr indicated that the event was a serious injury. Product analysis results indicate a lead malfunction occurred that maybe associated with the pain. This report is being submitted to correct this information. Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Implant date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of reportable event, corrected data: previously submitted mdr indicated that the event was a serious injury. Product analysis results indicate a lead malfunction occurred that maybe associated with the pain. This report is being submitted to correct this information. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.

Event Description
Lead analysis was approved on 08/22/2013. An analysis was performed on the returned lead portions. A portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer and one inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and one inner silicone tubing. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaint. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. An analysis was also performed on the generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 816 volts, as measured during completion of the final electrical test, shows a non-ifi condition. 73. 904% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Operation documentation indicated that the patient's pre-operative diagnosis was epilepsy with atypical facial pain.

Event Description
On (b)(4) 2013 it was reported that the patient underwent a full revision surgery on (b)(6) 2013. The explanted lead and generator were returned for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed.

Event Description
On (b)(6) 2013 it was reported that the vns patient was complaining of intermittent pain in her jaw which she thinks is occurring with stimulation. This has been occurring since around the end of last year. The patient reported that the dentist believes she has tmj (temporomandibular joint disorder), but she also stated that the dentist did not diagnose her with tmj. The patient was noted to have a memory problem which is why it was difficult for her to recall what the dentist said. Diagnostics were reported to have been ¿ok¿ and there was no report of trauma or manipulation. There also have been no programming or medication changes made around the onset of the event. It was reported that the patient may have a full revision surgery if the event continues. The patient¿s vns was disabled on (b)(6) 2013. Clinic notes from the patient¿s visit on (b)(6) 2013 indicated that there was no pain or other symptoms since the device was turned off. The patient was referred for surgery. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3164819


Title: Re: Painful Stimulation
Post by: dennis100 on November 29, 2018, 03:08:43 AM
Model Number 302-20
Event Date 05/06/2013
Event Type  Malfunction   
Event Description
On october 3, 2013, the manufacturer received a letter from the food and drug administration (fda) providing a report from the fda's medwatch program. Based on the nature and timing of the reported pain, dyspnea, and muscle spasms, it is possible that the event is related to the high impedance event. Below is the quoted event description from the medwatch report (mw5031542): "volun 27-aug-2013: i had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013. ".

Event Description
On (b)(6) 2013 it was reported that the lead impedance after surgery was noted to be ¿ok¿. Attempts were made for the return of both the lead and generator but neither product has been returned for product analysis to date.

Event Description
On (b)(6) 2013 it was reported that the vns patient was experiencing tightness and in her neck that started about two weeks ago. The nurse also stated that the patient has been experiencing an increase in seizures that started around the same time, two weeks ago. The device was interrogated on (b)(6) 2013 and the settings were output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1ma/magnet on time=30sec/magnet pulse width=500usec. High impedance was observed on (b)(6) 2013 with output=limit/lead impedance=high/dcdc=7/eos = no. The patient¿s vns was disabled due to the high impedance. The nurse stated that almost immediately after the device was disabled, the tightness that the patient was experiencing improved. There has not been any recent trauma and the patient denied any device manipulation. X-rays were ordered and the patient was referred for surgery. It was reported that the patient previously was followed by a different physician but that physician has left the practice. The patient was last interrogated in (b)(6) 2012 and per the patient¿s chart, device diagnostics were not performed at that time. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The nurse later reported that the patient had also been experiencing voice changes during the same time as the tightness in the neck. She stated that they do not have a copy of the patient¿s x-rays but that the patient might have a copy that could be sent to us; she stated she would follow-up with the patient regarding this. No further information has been provided to date. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator.

Event Description
On (b)(6) 2013 ap neck and chest and a lateral chest x-rays were received for review. The images were dated (b)(6) 2013. The generator was seen in normal orientation in the left chest area. The filter feedthru wires and lead at the connector pin appear intact. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator. A portion of the lead appeared to be present behind the generator. The electrodes were observed in the neck and appeared to be in proper alignment. Based on the x-ray images provided, the cause of the high impedance is unknown; however, it could be related to a possible lead pin insertion issue. The presence of additional micro-fractures in the lead also cannot be ruled out.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
On (b)(6) 2013 the nurse reported that pa and lateral chest x-rays have been performed and will be sent for review; however they have not been received by the manufacturer to date. The nurse also stated that around the time the patient started to notice voice changes and tightness with stimulation, her seizure frequency increased from 1-2 times per week to once per night. During this time the patient was also not sleeping well therefore it was unclear what was causing the increase in seizures. The surgeon noted that he suspects a malfunction of the vns as her chest x-ray revealed the vns to be in continuity. The patient underwent a full revision surgery on (b)(6) 2013. Attempts were made for the return of the explanted generator but it has not been received by the manufacturer.

Manufacturer Narrative
Follow-up report #1 should have stated that attempts were made for the return of both the lead and generator, instead of just the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167236


Title: Re: Painful Stimulation
Post by: dennis100 on November 29, 2018, 03:09:34 AM
Model Number 302-20
Event Date 07/04/2005
Event Type  Malfunction   
Event Description
Additional information indicated that the generator and lead were likely discarded. The hospital does not return explanted product due to the time and cost factor.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Event Description
During review of the programming history it was noted that he patient had high impedance. The patient had previously reported a lack of efficacy and painful stimulation in her chest as well as reporting that she did not feel magnet and normal stimulation. The patient had the generator and lead explanted due to the lack of efficacy. Product return attempts are in process. Follow-up with the treating neurologist at that time indicated that they had not seen the patient in a number of years and they no longer have any records for the patient. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167486


Title: Re: Painful Stimulation
Post by: dennis100 on November 29, 2018, 03:10:33 AM
Model Number 102
Event Date 01/20/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2013 information was received by the reporter at a physician office visit that the patient had his device disabled in (b)(6) 2012 due to pain he was experiencing. Attempts for additional information are still in continuation.

Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2013 information was received from the reporter that the patient¿s pain had first been observed on (b)(6) 2012 and was categorized as pain and shortness of breath. It was determined that the pain occurred whenever stimulation occurred or whenever the magnet was swiped. It was also noted that the patient had a cardiac stent implanted several days prior to the onset of pain. No further interventions have been taken or are planned since the device was disabled. No causal or contributory programming or medication changes preceded the onset of the pain. A manufacturer's review of the programming history database showed that programming history data is available from (b)(6) 2006 (date of implant) to (b)(6) 2009. Follow-up also provides data from (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167203


Title: Re: Painful Stimulation
Post by: dennis100 on December 01, 2018, 02:06:30 AM
Model Number 300-30
Event Date 05/29/2013
Event Type  Malfunction   
Event Description
It was reported that the explanting facility discarded the device and it will not be returned for analysis.

Event Description
On (b)(6) 2013 it was reported that vns patient¿s vns lead was being replaced due to an unknown reason. It was later observed in the patient¿s clinic notes that diagnostics revealed limited output and high lead impedance, with adequate battery life and that the patient sometimes experienced painful stimulation when the vns is on. The patient had vns replacement surgery on (b)(6) 2013. Good faith attempts are currently in progress for additional information and return of the explanted devices.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the high impedance was first observed on (b)(6) 2013 and that the diagnostic tests at the previous visit were within normal limits. It was reported that the patient underwent generator and lead replacement on (b)(6) 2013. The implant card confirmed that both generator and lead were replaced due to lead discontinuity. The lead impedance with the new system was marked "ok". Attempts for additional information have been unsuccessful to date. The generator and lead have not been received for analysis.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3234201


Title: Re: Painful Stimulation
Post by: dennis100 on December 01, 2018, 02:07:32 AM
Model Number 304-30
Event Date 06/25/2013
Event Type  Malfunction   
Event Description
An implant card was received which indicated that the patient underwent generator and lead replacement on (b)(6) 2013 due to pain. It was reported that the explanted devices were discarded by the explanting facility and will not be returned to manufacturer for analysis.

Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed both the generator and lead passed all functional tests prior to distribution.

Event Description
On (b)(4) 2013, clinic notes dated (b)(6) 2013 were received from the reporter. The notes dated (b)(6) 2013 indicate that the patient had received a neck soft tissue x-ray for increased neck pain radiating from the neck up toward the retroarticular region with vns stimulation. The generator was turned off for several minutes then turned on again at a lower output current setting, with the problem seemingly resolved. The pain began again (b)(6) 2013, increasing in intensity. It was stated from the (b)(6) 2013 x-rays that the vns lead was observed in the left neck at the c6 and c7-t1 levels and that it was observed that the vns generator was overlying the left chest wall with the leads extending into the base of the neck. A system diagnostics was performed on (b)(6) 2013, showing that all was alright and the physician decreased the output current and altered the pulse width and signal frequency without any success in the patient. A review of the manufacturer¿s device records was performed for the lead and generator, confirming that they passed all functional tests prior to distribution. A review of the manufacturer¿s programming history determined that data was available from (b)(6) 2012, the date of implant, to (b)(6) 2012. No anomalies were seen in the programming or diagnostics of the vns system history. Follow-up from the surgeon determined that the mechanical complication of the nervous system device that was mentioned in the (b)(6) 2013 notes was that the stimulation of the leads was causing the patient¿s pain. The surgeon does not believe causal or contributory programming or medication changes preceded the onset of the painful stimulation around the patient¿s neck and ear. Further follow-up with the other physician determined that the patient first noted the pain around her neck and ear on (b)(6) 2013. The physician also does not believe patient manipulation or trauma occurred that is believed to have caused/contributed to the painful stimulation around the neck and ear. The physician originally believed the output current was set too high and was causing pain, but he stated the pain and symptoms recurred even when the generator was programmed off. It has been noted that the patient is scheduled for lead replacement surgery and attempts for additional information are in continuation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3242637


Title: Re: Painful Stimulation
Post by: dennis100 on December 02, 2018, 02:00:51 AM
Model Number 302-20
Event Date 05/01/2013
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient was experiencing an increase in seizures for the last few months. The patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results showed high impedance (dc dc ¿ 7). The neurologist stated that the patient¿s increase in seizures was may be related to the reported high lead impedance or lack of stimulation.

Event Description
It was reported that pre-op diagnostics were performed which resulted in a high impedance reading. It was reported that the surgeon was preparing for a generator and lead replacement; however, surgery has not occurred to date.

Manufacturer Narrative
Brand name; corrected data: new information has been obtained which suspected the lead as the suspected device. Model #, serial #, lot #, expire date; corrected data: new information has been obtained which suspected the lead as the suspected device. Type of reportable event; corrected data: new information has been obtained which suspected the lead as the suspected device. Manufacture date; corrected data: new information has been obtained which suspected the lead as the suspected device. Review of device manufacturing records. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

Manufacturer Narrative

Event Description
It was reported that the patient underwent exploratory surgery on (b)(6) 2013. The patient had a bulge of fluid, and they wanted to see what it was. There was no sign of infection and no devices were explanted. It was also reported that nothing has been done regarding the high impedance to date.

Event Description
The physician¿s office clinic coordinator reported on (b)(6) 2013 that the patient¿s mother called the office to report that the patient stated that his vns hurts at the generator site and is swollen at the generator incision site. To the coordinator¿s knowledge, there has been no recent injury or patient manipulation. The patient had been complaining about the pain at the generator site for a few days, and when the mom took examined the area, she realized that the site was swollen but there was no redness. The coordinator was not sure whether or not the pain was occurring with the stimulation but stated that she got the impression that the pain was occurring all the time and was not only coinciding with stimulation times. She also explained that the patient is a very high-functioning young man and that he would be able to explain very well how he felt. The coordinator indicated that the patient is very skinny and could have slept on the device ¿funny¿ which may have caused some irritation to the site. Later, the patient was seen in the office on (b)(6) 2013, and labs were ordered on the generator site where the patient presented with swelling. It was not necessarily red, but the neurologist called the neurosurgeon to be seen the following day. With the new information available, the patient had been experiencing discomfort and swelling at the generator site on and off for the prior month. The patient had put ice on it to reduce the swelling; however, he then felt painful stimulation. This stopped after he removed the ice. Prior to this, the patient had not regularly felt stimulation. It was confirmed that diagnostics had not been performed at the visit. The physician does not know what this event is due to yet, and they are looking into it further. The surgeon was unable to see the patient as scheduled on (b)(6) 2013, so the neurologist informed the patient to go to the emergency room as the swelling became worse and the patient was unable to lift his arms above his "hard". Additional information received on (b)(4) 2013 indicated that the surgeon was considering exploratory surgery. Attempts for additional information have been unsuccessful to date. Although surgery may occur, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3215662


Title: Re: Painful Stimulation
Post by: dennis100 on December 02, 2018, 02:02:14 AM
Model Number 103
Event Date 06/06/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 were received on (b)(4) 2013. The notes indicated that the patient has not had any episodes concerning for seizures even after a medication change to generic lamictal. The patient had his last seizure on (b)(6) 2012 but has had some minor worsening in seizure frequency. The patient did not report any medication-related side effects. The patient¿s device was interrogated, and a magnet mode diagnostic was within normal limits. The device reportedly had approximately 25% of battery remaining. The patient experienced moderate pain in the neck with magnet swipes. An implant card indicated that the patient underwent generator revision on (b)(6) 2013 due to neos=yes. The explanted product is not expected for return per hospital policy.

Manufacturer Narrative

Event Description
Follow-up with the physician showed that the patient actually did not experience an increase in seizures: this was miswritten in the notes. The patient underwent generator revision due to end of service.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3232870


Title: Re: Painful Stimulation
Post by: dennis100 on December 02, 2018, 02:03:10 AM
Model Number 102
Device Problem Extrusion
Event Date 06/20/2008
Event Type  Malfunction   
Event Description
A vns patient reported that she began experiencing numerous issues with vns therapy since implantation including weight loss, continuous abdominal pain and painful stimulation. The patient indicated that she had attempted to inhibit vns stimulation by taping her vns therapy magnet to her chest, but this had only resulted in the initiation of magnet stimulation and added that she would be seeking surgical consult for device explantation. Additional information was received from the patient who reported that in addition to developing a new seizure type, her seizures have increased "a thousand fold" since implantation. The patient also indicated that her carotid artery had been cut during implant surgery and added that she has lost around "2/3rd of her body weight" since implantation without any changes in diet or exercise. The patient stated that due to this weight loss, her generator and lead are now visible under the skin. Follow up with the patient's implanting surgeon revealed that the patient's carotid artery had not been cut during her implant surgery and that she has actually only lost around (b) (6), since being implanted with her vns device. The surgeon indicated that he had agreed to remove the device at the patient's request and added that explant surgery would occur within the week. Device diagnostics were performed at the patient's recent surgical consult and reportedly confirmed proper device function. Good faith attempts to the patient's past and present treating vns therapy physicians for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1473053


Title: Re: Painful Stimulation
Post by: dennis100 on December 03, 2018, 04:30:32 AM
Model Number 102
Event Date 11/07/2009
Event Type  Malfunction   
Manufacturer Narrative
Review of device history records. Review of lead device history records confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Product analysis was performed on the returned generator. The pulse generator diagnostics were as expected for the programmed parameters. No obstructions were observed in the header lead cavity or connector blocks. A bench lead inserted past the connector blocks. In addition, the in-line cavity go gauge test passed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿painful stimulation¿). In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Event Description
The patient reported on (b)(6) 2013 that he felt his vns device was ¿not working right¿ because he was feeling his stimulation since a couple of days prior which he had never experienced before. He started to feel his device turn on and can feel it pulsating in his neck where his scar is which had never happened previously. He reported that the treating neurologist did increase the vns settings a few weeks ago, but he did not notice any problems then. He reported that he believed everything was fine at his last visit. The patient denied any trauma or event that would have initiated the symptoms. Later, the vns company representative attended the patient¿s follow-up appointment on (b)(6) 2013 with a treating vns physician to assess the patient¿s symptoms and check the vns device. The patient reported about six months prior, the patient started feeling pain with stimulation by his clavicle and that about a month ago, the painful stimulation got more intense and he described it as a ¿spreading pain¿ which began in the clavicle area. The patient also started experiencing intense voice alteration with stimulation and was not able to talk when the device was stimulating. Upon performing diagnostics on the patient¿s device on (b)(6) 2013, high lead impedance was obtained with impedance value greater than 10,000 ohms. Therefore, the patient¿s device was disabled on this date, per manufacturer labeling recommendations. Clinic notes from (b)(6) 2013 reported that the patient¿s output current was increased on (b)(6) 2013 from 2. 25ma to 2. 5ma. The patient continued to complain of a ¿vibrating sensation in the left cervical region which would be consistent with the area of the lead. ¿ the physician notes that ¿it appears the patient¿s lead is faulty and therefore the device is being turned off. ¿ the patient was referred for replacement surgery. However, the surgery has not occurred to date. The cervical spine and pa/lateral views of the chest x-ray report dated (b)(6) 2013 reported no anomalies regarding the vns device. Attempts for a copy of the x-rays and additional information have been unsuccessful to date.

Manufacturer Narrative
Date of event; corrected data: this information was inadvertently left off of supplemental mfr. Report #1.

Event Description
On (b)(6) 2013 it was reported that the patient¿s surgery ended up just a battery replacement. The surgical team could visually inspect that the lead pin was not fully inserted and full of fluid. When the pin was dried off and reinserted, the system diagnostics showed results within normal limits. On (b)(6) 2013 further details were received when it was reported that the patient¿s revision surgery was underway when the surgeons noted the pin on the generator was not fully inserted. The pin was cleaned and reinserted and the surgeons noted the pin came loose very easily when unscrewing the set screw. After pin reinsertion, the device was within normal limits with no high impedance observed. The surgeons, by referral from the neurologist, went forth with a prophylactic generator replacement. Again, diagnostics showed all systems within normal limits. The surgeons elected to not move forward with a lead revision at this point. The explanted generator was returned for product analysis on july 29, 2013. Product analysis is underway and has not yet been completed.

Manufacturer Narrative
Additional information was received which changes the product the report is reported on.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3199351


Title: Re: Painful Stimulation
Post by: dennis100 on December 05, 2018, 01:38:12 AM
Model Number 63850
Event Date 06/17/2013
Event Type  Injury   
Event Description
I had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3305360


Title: Re: Painful Stimulation
Post by: dennis100 on December 07, 2018, 10:24:35 AM
Model Number 304-20
Device Problem Fracture
Event Date 11/09/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient had high impedance. The patient was experiencing pain around the site of the generator with stimulation. The patient was sent for an x-ray and consult. The physician thought that the patient¿s high impedance may be related to something to do with a chainsaw that he used last week. The x-ray summary was received, and indicated that a break in the wire was seen on the level of c7. The note also indicated that the patient has been experiencing an increase in seizures. The patient's lead and generator were replaced. They have not been received to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8112599


Title: Re: Painful Stimulation
Post by: dennis100 on December 07, 2018, 10:25:15 AM
Model Number 304-20
Device Problem Fracture
Event Date 10/09/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the epileptologist ordered x-rays for this patient because there was an issue with the leads. X-ray assessments were received and stated that the device has an unchanged appearance, and the reason for the exam was that the device was not working. Device leads were noted and were stated to be unchanged compared with appearance on chest x-ray from (b)(6) 2018. Clinic notes dated (b)(6) 2018 state that the patient is not feeling the device, but it burns in the left posterior neck when the patient swipes the magnet and no reported side effects. Diagnostics from this visit were indicated to be abnormal because the lead impedance is high. The doctor decreased the pulse width, and it was stated that this was much better tolerated. The physician stated that the cause of the burning paint the patient is experiencing is unknown. Clinic notes were also received from (b)(6) 2018 stating that the vns was interrogated and is functioning normally and diagnostics were stated to be ok at this time. Later in the clinic notes the physician states that they ¿will investigate lead disfunction in vns¿ and ordered x-rays at that time. X-rays were provided and reviewed by the manufacturer. Chest x-rays were not provided and therefore the generator was unable to be assessed. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. No sharp angles or gross discontinuities were identified in the visible portion of the lead. The cause of the patient¿s painful stimulation could not be determined based on the images provided. Note that incomplete pin insertion and the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8088687


Title: Re: Painful Stimulation
Post by: dennis100 on December 07, 2018, 10:26:44 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
It was reported that the patient began experiencing painful stimulation and pain, in their neck and left arm, associated with vns after implantation of a back stimulator. The pain was said to occur every 3 minutes, and resulted in the patient's device being turned off. Device diagnostics were performed prior to the device being turned off, and were found to be within normal limits. After the device was turned off, the patient reported that they were still experiencing both neck and left arm pain due to the vns and felt as if the device was still providing stimulation and the physician stated that although the device was turned off, a device malfunction could not be ruled out. The patient wanted the vns removed, so the patient underwent device replacement surgery. The newly implanted device was turned on and previous symptoms that the patient had reported were not seen. Additional information was received from the physician that the patient started experiencing the pain sometime after her tens unit was placed in her back. The physician also stated that they are not sure what caused the pain however the patient thought it may have been related to the tens unit. The physician went on to state that the patient's surgery referral for the patient's comfort and to ensure that the patient continued to have benefit from the vns. The physician stated that they were not positive of what could be cause the painful stimulation and stated it could be possibly due to the tens unit, abnormality of vns, or related to patient anxiety, and the physician could not sure what could have caused the pain while the device was on. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8071032


Title: Re: Painful Stimulation
Post by: dennis100 on December 08, 2018, 02:10:25 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported by the patient's sister that the patient had a seizure and experienced painful stimulation with magnet activation following the seizure. The patient's sister wondered if this was the result of a low battery. It was stated the patient's physician was on vacation and unable to check the patient's vns. It was later reported that it was thought that the generator battery was dead. The patient was referred for replacement surgery. The patient underwent replacement surgery, which was reported via implant card as for prophylactic reasons. During attempts at product return, it was revealed that the facility, historically, discards explanted products. It was later reported that the reason for the replacement surgery was due to an increase in seizures and low battery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8048249


Title: Re: Painful Stimulation
Post by: dennis100 on December 12, 2018, 02:35:21 AM
Model Number 102R
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
An implant card was received which indicated that the patient underwent generator replacement surgery due to "inactive painful stimulation. " the lead impedance was marked as "ok". Attempts for additional information will be performed. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3365901


Title: Re: Painful Stimulation
Post by: dennis100 on December 12, 2018, 02:36:04 AM
Model Number 304-20
Event Date 08/26/2013
Event Type  Malfunction   
Event Description
An emergency room physician reported that the vns patient presented to the er with complaints of seizures, swelling in her throat and painful stimulation. The emergency room physician indicated that he was unsure if there was a lead malfunction, but wanted information on how to disable the device without the patient's magnet. The physician was informed that he could obtain magnets from the neurologist or obtain a cow magnet or if the hospital had a programming system he could disable the device with it. The physician stated that he would consider the options. No other information was provided at the time of the initial report. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3362443


Title: Re: Painful Stimulation
Post by: dennis100 on December 13, 2018, 04:51:25 AM
Model Number 100
Event Date 08/19/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator and lead confirmed all quality tests were passed prior to distribution.

Event Description
It was reported that the patient was experiencing painful stimulation and that the device needed to be programmed off. The physician reported that the patient's device was programmed off in 2001 and that she was not aware of it being programmed back on since that time. However, upon device interrogation by a company representative, the output current was at 5. 75ma which is outside of the range for output current (0-3. 5ma). Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3351087


Title: Re: Painful Stimulation
Post by: dennis100 on December 15, 2018, 02:52:06 AM
Model Number 102
Event Date 09/23/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a vns patient experienced painful stimulation at low settings. System diagnostic results were reported to be ok. Follow up with the patient's physician for additional information resulted in unclear information. Physician reported that the patient has a girdle, "viral incerfrolitis" (probably viral encephalitis), and has sustained a lot of injuries. The patient had problems with vocal cord paralysis, spells of breathlessness, and choking.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5191161


Title: Re: Painful Stimulation
Post by: dennis100 on December 16, 2018, 05:01:40 AM
Model Number 102
Event Date 01/14/2009
Event Type  Injury   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. X-rays reviewed by the manufacturer, migration of the generator was not able to be confirmed on the x-ray views received.

Event Description
It was reported to manufacturer that the treating vns physician saw the vns pt due to swelling in the left armpit and possible generator migration. X-rays were sent to manufacturer to review, and the migration event could not be confirmed as there were no baseline x-rays to compare them to. Diagnostic tests were performed following the onset of the reported event and revealed normal device function. Approximately a week later, the swelling appeared to be improving. Further info received revealed that the treating physician saw the pt again at a later date due to the continuation of the migration of the generator, which the pt believed was causing painful stimulation. Additionally, it was reported that the pt was experiencing an increase in seizure activity. The physician discussed with the pt, the possibility of surgical intervention. The pt then reported that she was seen by the primary care physician and stated that an infection was present, and that the swelling has gotten worse had moved down the left arm. The pt reported that antibiotics were prescribed. Additional info received from the treating vns physician's office revealed that the pt went to an emergency room and was treated with antibiotics and was subsequently released. The fever had resolved, and the swelling was improving. The vns device was disabled and they are continuing to monitor the pt. Good faith attempts to obtain additional info have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1341924


Title: Re: Painful Stimulation
Post by: dennis100 on December 18, 2018, 01:07:11 PM
Model Number 103
Event Date 07/19/2012
Event Type  Injury   
Event Description
The patient reported that she began to have pain behind the generator site after being implanted. The patient describes the pain as the muscles behind the generator becoming stiff and pullings when she turns her neck or move her shoulder. The patient's device was programmed off on (b)(6) 2013 to see if the pain was related to device stimulation; however, the patient indicated that the pain did not resolve and requested explant of the vns system. It was reported that the pain would occasionally occur with stimulation and that the physician directed that the device be programmed off. All device diagnostics were within normal limits. It was reported that the based on what the patient has told the physician he would attribute the pain to vns. Explant surgery is planned, but has not occurred to date.

Event Description
On (b)(6) 2015 it was reported that the patient¿s generator and a lead portion were explanted on (b)(6) 2013. The hospital reported that they do not return explanted devices, therefore the explanted products could not be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3406219


Title: Re: Painful Stimulation
Post by: dennis100 on December 20, 2018, 01:52:00 AM
Model Number 303-20
Event Date 04/01/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient did not feel stimulation as much as before. It was also reported that the patient experiences burning at the generator site with magnet stimulation. It was reported that the patient only felt stimulation a few times a day and that at times had sharp pain in the neck area with stimulation. It was reported that the patient's device was programmed off on (b)(6) 2013 due to the shocking sensation feeling after reducing the settings did not alleviate the pain. It was reported that the patient has not reported any further problems since programming the device off. It was reported that the physician was curious if there was something wrong with the device despite diagnostics being within normal limits. It was reported that chest and neck x-rays reviewed by the physician appeared that the lead was intact, but that they don't always show "something is going on". It was reported that the plan is to keep the patient's generator off unless the patient calls back.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Event Description
On (b)(6) 2014, it was reported that the patient was pursuing explant surgery. No explicit reason was provided; however, the patient was previously experiencing adverse events related to stimulation and the presence of the device. The device had been disabled; therefore, the explant is likely related to these adverse events. Explant surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3475356


Title: Re: Painful Stimulation
Post by: dennis100 on December 20, 2018, 01:52:59 AM
Model Number 304-20
Event Date 10/15/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).

Event Description
The mdr with manufacturing number 1644487-2016-02598houses the reports of chest pain and device repositioning. The patient reported experiencing neck pain associated with stimulation. The device was then disabled. The patient's surgeon elected to perform an exploratory surgery. During a pre-operative system diagnostics test the patient had severe pain at their neck and it was decided that the exploratory surgery would open the neck incision. The surgeon opened the neck incision and found scarring and inflammation present. The surgeon then dissected the lead and discovered that the electrodes were placed on the wrong nerve. A tension lead fracture was also observed. The lead was then removed and a new lead was inserted. A significant drop in lead impedance was observed from 3944 ohms to 1208 ohms once the new lead was placed on the nerve and connected to the generator the explanting facility disposed of the explanted lead and thus no product return is expected. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6122152


Title: Re: Painful Stimulation
Post by: dennis100 on December 21, 2018, 09:53:18 AM
Model Number 304-20
Event Date 07/11/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, an image of a patient¿s neck/chest area was provided where it appeared that the generator was sideways and protruding. Follow-up showed that the patient was implanted on (b)(6) 2013. The patient was seen on (b)(6) 2013 and reported that the device had been the way it was for a couple of weeks. Thee surgeon manipulated the device with some improvement of the protrusion. The patient was advised to continue to observe, but no intervention was recommended. There was no reported patient manipulation, trauma, or physiological changes that may have caused/contributed to the event. Follow-up with the surgeon showed that there was slight protrusion/flipping of the patient¿s generator. Clinic notes dated (b)(6) 2103 indicated that the patient had pain at the generator site when lying prone and on her side. The generator was mildly painful to palpitation. The device appeared rotated within the surgical pocket and was protruding beneath the skin. The device had not been programmed on. Clinic noted dated (b)(6) 2013 indicated that the patient returned for titration. The patient had continued pain at the generator site when lying prone or on her side. The device was interrogated: 0. 50/30/500/30/5/0. 75/60/500. The patient¿s pain would continue to be observed. Clinic notes dated (b)(6) 2013 indicated that the patient continued to have discomfort intermittently with stimulation, particularly when lying down at night. A system diagnostic was performed with results of 3282 ohms. The patient was unable to tolerate an increase in output current, so stimulation was returned to the previous settings. Device settings were provided: 0. 50/30/500/30/5/0. 75/60/500. A revision referral indicated that the patient was to be revised due to discomfort and slightly elevated lead impedance. Follow-up showed that the referral was for patient comfort. On (b)(6) 2013, the patient underwent lead revision. At the time of surgery, fluid was seen in the outer tubing. The generator was briefly soaking in betadine. It was also noted that the lead was placed on the wrong nerve (anysa) by the previous surgeon. The new surgeon fixed the issue and notified the neurologist. The implant card indicated that the replacement was due to an "adverse event" and "malfunction". No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3444285


Title: Re: Painful Stimulation
Post by: dennis100 on December 22, 2018, 11:18:40 AM
Model Number 102
Event Date 11/27/2013
Event Type  Injury   
Event Description
Although the reported allegation of chest pain at the generator site and pain with stimulation cannot be evaluated in the product analysis laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. However, the cored septum may have been a contributing factor. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the septum anomaly, there were no performance or any other type of adverse conditions found with the pulse generator. Attempts were made for additional information; however, they were unsuccessful. No additional information has been received.

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent generator explant due to pain and the patient no longer wanting the device. The lead was not removed. The generator was returned on (b)(6) 2013 and is pending analysis. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3531374


Title: Re: Painful Stimulation
Post by: dennis100 on December 22, 2018, 11:19:28 AM
Model Number 300-20
Event Date 09/01/2013
Event Type  Injury   
Event Description
The explanting facility does not return product; therefore, the explanted devices are not expected for return.

Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that the patient underwent full vns revision surgery. Per the implant card, the device was explanted due to the patient experiencing. Previously, it had been reported that the patient felt as though the vns lead body was pressing up against her skin and she could feel and see it. The patient also reported a painful shocking sensation that was believed to be associated with stimulation; however, it was not felt every time. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3443137


Title: Re: Painful Stimulation
Post by: dennis100 on December 22, 2018, 11:21:50 AM
Event Date 11/16/2009
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that the patient was referred for breast implant surgery as she has no breast tissue to attach the device to. Surgery is likely but has not taken place.

Event Description
Analysis of the generator was completed on 07/10/2014. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Clinic notes dated (b)(6) 2013 stated that this vns patient recently relapsed and began to have spells of confusion several times each day. The patient was seen on (b)(6) 2013. When the patient was seen on (b)(6) 2013, she had return to her baseline neurological status. Apart from the complex partial seizure with awareness and confusion impairments, there were no other positives in the patent¿s review of systems. The patient complained of pain at the generator site due to the sagging nature of the device related to the site of implant. The patient wanted breast augmentation and evaluation of the implant site. The device was interrogated, and the settings had been recently adjusted on (b)(6) 2013 to abort seizures. The patient was now doing well. The patient¿s condition was stable. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.

Event Description
Clinic notes dated (b)(6) 2014 note that device diagnostics were within normal limits. Clinic notes dated (b)(6) 2014 note that the patient has experienced issues with the position of the device over the last several months and now complained of pain related to stimulation of the device. At times the patient states the pain is not tolerable. The notes indicate that the patient's seizure frequency is much improved due to the device itself. The patient complains about pain in the neck at the site of the device. The patient also complains that pain in the left side of the chest is close to the device. It was noted that the generator seems to be hanging and it makes her more uncomfortable. The patient has tenderness at the site of the generator and also in the neck where the lead is placed. The notes indicate that the pain is intensified with magnet use. It was noted that the problem appears to be due to the suspension of the device. Device settings were adjusted and the patient was referred for an appointment with a neurosurgeon. The patient underwent generator replacement. The generator was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Additional information was received stating that the vns patient¿s lead was not replaced during the procedure on (b)(6) 2014. The replacement generator was tested with the existing lead and diagnostic results showed lead impedance within normal limits (impedance value - 3459 ohms). The patient¿s replacement device was programmed back on previous device settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3537553


Title: Re: Painful Stimulation
Post by: dennis100 on December 23, 2018, 10:42:09 AM
Model Number 302-30
Event Date 10/05/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Initial mfr. Report inadvertently listed the incorrected suspect device.

Event Description
It was reported that the patient underwent generator and lead replacement. Preoperative diagnostics were within normal limits. The physician's assistant reported that diagnostics in the physician's office were also within normal limits. During the surgery, the lead (including electrodes) and generator were removed. The surgeon indicated that the electrodes were wrapped tight around the vagus nerve and a "branch" and that there was a lot of scar tissue. The surgeon was certain that it was not the cardiac branches or the laryngeal branches. A new lead was placed on the vagus nerve and new generator was attached to the new lead. Diagnostic tests were within normal limits with the new system. The explanted devices were sent to the hospital pathology and the operating room nurse indicated that the hospital does not usually send back explanted devices. A returned product kit was given and a request to have the explanted devices was provided. It was reported that a company representative went to the site to assess diagnostics on the device prior to surgery being scheduled. It was reported that device diagnostics were unable to be performed due to the patient's complaints of pain and swelling in the neck area. It was reported that the patient was told by the physician that he recommended system replacement based on the patient';s pain and swelling and not based on "bad" diagnostics. The physician left the patient to decide on replacement. The patient reportedly decided on having the device replaced because it was felt that the device was of benefit to the patient. The generator and lead were received for analysis. Analysis of the generator was completed on 04/01/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 04/01/2014. The puncture mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, chlorine and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.

Event Description
On (b)(4) 2013, it was reported that the patient had the vns device disabled by an unknown doctor in (b)(6) due to chest and neck pain. This was found out by the physician when the patient was hospitalized and admitted to the epilepsy monitoring unit (emu) for an increase in seizures. The physician turned the device back on and performed diagnostics on (b)(6) 2013 (emu admit date) and the results showed low impedance. The patient continued to have chest and neck pain with stimulation. The neurologist turned off the device and it has been off since (b)(6) 2013. Follow up indicates that although the device was implanted since 2004, it was only turned on for the last year or so (per the patient). The patient may be proceeding with device replacement, but no surgery has taken place to date. Attempts for additional information have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3527747


Title: Re: Painful Stimulation
Post by: dennis100 on December 23, 2018, 10:43:05 AM
Event Date 11/01/2013
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. It was also reported that x-rays did not show a lead fracture. It was reported that the patient experienced discomfort in her jaw during device stimulation. The patient has been referred for surgery. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance. It is unknown if the physician programmed the device off after observing the high impedance. Attempts to obtain additional information will be made, but no additional information has been received to date. Surgery is likely, but has not occurred to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3530331


Title: Re: Painful Stimulation
Post by: dennis100 on December 24, 2018, 08:49:40 AM
Model Number 302-20
Event Date 07/15/2013
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient was experiencing chest pain associated with magnet stimulation. It was reported that the physician did not program the device off after observing the high impedance because the patient has good seizure control and the patient's mother did not want the device disabled. The magnet output current was reduced and the magnet mode stimulation did not cause the patient pain. X-rays were ordered and a lead revision was discussed. It was reported that the patient's family did not recall a fall, accident or manipulation that could have caused or contributed to the high impedance. It as later reported that x-rays were performed and surgery was scheduled. It was reported that the patient underwent lead replacement surgery on (b)(6) 2013. It was noted that pre-operative diagnostics resulted in high impedance (>=10,000 ohms) and that device diagnostics with the new lead and existing generator were within normal limits (1259 ohms). The lead has not been received for analysis to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed. X-rays dated (b)(6) 2013 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement; however, only a small portion of the generator is visible. The filter feed-through wires and the lead pin cannot be assessed with the images provided. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3523405


Title: Re: Painful Stimulation
Post by: dennis100 on December 24, 2018, 08:50:17 AM
Event Date 10/22/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 note that the vns is hurting the patient. The notes indicate that the patient is experiencing too much pain from the lead and in her neck and she wants the device programmed off and removed. The notes indicate that the patient complains of constant pain at the site of the vns. The notes indicate that the device was programmed off at that visit per the patient's request. Clinic notes from the patient's implant surgery note that the device was tested and found to be properly functioning. Then physician indicated that the patient complained of neck pain on (b)(6) 2013. The physician reported that the patient indicated that the neck pain occurred with device stimulation. The physician reported that the neck pain occurred prior to check the device, but that causal or contributory programming changes preceded the onset of the neck pain. The physician reported that the patient will be referred to surgeon for explant per patient's request. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3523135


Title: Re: Painful Stimulation
Post by: dennis100 on December 24, 2018, 08:51:22 AM
Model Number 103
Event Date 07/19/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that the patient had two bad seizures that friday. The office was pending approval from insurance to have the vns generator replaced at the time. The generator was replaced on (b)(6) 2013, due to an "adverse event". Previously it had been reported that the patient was experiencing pain with vns stimulation and was considering having the vns explanted for this reason. Clinic notes dated (b)(6) 2013 indicate the patient experienced continued pain at the generator site every five minutes. The vns device was turned off to 0ma and the pain completely went away. Pain during stimulation is rated as a 7-8 on a scale of 10. Device diagnostics indicate the lead impedance was 3100 ohms. The chest x-ray was normal. Clinic notes dated (b)(6) 2013 indicate the patient was still complaining of pain. Clinic notes dated (b)(6) 2013 indicate the patient returned for vns titration and was last seen about a month ago. The patient had continued pain at the generator site when the device is stimulating. The patient rates it about four to five on the pain scale. The physician tried to increase the normal output current and magnet output current to 1. 25 ma and 1. 5 ma respectively; however, this was uncomfortable to the patient and she did not feel as though she could tolerate it. The settings were decreased to be more comfortable and device diagnostics indicated the device was functioning.

Manufacturer Narrative

Event Description
The generator and lead were returned for analysis on 03/07/2014. Analysis of the lead was completed on 03/26/2014. Note that since the furthest electrode to the bifurcation was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator was completed on 03/27/2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. No patient manipulation or trauma occurred that is believed to have caused or contributed to the painful stimulation. The physician assistant reported that the painful stimulation resolved with vns system replacement. The physician assistant reported that they were not aware of a change in seizure pattern with the patient. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3521100


Title: Re: Painful Stimulation
Post by: dennis100 on December 29, 2018, 04:33:31 AM
Model Number 300-20
Event Date 11/04/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2013 it was reported that the patient underwent a full revision surgery due to a lead break with high impedance greater than 10,000ohms. The patient had a lot of pain at the generator site. It was stated that the x-ray did not show a lead fracture but when explanting the lead, investigation showed some silicone of the lead body had disappeared. It was stated that since there was conductor material in contact with soft tissue, which caused pain during stimulation. It was later reported that the device was programmed off following the high impedance observation. It was stated that the patient did hard work while moving houses which might have caused or contributed to the high impedance. The patient felt painful stimulation some days prior to (b)(6) 2013. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(6) 2013. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3495296


Title: Re: Painful Stimulation
Post by: dennis100 on December 30, 2018, 06:20:28 AM
Model Number 102R
Event Date 06/01/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2014, it was reported that this vns patient experienced an increase in seizure frequency during (b)(6) 2012 for an unknown reason. The physician reported that the patient's seizures were cyclic in nature and increased despite vns therapy and without any triggering factor. The seizures resolved to a normal baseline; however, no other information regarding interventions or device functionality at the time was available. It was also reported that the patient experienced pain in the left neck at the electrode site that was reported to the physician on (b)(6) 2012. The pain was occurring with stimulation on times and corresponding with voice alterations. The physician told the patient to tape the magnet over the device; however, this did not cause the pain to stop. X-rays were taken at the patient's appointment on (b)(6) 2012; however, there was nothing remarkable, per the x-ray report. The pain spontaneously resolved at an unknown date. Based on the information available, the physician did not believe the event was related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3575810


Title: Re: Painful Stimulation
Post by: dennis100 on January 01, 2019, 04:47:56 AM
Model Number 302-20
Event Date 12/11/2013
Event Type  Injury   
Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.
 
Event Description
It was reported that the patient experienced erratic device stimulation and that it "felt like the magnet was going off by itself all the time". The device was programmed to lower settings and the issues resolved, but then after five minutes, the patient reported that it was painful like prior to reducing the settings. The generator was programmed off and the patient was referred for x-rays. It was reported that device diagnostics showed dc dc code - 0 and that the patient would be referred to surgeon. There was no causal or contributory programming or medication changes that preceded the onset of the painful and erratic device stimulation. No patient manipulation or trauma occurred that could have caused or contributed to the painful and erratic device stimulation. It was reported that the pain is located at the patient's neck. The patient later reported that her seizures have worsened and that she was hospitalized for that as well as injuries sustained during falls due to seizures. It was confirmed that the device was still off. Surgery is likely, but has not occurred to date.
 
Manufacturer Narrative

Event Description
An implant card was received which indicated that the lead impedance with the new generator and existing lead was within normal limits (2117 ohms).
 
Event Description
Additional information was received that the patient had a generator replacement on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3556121


Title: Re: Painful Stimulation
Post by: dennis100 on January 03, 2019, 08:56:41 AM
Model Number 304-20
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. During the surgery, the surgeon saw fluid in the lead so completed a lead revision during the prophylactic generator replacement surgery. Attempts for product return have been unsuccessful to date. The products have not been received by the manufacturer. Previously, it was reported in (b)(6) 2013 that the patient was experiencing painful stimulation in the chest and neck areas. The painful stimulation resolved when the vns was disabled with the vns magnet. X-rays dated (b)(6) 2013 were later received and reviewed by the manufacturer. There was no evidence of lead twisting, or sharp angles suggestive of a lead break. It is noted the lead appears to be ¿stretched¿ across the chest, as if it may be pulled if the head was turned to the right. No obvious lead anomalies were seen. There was no known trauma or manipulation. The painful stimulation was reported to be positional and was thought to have resolved prior to referral for surgery, and the cause of the painful stimulation was unclear to the physician.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Manufacturer reviewed device history records. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of the lead device history records confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3639409


Title: Re: Painful Stimulation
Post by: dennis100 on January 03, 2019, 08:57:20 AM
Model Number 103
Event Date 01/23/2014
Event Type  Injury   
Event Description
It was initially reported that the patient was in the emergency room due to painful stimulation in her neck due to her vns. The patient felt her vns was stimulating more than it should and seems more painful. The pain was causing her seizures to be worse. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3639394


Title: Re: Painful Stimulation
Post by: dennis100 on January 04, 2019, 11:10:56 AM
Model Number 1000
Device Problem High impedance
Event Date 11/13/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient's device showed high impedance. X-rays had been performed and there were no observed issues with the lead or pin insertion. Per x-ray review by medical professional, there were no obvious break or crack. The patient also reported some neck pain with stimulation and the vns device was programmed off due to the high impedance. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the physician¿s manual, should still be followed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8140647


Title: Re: Painful Stimulation
Post by: dennis100 on January 04, 2019, 11:11:31 AM
Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 09/28/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's generator was prematurely depleting, as there was a unexpected decrease in the past four months. It was also reported that the patient had high impedance, low output current, and pain with stimulation, which is reported in mfr report #1644487-2018-02285. The patient's device was disabled. The patient's lead and generator were replaced. The devices have not been received into livanova to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8180507


Title: Re: Painful Stimulation
Post by: dennis100 on January 04, 2019, 11:12:32 AM
Model Number 302-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 11/21/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient's neurologist reported that they interrogated the device because the patient was having some discomfort. Upon interrogation, high impedance was observed and the neurologist thought there could be a disconnection along the electrode and stated that ¿the device cannot transmit the proper stimulation to the patient¿s vagal nerve. " additional information was received that the patient has been referred for a revision. It was stated that the patient's discomfort is occurring in the neck area and is associated with stimulation. There was no trauma reported to that area, and the physician does not have an assessment of the cause of the patient's discomfort. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8146223


Title: Re: Painful Stimulation
Post by: dennis100 on January 04, 2019, 11:13:25 AM
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced painful stimulation at the electrode site in the neck in the middle of the night for 10-15 minutes. Additionally, clinic notes from the next day indicated that the patient had experienced a very severe cough, voice alteration, sharp pain sensations in left arm/shoulder and chest, as well as shortness of breath. The patient's device was disabled due to these adverse events. The patient reported that the device stimulated despite the disablement and that the voice alteration and pain persisted with the device being programmed off. The patient had not experienced any known trauma. The physician reported that the patient's adverse events were likely due to a lead malfunction, however, device diagnostics for the patient were within normal limits. The physician indicated the patient would be referred for a generator and lead replacement for patient comfort and to preclude a serious injury, and that the patient's battery was low. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8127177


Title: Re: Painful Stimulation
Post by: dennis100 on January 05, 2019, 03:10:03 AM
Model Number 105
Event Date 04/28/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that during the patient's initial implant surgery on (b)(6) 2014, there were difficulties identifying the nerve due to a structure with a similar appearance. Therefore, following placement of the electrodes on the structure believed to be the vagus nerve, the patient¿s generator was programmed on (output current - 2ma) in an attempt to induce bradycardia and therefore identify if the electrodes were indeed on the vagus nerve. Bradycardia was observed as intended and resolved without intervention. Therefore, it was concluded that the electrodes were properly placed. The generator was inadvertently not programmed off after the tests were completed due to communication difficulties with the programming system. As a result, the patient experienced painful stimulation, neck muscle spasms, and severe coughing until the surgeon programmed the patient's generator off and administered morphine the following day.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3825172


Title: Re: Painful Stimulation
Post by: dennis100 on January 05, 2019, 03:11:20 AM
Model Number 103
Device Problem Fracture
Event Date 11/08/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient's device was showing high impedance. The patient was sent for x-rays of her neck and chest. The device settings were lowered and it was stated that the device was not bothering her after that; so the device was not turned off during the visit. Further updates were received noting additional diagnostics performed on the patient's device. Two diagnostics were performed confirming the high impedance. It was stated that the device was intended to be turned off due to painful stimulation in the neck. The patient had also reported that her neck locks up at times to the left side. After device settings were adjusted, the patient was concerned that fully disabling her device would lead to increased seizures, so the settings were kept at the lower output. The patient reported no longer feeling pain with the new settings. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8141647


Title: Re: Painful Stimulation
Post by: dennis100 on January 05, 2019, 03:11:58 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/20/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported experiencing an increase in seizures and painful stimulation. Further information was received that the patient is referred for replacement. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8150439


Title: Re: Painful Stimulation
Post by: dennis100 on January 06, 2019, 11:01:42 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/06/2018
Event Type  Injury   
Event Description
The patient reported that they experienced an increase in seizure frequency due to the low battery of the generator. The physician attributed the patient's increase in seizure frequency to battery depletion. Per the physician, the patient also indicated that she experienced pain, with and without stimulation, all over her body that worsened with stimulation. The patient stated that the pain was due to the low battery of the generator as well. The physician indicated that the patient was referred for generator replacement due to patient comfort. The manufacturer's battery life estimation tool was unable to verify battery depletion based on the available patient programming data. No relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8122322


Title: Re: Painful Stimulation
Post by: dennis100 on January 08, 2019, 07:56:20 AM
Model Number 105
Event Date 02/25/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s neurosurgery consultation on (b)(6) 2014. The notes indicate that the patient was experiencing a recent increase in seizures along with a shocking sensation at the generator site; therefore, the patient was admitted to the hospital through the emergency room on (b)(6) 2014. The patient stated that his seizure frequency had increased from five seizures a day to a seizure every hour. The baseline seizures appeared to last approximately 15 seconds and were tonic-clonic or absence seizures. Radiology reported that neck x-rays showed that lead wires were ¿off. ¿ chest x-rays were reported to be unremarkable. Operative notes were received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. The notes indicate that the patient was experiencing a shocking sensation in his neck with stimulation. Imaging revealed abnormal placement of the lead electrodes. The generator was replaced during the procedure as it was nearing end of service. An implant card was received stating that the lead was replaced due to lead discontinuity. Diagnostic results with the replacement generator and lead revealed lead impedance within normal limits (impedance value ¿ 1906 ohms). Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts for additional relevant information were made, but have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed high impedance never occurred. Analysis of the returned lead portion found abraded openings on the outer silicone tubing which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: additional information indicates that a device malfunction did not occur. Brand name; corrected data: additional information indicates that the suspect device is the generator. Type of device, name; corrected data: additional information indicates that the suspect device is the generator. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator. Date of implant; corrected data: additional information indicates that the suspect device is the generator. Type of reportable event; corrected data: additional information indicates that a device malfunction did not occur. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3701858


Title: Re: Painful Stimulation
Post by: dennis100 on January 08, 2019, 07:57:09 AM
Model Number 105
Event Date 01/01/2014
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized for an increase in seizures that began the week prior. It was reported that the patient has experienced about 60 seizures over the past week. It is unknown if the increase in seizures was above the patient's pre-vns baseline frequency. It was reported that the patient was also experiencing painful stimulation at the electrode site that improves with pressure applied to the site. The physician decreased the patient's settings; however, this did not resolve the patient's pain. The device was later disabled. It was reported that device diagnostics were within normal limits (1326 ohms). The physician reported that he wanted to prophylactically replace the lead since it is 10 years old. X-rays were taken, but the results were not provided to manufacturer. It was reported that despite the diagnostics being within normal limits the physician still believes the painful stimulation and increase in seizures are due to a lead issue. It was reported that there was no trauma, medication changes or other recent changes that could have causes the increase in seizures and painful stimulation. Further follow-up revealed that the patient was airlifted to a hospital in a bigger city and it was decided to not replace the patient's lead. The patient's medication was adjusted and the vns was programmed back on and ramped up to 1ma output current. The physicians would not provide any additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3606770


Title: Re: Painful Stimulation
Post by: dennis100 on January 09, 2019, 09:06:06 AM
Model Number 105
Event Date 01/25/2014
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient began experiencing pain at the electrode site on the left side of her face and neck on (b)(6) 2014. Additionally, the patient had difficulty chewing during stimulation. According to the neurologist, the relationship between the reported pain and vns is increased sensitivity to vns stimulation due to unknown etiology. The pain appeared to occur with stimulation. To preclude a serious injury, the neurologist lowered the patient¿s programmed settings. Product information is not available due to hospital policy. The available programming history did include any diagnostic results.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677841


Title: Re: Painful Stimulation
Post by: dennis100 on January 09, 2019, 09:06:44 AM
Model Number 103
Event Date 10/01/2013
Event Type  Injury   
Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. Additional information was received stating the neck pain was the reason for the replacement surgery. The patient began experiencing the pain around (b)(6) 2013. The pain occurred with stimulation and ceased when the magnet was used to disable the device. Diagnostic results revealed lead impedance to be within normal limits (impedance value ¿ 3114 ohms). Causal or contributory programming or medication changes did not precede the onset of the pain. The epileptologist stated that a thyroid lesion may have contributed to the pain. The pain resolved when the device was programmed off and did not recur when the replacement device was programmed on. Attempts for product return have been unsuccessful.
 
Manufacturer Narrative
Date received by manufacturer; corrected data: the date received by manufacturer was incorrectly reported on the initial manufacturer report. The date should have been (b)(4) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3675824


Title: Re: Painful Stimulation
Post by: dennis100 on January 10, 2019, 02:12:50 AM
Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient needs a lead replacement because the lead is "malfunctioning". It was reported that the patient went through a metal detector and now the lead is "malfunctioning". Clinic notes dated (b)(6) 2014 note that the patient went through a metal detector on (b)(6) 2014 and after that the patient experienced some vague soreness which intensified into severe pain on (b)(6) 2014. The patient described the pain as burning in the neck/chest area. It was noted that the magnet was placed over the generator with no improvement, but gradually subsided. It was noted that the patient still feels very sore and there was no trauma to the neck and no infectious symptoms. The device output current was decreased and the pulse width increased. The notes indicate that the patient will be referred to surgery. The surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. The physician reported that x-rays were taken, but will not be sent to manufacturer for review. The pain was reported to be with device stimulation. The patient underwent generator and lead replacement on 02/14/2014. An implant card was received that indicated that the patient underwent generator and lead replacement due to "adverse event - pain in left neck". The generator and lead were returned for analysis. Analysis of the generator was completed on (b)(4) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
The initial mfr. Report stated "the surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. " this sentence is being corrected to "the surgeon reported that in the lead revision in 2011 that there was a significant amount of scar tissue but was able to remove the electrodes from the nerve and replace with the new (current) lead. " device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 03/17/2014. Note that a portion of the lead assembly including the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 43mm portion quadfilar coil 1 appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, fine pitting and evidence of a stress induced fracture (torsional appearance) on two of the broken coil strands, which most likely completed the fracture. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3666903


Title: Re: Painful Stimulation
Post by: dennis100 on January 10, 2019, 02:13:37 AM
Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity and battery depletion. It was reported that the explanted devices were sent to pathology and disposed of. No product analysis can be performed.
 
Event Description
It was reported that x-rays were performed because the patient's device was not working. X-rays were sent to manufacturer for review. Review of the x-rays did not identify any obvious discontinuities with the vns system; however, the presence of a microfracture could not be ruled out. Further follow-up with the physician identified that high impedance (dc dc code - 7) was observed. It was reported that the patient had complained of discomfort and burning at the back of the throat. It was reported that device frequency was reduced from 25hz to 20hz for the discomfort. The patient reported that the discomfort and burning began approximately two months prior and occurs with device stimulation. The patient mentioned that the pain and burning worsens when moving the head from side to side. The patient denied and trauma that may have caused or contributed to the high impedance. The physician reported that the device was programmed off and the patient would be referred for surgical consult. No surgical intervention has been performed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3782517


Title: Re: Painful Stimulation
Post by: dennis100 on January 11, 2019, 03:04:54 AM
Model Number 102
Event Date 09/28/2006
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that the patient experiences painful stimulation that started two weeks prior. The patient has not experienced any trauma to the neck area. The neurologist reviewed x-rays and reported that nothing unusual was noted. The patient was referred for surgery. The physician reported that the device was programmed off after observing the high impedance. The physician reported that x-rays would not be sent to manufacturer for review. Surgical intervention has not occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent surgery and that only the generator was replaced. It was reported that the generator was discarded after the surgery and would not be received for analysis. Attempts to obtain additional relevant information have been unsuccessful to date. It appears that the high impedance resolved with generator replacement since only the generator was replaced indicating a likely generator/lead connection problem.
 
Manufacturer Narrative
Date of event, corrected data: supplemental manufacturer report #01 inadvertently did not update this information. Operator of device, corrected data: supplemental manufacturer report #01 inadvertently did not update this information.
 
Manufacturer Narrative
New information changes the suspect device.
 
Event Description
Additional information was received indicating that the vns patient¿s generator replacement resolved reported high impedance. The replacement device was tested with the existing lead multiple times and showed lead impedance within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3761805


Title: Re: Painful Stimulation
Post by: dennis100 on January 12, 2019, 12:26:45 AM
Model Number 103
Event Date 02/25/2014
Event Type  Injury   
Event Description
Operative notes from the surgeon reported that because of intermittent painful stimulation, there was concern of a microfracture of the lead or a generator issue. The patient also believed something was wrong with the device. No further relevant information has been received to date.
 
Manufacturer Narrative
The initial portion of the event description in supplemental mdr 2 was corrected as supplemental mdr 2 inadvertently implied that it was alleged that the motor vehicle accident had caused the painful stimulation in (b)(6) 2014 for which intervention had occurred.
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial manufacturer report inadvertently did not specify that the patient¿s fall may have ¿dislodged¿ the device again.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient fell off a horse on (b)(6) 2014. During an office visit the following day, the patient reported pain occurring with stimulation. The device was subsequently programmed off but the pain persisted. Diagnostic results revealed normal device function at the time. The patient underwent generator and lead replacement surgery due to pain on (b)(6) 2014. The patient's pain had resolved since the replacement surgery, which was performed as a precaution and for patient comfort. The neurologist also noted that the patient¿s fall may have ¿dislodged¿ the device. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
The patient's mother reported that the patient first time the patient had experienced painful stimulation was involved in a motor vehicle accident in (b)(6) 2013 where the car went off of the road and over a six foot culvert. The vehicle landed on the passenger side and caused the patient to dangle from the seat belt. The mother noted that the painful didn't have painful stimulation again until (b)(6) 2014, which was already reported as when the patient fell off her horse, and the patient was instructed to tape the magnet over the generator to disable the device.
 
Event Description
The neurologist also noted that the patient¿s fall may have ¿dislodged¿ the device again. It is unclear when the previous occurrence was as a previous report of painful stimulation subsided with device disablement. Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Review of the decoder data did not reveal any anomalies. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Abrasions were observed in various locations, possibly caused by wear. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
The patient's mother reported that the patient was involved in a motor vehicle accident in (b)(6) 2013 where the car went off of the road and over a six foot culvert. The vehicle landed on the passenger side and caused the patient to dangle from the seat belt. The mother noted that the painful stimulation did not occur until (b)(6) 2014 and the patient was instructed to tape the magnet over the generator to disable the device. The following day, the patient was seen by the physician. The physician removed the magnet and the patient again experienced painful device stimulation. The device was programmed off for three days and when programmed back to on, the patient again experienced painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3735544


Title: Re: Painful Stimulation
Post by: dennis100 on January 12, 2019, 12:28:37 AM
Model Number 103
Event Date 03/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the generator was replaced prophylactically and that the migration of the device was believed to be due to the trauma from the patient falling off of the porch. The increase in seizures was reported to be not related to vns. The patient was reported to be doing "fine" since generator replacement and no longer experiencing the reported events.
 
Event Description
It was reported that the patient suffered a fall off of the front porch which resulted in injury to her left neck. The patient indicated that she began experiencing an increase in seizures. It was reported that the patient began experiencing painful stimulation the night of the fall after she felt something "snap" while laying in bed. It was reported that the patient also began experiencing pain in her chest around the generator and felt as if the generator had slipped down lower toward her breast. The patient was awaiting scheduled prophylactic battery replacement at the time of the fall; however, the physician wanted to get the patient to surgery sooner as a result of the events. The patient underwent generator replacement. It was reported that pre-operative device diagnostics were within normal limits (2323 ohms). The generator was replaced and diagnostics were again within normal limits (2048 ohms). It was reported that the explanting facility does not return explanted devices; therefore, no analysis can be performed. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3757141


Title: Re: Painful Stimulation
Post by: dennis100 on January 12, 2019, 12:30:02 AM
Model Number 103
Event Date 03/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing pain on the left side of her neck with magnet mode stimulation while being able to tolerate normal mode stimulation. Changes to the patient¿s programmed settings were unsuccessful in resolving the pain. The patient had a surgical consultation on (b)(6) 2014 to plan interventions to preclude a serious injury and for patient comfort. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the neurologist and the surgeon indicated that the lead looks ok and they aren't going to do anything further.
 
Event Description
It was reported that the patient is having a consult with the neurologist regarding the vns. Interrogation during consult showed that the generator has 50% battery and therefore there are no plans for surgery currently. Diagnostics were reported to be within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3735489


Title: Re: Painful Stimulation
Post by: dennis100 on January 14, 2019, 04:22:39 AM
Model Number 302-20
Event Date 04/13/2014
Event Type  Injury   
Event Description
It was reported on the implant card that the reason for lead replacement was a ¿lead discontinuity¿. It was reported that the hospital discards the explants and therefore cannot be returned for product analysis.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient was still having symptoms after generator settings changes. It was noted that the patient needs replacement of the lead to see if that will help with her symptoms and allow her to receive full vns therapy. It was noted that no other major changes have occurred in the patient's medical history. An implant card was received indicating that the patient underwent lead replacement on (b)(6) 2014. The explanted device has not been received for analysis to date.
 
Manufacturer Narrative
Describe event or problem; corrected data: inadvertently did not include that the lead replacement was due to a lead discontinuity on follow-up report #1.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 due to painful erratic stimulation. The er physician and neurologist stated that the patient¿s generator may be at end of service. The patient had not felt stimulation for the past eight months. Before going to the er, the patient was on a swing and was hanging by her left arm. The patient began experiencing painful stimulation at 45 second intervals. The patient was also experiencing tightening in her chest and reported that her magnet was not working. The patient had to press the magnet extremely hard against her generator to disable her device. Taping the magnet over the generator was ineffective in disabling the device. The patient was uncertain if her generator had migrated. The patient was seen by her neurologist on (b)(6) 2014. The neurologist decreased the patient¿s device settings during the office visit. The neurologist noted that the patient¿s voice alteration had significantly increased with stimulation. The patient felt that stimulation was traveling up her ear and around her temple. The physician stated that the generator pocket may have expanded and the generator may have migrated causing the magnet to activate magnet mode stimulation instead of disabling the device. The patient¿s device was tested during the office visit and diagnostic results showed lead impedance within normal limits. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 but continued to have painful stimulation after surgery. The replacement device had been programmed on to the patient¿s previous device settings. A radiology report was received but did not observe any issues with the generator and lead. The patient was referred for lead replacement surgery. Lead replacement surgery has not occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed approximately 1. 77 years until eri = yes. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840370


Title: Re: Painful Stimulation
Post by: dennis100 on January 16, 2019, 02:53:27 AM
Model Number 101
Event Date 03/01/2014
Event Type  Injury   
Event Description
It was reported that the patient underwent prophylactic generator replacement. It was reported that preoperative and postoperative device diagnostics were within normal limits (dc dc code - 2). It was reported that the patient has not yet been seen for follow-up with the neurologist since the surgery. It was reported that the explanting facility discarded the explanted generator; therefore analysis cannot be performed.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
Additional information was received stating that the vns patient had a big aura on (b)(6) 2014. The patient became light-headed and was diaphoretic. The patient swiped her magnet but it did not help her aura. The patient stated that her previous auras were similar but not back up to pre-vns baseline levels. The patient did not have any auras after (b)(6) 2014. The patient also reported that her vns stimulation was no longer as strong as it was in the past. The patient¿s pre-operative evaluations had been completed. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the vns patient was experiencing an increase in seizures and pain/tightening at her lead site for the month prior to her office visit on (b)(6) 2014. The patient¿s device was not at end of service and had normal lead impedance (dc dc 2). The neurologist stated that the generator battery was probably low and was causing the patient¿s issues. Until recently, the patient was seizure free since vns. The patient also recently began experiencing daily auras. The patient had a bump on her neck that appeared a month before the office visit. The neurologist stated that the lead may no longer be tied down. The patient did not experience any pain when the lead site was touched but intermittently when vns stimulation occurred. X-rays were taken but have not been provided to the manufacturer for further evaluation. The patient was referred for generator replacement surgery. No known surgical interventions have occurred to date. Clinic notes were received indicating that the patient¿s device had not been interrogated for the past ten years. The patient reported having a tingling feeling at the generator site and can still feel stimulation that sometimes caused her to have voice hoarseness. As the patient¿s auras were becoming more frequent, the patient¿s settings were increased. Review of the available programming and diagnostic history showed the last known device settings were from 04/11/2003.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3804675


Title: Re: Painful Stimulation
Post by: dennis100 on January 16, 2019, 02:54:36 AM
Model Number 105
Event Date 04/11/2014
Event Type  Injury   
Manufacturer Narrative
Date of event; corrected data: additional information indicates that the patient¿s issues were noted on (b)(6) 2014.
 
Manufacturer Narrative

Event Description
Additional information was received indicating that the vns patient¿s pain and rash was noted on (b)(6) 2014. The neurologist stated that the patient was too thin and that the device was bothering her. The patient¿s device was disabled but the patient¿s issues did not resolve. The patient¿s will be explanted for patient comfort but no known surgical interventions have occurred to date.
 
Event Description
Additional information was received. Clinic notes dated (b)(6) 2014 from surgery consult reported that the patient's generator was causing more pain and weakness than her previous device due to the size, which was worse if it was manipulated. The surgeon advised that the device was likely not the source of all of her pain and does not expect all of the pain to resolve after removal. No known surgical intervention has occurred to date.
 
Event Description
It was reported that the patient has been complaining of painful stimulation and a rash at the generator site. The patient is going to see surgeon for device explant. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3801005


Title: Re: Painful Stimulation
Post by: dennis100 on January 18, 2019, 03:37:24 AM
Model Number 302-20
Event Date 05/22/2014
Event Type  Malfunction   
Manufacturer Narrative
\device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient was having painful stimulation and an increase in seizures. System diagnostic results revealed high impedance. The patient¿s device was subsequently programmed off. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. The patient was in a car accident a few years ago and reported having pain in his chest and neck. The patient¿s device showed normal device function after the car accident until his recent office visit where high impedance was observed. The patient had up to five seizures per day prior to vns. The patient was doing well with vns and was almost seizure free with vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3881786


Title: Re: Painful Stimulation
Post by: dennis100 on January 20, 2019, 03:39:28 AM
Model Number 103
Event Date 05/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient was being referred for revision surgery due to an onset of painful stimulation for the past week. The physician believes that the generator is malfunctioning due to the painful stimulation at the generator pocket. It was reported that device diagnostics were within normal limits. The patient was scheduled for surgery. The patient underwent generator replacement. An implant card was received indicating that device diagnostics with the new generator attached to the existing lead were within normal limits (2350 ohms). The generator was received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned generator was completed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854018


Title: Re: Painful Stimulation
Post by: dennis100 on January 20, 2019, 03:40:07 AM
Model Number 300-20
Event Date 09/21/2010
Event Type  Injury   
Event Description
Reporter indicated that a vns pt was unable to have the vns settings increased to therapeutic levels due to coughing, painful stimulation, and muscle twitching. The patient's seizures have increased slightly but are still below pre-vns baseline levels due to the vns settings not being therapeutic. Different vns settings were tried but the events have continued. No changes to the vns settings were made prior to when the events began. Prior to the pt being unable to tolerate the stimulation, she had a neck adjustment by a chiropractor, which may be contributing to the issues. X-rays were reviewed which did not note any anomalies. Surgery to replace the vns appears likely.
 
Manufacturer Narrative
Mfr reviews x-rays of implanted device. X-rays reviewed by the mfr, no anomalies visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026137


Title: Re: Painful Stimulation
Post by: dennis100 on January 20, 2019, 03:40:57 AM
Model Number MODEL 250
Event Date 06/27/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns patient was having intolerable voice issues on an hourly basis. The patient¿s device was interrogated and found to be programmed to settings indicative of an interrupted system diagnostic test. The patient¿s device was tested during an office visit the previous day, but the system diagnostic test had to be interrupted because the test was too painful for the patient to tolerate.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3952700


Title: Re: Painful Stimulation
Post by: dennis100 on January 20, 2019, 03:41:38 AM
Model Number 105
Event Date 05/12/2014
Event Type  Malfunction   
Event Description
It was reported by the patient that her device settings had changed on their own from 5 to 10. It is unclear which device settings she was referring to. The patient was experiencing erratic stimulation, pain with stimulation, coughing and voice alteration. The pain was reported to be unbearable at times. The pain occurred at her electrode site and travelled up the left side of her head and down to her shoulder. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854286


Title: Re: Painful Stimulation
Post by: dennis100 on January 20, 2019, 03:42:40 AM
Model Number 302-20
Event Date 08/25/2009
Event Type  Injury   
Event Description
It was reported that the patient underwent generator replacement. The lead was not replaced. Device diagnostics prior to and during surgery were within normal limits. It was reported that the explanting facility does not returned explanted devices for analysis.
 
Event Description
On (b)(6) 2015 the patient reported that his vns has been turned off for about 5. 5 months because of ¿several problems¿. It was later reported that the patient has had his device for a while due to painful stimulation. The patient will be proceeding with explant of the vns device. Although surgery is likely, it has not occurred to date.
 
Event Description
Initially, it was reported that the patient has experienced pain in the left jaw and teeth. The patient was evaluated by a dentist, but nothing was found wrong with the patient's mouth or teeth. The patient disabled the device with the magnet and the pain went away; however, when the magnet was removed the patient began choking and gagging. The patient reported that there appears to be muscles twitching in his neck area. The patient indicated that he is no currently followed by a treating physician and the patient was provided with vns treating physicians. It was later reported that the patient would be referred to surgeon for full vns revision surgery. Clinic notes dated (b)(6) 2014 note that the patient is having trouble with vns and the device was disabled and will likely require a full revision. No additional relevant information has been received to date. No surgical intervention has been performed to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient was turned up that day from 1. 0ma to 1. 25ma. Everything was fine while he was at the physician¿s office but when he got home he experienced pain in his jaw again. It only lasted a little bit. The physician stated that the patient is having the same pain in the jaw with the new generator. The patient used to be set at 1. 75ma, but now when they turn the current up to 1. 25ma the patient experiences instant pain when the device turns on. He also states that after a few hours of normal operation the pain gets worse. Settings are output=1-1. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5omin. Diagnostics are ok; impedance=2213ohms. The physician stated that they would try adjusting the pulse width and decreasing the duty cycle.
 
Manufacturer Narrative
Device manufacture date; corrected data: additional information was received that changes the product from the generator to the lead.
 
Event Description
Follow-up revealed that the vns patient¿s device was disabled on (b)(6) 2014. The patient underwent surgery on (b)(6) 2015 to explant his device due to pain and to pursue an alternative treatment option. During the procedure, the surgeon noted that the electrodes were not in proper alignment and had been implanted upside-down. Additionally, a tie-down had been placed on the electrode coil on the nerve. No other tie downs were observed. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845774


Title: Re: Painful Stimulation
Post by: dennis100 on January 20, 2019, 03:43:50 AM
Model Number 103
Event Date 04/22/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the medical staff believed the vns patient¿s generator was fried due to cautery. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Event Description
Good faith attempts for further, relevant information have been unsuccessful. It was reported that the patient is a complex medical case, and there are a lot of other factors, such as psychiatric issues.
 
Event Description
It was reported by a surgeon that the patient experienced sharp pain with stimulation prior to replacement in the left neck, left shoulder and back of scapula accompanied by stomachache.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator. It was reported that the surgeon told the patient that the generator was "fried". It was reported that the surgeon interrogated the generator after removing it from the patient after electrocautery was used. Since diagnostics prior to surgery were within normal limits, it appears that the surgeon caused the premature end of service with the electrocautery. An implant card received confirmed that only the generator was replaced.
 
Event Description
It was reported that after going through airport security, the vns patient was experiencing increased headaches and auras, pain at her generator site, and issues with her magnet. The patient felt five constant jolting sensations at her generator site every few minutes. The patient¿s magnet had to be swiped at least three times to activate magnet mode stimulation. Prior to the event, the patient¿s magnet always activated magnet mode stimulation immediately. At airport security, the patient did not go through the metal detector but was within 10 feet from the airport security wand. The patient taped her magnet over her generator but continued to feel pain and jolting sensations. The patient went to the er on (b)(6) 2014 due to pain at her generator site that radiated through her arm and armpit every three minutes. When the magnet was placed over the patient¿s device, the patient had a burning pain and her generator site turned red. The magnet was removed and the patient¿s device was disabled as of (b)(6) 2014. The pain and redness subsequently resolved. The patient device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 2870 ohms). The patient was admitted to the hospital due to pain, erratic stimulation, increase in seizures and lack of magnet control. The patient stated that she experienced severe pain in her shoulder whenever her device was tested and did not have the same seizure control since her generator was replaced in (b)(6) 2013. Since her device was disabled, the patient experienced six generalized seizures. The patient underwent generator and lead replacement surgery on 05/20/2014. The patient¿s family believed there was an issue with the patient¿s lead and that her generator was fried due to cautery. The explanted devices have not been returned to date.
 
Event Description
Additional information was received that the patient's generator could never get regulated correctly. It is suspected that the regulation of the device refers to titration. Available programming history for the generator was reviewed. The patient's device was disabled the day of explant. Diagnostics at that time were within normal limits. After implant of the device, it was titrated to 0. 25 ma and the output current was increased up to 1. 5 ma a few months later. However, the settings were reduced down and disabled shortly after.
 
Manufacturer Narrative
Only the generator was replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845253


Title: Re: Painful Stimulation
Post by: dennis100 on January 20, 2019, 03:44:51 AM
Model Number 103
Event Date 07/08/2014
Event Type  Injury   
Event Description
Additional information was received that the patient's painful stimulation and tingling began reoccurring in the neck and chest on (b)(6) 2015 despite no abnormal or strenuous activity by the patient. The vns device was interrogated and two diagnostic tests were performed which showed normal results. The generator was disabled. At first, the patient stated that she still felt stimulation, but after she was told that the device was off, then she said she couldn¿t feel it anymore. The patient's neurologist says that it could be psychosomatic symptoms. X-rays were taken but the radiologist stated there was no change from the previous x-rays in (b)(6). The device was thus temporarily disabled with magnet mode left enabled. Clinic notes were received from the appointment which confirmed the allegation that the patient was having pain in her left neck and left chest and that the device was disabled. It was also stated that these patient adverse events are similar to the pain event reported in mfr. Report # 1644487-2011-02585. Additional clinic notes stated that diagnostics were taken again and were within normal limits. The diagnostic tests reportedly caused significant discomfort immediately and resolved as the device turned off. The referring physician suspected that perhaps there is conduction of stimulation to surrounding tissues. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
Additional information was received via implant card that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to the painful stimulation. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Event Description
It was reported that the vns patient was having some breakthrough myoclonic seizures while previously being seizure free. The patient was also experiencing a tingling sensation but was unable to feel magnet mode stimulation when she swiped her magnet. The patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device settings were increased, but the patient reportedly did not feel stimulation in the same way as before and began having pain in her left arm with stimulation. The neurologist decreased the patient¿s device settings and the patient was reported to be doing well. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block; however, this could not be confirmed as the pin was not clearly shown to pass all the way through the connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported events remains unknown. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3970627


Title: Re: Painful Stimulation
Post by: dennis100 on January 21, 2019, 12:19:35 PM
Model Number 101
Event Date 06/17/2002
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to end of service. Additionally, the patient was having some discomfort when system diagnostic tests were performed. Surgery was performed for patient comfort and not to preclude a serious injury. The explanted generator was returned to the manufacturer for analysis. An open can measurement of the battery voltage determined that the generator battery was depleted. The end of service condition was the result of expected battery depletion based on the battery life calculation. Supply current pulsing and supply current 1ma were out-of-specification. Analysis indicated that during manufacture of the generator, the r35 resistor (a selectable value resistor) could have been more optimally chosen. A lower value resistor would have more suitably centered the currents within their limits. After r35 was optimally reselected, the device performed according to functional specifications. The out-of-specification supply current pulsing could potentially be a contributing factor to the end of service condition; however, results of the battery longevity calculation indicated that the end-of-service condition was an expected event. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3940931


Title: Re: Painful Stimulation
Post by: dennis100 on January 21, 2019, 12:20:36 PM
Model Number 102
Event Date 06/01/2014
Event Type  Injury   
Event Description
Additional information was received that the generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Manufacturer Narrative

Event Description
It was reported that the patient has recently felt erratic stimulation. The patient reported that the device stimulation can be strong at times and that he feels short bursts of strong stimulation. It was reported that the patient experiences pain in the neck area. Interrogation of the generator showed the device was not at end of service. It was reported that the patient was referred for surgery. Clinic notes dated (b)(6) 2014, note that the patient is having occasional sharp electric pains in the generator pocket or his neck. It was noted that the physician recommends having the generator replaced as he thinks this might be the problem. No known surgical intervention has been performed to date.
 
Event Description
Additional information was received that the patient had a generator replacement. Attempt for product return have been unsuccessful.
 
Event Description
Additional information was received that product analysis was completed on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Attempts for additional information have been unsuccessful.
 
Event Description
Additional information was received that indicated the painful and erratic stimulation was first noticed 6/2014. The generator replacement was done for patient comfort it is unknown how the patient is doing since generator replacement. There was no manipulation or trauma or contributory programming or medication changes that caused or contributed to the events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3938988


Title: Re: Painful Stimulation
Post by: dennis100 on January 21, 2019, 12:21:23 PM
Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
Clinic notes were received indicating that the vns patient was experiencing an increase in seizures in (b)(6) 2013. The patient¿s device settings were increased during an office visit on (b)(6) 2013 and the patient subsequently developed throat pain and voice hoarseness. The patient¿s device settings were adjusted on (b)(6) 2013. The patient did not have any seizures but continued to have painful stimulation. On (b)(6) 2013, the patient¿s device settings were increased and the patient reported no pain but persistent voice hoarseness. Follow-up revealed that diagnostic results at the time showed normal device function. The patient¿s seizures were above pre-vns baseline levels, but not all of the patient¿s seizures types increased. No changes occurred to the patient¿s medications or device settings which may have caused or contributed to the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3941357


Title: Re: Painful Stimulation
Post by: dennis100 on January 24, 2019, 05:10:00 AM
Model Number 102
Event Date 07/28/2014
Event Type  Injury   
Event Description
It was reported that the vns patient was referred for surgery during an office visit on (b)(6) 2014 due to lead protrusion and painful stimulation. The patient¿s device was subsequently disabled. Patient manipulation or trauma is not believed to have caused or contributed to the lead protrusion. Diagnostic results showed normal device function at the time. Follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 due to painful stimulation and eri. The lead protrusion was determined to be minor and did not require revision surgery. The patient¿s device was programmed on at a follow-up office visit after surgery. The patient no longer had complaints of lead protrusion or painful stimulation. The explanted generator has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient continued to experiencing painful stimulation in her left arm. The patient had been experiencing an increase in seizures and pseudo-seizures since the device had been disabled due to the painful stimulation. The lead impedance was within normal limits. X-rays were taken and reported by the physician to be unremarkable. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin cannot be confirmed to be fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. The patient was referred for surgery for the painful stimulation but no known surgical interventions have occurred to date.
 
Event Description
Additional information was received stating that the patient underwent a lead revision surgery (b)(6) 2015. The explanted lead was discarded and thus will not be returning to the manufacturer for analysis.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4035016


Title: Re: Painful Stimulation
Post by: dennis100 on January 24, 2019, 05:11:00 AM
Model Number 103
Event Date 06/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was unable to turn off the vns with any of the magnets she has. The vns was later disabled. The patient reported that she tried to disable her generator because of severe pain at the time of stimulation. She has had the magnets since 2006, when she was first implanted. The physician turned the 2. 5ma down to output of 2. 25ma, then 2. 0ma, 1. 75ma, and then 0ma and back to 0. 25ma. The planned intervention is for the patient to undergo a generator replacement surgery. The physician stated that the magnet did cause/trigger violent coughing episodes upon application. System diagnostics were performed and no abnormalities were noted and the device was not near eos. No causal or contributory programming changes preceded the onset of the painful stimulation. The surgery was planned to preclude a serious injury, per the physician. The physician further stated that the patient¿s magnet mode stimulation is always off unless it is ¿spontaneously switching¿. The patient later clarified that she had begun to experience painful stimulation when she received her original implant in (b)(6) 2006. The anatomical location of the painful stimulation comes from the vagus nerve, up and down her neck, during stimulation. There has been no trauma to the left side or the vagus nerve. The patient has been using new magnets that she received a few weeks ago. The physician stated that he could not provide clarification on his statement that the device may be ¿spontaneously switching¿; he stated that he has never activated magnet current and no other physician programs the device. He stated that the ¿device is faulty no matter what¿. The physician indicated that the patient was slowly titrated up after implant in order to allow for accommodation to the stimulation. The physician later stated that the patient underwent a cervical rhizotomy soon after the issue began with the generator. The patient stated that she always has had pain with stimulation. She said it is at a low level and has never bothered her. She stated that her current generator has caused her different side effects than with her previous ones. The physician interrogated it at every visit to make sure the generator is functioning at the levels, he has set. She stated that at the end of (b)(6) 204, she suddenly had intense pain. She immediately put the magnet in place and instantly began to cough violently and her throat constricted so much she couldn¿t breathe. The physician set up an emergency visit for her to see him and at that visit she demonstrated what happened when she put the magnet in place over the generator. She again when into a violent coughing attack and her throat constricted as it had when she tried to use it in june. The physician quickly lowered the current down and got the same response. After doing so, a couple of times, he turned the generator off completely. After a bit, he turned the generator back on to 0. 25ma. The physician instructed her to put the magnet in place as he increased the output to 0. 25ma and interrogated it at the same time. The magnet worked normally and the diagnostics of the generator showed it functioning normally as well. The patient clarified that she is fully aware how to use the magnet. The patient stated that before the event in june she had just seen her physician two weeks prior, when her device was interrogated, and the physician did not change anything at that visit. The patient underwent generator replacement on (b)(6) 2014. The explanted generator has not been returned for product analysis to date.
 
Event Description
On (b)(4) 2014 the explanted generator was returned for product analysis. Product analysis was completed on the generator on (b)(4) 2014. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. No magnet parameters (as received or programming history) available for this generator, magnet current was set to 0. 50ma. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The reported allegations against the generator were not duplicated in the product analysis lab. The battery, 3. 036 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
The patient's magnet was tested with the new generator, and the physician reported that it was working well. It is also noted that the as-received explanted generator frequency parameter was set to 1hz. Per manufacturer labeling, frequencies programmed to <10hz do not ramp and cause excessive battery drain regardless of output current.
 
Event Description
On (b)(6) 2014 the physician reported that the patient has not yet tried the magnet with her new generator but that they will test it at the next visit.
 
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4036475


Title: Re: Painful Stimulation
Post by: dennis100 on January 26, 2019, 04:09:13 AM
Model Number 302-20
Device Problems Fracture; High impedance
Event Date 07/07/2014
Event Type  Malfunction   
Manufacturer Narrative
Corrected data: the initial mfr. Report reported the incorrect date. The date should have been 07/15/2014. The change of date does not change that the report was submitted prior to the 30 day deadline. The initial report is not late as a result of the changed date.
 
Event Description
The explanted products were received for analysis. Analysis was completed for the returned generator 02/04/2016. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The septum was not cored. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed for the returned portion of the lead on 02/16/2016 and the reported event was not verified within the returned lead portion. Note that since a portion of the lead including the electrode array was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that since a lead fracture could not be found at surgery on (b)(6) 2014 the family of the patient decided not to have the lead changed. The device was programmed off to assess whether the patient needed vns before deciding to replace the device. Since the device had been turned off over the year prior, the patient experienced a "major backslide". The patient has been referred again for revision of the lead and generator. No known surgical intervention has occurred to-date.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation and coughing.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was disabled during an office visit on (b)(6) 2014 and the pain subsided. The patient was referred for surgery and seen on (b)(6) 2014 for a surgical consult. Several positional system diagnostic tests were performed, and all showed lead impedance within normal limits except one. When the patient was standing and leaning over with his head on the exam table, the patient¿s device showed high impedance. The high impedance observation was believed to be due to a microfracture. It was reported that the patient may have manipulated the device. The patient¿s seizures had also increased but not above pre-vns baseline levels. X-rays were taken and were reported by the physician to be unremarkable. The patient was scheduled for surgery on (b)(6) 2014. Several system diagnostic tests were performed before and during the procedure which all showed lead impedance within normal limits (dc dc ¿ 2). Thus, the surgeon elected to cancel the procedure. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
The initial report inadvertently did not report that the patient also experienced coughing in addition to the painful stimulation.
 
Manufacturer Narrative
Event description, corrected data: the date of the clinic visit where the device was disabled was inadvertently reported in the initial report as (b)(6) 2014, when the visit had occurred on (b)(6) 2015.
 
Event Description
The generator and lead were replaced on (b)(6) 2015. The reason for replacement was reported as due to a lead discontinuity. The explanted products have not been received to-date. No additional relevant information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4006205


Title: Re: Painful Stimulation
Post by: dennis100 on January 26, 2019, 04:10:06 AM
Model Number 106
Event Date 05/02/2016
Event Type  Injury   
Event Description
It was reported that a vns patient was complaining of sporadic painful stimulation at the generator site and radiating down through his left arm starting. Clinic notes received indicate the symptoms started on (b)(6) 2016 and were more intense with magnet activation. The condition progressed to constant sensation of tightness in chest and shortness of breath of approx. 1 hour duration until he taped the magnet over the device. The symptoms were alleviated for around 24 hours following pulse width adjustment from 500usec to 250usec and frequency adjustment from 30hz to 20hz on (b)(6) 2016 but then recurred. Full diagnostics were performed on (b)(6) 2016 and lead impedance on (b)(6) 2016 was normal 3,093 ohms. It was stated that the lead impedance was checked in varying neck positions. The physician elected to disable the device on (b)(6) 2016 and the patient was referred to a surgeon for anticipated exploratory surgery to explant and replace generator due to presumed malfunction/bleeding of current of vns system. X-rays were taken but nothing conclusive could be diagnosed by the providers. The x-rays were not provided to the manufacturer for review. The generator was successfully explanted and replaced on (b)(6) 2016 with no complications noted. The explanted generator was discarded by the explanting facility.
 
Manufacturer Narrative
(b)(4).
 
Event Description
An implant card was subsequently received for the procedure on (b)(6) 2016 indicating that a normal lead impedance of 3,373 ohms was observed with the newly implanted generator in place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5685905


Title: Re: Painful Stimulation
Post by: dennis100 on January 26, 2019, 04:10:58 AM
Model Number 103
Event Date 06/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing an increase in seizures for the past month and was having headaches every five minutes during normal stimulation on-times. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3987030


Title: Re: Painful Stimulation
Post by: dennis100 on January 27, 2019, 10:08:01 AM
Model Number 102R
Event Date 05/14/2014
Event Type  Injury   
Event Description
It was reported that the patient was still very weak. The device was not checked. It was later reported that the patient was doing better and walking and gaining strength. It was reported that the plan is for the patient to be seen in a few weeks to discuss proceeding forward with the revision. No surgical intervention was performed to date.
 
Event Description
Additional information was received stating that the vns patient¿s seizures had improved but the patient¿s magnet appeared to making the seizures worse. The patient was also experiencing pain in her neck whenever the magnet was used. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the lead revision had been cancelled. Additional information was later received that the patient was referred for generator replacement for an unrelated reason.
 
Event Description
The explanted generator was received on 6/3/2015. In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information reported that the patient was scheduled for generator replacement. Generator replacement occurred on (b)(6) 2015 but the lead was not replaced.
 
Event Description
Additional information was received that the patient is now going to have generator replacement and prophylactically replace the lead to prevent a potential revision in the future for patient comfort. No known surgical intervention has occurred to date.
 
Event Description
It was reported that the vns patient was hospitalized due to a seizure she experienced when a system diagnostic test was performed on (b)(6) 2014. The patient had also been experiencing painful stimulation in her chest and neck as well as coughing and facial twitching with stimulation. The patient again experienced a seizure when the next system diagnostic test was performed on (b)(6) 2014 so the patient¿s neurologist stated that the system diagnostic tests were causing the seizures. The patient was given medication and taken to the er. It was noted that the patient¿s device settings were higher than those for system diagnostics and that system diagnostic results showed lead impedance within normal limits (dc dc ¿ 2). Follow-up revealed that the patient¿s seizures were above pre-vns baseline levels. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The notes indicate that the patient had been experiencing an increase in seizures since she began using a hearing aid and that she had three seizures since her last office visit. The patient experienced a seizure the before the office visited which resulted in bruising in the arms. The patient stated that she was unable to tolerate magnet mode stimulation. The patient¿s device was tested during the office visit and the patient again experienced a seizure. Diagnostic results showed lead impedance within normal limits. The patient was sent to the er where the patient¿s device settings were lowered. X-rays were taken and were reported by the physician to be unremarkable. The physician recommended replacement surgery due to concerns with the patient¿s lead. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4052095


Title: Re: Painful Stimulation
Post by: dennis100 on January 27, 2019, 10:08:45 AM
Model Number 304-20
Event Date 03/07/2014
Event Type  Injury   
Event Description
Further follow-up revealed that the patient was not reimplanted. It was reported that the patient reported neck tightness and pulling at the nerve attachment site of the lead.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis, which did not revealed any anomalies.
 
Event Description
It was reported that the patient underwent generator and lead explant due to painful stimulation. The generator and lead were received for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator was completed on (b)(4) 2014. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. No additional relevant information havs been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4128688


Title: Re: Painful Stimulation
Post by: dennis100 on January 27, 2019, 10:09:31 AM
Model Number 302-20
Event Date 06/29/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for generator and lead replacement due to shooting pain up to the patient's ear with device stimulation. It was reported that the generator would be replaced prophylactically due to the amount of time implanted. An implant card was received indicating that the patient underwent generator and lead replacement due to prophylactic reasons. The explanting facility discarded the explanted devices; therefore, product analysis cannot be performed. The physician reported that the patient was hit in the neck with something and the pain with device stimulation began. It was reported that device diagnostics were within normal limits prior to explant. The physician believed it would be best to have the entire vns system replaced due to the pain and time the generator had been implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4120189


Title: Re: Painful Stimulation
Post by: dennis100 on January 28, 2019, 06:08:35 AM
Model Number 300-20
Event Date 08/28/2014
Event Type  Malfunction   
Event Description
Product analysis for the generator that was completed on 04/16/2015 concluded that the generator detachment of components was most likely attributed to explant related events. Therefore the possibility of a lead break cannot be ruled out. The patient's lead has not been explanted to date.
 
Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2015. It was stated that the generator was in two pieces as the header was detached from the generator. The lead was not replaced. When the new generator was attached to the old lead impedance values were good at 2825 ohms. The generator was returned for analysis on 03/19/2015. Analysis is currently underway but has not been completed to date.
 
Event Description
Product analysis for the generator was completed and approved on (b)(4) 2015. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. The output exhibited output variations on chart. This condition was due to an intermittent connection on the alligator clip, used to establish an electrical connection to the generator. The pulse generator was monitored again for more than 24-hrs and results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The reported ¿detachment of components(s)/header¿ allegation, most likely occurred during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator as received photo shows no evidence of bodily fluid remnants in the case/header area. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. The generator performed according to functional specifications. Other than the intermittent connection issue that is not related to the generator and the header anomaly (visual analysis), there were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Corrected data: changed suspect device to lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 6). X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4115750


Title: Re: Painful Stimulation
Post by: dennis100 on January 28, 2019, 06:09:22 AM
Event Date 08/27/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient had developed an infection at his neck incision site and was experiencing voice alteration and painful stimulation. The patient had been implanted with vns for over a year. No further information relevant to the event has been received to date.
 
Event Description
It was identified that a duplicate report of this patient's infection was submitted in mfg report #: 1644487-2014-02440. Manufacturer report # 1644487-2014-02440 will house any future information related to the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4113796


Title: Re: Painful Stimulation
Post by: dennis100 on January 29, 2019, 08:11:18 AM
Model Number 302-20
Event Date 08/08/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was having issues with pain and with device migration. Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months. She later reported having a strange tremor in her head that occurred several times per day. It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla. Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck. The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside. An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity. The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4103125


Title: Re: Painful Stimulation
Post by: dennis100 on January 30, 2019, 09:16:24 AM
Model Number 105
Event Date 05/01/2014
Event Type  Injury   
Event Description
It was reported that the patient started having shoulder pain 1 year after surgery. She saw a physician who turned her device off but this has not subsided the pain. It was later reported that the patient saw the physician again and he turned the device back on and everything is now fine.
 
Event Description
It was reported that the physician was unsure if the pain and migration at the chest were attributed to the patient's fall in (b)(6) 2014. It was reported that the pain is constant and does not occur only with device stimulation. No system diagnostics have been run. The patient has moved to another state and is trying to establish care with a new physician. It is unknown if a non-absorbable suture was used to secure the generator to the facia during implant of the device. No additional relevant information has been received to date.
 
Event Description
It was reported that the vns patient was experiencing intolerable painful stimulation when a diagnostic test was performed during an office visit on (b)(6) 2014. The patient was having sharp pain in the auxiliary region. The patient¿s magnet mode output current was increased, but the patient refused any other changes in device settings. The neurologist stated that the pain was due to the positioning of the device and felt the patient¿s device should be repositioned. It was noted that the patient fell off her bicycle in (b)(6) 2014. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the patient's generator is turned off and she is doing alright. The patient is still searching for a new physician. She does not have a consistent following neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4063923


Title: Re: Painful Stimulation
Post by: dennis100 on January 31, 2019, 02:37:11 AM
Model Number MODEL 250
Event Date 09/22/2014
Event Type  Malfunction   
Manufacturer Narrative
Brand name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Type of device, name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Model #, serial #, lot #, expiration date, other, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, these fields are being updated to reflect the suspect medical device. Operator of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the user of the suspect medical device. If implanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. If explanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Device manufacture date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Labeled for single use, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Usage of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient was seen in clinic on (b)(6) 2014 for a vns follow-up visit; system diagnostics were performed and the patient experienced pain at the electrode site with stimulation. No changes were made to the patient¿s device settings during the office visit. The patient reported that when he swipes his magnet, he feels the same pain. The patient returned to the clinic on (b)(6) 2014 and the device magnet current different than what was previously programmed. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4207463


Title: Re: Painful Stimulation
Post by: dennis100 on January 31, 2019, 02:37:49 AM
Model Number 102
Event Date 09/01/2014
Event Type  Injury   
Event Description
On (b)(6) 2014, product analysis was completed on the explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications, there were no anomalies found with the pulse generator.
 
Event Description
It was reported that the patient was having painful stimulation in his throat that he believed to be due to the generator reaching end of service. The patient stated that something similar occurred when his last generator reached end of service. The patient also reported that the generator was going off more often. The physician confirmed that the generator was not at end of service but the patient was insistent to have it replaced. Surgery is likely but has not occurred to date.
 
Event Description
On (b)(6) 2014 it was reported that the patient underwent prophylactic generator replacement on (b)(6) 2014. The explanted generator was returned for product analysis on (b)(6) 2014. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4209245


Title: Re: Painful Stimulation
Post by: dennis100 on January 31, 2019, 02:38:42 AM
Model Number 303-20
Device Problems Degraded; Unexpected Therapeutic Results
Event Date 08/03/2014
Event Type  Injury   
Event Description
Clinic notes were received for patient's referral for vns implantation. Per notes, patient requests for the vns to be re-implanted due to increased frequency of seizures.
 
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 due to painful stimulation in her neck which was occurring every 10 minutes for the past month. During the patient¿s last office visit in (b)(6) 2014, the device output current was increased from 2. 75ma to 3. 25ma. The patient¿s device was tested during the visit and diagnostic results showed normal device function. The patient underwent surgery on (b)(6) 2014 to explant her generator and lead due to electrode failure and pain. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. The patient has not been re-implanted to date to allow sufficient time to let her vagus nerve heal.
 
Manufacturer Narrative
This information was inadvertently left off of initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210450


Title: Re: Painful Stimulation
Post by: dennis100 on February 01, 2019, 12:24:25 PM
Model Number 304-20
Event Date 04/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
During product analysis is was found that the explanted lead had a lead break. A coil break was identified in both the positive and negative lead coils. Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) occurred at the coil ends. Secondary fractures were observed in at least two strands of the quadfilar coils. The negative coil shows what appears to be wear (flat surfaces) resulting in reduction of the strand diameter. Although not conclusive the appearance of the lead break location is consistent with patient manipulation of the implanted device, a ¿twiddler¿. The patient had reported painful stimulation for months and the identified coil breaks may confirm this to be a contributing factor. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4202860


Title: Re: Painful Stimulation
Post by: dennis100 on February 02, 2019, 08:50:37 AM
Model Number 302-20
Event Date 01/01/2014
Event Type  Injury   
Event Description
It was reported that the patient was complaining of a constant ear ache and feels that the lead wire is sticking out at the generator site. The patient was referred to the surgeon. It was reported that the ear pain started with device stimulation and is now constant. Device diagnostics were reported to be within normal limits. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166466


Title: Re: Painful Stimulation
Post by: dennis100 on February 02, 2019, 08:51:39 AM
Event Date 09/08/2014
Event Type  Injury   
Manufacturer Narrative
Adverse event and/or product problem; additional information indicates that the event was not a product problem but an adverse event. Type of reportable event; additional information indicates that the event type was not a malfunction but a serious injury.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis and discard explants after 30 days; therefore, no analysis can be performed. Clinic notes were received indicating that the patient's device was tested during an office visit on (b)(6) 2014 and diagnostics showed lead impedance within normal limits (impedance value - 3000 ohms). After disabling the patient's device, the er physician prescribed medication for the patient. The notes indicate that the patient's painful stimulation occurred abruptly at her until the device was disabled and subsequently began having breakthrough seizures. A lead issue was suspected because of the patient's painful stimulation and not based on diagnostic results or x-rays. Operative notes for the patient's replacement surgery indicate that there was a significant amount of scarring around the nerve which required an external neurolysis as well as neurorrhaphy to prepare the nerve for placement of the new lead. The notes indicate that following placement of the new devices, the device was programmed on and showed low impedance. It is unclear whether the notes were referring to a low impedance reading or a low numerical impedance value that was within normal limits.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation and went to the er on (b)(6) 2014. The er physician stated that the patient¿s device was ¿misfiring¿. Follow-up revealed that during the er visit, the er physician had concerns of a potential lead break and subsequently disabled the device. The patient was sent for x-rays. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician¿s office that the patient experienced painful stimulation on the left side of the face, neck and chest abruptly on (b)(6) 2014. The patient was seen post- surgery by the physician on (b)(6) 2014 and that the incision sites were reported to be healing well. Attempts were made for product information but were unsuccessful.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4171248


Title: Re: Painful Stimulation
Post by: dennis100 on February 03, 2019, 04:12:28 PM
Model Number 102R
Event Date 04/01/2014
Event Type  Injury   
Event Description
Additional information was received that the patient underwent replacement of the generator and lead on (b)(6) 2014. The portion of the lead that was explanted was discarded by the explant facility. The explanted generator was received on (b)(6) 2015. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. During the product analysis, there were no anomalies found with the pulse generator.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient began experiencing pain in her chest during stimulation on-times after falling into a glass table. The pain resolved when the magnet was used to temporarily disable the device. The device was programmed off during an office visit on (b)(6) 2014. Diagnostic results did not indicate any issues with the patient¿s device. The patient previously reported occasional tightness in her chest, erratic stimulation and stimulation on-times not perceived. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4262629


Title: Re: Painful Stimulation
Post by: dennis100 on February 03, 2019, 04:14:08 PM
Event Date 09/19/2014
Event Type  Injury   
Event Description
It was reported that the neurologist noted redness at the generator site and thought the surgeon should order antibiotics. The patient denied pain or drainage but indicated that the generator site was warm. The patient later reported that she was seen by her primary care physician for an upper respiratory infection and that the antibiotics she was given for that also decreased the redness to the generator site. The patient has been applying neosporin to the incision sites and the chest incision is now light pink and no longer feels warm.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the patient went to the er on (b)(6) 2014 due to chest pain associated with stimulation. The er physician was advised to use the magnet to temporarily disable the device. Further follow up with the physician's office indicated that the patient had recovered from infection on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4262265


Title: Re: Painful Stimulation
Post by: dennis100 on February 04, 2019, 03:18:19 AM
Model Number 102
Event Date 01/30/2013
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2014, it was reported that the patient¿s vns was being explanted due to discomfort at the generator site and that the vns has been disabled for 2 years. The patient underwent explant of the device and good faith attempts for the return of the explanted product has not been successful to date. It was previously reported on (b)(6) 2013 that the patient was experiencing pain along the lead site upon stimulation and had been going on at all levels of stimulation (0. 25ma and higher). The patient¿s device was interrogate and turned off. It was then reported on (b)(6) 2013 that the patient complained of pain along the whole lead and generator site, and it came and went with stimulation cycles. The patient has always felt the pain since implantation on (b)(6) 2013. The patient was seen by the physician on (b)(6) 2013 gain and the device was turned back on to output=0. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 25ma/magnet pulse width=250usec/magnet on time=60sec. The patient immediately complained of discomfort along the lead path. Normal mode diagnostics were then performed which showed a dcdc of 0. Then system diagnostics were performed which showed a dcdc of 3. The patient stated that he had discomfort along the lead the entire time and that it subsided once the generator was turned off. It was noted that the patient has had his generator up to output=1. 25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet pulse width=250usec/magnet on time=60sec which is when he was subsequently turned down due to discomfort. The patient was referred for x-rays and noted that if a lead break is observed then he would like the device removed, but if there is no lead break then he wants the device explanted. X-rays were received on (b)(6) 2013. The generator is visible in the left chest and is normally placed. The lead pin appears fully inserted inside the connector block. Feed thru wires appear intact. Lead wires at the connector pin appear intact. Lead is present behind the generator. The lead is visible routing upwards to the left neck. The electrodes appear aligned. A strain relief bend is present and is placed per labeling. One tie-down is present and is securing the bend. The presence of a strain relief loop cannot be assessed due to poor image quality. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. Based on the images available, a cause for the painful stimulation cannot be established. Note that an anomaly in the lead portion not visible cannot be ruled out.
 
Event Description
The explanted lead and generator were received by the manufacturer. Lead product analysis was completed. A section of the lead was returned for analysis with the lead connector still attached to the generator. A continuity check was performed between the set-screw and the end of the lead portion while attached to the generator. Proper contact between the set-screw and the lead pin was present. No discontinuities were identified within the returned lead portion. Set-screw marks were identified on the connector pin, indicating that proper contact between the set-screw and the connector pin was present at one point. Due to a portion of the lead not being returned for analysis, an evaluation cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Generator product analysis was completed. The device output signal was monitored for more than 24 hours with the generator placed in a simulated body temperature environment. There was no signs of variation in the generator's output signal and the device provided the expected level of current. The generator communicated as received and no eri flag was set. The diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. There was no abnormal performance or other adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4242424


Title: Re: Painful Stimulation
Post by: dennis100 on February 04, 2019, 03:19:03 AM
Model Number 102
Event Date 10/06/2014
Event Type  Injury   
Event Description
It was reported that the vns patient began experiencing painful stimulation from the generator site up to the neck after experiencing a fall. The patient went to the er on (b)(6) 2014 due to intolerable pain and was given pain medication. Clinic notes were received indicating that the patient was referred for surgery although diagnostics showed normal device function at the time. The notes briefly mention that patient¿s painful stimulation. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator was returned to the manufacturer for analysis which concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The device performed according to functional specifications. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the surgical intervention was not taken to preclude a serious injury. It is unknown if the patient's pain with device stimulation has resolved as the patient has not been seen by the physician since generator replacement.
 
Event Description
Additional information was received that the patient has been seizure free for the past two months.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4243940


Title: Re: Painful Stimulation
Post by: dennis100 on February 04, 2019, 03:19:41 AM
Model Number 102
Event Date 06/28/2013
Event Type  Injury   
Manufacturer Narrative
Previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Event Description
On (b)(6) 2014, it was reported that this patient¿s explanted generator was discarded at the time of explant. Attempts for additional information have been unsuccessful.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation in his neck. The patient¿s device settings were lowered but the patient subsequently experienced an increase in seizures. The patient¿s device settings were programmed back to previous settings and the patient¿s painful stimulation returned. X-rays dated (b)(6) 2013 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported event remains unknown. Follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. The replacement generator was tested with the existing lead and diagnostics showed lead impedance within normal limits (impedance value ¿ 1650 ohms). The patient continued to experience painful stimulation following surgery. The explanted generator has not been returned to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4245608


Title: Re: Painful Stimulation
Post by: dennis100 on February 04, 2019, 03:20:49 AM
Model Number 102R
Event Date 10/01/2014
Event Type  Injury   
Event Description
It was reported that the patient was experiencing pain at the generator site and wants to have a complete system replacement. It was reported that the pain was occurring with device stimulation. The patient was scheduled for vns system replacement. No surgical intervention has been performed to date.
 
Manufacturer Narrative

Event Description
The explanting facility does not return explanted products unless they are notified beforehand. The explanted devices are therefore not available for return for analysis.
 
Event Description
It was reported that the patient underwent a full replacement on (b)(6) 2014 due to the patient's discomfort. Attempts have been made for product return but the explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274291


Title: Re: Painful Stimulation
Post by: dennis100 on February 04, 2019, 03:21:44 AM
Model Number 304-20
Event Date 09/09/2014
Event Type  Injury   
Event Description
Additional information was received stating that during an office visit on (b)(6) 2014, the vns patient complained of having shocking sensations in her neck along with dysphagia and muscle spasms. The patient had temporarily disabled her device with her magnet and the physician programmed the device off during the office visit. During an office visit on (b)(6) 2014, the patient¿s device was programmed back on and the patient subsequently had a nose bleed and coughing with stimulation. The patient¿s device was tested and showed normal device function at the time. The patient¿s device was again disabled for comfort. No patient trauma or programming changes preceded the onset of the patient¿s issues. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was subsequently disabled and the patient was referred for surgery. The patient¿s physician was suspecting a potential issue with the lead. No known surgical interventions have occurred to date.
 
Event Description
Follow-up report #1 inadvertently did not include that the patient also experienced difficulty speaking during clinic visit on (b)(6) 2014.
 
Event Description
Information was received that the patient underwent full revision of the generator and lead on (b)(6) 2015. The explanted products were reported to be discarded and could not be returned to manufacturer.
 
Manufacturer Narrative

Manufacturer Narrative
Event description, corrected data: follow-up report #1 inadvertently did not include patient's difficulty speaking during clinic visit on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4132917


Title: Re: Painful Stimulation
Post by: dennis100 on February 04, 2019, 03:22:53 AM
Model Number 302-20
Event Date 10/30/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was shocked by an electric fence which supplies about 10,000 volts the day prior and since the patient has experienced severe pain with device stimulation. It was reported that the output current was decreased from 2. 5ma to 1. 25ma and that the patient still experienced pain, but that it was lessened. Device diagnostics were within normal limits. The device was programmed off and the physician plans to program the device back on in a few months. The physician indicated that the patient is mentally retarded and can not explain where the pain was felt, but that the patient was red in the face with tears in his eyes and a cough as soon as device stimulation began.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4281723


Title: Re: Painful Stimulation
Post by: dennis100 on February 04, 2019, 03:23:46 AM
Model Number 102
Event Date 08/13/2014
Event Type  Injury   
Manufacturer Narrative
Type of reportable event; corrected data: the initial mdr inadvertently selected malfunction instead of serious injury for this field. This mdr is being submitted to correct this data.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient had been experiencing painful stimulation, dyspnea and coughing with stimulation for the last two weeks. The patient described the pain as beginning at the generator site and then traveling up to the left side of her face to her jaw during stimulation on-times. The patient indicated that the painful stimulation was to the point of wanting the device disabled, so the device was programmed off. A system diagnostic showed normal device function. The patient underwent generator replacement surgery on (b)(6) 2014. The explanted device has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4266673


Title: Re: Painful Stimulation
Post by: dennis100 on February 04, 2019, 03:24:32 AM
Model Number 103
Event Date 09/01/2014
Event Type  Injury   
Event Description
It was inadvertently reported in the initial mdr that no surgical interventions have occurred to date. The patient underwent explant of the vns device but the explant facility chose not to return the explanted generator. Therefore, product analysis of the explanted generator could not be performed.
 
Manufacturer Narrative
Event description, corrected date: it was inadvertently reported in the initial mdr that no surgical interventions have occurred to date. If explanted, give date (mo/day/yr), corrected data: 11/17/2014. The explant date was inadvertently left off from the initial mdr report.
 
Event Description
It was reported that the vns patient was experiencing increased painful stimulation at the generator site and an increase in seizures since (b)(6) 2014. The patient¿s vns generator was disabled due to pain and the patient was referred for surgery to explant the device. The patient¿s explant surgery was being planned for patient comfort. No known surgical interventions have occurred to date. Follow-up revealed that the patient¿s increase in seizures were worse with vns stimulation. The patient did not have any seizures while the device was disabled. The physician stated that the pain was due to the presence of the device. The patient¿s device was tested and showed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4277380


Title: Re: Painful Stimulation
Post by: dennis100 on February 04, 2019, 09:56:42 AM
Model Number 302-20
Event Date 01/01/2005
Event Type  Injury   
Event Description
It was reported that the patient had vns explant in 2006 due to cardiac episodes and painful stimulation. The patient had previously had generator replacement on (b)(6) 2006. Review of the generator programming history revealed that the device was programed off on (b)(6) 2007. The explant therefore occurred sometime after that time. The patient had vns re-implant surgery on (b)(6) 2014. During surgery, the surgeon noted that the old lead electrodes were inverted on the vagus nerve (with the positive and negative electrodes inverted). It was reported that in 2005, the patient had a cardiac episode and was hospitalized for bradycardia. Additionally, the patient had painful stimulation. As a result, the device was turned off, and the generator and a portion of the lead in the chest area was explanted. Review of programming history in-house reveals the device was programmed off on (b)(6) 2007. Follow-up with the patient's treating neurologist revealed that there is only limited information regarding the events, as the patient was treated by a different physician at the practice at the time of the events and that physician no longer works at the practice. The currently treating physician's recollection is that there were "big problems" with getting the patient regulated which would be explained by the inverted electrodes, per the physician. The explanted portion of the lead from surgery on (b)(6) 2014 was received by the manufacturer for analysis. Note that a large portion of the lead assembly (body); including the connector pin / boot section with model and serial number tag and the electrodes was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuity in the returned portion of the device which may have contributed to the stated allegations. Additionally for the explanted generator on (b)(6) 2006, analysis was completed. Based on the battery life analysis, the pulse generator approached a normal end of life condition. In addition, the pulse generator was operating at an increased duty cycle (71%) and, as defined in the physician¿s manual, this will deplete the battery faster than a low duty cycle; this may have been a contributing factor. The reported condition of erratic stimulation at that time was not verified in the laboratory. Delivered generator output across an electrical load confirmed a steady output voltage consistent with programmed parameter settings. There were no signs of variation in the output signal. The pulse generator would not interrogate, therefore was opened. The measured battery voltage was below the low battery operation level specified for the pulse generator, which indicates that the pulse generator had reached the end of life. These measurement in the lab demonstrate appropriate current consumption for the device, resulting in normal battery depletion. No performance anomalies were noted.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. However, lead electrodes were noted to be inverted on the nerve.
 
Event Description
The surgeon's office reported that the patient had explant surgery on (b)(6) 2008. It was also reported that the explanted generator and portion of the lead explanted at that time were discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4233217


Title: Re: Painful Stimulation
Post by: dennis100 on February 05, 2019, 03:29:37 AM
Model Number 102R
Event Date 10/03/2013
Event Type  Injury   
Event Description
On (b)(6) 2014, it was reported that the patient¿s device was still disabled and that the patient was referred for full revision due to a report of painful stimulation. The surgery was both for patient comfort and to preclude a serious injury: the patient was now experiencing an increase in seizures due to the device being programmed off. It was initially reported that this patient was experiencing an increase in seizures related to menopause. The patient didn¿t feel stimulation all the time like she used to and only felt it when diagnostics were performed. It was presumed that the patient just became used to the settings. Ap and lateral chest x-rays dated (b)(6) 2013 were received and reviewed on (b)(6) 2013. The reason for the exam, per attached documentation, was vns placement and possible lead breakage. X-rays showed that the generator is visible in the left chest and is normally placed. The lead pins appear fully inserted into the connector blocks. The feedthru wires appear intact. The lead wire at the connector pins appears intact. Lead is present behind the generator and cannot be assessed. The lead wire is seen routing up towards the left neck. The electrodes appear normally placed. No gross fractures, lead discontinuities, or sharp angles are present. Based on the images present, the generator placement appears normal, and no lead discontinuities appear to be present. It was later reported that the patient¿s device was currently off, and the patient was to undergo an mri. The device had been disabled because the device was shocking the patient. When the patient used the magnet, nothing happened, even when she wasn¿t having a seizure. Additional clarification showed that it was unknown if the painful stimulation and magnet events were occurring with stimulation. Sometimes the patient would be sitting or lying down, and would experience the ¿shocking. ¿ the patient¿s device had been disabled since (b)(6) 2013 due to the shocking. The patient didn¿t feel the stimulation from magnet activations (stimulation not perceived). The patent had previously experienced choking with stimulation when she was eating or drinking, but she knew this feeling now, and the shocking was different and painful. The patient¿s father believed that the problem would resolve with replacing the patient¿s whole system with the newest model. Surgery is likely but has not taken place.
 
Manufacturer Narrative
Review of programming history; manufacturer reviewed x-rays of implanted device; x-rays reviewed by the manufacturer, no gross lead discontinuities or anomalies visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4358279


Title: Re: Painful Stimulation
Post by: dennis100 on February 05, 2019, 03:30:52 AM
Model Number 102
Device Problem Programming Issue
Event Date 12/02/2014
Event Type  Malfunction   
Event Description
An implant card was received indicating that the device was still unable to interrogate at the replacement surgery. The reason for replacement was identified as "battery depletion, unable to interrogate due to battery depletion. " the explanted generator has been received by the manufacturer. Analysis is underway , but has not been completed to-date.
 
Manufacturer Narrative

Event Description
It was reported that no further attempts have been made to interrogate the patient's device. Insurance coverage is being obtained for revision surgery. The patient experienced returns of suicidal thoughts which was reported to be related to the progression of the patient's depression. Suicidal ideations are not new for this patient and the return of the suicidal thoughts are unrelated to vns.
 
Event Description
It was reported that the patient has had an increase in depression, and has made suicide attempts. Medication changes were considered. The patient had generator replacement surgery on (b)(6) 2015. The explanted product has not been received to-date.
 
Event Description
Analysis was completed for the returned generator. The reported failure to program was determined to be the result of normal battery depletion. The depletion was an expected event as determined by battery life calculation and battery voltage measurement. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device had been disabled in (b)(6) 2008 due to painful stimulation. It was reported that during an office visit on (b)(6) 2014, the physician was considering programming the device back on due to the patient¿s condition, but was unable to interrogate the patient¿s device despite using two known working programming systems. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Initial reporter: the incorrect contact information for the initial reporter was provided inadvertently. Relevant tests/laboratory data: the available device settings and estimate of battery life calculation were inadvertently not provided in the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4369050


Title: Re: Painful Stimulation
Post by: dennis100 on February 05, 2019, 03:31:58 AM
Model Number 102
Event Date 07/07/2014
Event Type  Injury   
Event Description
An implant card was received indicating that the patient underwent generator replacement on (b)(6) 2014. Attempts made for the return of the explanted product were unsuccessful. The explanted product could not be located by the explant facility. Analysis of the product could not be performed as the product has not been received to date.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the patient experienced painful stimulation at the generator site. The generator replacement surgery was reported to be planned for patient's comfort and not to preclude a serious injury. There were no known vns setting changes or trauma to the site that could have caused or contributed to the painful stimulation. No known surgical interventions have occurred to date.
 
Event Description
A surgery referral form was received indicating that the patient was referred for generator replacement because of pain with vns stimulation for 2-3 months. It was noted that the generator is likely nearing end of service. Clinic notes dated (b)(6) 2014 indicate that the patient experiences more auras and will be referred for generator replacement because the generator battery is low. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4224345


Title: Re: Painful Stimulation
Post by: dennis100 on February 05, 2019, 03:33:27 AM
Model Number 302-20
Event Date 09/24/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the high impedance was first observed (b)(6) 2014.
 
Event Description
It was reported that the vns patient was sent for x-rays due to concerns with her device lead impedance. X-rays were taken and were reported by the physician to be unremarkable. Follow-up revealed that the patient¿s concerns with lead impedance were due to pain occurring with magnet mode stimulation on-times. The patient¿s magnet output current was subsequently reduced. Patient manipulation or trauma is not believed to have caused or contributed to the event. Follow-up revealed that the patient¿s device was tested and diagnostic results revealed high impedance (dc dc ¿ 6). X-rays dated (b)(6) 2013 and (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin cannot be confirmed to be fully inserted into the generator connector block with the images provided. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4230225


Title: Re: Painful Stimulation
Post by: dennis100 on February 06, 2019, 03:06:37 AM
Model Number 102
Event Date 11/20/2014
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
On (b)(6) 2016, it was confirmed that the patient's device was able to be interrogated. Patient was seen at the neurologist's office due to recent increase in seizures to evaluate her for continuation of her vns therapy or replacement since her device disablement on (b)(6) 2008 due to seizure freedom. A diagnostic test was performed and patient was able to feel vns stimulation. During the stimulation period of the diagnostic test, patient experienced pain with stimulation in neck area pulled away before the test was completed. Additional information was received that the patient's diagnostic test results were not available as they could not be completed.
 
Event Description
It was reported that the patient's generator was unable to be interrogated. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4330779


Title: Re: Painful Stimulation
Post by: dennis100 on February 06, 2019, 03:07:29 AM
Model Number 103
Device Problem Migration or Expulsion of Device
Event Date 10/30/2014
Event Type  Injury   
Manufacturer Narrative
 
Event Description
On (b)(6) 2015 it was reported through clinic notes dated (b)(6) 2015 which indicate that the patient is considering re-implant of the vns device after having it removed due to irritation in (b)(6) 2014. Although re-implant surgery is likely, it has not occurred to date.
 
Event Description
Initially, it was reported that the patient was seen in the emergency room with complaints of device migration and painful device stimulation. The patient was seen on (b)(6) 2014 to program the device off while the issues were being addressed. A chest x-ray confirmed proper positioning of the device. The nurse practitioner indicated that there is no belief that the reported issues are related to vns. It was later reported that the pain occurred approximately three times a day for approximately thirty minutes each occurrence. It was also reported that the patient has lost twenty pounds which caused the device migration. The device output current was decreased from 2. 25 ma to 0. 50 ma and then later programmed off. The patient continued to report pain despite the device being programmed off. The patient';s father reported that the patient was scheduled for vns explant due to her discomfort and pain with the migration. It was reported that the vns has helped with the patient's seizures, but that the generator would not be replaced for now. The physician reported that the surgery was being performed for