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dennis100
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« Reply #60 on: January 07, 2018, 03:29:32 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 10/01/2017
Event Type Injury
Event Description
It was reported that the patient was experiencing discomfort at the generator implant site and was concerned that the generator had moved into her armpit. There was more discomfort noted when a shoulder seat belt and backpack straps were present. The generator was noted to be palpable sitting medially to the anterior axillary line incision. The patient was referred for surgery where the generator was going to be repositioned and potentially replaced. No additional relevant information has been received to date. No surgical interventions are known to have occurred to date.

Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7074866
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dennis100
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« Reply #61 on: January 09, 2018, 02:39:40 AM »

Model Number 102
Event Date 01/14/2009
Event Type Injury
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. X-rays reviewed by the manufacturer, migration of the generator was not able to be confirmed on the x-ray views received.

Event Description
It was reported to manufacturer that the treating vns physician saw the vns pt due to swelling in the left armpit and possible generator migration. X-rays were sent to manufacturer to review, and the migration event could not be confirmed as there were no baseline x-rays to compare them to. Diagnostic tests were performed following the onset of the reported event and revealed normal device function. Approximately a week later, the swelling appeared to be improving. Further info received revealed that the treating physician saw the pt again at a later date due to the continuation of the migration of the generator, which the pt believed was causing painful stimulation. Additionally, it was reported that the pt was experiencing an increase in seizure activity. The physician discussed with the pt, the possibility of surgical intervention. The pt then reported that she was seen by the primary care physician and stated that an infection was present, and that the swelling has gotten worse had moved down the left arm. The pt reported that antibiotics were prescribed. Additional info received from the treating vns physician's office revealed that the pt went to an emergency room and was treated with antibiotics and was subsequently released. The fever had resolved, and the swelling was improving. The vns device was disabled and they are continuing to monitor the pt. Good faith attempts to obtain additional info have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1341924
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dennis100
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« Reply #62 on: January 09, 2018, 02:40:46 AM »

Model Number 102
Event Date 05/02/2011
Event Type Injury
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns pt wants to have her device explanted because she is experiencing a "voice tick", heart fluttering, coughing, and numbness on one side of cheek and throat. The pt had been implanted (b)(6) 2011. She was scheduled to see her nurse practitioner on (b)(6) 2011. On (b)(6) 2011 clinic notes dated (b)(6) 2011 from the vns treating nurse practitioner were received. The clinic notes report that the pt is experiencing an uncontrolled cough and clearing of the throat (worse with stress), pain at the vns generator site, numbness and tingling to chin through her left ear/facial, and was very nervous describing the increasing discomfort the vns has caused. The pt went for f/u with the surgeon and after the pt told him about the numbness and tingling he suggested immediate removal of the vns. The pt's medical history lists migraine headaches, esophageal reflux, and tia; it is unk the relationship of the events to vns. The pt's neurological exam showed headaches associated with dizziness and seizures and the pt feels like her device moves around from the chest area to under her armpit at times. The physician is referring the pt for vns removal and educated the pt about how some of her symptoms may be related to stress and not completely due to vns implant, since they were ongoing after the device was disabled that day. Good faith attempts for additional info from the pt's nurse practitioner have been to no avail thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2103698
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dennis100
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« Reply #63 on: January 11, 2018, 02:21:15 AM »

Model Number 302-20
Event Date 08/08/2014
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
It was reported that the vns patient was having issues with pain and with device migration. Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months. She later reported having a strange tremor in her head that occurred several times per day. It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla. Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck. The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside. An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity. The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4103125
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dennis100
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« Reply #64 on: January 15, 2018, 02:22:22 AM »

Model Number 100
Event Date 12/04/2001
Event Type Injury
Event Description
It was reported that a patient underwent generator revision surgery due to vibrating pain that occurred in the left axilla during stimulation on times. Once the patient's device was replaced, the pain appeared to resolve. Good faith attempts to obtain additional information from the patient's treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1504664
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dennis100
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« Reply #65 on: February 04, 2018, 02:10:52 AM »

Model Number 102R
Event Date 03/31/2011
Event Type Injury
Event Description
On (b)(6) 2011, it was reported by a vns implanting surgeon to the case manager that the vns patient was seen on (b)(6) 2011, complaining of a "burning sensation" in her neck. The patient's generator had been recently replaced and the generator was placed in her axilla region instead of the clavicular region. The patient is having discomfort with the generator in her axilla region, especially when she sleeps at night, therefore, she was referred to the surgeon for repositioning of her generator. No diagnostics were performed. On (b)(6) 2011, the surgeon moved the patient's generator to just under the clavicle. However, the surgeon used electrocautery to open up the patient. The manufacturer's consultant was advised that there is a safety alert regarding the use of electrocautery with vns because it could possibly disable the generator or affect the battery life. The consultant was informed that he needed to review the safety alert with the surgeon. It was reported that they were able to communicate with the generator and everything was fine after the surgery. Good faith attempts for further information from the patient's physician have been to no avail thus far. If additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2070197
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dennis100
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« Reply #66 on: February 06, 2018, 02:26:34 AM »

Model Number 102R
Event Date 04/14/2011
Event Type Injury
Event Description
Reporter indicated the patient developed seromas in the chest and neck that later developed into abscesses, which is why the patient's vns was explanted. The events are felt to be related to trauma to the arms and neck by the patient's attendants while repeatedly moving the patient. The patient is recovering satisfactorily from the explant surgery. Analysis of the explanted vns generator was completed. Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator shows no evidence of bodily fluid remnants in the case/header areas. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Event Description
Reporter indicated that a patient presented on (b)(6) 2011 with vns generator migration to the axilla along with generator extrusion through the skin. No infection was present. It was unknown what caused the migration or generator extrusion to occur, or if anything precipitated the events. It is not known if the patient had any trauma or if device manipulation occurred. The patient is developmentally delayed. The generator was surgically repositioned on (b)(6) 2011 in a new pocket under the pectoralis muscle and was secured to the fascia with a silk suture. No devices were explanted. The patient was also given antibiotics and is healing well.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of the device manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported on (b)(6) 2012, by a caregiver to the manufacturer that the vns patient had surgery on (b)(6) 2011, due to generator migration, infection and wound dehiscence at the generator site. The patient recovered per the caregiver until (b)(6) 2012, when it was noted there was swelling and redness along the vns lead wire in the neck area. On (b)(6) 2012, the patient had surgery to debride the neck area, and the patient was given antibiotics. The wound was also packed daily with gauze. 8 weeks after the surgery the wound opened up and the patient was again put on antibiotics. It was previously reported by the treating surgeon that no infection was present at the generator site at the time of surgery on (b)(6) 2011, but wound dehiscence and migration at the generator site had occurred. Clinic notes were also received from the treating surgeon documenting the neck abscess/dehiscence reported by the caregiver, and that cultures of the neck wound site noted rare (b)(6) bacteria. The patient had developed a neck abscess that had healed, but subsequently opened up recently and was very superficial. The area was cauterized with silver nitrate. The patient was also on oral antibiotics. The patient also has a chest seroma in the area of the vns generator that may be due to trauma, and is being watched for now. Additional manufacturer follow-up with the treating surgeon revealed the neck abscess/dehiscence was felt to be due to trauma and patient manipulation. No medication changes contributed to the events, and no additional interventions have been performed for the neck abscess/dehiscence or chest seroma. The patient is recovering per the surgeon.

Event Description
Reporter indicated the patient may be reimplanted with the vns in the future, but no surgery has been scheduled to date. The vns has been helpful for the patient's seizures in the past per the reporter.

Manufacturer Narrative
(b)(4).

Event Description
Reporter indicated the patient would have vns lead and generator explant surgery due to infection at the left chest generator site. Prior to the surgery, it was noted on (b)(6) 2012 that the chest wound was opened. The patient had developed seromas of the neck and chest over the last year, which were opened up and packed. The seromas had abscesses. The neck wound had recently healed. The chest wound was packed with nu gauze, and the patient was to continue daily wound packing. The patient later had generator and lead explant surgery performed on (b)(6) 2012. No new devices were implanted. The generator only was returned and is pending analysis. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098698
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dennis100
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« Reply #67 on: February 15, 2018, 02:28:34 AM »

Model Number 103
Event Date 09/01/2011
Event Type Malfunction
Event Description
Product analysis of the explanted generator has been completed. Results of diagnostic testing indicated that the device was operating properly and communicated properly. Post burn-in electrical test results showed that the pulse generator performed according to functional specifications.

Event Description
It was initially reported that the patient that after losing (b)(6) lbs. Intentionally, she feels like her generator has migrated to her armpit. The patient is also having severe headaches on the left side and has been experiencing them for the past (b)(6). The pain in intermittent and feels like it is occurring when the device stimulations. The pain is sharp and does not resolve with medication treatment. The patient was instructed to follow up with her physician. Later information was received indicating that the headaches resolved when the magnet was used to disable the device. The patient is going to be referred to a surgeon for the migration. The pain was quite significant in that the patient had absolutely no relief unless the magnet was secured over the generator site however then the patient ran the risk of not getting the therapy. The reason they believed the device was malfunctioning was because the patient did not have these headaches before and the pain began rather quickly and worsened only to improve when the device was disabled with the magnet. There were no medication changes or other factors preceding the onset of the headaches. There were no reports of trauma either. The generator was replaced and the patient has been doing well since replacement with no further pain. The explanted generator has been returned to the manufacturer and is currently undergoing product analysis.

Event Description
Additional information received revealed that 3-0 vicryl sutures were used to secure the generator to the fascia during implant on (b)(6) 2010.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341941
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dennis100
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« Reply #68 on: February 17, 2018, 04:36:12 AM »

Model Number 300-30
Event Date 12/02/2011
Event Type Malfunction
Event Description
Clinic notes dated (b)(6) 2011, were received from case management which revealed that the patient had experienced chest pain for the past (b)(6) months, which radiated down her axilla and arm. The patient has had catamenial seizures affecting her right arm since age fifteen. She has had spells of right arm stiffening two years prior to her first generalized tonic-clonic seizure at age (b)(6). It was reported that vns has "reduced her seizures from daily to only associated with menses. " the patient was seen on (b)(6) 2011, on an urgent basis due to a new onset of headaches that required hospitalization, as well as seizures. The patient's seizures have been variable over the years from five seizures per day, to as many as twenty per day (30% during wakefulness and 70% waking her from her sleep), especially during ovulation and onset of menses. However prior to vns, she had them outside her menses as well. The patient experiences multiple focal seizures around her menses. The patient's chest pain is described as sharp affecting the lateral and posterior region of her left chest. However, palpation does not recreate pain, rather, the pain is created by stretching. The patient takes hydrocodone and ibuprofen for the left chest pain. The patient was concerned that vns may be causing the pain. Further more, the patient called the physician on (b)(6) 2011, as documented in the clinic notes because she was having chest pain and went to a cardiologist who alleged that she has a "broken wire" in her vns. The patient reported that the cardiologist felt around it and stated that he "felt a pulse where it was broken. " the patient reported that the pain was so bad, when she got home that she took a percocet, but the pain still persisted around her heart area, left axilla, and down her left arm to her hand. The patient wanted to know what to do because the pain was progressing. The patient was referred for a stat chest x-ray to check the leads. However, no lead breaks were noticed by the physician during a review of the x-rays. The patient was prescribed percocet. The patient was also referred for a consult with a surgeon for a new generator or vns adjustment. The x-rays were not sent to the manufacturer for analysis. The patient had generator replacement surgery on (b)(6) 2011. Attempts for additional information from the patient's neurologist's office have been unsuccessful thus far. The reason for generator replacement is not known at this time. The diagnostics performed on (b)(6) 2011, did not indicate that there was a device malfunction. A batter life calculation was performed with the history available in the in-house programming database, and the results were approximately 3. 91 years until eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2387860
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dennis100
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« Reply #69 on: March 08, 2018, 09:43:53 AM »

Model Number 302-20
Event Date 09/08/2010
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history. Device failure is suspected but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury. Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".

Event Description
Attempts for additional information have been unsuccessful to date.

Event Description
The explanted lead and generator were returned and underwent analysis. An implant card and returned product form were received indicating the reason for replacement was lead discontinuity. The entire lead was not returned. No anomalies were observed in the returned lead portions except two abraded openings in the outer tubing. Analysis of the generator found it performed to functional specifications.

Event Description
It was reported that the patient's vns was now indicating high impedance. The patient's mother indicated that the patient's generator is implanted underneath his armpit due to his young age. The mother indicated that the patient roughhoused on occasion and they also frequently picked the patient up from under his armpits. Per the mother, the patient had been experiencing an increase in seizures below the pre-vns baseline seizure frequency since (b)(6) 2011. The magnet no longer was aborting seizures and the patient's voice no longer changed with stimulation around this time as well. No x-rays have been taken to evaluate for a lead fracture. The device has reportedly not been disabled as recommended in manufacturer labeling. Review of the programming history available to the manufacturer found that the lead impedance was normal on (b)(6) 2010 at 2900 ohms however, a significant change in impedance occurred on (b)(6) 2010 when the impedance changed from 5386 ohms to 2700ohms. This could be indicative of an intermittent lead issue beginning at that time eventually developing into the current issue. Surgery to replace the patient's lead and generator has occurred. Attempts for the return of the explanted products and for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2596398
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dennis100
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« Reply #70 on: March 09, 2018, 03:29:12 AM »

Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type Injury
Event Description
It was reported that the patient was referred for vns repositioning surgery due to severe pain around her neck and chest region and muscle spasms radiating to the axillary region. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7289823
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dennis100
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« Reply #71 on: March 15, 2018, 02:08:37 AM »

Model Number 102
Event Date 04/12/2012
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization prior to distribution.

Event Description
It was reported through clinic notes received on 8/21/2012 and dated (b)(6) 2012, that the patient had been fighting recurrent left axillary abscesses and had recently been put back on medications. No additional information is known.

Manufacturer Narrative

Event Description
The device manufacturing records for the implanted generator were reviewed and sterilization, prior to distribution was confirmed.

Event Description
Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2750888
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dennis100
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« Reply #72 on: March 19, 2018, 01:54:23 AM »

Model Number 102
Event Date 06/18/2012
Event Type Injury
Event Description
A registered nurse at the treating physician's office reported on (b)(6) 2012 to the company representative that the patient complained of left mid axillary pain and thought it was due to the vns having moved. A chest x-ray was ordered, and the nurse reported that it appears to have shifted slightly inferomedially. The electrode reportedly has moved as well. Previously, it was reported on (b)(6) 2012 from the surgeon's office that they were planning on seeing the patient for evaluation of the patient's reported complaint of pain at the generator site. The neurologist's office referred the patient to the ent to see if the complaint she had was related to another reason other than vns. An ent evaluated the patient and concluded that there may be generator migration which may be causing the discomfort at the generator site. Clinic notes dated (b)(6) 2012 reported that the patient still remains with difficulty tolerating the device. She has intermittent dysphonia, pain in the neck radiating to the ear and the mandible and sometimes problems swallowing. The previous visit they discussed referral to ent for evaluation, and the patient requested for the referral. The referral requested for evaluation of the neck, ear and mandible pain related to vns to see if there is a need to revise the area where the device is placed. On the previous visit on (b)(6) 2012, the patient presented with no side effects. Follow up with the referring neurologist revealed that the pain was first observed on (b)(6) 2010. The dysphonia and trouble swallowing are reportedly recurring problems noticed in (b)(6) 2010. The patient was advised to have x-rays taken and to be evaluated by a neurosurgeon. No patient manipulation or trauma occurred that is believed to have caused/contributed to the events, and no causal or contributory changes preceded the onset of the events either. The neurologist reported that the pain, trouble swallowing, and dysphonia are associated with stimulation. The patient does not have a pre-existing medical history of having difficulty swallowing prior to vns. Although surgery was still being considered in (b)(6) 2012, it had not been scheduled to date due to the physician wanting the patient undergo imaging studies. Attempts for additional information from the surgeon and treating physician's office have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received from the treating neurologist which revealed that medical/surgical intervention was planned with regards to the migration and discomfort at the generator site due to patient comfort and not to preclude a serious injury. The outcome of the repositioning surgery was "good", per the physician. The lead migrated due to "body habitus" (patient physique), however details were not provided. No causal or contributory programming or medication changes precede the onset of the lead migration. X-rays of the patient's vns were taken but have not been received by the manufacturer to date. The x-ray report was provided by the physician which indicated that the patient "complained of pain in the region of the vns device. Also states that she feels the device has shifted. Exam was done for vns placement. " chest x-ray of (b)(6) 2012 and also compared to soft tissues of the neck x-ray of (b)(6) 2010. The vns generator reportedly appeared to have shifted slightly inferomedically relative to its position previously. The electrode coursing into the base of the left neck appears intact; however, it also appeared to have shifted slightly, per the report. Previously, it was overlying the 2nd rib and on (b)(6) 2012 appeared to have shifted interomedially and was overlying the left apex. It coursed into the base of the neck as previously.

Manufacturer Narrative

Event Description
The patient had vns repositioning surgery on (b)(6) 2012. Further details were not available. Attempts for additional information have been unsuccessful to date. The clinic notes dated (b)(6) 2012, reported that the generator appeared to have shifted slightly inferomedially which was believed to have caused pain to the neck and left face area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2792685
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dennis100
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« Reply #73 on: March 26, 2018, 12:53:46 AM »

Model Number 304-20
Device Problem Fluid leak
Event Date 08/26/2012
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The patient reported that the surgeon informed her that the lead had fluid in it when it was explanted which he believed caused her pain.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all quality and functional testing prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by the patient's physician that the patient had been experiencing some adverse events associated with stimulation. The events started on (b)(6) 2012 and were described as a shocking pain, at the collar bone, which did not occur with every stimulation cycle. Additionally, the patient reported that she could see the lead pulsating during the stimulation. The patient was swollen all the way along the leads from the generator to the electrodes. The device was checked on (b)(6) 2012 and the diagnostics results were all normal and within normal limits. There was no reported trauma. It was reported that when the pulse width was lowered from 500usec to 250usec, the swelling went way within 15 minutes. X-rays were performed and the device was left enabled as the patient could tolerate the events and was doing well with vns therapy. Ap and lateral views of the neck and chest for patient were reviewed. The generator is seen in the left chest area. The filter feedthru wires appear intact and the lead pin can be seen past the second connector block indicating that it is fully inserted into the generator. A portion of the lead appears to be behind the generator. The electrodes were observed in the neck and appear to be in proper alignment. The lead is seen routed down toward the generator. No lead breaks or fractures were observed. Based on the x-ray images provided, it appears that the generator and lead were implanted per labeling guidelines and no fractures or discontinuities are present. The cause of the reported issues could not be identified. Clinic notes were later received for this patient which indicated that the patient was also experiencing increased hoarseness with stimulation and protrusion of the lead. The swelling was said to noticeable and cause redness of the area. Additionally, the patient indicated that she was experiencing muscle spasms with stimulation as well. Following the decrease in settings, the muscle spasms and electrical shocks continued to a lesser degree and the patient also started experiencing an increase in seizures thought to be related to the lowered settings. On (b)(6) 2012, the pulse width was increased again to 500usec, and these settings were tolerated without issue for an hour. On (b)(6) 2012 the patient reported that she continued to have daily "shocking sensations" and "fluttering sensations" in the neck and near her armpit. These were said to be not severe. Additionally the patient reported that she is not performing any particular movements or actions when these feelings are occurring as it can happen when she is not moving and at rest. On (b)(6) 2012 the patient again reported daily electrical shocks with the shocking occurring 4 times on (b)(6) 2012. Additionally she reports neck swelling but indicated that she would not disable the device as therapy has been working for the patient. The patient was seen again on (b)(6) 2012. She reported that her shocking is dally and she can have up to 2 of the "shocking symptoms that startle her and make her jump" otherwise does feel the fluttering (feels electrical flutter) and pain with stimulation along the lead wires just under left collar bone. If she has those shocks, her neck swells and then it becomes red, then it goes into a chest pain/pressure. Diagnostics performed on that date were still within normal limits. While the patient indicated that there had been no manipulation or trauma, her husband indicated that there was pain in her chest caused by their dogs jumping on her. The patient was referred for revision and underwent a lead replacement procedure on (b)(6) 2012. It was reported by the patient's neurologist that, during the procedure, the surgeon identified small pin holes in the lead and bodily fluid inside the insulation. Attempts for product return have been unsuccessful to date as the hospital indicated that they do not have anything to return.

Event Description
Additional information was received on (b)(6) 2012 indicating that the revision surgery had resolved the pain issues. Additionally a review of the device manufacturing records indicated that the lead had passed all functional and electrical tests, as well as all quality inspections prior to distribution. A user facility report; number: (b)(4), was also received. This reported that the patient was experiencing "electric like shock above the stimulator and over the pectoral region". During revision, fluid was observed inside the lead insulation. The generator was tested during the procedure and was found to be functioning properly. No additional information has been made available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2824925
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dennis100
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« Reply #74 on: April 01, 2018, 01:41:19 AM »

Model Number 103
Event Date 03/02/2012
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of device history records confirmed that both the lead and generator were sterilized prior to distribution.
 
Event Description
On (b)(6) 2012, it was reported that this vns patient had an infection. The patient's device was explanted. On (b)(6) 2012, the patient underwent re-implant. The patient had autism and picked at the incision which caused infection. During revision, the generator was re-implanted far under the patient's armpit. It is unknown when the patient's device explanted prior to replacement. No additional information is available. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2855995
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« Reply #75 on: April 02, 2018, 01:06:22 AM »

Model Number 103
Event Date 01/13/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received that the patient¿s arm paralysis was approximately six years prior. The event had resolved, was no longer an issue, and was not believed to be related to vns.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 indicated that the patient suffered from seizures, headaches, and hemiparesis. Clinic notes dated (b)(6) 0213 indicated that the patient experienced increased back pain and that her hips were still sore because of injections. Clinic notes dated (b)(6) 2013 indicates that the patient had increased back pain with a possible event in her hips. The patient had to use her magnet over the last few days. Additional information was received indications that provided recent diagnostics results. The patient was referred for generator replacement. Surgery is likely but has not taken place.
 
Event Description
The generator analysis was completed on (b)(4) 2013. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
On (b)(6) 2013, it was reported that this vns patient was having breakthrough seizures and now feels tired all the time. The patient reported that the generator was put in arm pit, a pointy thing sticking out of the armpit that she had to get used to. The patient wasn't sure if the surgery caused nerve damage for she had a problem with her arm for 1 year post operatively and could not move her arm. Surgery is likely but has not taken place.
 
Event Description
On (b)(6) 2013, this vns patient underwent generator revision. The explanted generator was returned on (b)(4) 2013 and is pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3106886
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dennis100
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« Reply #76 on: April 14, 2018, 12:36:54 AM »

Model Number 303-20
Event Date 02/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a serious injury.
 
Event Description
Reporter indicated intermittent high lead impedance was noted for a patient who recently had vns generator replacement on (b)(6) 2013. The patient had no known trauma. The patient is also experiencing painful stimulation at the electrode site in the neck. X-rays were reviewed by the manufacturer. The electrodes are visualized at approximately t1 and are in alignment; the electrodes are implanted lower than what is usually seen. The generator is implanted in the left axilla. This is much more lateral than what is normally seen. The view does not allow full assessment of the lead pin insertion. The lead wire is intact at the lead pin. The filter feedthroughs are intact. There is a small amount of lead behind the generator that cannot be assessed. The cause of the high lead impedance is unknown at this time, but may be due to inadequate pin insertion or a lead fracture. Attempts for additional information are in progress.
 
Event Description
Reporter indicated the patient had vns lead pin reinsertion surgery performed on (b)(6) 2013. After the lead pin was reinserted into the generator header, diagnostics were within normal limits (3218 ohms). No new devices were implanted.
 
Event Description
Manufacturer review of the device history records for the vns lead and generator confirmed both devices passed all final testing prior to distribution.
 
Event Description
Additional x-rays were reviewed by the manufacturer. The lead pin did not appear to be fully inserted. No additional anomalies were noted. The surgeon indicated he felt the lead pin had been fully inserted as two audible clicks were heard when tightening the setscrew. However, the possibility of a lead fracture may also exist. Reporter indicated the patient was also having increased seizures and that the plan of care is to have vns revision surgery; however, this has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993250
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« Reply #77 on: April 17, 2018, 01:07:39 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Information was received that the patient was seen on (b)(6) 2013 for consult. The notes indicated that the patient¿s pain in the chest was not consistent with vns. It was stated that the (b)(6) event was a recurrent infection ((b)(6)), but it is unknown when this started as this information was provided by the patient. There was no documentation was available regarding the ¿heart problems¿; however, it was documented that the patient was negative for murmurs or gallops. No additional information or x-rays were available. Attempts for product return have been unsuccessful. An implant card indicated that the patient was explanted due to painful stimulation.
 
Event Description
On (b)(6) 2013, this patient underwent generator revision. The product has not been returned to date.
 
Event Description
On (b)(6) 2013, it was reported that this patient's device has shifted due to weight loss beginning in 2011. This was not causing the patient pain that began four days prior. For the past month, the patient had been observing a lump over the generator site, and since then, it has tripled in size. There was no manipulation/trauma and no medication changes or programming changes. The patient stated that she was last seen two months prior by her vns physician, and her device was found to be functioning properly. Additional information was received indicating that the a little over a month ago, a quarter-sized nodule was noticed near her generator. Now the area is swollen from the left side of her sternum to her arm pit, approximately the size of a hand. The outline of the generator is visible. The area is painful and bruising. There is no drainage or opening in the incision area, and there was no trauma to the area. Vns had controlled her seizures as she has gone from 15 per day to 2 to 3 per month. Clarification was given that the generator migrates from mid-left ribs to under the arm pit settings and diagnostics from (b)(6) 2013 were provided. The patient was referred for prophylactic replacement and pocket revision additional information was received that there may be a disc in the patient's neck that is out of place. (the left side of her neck had been swollen for several months, and she has limited movement on her left side. ) this is not related to vns. It was also suggested that the patient had heart problems, and the patient is a (b)(6) carrier. Surgery is likely but has not taken place.
 
Manufacturer Narrative
Event description, corrected data: previously submitted mdr inadvertently omitted information received during follow-up. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3069093
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dennis100
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« Reply #78 on: April 18, 2018, 01:19:00 AM »

Model Number 103
Event Date 03/12/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this vns patient required a lead revision for an unknown reason. Follow-up showed that the surgery was for repositioning of the lead. During surgery on (b)(6) 2013, the patient's generator was in the axillary position and moved to chest area. It is unknown where in the chest the device was initially implanted. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative

Manufacturer Narrative
Corrected data: previously submitted mdr indicated the patient was the operator of the device. Additional information was received indicating that the physician may have contributed to the error. This report is being submitted to correct this data.
 
Event Description
Additional information was received indicting that the patient was referred for surgery due to pain/pinching in her axillary area. It is unknown exactly when this began. The surgery was for patient comfort. No patient manipulation or trauma occurred that is believed to have caused/contributed to the event. A non-absorbable suture was not used to secure the generator to fascia during implantation of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3043572
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« Reply #79 on: April 22, 2018, 12:47:57 AM »

Model Number 102
Event Date 04/15/2013
Event Type  Malfunction   
Event Description
The surgeon reported that a non-absorbable suture used to secure the generator to fascia during implantation of the device on (b)(6) 2012.
 
Manufacturer Narrative
Review of manufacturing records performed. Review of the generator manufacturing records confirmed all quality tests were passed prior to distribution.
 
Event Description
It was initially reported that the patient reported to the neurologist that her generator migrated to the left axillary area. The neurologist¿s office reported on (b)(6) 2013 that they were referring the patient back to the implanting surgeon as they suspect that the lead has come disconnected from the generator, and the patient was having an increase in seizures since the early part of the prior week. Additionally, the neurologist¿s office was unable to interrogate the generator on (b)(6) 2013. It was unknown by the nurse at the neurologist¿s office if patient manipulation or trauma occur that is believed to have caused/contributed to the generator migration. The patient later reported on (b)(6) 2013 that she is considering having her device removed. She reported that three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking; these events are captured in mfg report number: 1644487-2013-01474. She also reported experiencing hot flashes. She reported that her seizures have reduced from daily to 5 times in the last year. The last vns dosing adjustment was (b)(6) 2013, in which she reported that the neurologist turned the vns settings up. However, this has not been confirmed by the neurologist to date. Attempts for information from the neurologist have been unsuccessful. Additionally, attempts to the surgeon regarding type of suture used to secure the generator to the fascia during implant surgery have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3123691
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« Reply #80 on: April 29, 2018, 01:49:26 AM »

Model Number 103
Event Date 05/23/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 information was received that the physician had had a visit with the patient that morning for follow-up after a recent generator replacement surgery. The physician noted that the patient¿s generator site was exposed by approximately 1 cm, that the generator was visible, but that there appeared to be no signs of infection. The patient¿s mother stated that the patient had been picking at the incision site. The physician stated that the site appeared to be healing and that he would see the patient after another week to monitor the healing process. If the site is not healed by then, the surgeon was considering removing the generator and placing it in another site. The physician did not prescribe any antibiotics during the visit because the site did not appear to be infected. A review of manufacturing records confirmed that both the generator and lead passed all functional tests prior to distribution, as well were properly sterilized prior to distribution. Follow-up with the physician indicated that at the follow-up visit he had observed that the implant, which had been implanted into the axillary incision from prior implant, was visible through the sutures. The physician stated that at the (b)(6) 2013 visit there had been erythema around the generator site and that at the follow-up visit the erythema had decreased considerably so and that the site was beginning to look better and beginning to granulate slowly. The physician stated that if the site does not granulate completely that he would have no choice but to explant the generator and either let the incision heal completely before reimplanting again in that location or placing the generator elsewhere instead. The physician will continue to monitor the situation. Attempts for additional information are still in continuation.
 
Event Description
A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 072 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 2. 826% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a small portion of the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Dried body fluids inside the outer and inner tubing was observed in some areas. Continuity checks of the returned lead portion 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 portion of the device. Note that since a small portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No other information has been provided.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead and that they passed all functional tests prior to distribution.
 
Event Description
Additional information was received stating that the vns patient was re-implanted with a new generator and lead on (b)(6) 2014.
 
Event Description
On (b)(4) 2013 information was received by the reporter that the patient had been tentatively scheduled for a vns revision surgery on (b)(6) 2013 due to the generator being exposed at the chest incision site. Follow-up determined that the patient instead underwent surgery on (b)(6) 2013. The patient had completely removed the generator from his chest and approximately 5 cm of the lead wire was also exposed. The generator and lead were both explanted by the physician and the physician intends to wait a month to allow the incision sites to fully heal before reimplanting vns in the patient. It was also reported that the patient had a skin condition and will be referred to a dermatologist for diagnosis. The explanted lead and generator have been returned to the manufacturer and will soon undergo product analysis. Attempts for additional information will remain in continuation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3165711
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dennis100
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« Reply #81 on: May 08, 2018, 02:21:16 AM »

Model Number 102
Event Date 06/10/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent explant after experiencing a severe wound infection. It was reported that the patient was seen at a hospital and was given antibiotics. Then approximately a month and a half later, the patient was seen by the physician to have the device explanted. It was reported that cultures were negative, but that they were most likely negative due to the antibiotics the patient took. The physician indicated that the patient may have induced the infection by "scrubbing" the infection and because of his low socio-economic status. Further follow-up revealed that the patient experienced a focal axillar dehiscence three weeks post op which had reported healed after a few days. It was reported that two months post op the patient experienced major wound dehiscence with purulent discharge. Attempts to have the device returned for analysis have been unsuccessful to date. It was reported that the hospital is refusing to release the device.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3355839
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« Reply #82 on: May 11, 2018, 01:10:50 AM »

Model Number 102
Event Date 10/04/2013
Event Type  Injury   
Event Description
Further follow-up revealed that the patient's surgery occurred as planned on (b)(6) 2013. Only the generator was explanted. It was reported that the surgery was for patient comfort. It was reported that the patient was not using vns therapy as prescribed because the patient wasn't being followed by a psychiatrist and having the device programmed as needed. No known causal or contributory factors preceded the onset of the events. It is unknown if a non-absorbable suture was used to secure the generator to the fascia during the implant surgery. Attempts to have the generator returned for analysis have been unsuccessful to date.
 
Event Description
Initially, it was reported that the patient has been experiencing difficulty swallowing and shortness of breath. The patient reported that this is more often than not. The patient also reported that it feels like the device is shocking her from the generator to up under her tongue. The patient reported that taping the magnet over the generator was attempting, but was too painful. The patient also reported that the generator feels like it is slipping down into her armpit. The patient reported that the device has not been checked in three to four years. The patient was later seen by a surgeon and surgery was scheduled. It is unknown whether or not surgery occurred as planned. Attempt to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3472747
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« Reply #83 on: June 10, 2018, 12:35:41 AM »

Model Number 106
Device Problem No Known Device Problem
Event Type  Injury   
Event Description
It was reported that the patient was experiencing generator migration in the breast and armpit areas, protrusion, and pain to the point where it was noticeable. The generator was believed to have either never been secured, or the stitch had broken. The generator was also larger than her previous model. No surgical intervention to correct the migration/protrusion has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7517351
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« Reply #84 on: July 06, 2018, 08:36:28 AM »

Model Number 304-20
Device Problem Mechanical issue
Event Date 06/26/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was scheduled for a full revision. It was reported that since the time of the patient¿s battery replacement in (b)(6) 2017, the patient has complained of intermittent shocking pain that travels from his armpit area up to his lateral left neck and only occurs when the vns is on. The device was turned off and the events stopped. X-rays were stated to show nothing. The patient underwent a full replacement. The surgeon state that the lead insulation near the generator was no longer present, causing the wires to be exposed. This was the area the patient was feeling the shocking sensations. System diagnostics were performed before surgery and impedance was ok. The generator was on prior to the surgery staring. It was stated he was on rapid cycling according to the surgeon¿s notes. However it was stated he was in patient for an emu stay at some point in the last 24 hours and his settings were changed. The explanted generator and lead were received for analysis. Analysis is underway but has not been completed 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=7650646
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« Reply #85 on: August 10, 2018, 03:41:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/04/2018
Event Type  Injury   
Event Description
It was reported that surgery was being taken to reposition the patient's generator as the generator had migrated to an axillary position. It was also reported that the generator had been replaced recently and since there had been issues with wound healing and the wound had opened. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7726467
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« Reply #86 on: August 25, 2018, 06:02:20 AM »

Model Number 100
Event Date 04/21/2011
Event Type  Injury   
Event Description
It was reported to the manufacture from explanting physician in (b)(6) that he had a patient with lack of efficacy with their vns therapy and who was having pain at their generator site, left infraclavicular. In the last 2 years, the patient had experienced pain in the area of the generator in the left infraclavicular and axillary regions. The generator had been turned off for 3 years due to battery exhaustion. The patient insisted on having their vns system explanted related to their pain events. It is unknown if this surgery was for patient comfort or to preclude a serious injury to the patient. During the explant procedure at a depth of about 1. 5 cm, the first securing clip was found. The suture was detached and the clip dissected from the fibrin sheath. The cable was followed in the proximal direction and the next securing clip found after 1 cm at the level of the carotid. Here, the suture of the securing clip had pierced the adventitia of the carotid artery. The fibrin sheath surrounded the securing clip, forming a cuff on the carotid. Since the stimulator cable ran through a scar between the jugular and carotid arteries into the depths, dissection was attempted here as well. The project had to be aborted, however, because it was too risky, and both the carotid and the jugular could have been injured. Their explanted generator was returned for analysis. In the product analysis laboratory, it was determined that the device was at and end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. No programming history records were found; consequently, a battery life calculation could not be performed. The device performed according to functional specification. Therefore, the electrical performance of the generator, as measured in the product analysis laboratory, will be used to conclude that no performance or any other type of adverse condition was found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133608
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« Reply #87 on: September 21, 2018, 01:28:49 PM »

Model Number 102
Event Date 03/01/2014
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient may have experienced some sort of an axillary infection in (b)(6) 2014 from poking and scratching at his device. The patient¿s device was reported to be functioning well at the time. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 reported that the patient had been treated for an ¿abscess¿ in the left axillae with an incision and drainage by his primary care physician on two occasions recently. The most recent was about a week and a half prior. The patient denied any antibiotic prescription given. The patient reported that it had returned somewhat. Upon physical examination, there was an approximate 1. 5 inch length palpable lesion in the left axillae which was soft but not mobile. There was no redness or skin breakdown. There was no tenderness to palpitation. The physician¿s assessment at that time was that the lesion may represent a sterile cyst versus infection abscess with the infection abscess less likely. Clinic notes dated (b)(6) 2014 reported that the patient had an axillary cyst which had since been drained and appeared to have improved at that point.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the generator device history records confirmed sterilization was performed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3882083
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« Reply #88 on: October 06, 2018, 04:58:23 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2018
Event Type  Injury   
Event Description
It was reported that the patient's vns had migrated from the chest to the underarm and was causing pain. The patient expressed her desire to have the device removed. It was later reported that the patient was referred for generator replacement surgery. Device diagnostics were reported to be normal. 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=7878253
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« Reply #89 on: October 10, 2018, 02:44:52 AM »

Model Number 302-20
Event Date 04/05/2012
Event Type  Malfunction   
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".
 
Event Description
It was reported that the patient's vns was now indicating high impedance with dcdc=7 during a system diagnostic test. The patient has not had any adverse events however the physician indicated that she believes the generator has been migrating towards the patient's armpit. The physician indicated that this migration could have contributed to the high impedance. X-rays were taken that reportedly did not indicate any issues however they will not be sent to the manufacturer for review. No trauma or manipulation is believed to have occurred. Last known diagnostics were taken on (b)(6) 2010. Attempts for additional information have been unsuccessful to date.
 
Event Description
Surgery to replace the patient's lead and generator has occurred. Diagnostic results following lead and generator replacement were normal following replacement. It was noted that a non-absorbable suture had been previously used to secure the generator. Attempts for the return of the explanted lead and generator were unsuccessful as the implant hospital indicated they believe the explants had been discarded after surgery.
 
Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2560371
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