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dennis100
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« Reply #540 on: April 02, 2019, 01:44:27 AM »

Model Number 103
Event Date 04/05/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received for patient's prophylactic replacement referral due to ifi=yes. Notes mention that the patient feels the device shocking him similar to when his battery has gotten low in the past and seizures are increased in the last 2 weeks. Additional relevant information has not been received.
 
Event Description
Additional information was received from the neurologist that the patient has experienced neck pain with stimulation several times when the (vns) battery is weakening. The patent has not had more seizures compared to pre-vns baseline level. There were no known changes to medications, vns settings or other external factors which preceded the onset of the increase in seizures. Patient underwent prophylactic generator replacement on (b)(6) 2016 due to ifi - yes. The explanted generator was received on 06/02/2016. Analysis is underway but has not been completed to date.
 
Event Description
The pulse generator was explanted/returned due to "prophylactic replacement. " although the reported allegations of "increased seizures" and "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. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. This was successfully verified in the pa lab. In the pa lab, 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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. The reported allegation of "low battery" was not duplicated in the pa lab. The battery, 2. 818 volts, shows an ifi=no condition. 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=5660851
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dennis100
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« Reply #541 on: April 02, 2019, 01:45:08 AM »

Model Number 103
Event Date 04/12/2016
Event Type  Injury   
Event Description
It was reported on (b)(6) 2016 that the physician saw the patient that day and she was complaining of painful erratic stimulation in her left neck when she turns her head to the left. This started about 1 week prior and there was no trauma or event that seemed to have started it. The physician checked diagnostics with her facing forward and also turning her head to the left. Notes state to follow-up to replace vns / lead if malfunction continues but this likely refers to the painful stimulation as diagnostics showed the vns was functioning well and physician lowered settings to help tolerability. No malfunction of the device was observed. The patient is now scheduled for an explant of the device. Surgery has not occurred to date.
 
Event Description
It was reported on (b)(6) 2016 that the patient underwent generator replacement surgery on (b)(6) 2016. The explanted generator was discarded after explant.
 
Manufacturer Narrative
Corrected data, supplemental mdr #1 inadvertently reported that the patient had a replacement while the surgery was only an explant surgery.
 
Event Description
The patient generator was explanted (b)(6) 2016. Clinic notes were received on 10/21/2016 for the patient to be re-implant with a m106. The notes state that the previous vns stimulator was removed (model 103) because painful stimulation was triggered by turning head towards it and she has to turn her entire body not just head to avoid trigger of vns stimulation. The electrodes are still in place but the surgeon suspects the electrodes may be fractured but he will check the old lead with the new vns during surgery to see if it¿s still working, otherwise he will implant new electrode. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5653184
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dennis100
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« Reply #542 on: April 03, 2019, 01:30:56 AM »

Model Number 304-30
Event Date 05/07/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient had high impedance at about 9,000 ohms. The patient also reported feeling discomfort in her neck periodically with stimulation. The patient's device was noted to have been left on. There were no reported causes for the impedance issues or when the last known diagnostics were performed at the time of the call. The patient was being referred for full replacement surgery. The generator was going to be replaced due to the patient's desire for the newer model. No surgical intervention has occurred. No further relevant information has been received to date.
 
Event Description
The explanted generator had product analysis completed. Product analysis of the generator confirmed proper generator functionality. The generator confirmed its ability to provide appropriate programmed output currents. Additionally, a comprehensive automated electrical evaluation showed that the generator performed according to all functional specifications. There were no performance or any other type of adverse condition found with the generator.
 
Event Description
The patient had full replacement surgery on (b)(6) 2016. The explanted lead and generator were returned to the manufacturer for analysis. A section of the lead assembly was returned for analysis in one piece. Setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. Also, the connector ring had scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. Abrasions were noted on the connector boot and on the outer silicone tubing at multiple locations. The outer silicone tubing had a compressed appearance at multiple locations. A suspected coil break was identified at the end of the negative coil. The negative coil also had a discolored appearance in the vicinity of the broken end. Scanning electron microscopy images of the positive coil showed that pitting or electro-etching conditions had occurred at the break location. The returned lead assembly had kinks in at least one of the coils in two locations. The lead assembly had dried remnants of what appeared to have once been body fluids in the small o-ring boot location inside the inner silicone tubing. Scanning electron microscopy of the positive coil showed that pitting or electro-etching conditions had occurred at the coil end, showing evidence suggestive of a stress-induced fracture. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5763552
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dennis100
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« Reply #543 on: April 03, 2019, 01:31:45 AM »

Model Number 304-20
Event Date 02/01/2016
Event Type  Malfunction   
Event Description
It was reported through clinic notes that the patient had two lumps on his neck and the vns lead was protruding. At the same time, he was experiencing painful stimulation along with muscle spasms and dysphagia. In addition when the patient attempted to swipe his vns magnet, he became nauseated. His physician then referred him to a surgeon for evaluation due to a suspicion that his vns lead had become loose. Further follow-up with the physician found that she did not believe the lead was coming off the nerve however she did think it was displaced. The physician stated that she did not run a system diagnostics tests because the vns stimulation was already causing the patient a severe amount of pain. The reported symptoms began within the last several months. The physician did not know why these symptoms were occurring which is why the patient was referred for further evaluation by a surgeon. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5630792
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dennis100
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« Reply #544 on: April 03, 2019, 01:32:27 AM »

Model Number 302-20
Event Date 01/30/2016
Event Type  Malfunction   
Event Description
It was reported that the patient铠lead experienced high impedance. He was scheduled for a full revision surgery. The patient also reported painful stimulation in the neck, and the device was disabled in relation to the high lead impedance. Surgery has not been reported to occur to date. Additional pertinent information has not been received to date.
 
Event Description
The patient's vns system was fully replaced on (b)(6) 2016. The impedance value of the replacement system was within normal limits. The explanting facility does not return explanted devices, so product return of the explanted generator or lead is not expected. No additional pertinent information has been received to date.
 
Event Description
The explanted generator and lead portion were received and underwent product analysis. It was noted that the lead was still inserted into the generator when it was received. A continuity check was performed on the lead and setscrew of the generator which verified proper contact between the lead pin and setscrew. Analysis on the lead found a kink in the lead coils however no discontinuities were identified in the returned portion of the lead. It was noted the portion of the lead with the electrode segment was not returned. Therefore it could not be evaluated and its role in the reported high impedance could not be determined. During analysis on the generator various impedance loads were attached to the generator and the subsequent diagnostic tests resulted in the accurate resistance measurements in all instances. The generator found that it performed to functional specification. The internal data of the generator was reviewed and noted the last >25% change in impedance occurred on (b)(6) 2016 when the prechange value was 2460 ohms and the postchange value was 11807 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5639498
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dennis100
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« Reply #545 on: April 04, 2019, 01:43:23 AM »

Model Number 302-20
Event Date 01/07/2010
Event Type  Injury   
Event Description
It was reported by a nurse that a vns pt experienced a loss in weight and had to decrease the pt's vns settings due to the pt losing weight. The event of loss in weight started last yr. Further info from the nurse indicated the pt was also complaining of severe neck and left lateral chest pain which was positional. Additional info was received from the treating nurse indicating the cause of the pt's loss of weight was related to vns pain in the throat as the pt could not eat due to pain. The nurse did not know a cause for the pt's positional pain as the pt stated that the event has been ongoing since vns placed. Interventions planned are to have a second opinion and replace vns as it significantly improves the pt's seizures. Additional info was received through clinic dated (b)(6) 2011 notes indicating the pt's seizures are worse due to lack of rest, pt is experiencing painful stim, cannot swallow, increase in acid reflux allegedly due to vns, device disabled (b)(6) 2011 - pain stopped as a result of device being disabled. Interventions taken were to increase meds as vns is disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1999589
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dennis100
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« Reply #546 on: April 05, 2019, 01:49:14 AM »

Model Number 302-20
Event Date 05/19/2016
Event Type  Malfunction   
Event Description
It was reported on 05/23/2016 that this patient's device is showing high lead impedance. The lead has been implanted since 2007 but the generator has only been implanted since (b)(6) 2015, so until x-rays or surgery occurs, it is unknown if pin insertion is the cause of the high impedance or a lead fracture. The patient has not yet had x-rays although they are requested. No surgical intervention has occurred to date.
 
Event Description
Clinic notes were received on 10/27/2016. Notes mention the broken lead and that the patient has decreased tolerance for stimulation. Surgical intervention has not occurred to date.
 
Event Description
It was indicated that the decreased tolerance in stimulation was reported to be painful stimulation at the patient's neck.
 
Event Description
On (b)(6) 2017 an implant card was received indicating that the patient had a full replacement on (b)(6) 2017. Explant products have not been received to date.
 
Event Description
The explanted devices were discarded after explant and are not available for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5720883
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dennis100
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« Reply #547 on: April 05, 2019, 01:50:01 AM »

Model Number 106
Event Date 02/18/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing a shortness of breath, voice hoarseness, and painful stimulation in the neck after initial implant surgery. The reported voice hoarseness occurred immediately after implant surgery and was slightly worse when the device was programmed to 0. 25ma output current. The pain in the neck occurred with the patient was programmed on. The patient was reportedly programmed off immediately after surgery. In the first week of may, the patient had a tracheostomy due to the reported shortness of breath. It was also noted that the patient had a thyroid removed prior to vns implant surgery in (b)(6) and it was unclear if this surgery caused any of the symptoms. No additional relevant information has been received to date.
 
Event Description
Follow-up to the patient's treating physician revealed that the patient had post-operative bilateral vocal cord paralysis, prior to turning on the vns. Unilateral vocal cord paralysis was also suspected as a result of a prior thyroidectomy. The shortness of breath was reported to be attributable to vns implant surgery, and ultimately required tracheostomy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5707285
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dennis100
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« Reply #548 on: April 05, 2019, 10:20:41 PM »

Model Number 302-20
Device Problem Fracture
Event Date 02/28/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was scheduled for a generator and lead replacement due to high impedance and painful stimulation in the left shoulder area. The patient's output current was decreased due to the painful stimulation. It was reported that there was no known trauma or manipulation to the area to contribute to the high impedance. 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=8448215
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dennis100
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« Reply #549 on: April 06, 2019, 02:31:41 AM »

Model Number 1000
Device Problem Premature End-of-Life Indicator
Event Date 01/13/2019
Event Type  Malfunction   
Event Description
It was reported that on (b)(6) 2019, interrogation of the patient's device showed a low battery warning and the device was pulse-disabled. The patient's model 1000 generator was placed in (b)(6) 2018, battery life was normal at 75-100%. Impedance was within normal limits. Note that the patient experienced coughing and severe pain upon advanced interrogation, which re-enables the device. Because of this, the device was disabled. It was believed the pain/coughing with stimulation was due to the patient losing tolerance of stimulation after the device was pulse-disabled due to battery depletion. This message occurred with two different programming systems. The generator was reset it was noted that the device was now showing low impedance along with end of service. The low impedance was an expected event due to the magnet being left on after generator reset - no device failure is expected regarding the low impedance. Review of x-rays verified that there were no obvious anomalies in the lead. Review of internal data of the generator found that the generator voltage was lower than expected since implant (prior to low battery/disablement) and did not gradually increase as would be expected in the beginning of an implanted generators life. Instead the generator voltage appeared to decrease from implant. It was noted that the 3 battery status indicators (ifi -intensive follow-up indicator, neos- near end of service, eos - end of service) occurred on the same day in january, which indicates that the voltage dropped suddenly on this day. The device history records of the generator were reviewed. The generator passed final functional and quality tests prior to release. No anomalies in testing were noted. No known 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=8404859
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dennis100
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« Reply #550 on: April 07, 2019, 03:31:43 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/10/2018
Event Type  Injury   
Event Description
It was reported that the patient had been referred for vns generator replacement surgery. Clinical notes were received as part of this process which reported the patient was experiencing painful stimulation in the chest as well as coughing with vns magnet stimulation. These began after the patient's vns was adjusted at the previous office visit. The pulse width was lowered due to these events, and then the frequency, pulse width, and magnet output current were lowered and it is indicated the coughing resolved after this further decrease. The neurologist speculated that a lead issue was contributing to these tolerability issues and requested that the lead be replaced if a lead issue is found during the surgery. Lead impedance was measured at the office visit and noted to be within normal limits. Follow up with the patient's neurologist determined that the replacement surgery was being taken to potentially prevent a serious injury. 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=8403687
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dennis100
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« Reply #551 on: April 07, 2019, 03:32:21 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/29/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had pain in their left ear all the time, but pain felt stronger during vns stimulation. It was reported that there was a lot of earwax removed, no inflammation, and that the pain is relieved when the patient lays down with a pillow against their ear. It was also reported that the patient experienced dyspnea and pain in left cheek and teeth. The physician decreased the patient's vns settings to prevent chronic nerve pain in the left cheek and teeth area. The patient's diagnostics were reportedly within normal limits. It was additionally reported that the pain occurred only during stimulation and became less severe. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8424598
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dennis100
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« Reply #552 on: April 08, 2019, 03:04:35 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/05/2019
Event Type  Injury   
Event Description
It was reported that a patient was experiencing pain in the neck. Follow up was received indicating that the pain was extreme and was not associated with any injuries or seizure, although the patient's last seizure was in (b)(6) 2018 and the patient noted that she may have hit her face during the seizure. It was noted that the patient had not had any recent changes in medication. Per the physician, the patient's device had been programmed off. The pain had become mild and her neck was sore at the lead location. Diagnostics were within normal limits. Settings were adjusted to mitigate the painful stimulation. It was stated that the patient felt as if the nerve was irritated or sore likely due to the painful stimulation. The patient's device was then programmed on, initially to 0. 75 ma. However, the patient could not tolerate the stimulation at this current. The settings were then reduced further and the patient was left at reduced settings and no other medical intervention was reported. An implant card was received indicating that the patient underwent a replacement surgery due to "unexplained neck pain". No additional, relevant information was received to date. No device was received for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8413663
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dennis100
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« Reply #553 on: April 08, 2019, 03:05:13 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/28/2019
Event Type  Injury   
Event Description
It was reported that the patient underwent prophylactic replacement. The patient alleged feeling like stimulations were more painful than before. It is not clear if the painful stimulation was a contributing factor to the patient's referral for replacement. No additional or relevant information has been received to date. The explanted device has not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8399500
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dennis100
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« Reply #554 on: April 09, 2019, 12:55:24 AM »

Model Number MODEL 250
Event Date 05/09/2016
Event Type  Malfunction   
Event Description
It was reported that during an office visit on (b)(6) 2016 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2016. The settings found were indicative of a faulted diagnostic test which occurred on (b)(6) 2016. The device was not interrogated prior to the patient leaving the office on (b)(6) 2016 as recommended by device manufacturer to ensure the device is at the correct settings; therefore, the settings were not corrected prior to the patient leaving the office. As a result of the changed setting the patient experienced painful stimulation. The settings were then adjusted on (b)(6) 2016. No additional relevant information has been received to date.
 
Event Description
An sd card containing a copy of the physician's tablet was received. The data was reviewed and confirmed that the output current was set to 0ma prior to a faulted diagnostic test with no final interrogation. The following day the generator was interrogated and output current was found to be set to 1ma. The data also confirmed that diagnostic results were within normal limits when the patient was experiencing the painful stimulation. Additionally, the data indicated that the patient was programmed off on (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698270
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dennis100
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« Reply #555 on: April 10, 2019, 01:43:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/18/2017
Event Type  Injury   
Event Description
A patient was experiencing horrendous pain in a tooth on the left side of his mouth and in the middle of his chest. The pain occurred only once initially, when the patient accidentally swiped his vns magnet over his generator. At a clinic visit 2 weeks prior, the patient's neurologist believed the device was operating normally, per the patient. The following month, the neurologist suspected that a problem with the patient's lead may have occurred based on the clinical symptoms that patient was experiencing. The neurologist ordered x-rays of the patient's vns system; however, the x-rays were not reviewed by the manufacturer. No device malfunction was reported at that time. Two months after his initial report, the patient stated that he felt like a woodpecker was hitting his chest when he turned onto his left side, and he continued to experience pain in his gums. The sensation occurred every 3 minutes with stimulation and went away when stimulation stopped. The patient was evaluated by his dentist, who stated that nothing was wrong with the patient's teeth or gums. The patient reported that though he initially felt stimulation when he was implanted, he stopped perceiving stimulation until his initial report of pain two months prior. The patient noted that the pain was impacting his sleep. The patient had taken pain medication to treat the painful stimulation, but the medication did not help. The patient was seen in clinic a week after the updated report, and device diagnostics were performed and returned results within the normal limits. The patient reported that magnet swipes made him feel as though he could not breathe in addition to the painful stimulation he was previously experiencing. The patient's settings were reduced as intervention for the painful stimulation and dyspnea. The patient was referred for surgery as the neurologist believed that the vns was clearly causing the patient's pain, despite diagnostics being within the normal limits. The surgery was reportedly both required to preclude a serious injury and for patient comfort. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. The explanted generator was not returned to the manufacturer by the explanting facility. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6760034
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« Reply #556 on: April 10, 2019, 01:44:28 AM »

Model Number MODEL 250
Event Date 06/24/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a company representative attended a patient's clinic visit on (b)(6) 2016. During device diagnostics, the patient experienced pain during stimulation in the neck area and pulled away. The patient would not allow the company representative to interrogate the device to confirm the settings. After the appointment and having left the physician's office, the patient called saying that her device was stimulating about every 30 minutes. The company representative and the patient returned to the physician's office. It was confirmed that the settings had been changed as the output current was 1ma and off time was 60 minutes. The settings were corrected at that time. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5815816
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« Reply #557 on: April 11, 2019, 10:17:45 AM »

Model Number 304-20
Device Problem High impedance
Event Date 06/15/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that high impedance was observed during device diagnostics with an impedance value of 5897 ohms. At the recent implant of the lead and generator the impedance was noted to be 2948 ohms. The physician then left the patient programmed at 0. 25ma since the patient was not experiencing painful stimulation and she had been receiving efficacy from vns. Further follow-up with the physician found that patient manipulation or trauma are not suspected to have contributed to the high impedance. Instead the physician suspects the lead pin may have shifted which has caused the high impedance. The patient was sent for x-rays however they have not been reviewed by the manufacturer to date. The manufacturing records of the lead and generator were reviewed and found that both devices passed qc inspection prior to distribution. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient was seen by the physician at a follow-up appointment and the high impedance warning message was still presenting. During the appointment the patient reported experiencing painful stimulation in her chest. The generator was then disabled. X-rays were received and reviewed by the manufacturer. There did not appear to be any obvious lead discontinuities in the portion of the lead that could be visualized and the connector pin appeared to be fully inserted. However the presence of a micro-fracture in the lead cannot be ruled out. The x-rays did show that the lead did not have adequate strain relief as described in labeling. The implanting physician was then retrained on proper lead placement. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient underwent lead replacement surgery. A system diagnostic test was performed during pre-op which showed high impedance 10,000 ohms. The generator was then detached from the lead and the generator was tested on it's own. This generator diagnostic test resulted within acceptable limits. The lead was then replaced and the new lead was connected to the existing generator. A system diagnostic test with the new lead and existing generator resulted in an acceptable lead impedance. The explanted lead has not been received to date.
 
Event Description
It was reported that during the lead revision surgery on (b)(6) 2016 the surgeon attempted to re-insert the existing lead into the generator. However the high impedance did not resolve therefore the lead was replaced.
 
Manufacturer Narrative
This information was inadvertently reported incorrectly on mfg. Report #2.
 
Event Description
A company representative reported that the explanted lead was discarded by the hospital following the replacement surgery.

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« Reply #558 on: April 11, 2019, 10:18:37 AM »

Model Number 304-20
Event Date 04/15/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient was being referred for generator replacement surgery due to an unknown reason. Further clarification was provided stating that the patient was being referred for generator replacement due to the impedance being on the "higher end". The event date provided is the date that the impedance value on the "higher end" was noted. Diagnostics were performed and showed that the impedance values were at higher values, but not values considered high impedance by the manufacturer. After device explant, the implant card was received stating that a full replacement was done and the reason for the lead explant was lead discontinuity and an adverse event. Post-op impedance values were reportedly within normal limits. The lead has been returned to manufacturer, but product analysis has not been completed to date. The implant card received by the manufacturer also indicated that an adverse event occurred which was part of the reason for device explant. No further relevant information has been received to date.
 
Event Description
It was reported that the patient had a diagnostic run before replacement which showed impedance values within normal limits. The patient had reportedly dropped a weight on his chest and was experiencing painful stimulation in his chest after that occurred at output currents greater than 1ma. High impedance was reportedly never found. The explanted lead and generator were returned for product analysis. The explanted lead was returned in 1 piece and product analysis was completed on 07/25/2016. The connector pin contained two sets of screw marks providing evidence that proper contact between the setscrew and connector pin existed at least once. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The explanted generator was analyzed and showed that the generator exhibited proper functionality in its ability to provide appropriate programmed output currents. 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 data from the pulse generator was reviewed and showed that no high impedance instances were identified and the generator battery depleted at normal levels.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5788108
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« Reply #559 on: April 12, 2019, 01:29:47 AM »

Model Number 302-20
Event Date 12/16/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic notes were received in regards to a replacement referral for the patient. Within the clinic notes it was found the patient was experiencing pain at the electrode site during interrogation. This pain appeared to begin on (b)(6) 2014. Additionally, clinic notes from (b)(6) 2014 showed the patient was a normal therapy settings and found that the diagnostic results were ok with dcdc values for both system and normal mode diagnostics at 3. However, during the next visit, it was noted the patient's vns therapy settings were the same, but that one diagnostic value was at dcdc = 3 and the other was at dcdc = 0. It was not specified which diagnostic result was system and which was normal mode. The patient's following three visits showed that the therapy settings did not change, but there were notes indicating the physician was unable to perform vns diagnostics due to pain. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient was referred for surgery and underwent a generator replacement on (b)(6) 2016. System diagnostics were performed prior to the explant of the device showing the device was working as expected. The generator was replaced with a new generator and diagnostics were run again showing this device was working as expected. It was later reported by the patient that she had actually had painful stimulation in her neck for over two years. It was noted the device was programmed off for an unknown amount of time; however, the patient's seizures came back, so they programmed her device back on. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Describe event or problem; device manufacture date; evaluation codes, method, results, conclusions: corrected data: this information was inadvertently left off of supplemental #01 mfr. Report.
 
Event Description
Since the vns diagnostic results were within normal limits both before and after the surgery, it can be determined there was no issue with the vns lead. An assumption was made that the lead may have had low impedance as the clinic notes showed that the patient had painful stimulation, and at the same time the dcdc value changed from dcdc = 3 to dcdc = 0. It is known that impedance values can fluctuate; however, a drop or increase in dcdc values associated with painful stimulation can be an indication of a malfunction. Once it was clarified by the patient that her painful stimulation onset was 2 years prior to the change in impedance, and impedance value was confirmed to be within normal limits even with the new generator, there was no longer a suspicion of a lead malfunction.
 
Event Description
The explanted generator was received by the manufacturer for analysis. Analysis is expected, but has not been completed to date.
 
Event Description
Product analysis (pa) for the returned generator was approved on (b)(6) 2016. The reported painful stimulation allegation was beyond the scope of the pa lab. However, the device output signal of the generator was monitored for more than 24-hours, while placed in a simulated body temperature environment. Results showed no signs of variation in the generator¿s output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the generator and 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=5916851
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« Reply #560 on: April 13, 2019, 04:57:22 AM »

Model Number 103
Event Type  Injury   
Event Description
It was initially reported by the mri technician that the patient's device was not activated and it had been programmed off some time prior to (b)(6) 2014, but it was unknown why this occurred. The in-house programming history database was reviewed and found that the device was found programmed off on (b)(6) 2014, indicating the device was programmed off sometime before that date. It was later reported by the physician that the patient had his device programmed off sometime in 2014 due to the fact the patient didn't like the vns. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was further explained that the patient wanted the vns programmed off because the stimulation made him uncomfortable and it hurt his neck. The physician noted diagnostics were normal and there were no issues with the device, just that the patient was uncomfortable and wanted the vns programmed off.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5885172
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« Reply #561 on: April 14, 2019, 01:46:55 AM »

Model Number 102R
Event Date 12/17/2004
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient never tolerated high vns settings and experienced coughing, gagging and painful stimulation in the throat when stimulation was higher than 0. 5ma. On (b)(6) 2014, the vns was near end of service. As patient only had few seizures per year, the output current was disabled but magnet was left on. No diagnostics were able to be performed successfully due to patient's low vns settings and intolerability to high settings. Additional information was received that the patient underwent explant surgery on (b)(6) 2016. The explanted device(s) were not received to date.
 
Event Description
Additional information was received that the surgery was due to device reaching end of service and family request to remove the device. The surgery was for patient comfort and not to preclude a serious injury. Patient was never able to tolerate advancement to therapeutic levels on vns device due to significant coughing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5869272&pc=LYJ
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« Reply #562 on: April 15, 2019, 01:39:27 AM »

Model Number 302-20
Event Date 12/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes for a patient replacement referral were received indicating the patient was choked (assaulted) in 2015, causing the vns device to move. The patient has also been experiencing painful stimulation in her left throat and dysphagia since the choking. All diagnostic results were within normal limits following the patient being choked. No further relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement on (b)(6) 2016 due to a prophylactic replacement. The explanted generator was reportedly discarded after surgery. Post-op diagnostics showed results within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5841177
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« Reply #563 on: April 15, 2019, 01:40:16 AM »

Model Number 302-30
Event Date 02/01/2016
Event Type  Malfunction   
Event Description
It was reported that in (b)(6) 2016 the patient reported erratic stimulation. It was reported that in (b)(6) 2016 the patient reported that he had fullness in his head, continuous stimulation for 2 hours, voice hoarseness, and painful stimulation. The patient reported that it started when he turned his head a certain way, and demonstrated it to the physician. Due to these symptoms, the patient's device was disabled in (b)(6) and the patient was referred for generator replacement surgery. After disablement, the patient continued to report feeling intermittent stimulation, pressure in his head, and painful stimulation. The patient reported that when he turns his head, he can feel his voice change and stimulation, despite the fact that the output currents were off. The painful stimulation was reported as occurring in the neck and the head. Impedance was reported to be normal at 1171 ohms. A review of ap chest x-rays identified a potential lead fracture located on the upper left side of the generator. The treating physician also believed that there was a lead fracture. There was no known trauma or manipulation at the site of the fracture. The patient has had anxiety in the past, and this was indicated by the physician as a possible reason for the patient's symptoms post-generator disablement. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
Further programming/diagnostic history from the physician's tablet was reviewed. All reported impedance values were within normal limits. Internal data was reviewed and found that, given the small values of impedance, the changes in impedance detected could be normal. No additional relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5980471
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« Reply #564 on: April 15, 2019, 01:41:08 AM »

Model Number 102
Event Date 12/01/2015
Event Type  Injury   
Event Description
It was reported by the physician's assistant that the patient was referred for prophylactic generator replacement due to painful stimulation the patient was experiencing. System diagnostics were unable to be performed due to the pain the patient would experience while running the diagnostics, so x-rays were taken. The x-rays were reviewed by company representative and based on the images the cause for the patient's painful stimulation could not be determined. There did not appear to be any gross fractures or discontinuities. However, the portion of the lead not visualized that would be in the chest could not be assessed; therefore, a lead fracture in that portion of the lead couldn't be ruled out. The presence of a micro-fracture could also not be ruled out. On the date of surgery, after the patient was put under, system diagnostics were run on two occasions with the patient's neck turned in different direction. The diagnostics showed the device was functioning as intended and no high impedance was detected. The surgeon decided to only replace the generator since there was no evidence that the leads had any issues. Surgery was completed on (b)(6) 2016. No additional relevant information has been received to date.
 
Event Description
Product analysis (pa) for the returned generator was completed. During analysis if was confirmed that the septum of the generator 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 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5850759
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dennis100
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« Reply #565 on: April 15, 2019, 01:41:50 AM »

Model Number 103
Event Date 06/01/2016
Event Type  Injury   
Event Description
Clinic notes were received for a patient¿s generator replacement referral. It was reported in the notes that the patient was experiencing painful stimulation and the feeling like the device was ¿cycling rapidly¿. The notes provide the impedance when checked on (b)(6) 2016 to be within normal limits. It was stated that x-rays showed no indication of a fractured lead. The device was disabled during a visit to the er in the beginning of (b)(6) 2016 and a new medication was added. It was noted the patient has previously failed several aed¿s or had side effects from them. Additional information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Revision surgery occurred on (b)(6) 2016. The company representative who attended the surgery provided that after speaking with the patient had been experiencing the pain for the past few months. Lead impedance was within normal limits pre-operatively. During surgery the surgeon inspected the lead and said it was corroded. A full revision was performed and upon removing the lead he noticed that a suture had been pushed through the lead. The explanted generator has not been received by the manufacturer to-date.
 
Event Description
The explanted devices were received for product analysis on 09/28/2016. Analysis was completed on the returned lead portions 10/11/2016. During the visual analysis a suture was observed sewn through a tie down and outer silicone tubing approximately 266mm from the end of the silicone tubes. The suture did not appear to have penetrated the inner silicone tube. The incision mark and the suture sewn through the outer silicone tubing and the cut ends 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. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the suture sewn through the outer silicone tubing. 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. Analysis was completed for the returned generator 10/18/2016. The septum was not cored. 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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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 983 volts and shows the intensified follow-up indicator was not set. The downloaded data revealed that 42. 695% of the battery had been consumed. Measured battery voltage and consumed capacity parameters were as expected. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Evaluation codes: the evaluation codes for results and conclusions were inadvertently provided incorrectly on follow-up report #2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5857154
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« Reply #566 on: April 15, 2019, 01:42:39 AM »

Model Number 103
Event Date 02/01/2016
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing painful stimulation and muscle spasms in the throat. At times the pain was so severe it caused the patient to vomit. The physician reported that there was no trauma or injury the preceded the onset of the symptoms. The physician planned to perform surgery but decided to have the patient use the vns magnet to temporarily disable the vns generator. He then wanted to assess the patient's symptoms and seizure frequency without vns stimulation occurring before deciding if to replace or explant the vns generator. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient never used the magnet to disable the device. A diagnostic test was performed at a follow-up appointment and the results were within acceptable limits. The physician decided to adjust the vns settings in response to the previously reported symptoms. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient underwent generator replacement surgery. The explanted generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5839805
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« Reply #567 on: April 16, 2019, 01:29:14 AM »

Model Number 103
Event Date 05/01/2016
Event Type  Injury   
Event Description
It was reported that the patient was in a car accident and following the accident she began experiencing painful stimulation in her ear. A diagnostic test at a follow-up visit resulted within normal limits which indicates that the device was not malfunctioning. The neurologist then disabled the device and referred the patient to a lead and generator replacement. The explanted lead and generator were discarded following the surgery. Therefore product analysis cannot be completed. Further follow-up with the neurologist found that he had referred the patient for a lead and generator replacement both for the patient's comfort and to preclude a serious injury. Additionally, it was reported that the physician's assessment of the painful stimulation was related to vagus to auricular nerve/facial nerve aberrant transmission. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5966432
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« Reply #568 on: April 16, 2019, 01:30:11 AM »

Model Number 106
Event Date 07/08/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient that recently had generator replacement surgery ((b)(6) 2016) had high impedance about a month prior to the report (>10000ohms). The patient was then referred for surgery, but the surgeon performed diagnostics and no high impedance was present. The patient was referred back to the neurologist, and the impedance was 2200ohms and 3000ohms upon diagnostics. The patient then started to feel intermittent pain at the generator site. The patient was then referred to another surgeon. No surgical intervention has occurred to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient had a consult with a different surgeon, and it was believed that the lead pin was not fully inserted. The patient was experiencing painful stimulation in the chest and neck, trouble swallowing, and more voice alteration than he previously experienced. X-rays were performed. There were ap and lateral chest and neck x-rays from (b)(6) 2016. The x-rays showed that the lead pin was not fully inserted into the connector block, as the connector pin could not be visualized past the connector block. The generator was placed in the left chest per labeling, and the feedthru wires appeared intact at the connector block. No gross fractures were identified with the provided images. No sharp angles were noted. Additionally, a portion of the lead was identified to pass behind the generator and an assessment could not be made on this portion of the lead. There were no noticeable differences between the x-rays taken on (b)(6) 2016. No surgical intervention has occurred to date.
 
Event Description
The patient's generator was programmed off due to the intermittent high impedance, and the patient was referred to the surgeon for possible explant surgery. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5965583
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« Reply #569 on: April 17, 2019, 07:16:45 AM »

Model Number 103
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
It was reported that the patient attempted to disable the vns device by taping the magnet over the generator however the device did not disable. The patient's magnet placement has not been observed by the physician to ensure that it is sufficient to disable the generator. The most recent lead impedance was reportedly normal. No additional relevant information has been received to date.
 
Event Description
It was reported that the generator had been programmed off by the physician after the patient was unable to disable the device with the magnet. The reason for the device being programmed off was due to the patient experiencing chest pain, painful stimulation and an increase in seizures. No additional relevant information has been received to date.
 
Event Description
It was later reported that the patient passed away from a drug overdose. During follow-up with the physician it was reported that the patient had a long history of being non-compliant and was suffering from other issues that were not related to vns. The physician suspected that the reported symptoms and issues with her vns were likely more related to the patient's "extracurricular activities" rather than vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5945770
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