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Author Topic: Painful Stimulation  (Read 37631 times)
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dennis100
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« 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
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dennis100
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« Reply #1 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

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dennis100
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« Reply #2 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
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dennis100
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« Reply #3 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
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dennis100
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« Reply #4 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
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dennis100
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« Reply #5 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
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dennis100
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« Reply #6 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
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dennis100
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« Reply #7 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
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dennis100
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« Reply #8 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
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dennis100
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« Reply #9 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
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dennis100
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« Reply #10 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
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dennis100
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« Reply #11 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
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dennis100
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« Reply #12 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
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dennis100
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« Reply #13 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
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dennis100
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« Reply #14 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.

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« Reply #15 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.

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« Reply #16 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.

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« Reply #17 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.

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« Reply #18 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.

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« Reply #19 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.

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« Reply #20 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.

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« Reply #21 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.

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« Reply #22 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
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dennis100
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« Reply #23 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
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dennis100
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« Reply #24 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
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dennis100
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« Reply #25 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
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dennis100
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« Reply #26 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
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dennis100
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« Reply #27 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
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dennis100
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« Reply #28 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
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dennis100
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« Reply #29 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
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