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dennis100
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« Reply #30 on: February 10, 2017, 04:12:03 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 10/12/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the patient's mother that the patient was experiencing painful stimulation when using the vns magnet. It was stated they had communicated the pain to the physician and the physician decreased the vns settings as they believed this would resolve the pain; however, the pain continued. It was noted the patient has fallen a few times, but the mother was unaware of any other trauma which could have caused the pain. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The event of painful magnet mode stimulation did not lead to a death or serious injury, nor would it be expected to lead to a death or serious injury if it were to recur. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6230577&pc=LYJ
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dennis100
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« Reply #31 on: February 12, 2017, 08:45:12 AM »

Model Number MODEL 250
Event Date 02/20/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
Vns programming history was received from the reporter and reviewed by the manufacturer. The dates range from 04/27/2009 to 03/26/2013. The last settings on (b)(6) 2013 are 2ma/20hz/250pulsewidth/30sec on/1. 8min off/2. 25ma mag/500pulsewidth/60sec on. The last magnet mode diagnostics were on (b)(6) 2009, ok/ok/1ma delivered/2827 ohms. The last diagnostics were on (b)(6) 2013, systems, output status = ok, lead impedance = ok, 2ma delivered/2417 ohms/ok. Per the history, no magnet mode diagnostics were done on (b)(6) 2013, which was when the reporter stated magnet mode testing was performed. Six diagnostics tests were done on (b)(6) 2013; 3 faulted normal mode tests and 3 successful systems tests only. Magnet history documents 2 magnet swipes were detected on (b)(6) 2013, which was when the reporter indicated she was doing the magnet swipes. The swipes consistently increase in the history, which is an expected event.

Manufacturer Narrative
Analysis of programming history.

Event Description
Reporter indicated that a patient's vns magnet swipes were not being detected during magnet mode diagnostics testing. The patient did feel magnet mode stimulation, but this was not reflected in the magnet history during magnet mode diagnostics testing. The magnet was tested on a metal object and appeared to have appropriate magnetic strength. Review of available programming history for the patient revealed the magnet swipes show regular increases. Attempts for additional vns programming history are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3015741
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dennis100
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« Reply #32 on: February 12, 2017, 08:46:02 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
It was reported that the explanted generator was discarded by the hospital. Therefore, analysis cannot be performed.

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

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

Manufacturer Narrative

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3025829
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dennis100
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« Reply #33 on: February 13, 2017, 04:13:59 AM »

Model Number MODEL 250
Event Date 02/27/2012
Event Type Malfunction
Event Description
It was reported by a physician's assistant that the patient's magnet activations were showing the same dates and times over and over again. The physician's assistant also reported that the generator's total operating time had rolled over. No additional information was provided and attempts for additional information have been unsuccessful to date. A manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (b)(4) being mis-declared as static variable, however the trigger for this event has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2506428
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dennis100
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« Reply #34 on: February 13, 2017, 04:15:01 AM »

Model Number MODEL 250
Event Date 08/01/2011
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012, when a copy of the physician's flashcard was received and the magnet activations were reviewed. The data was available from (b)(6) 2011 to (b)(6) 2012. The first magnet activation listed is on (b)(6) 2011, however the total at that time is 2331. On (b)(6) 2012, there are also multiple magnet activations however the number did not change from the total of 6916 that was first displayed on (b)(6) 2012. On (b)(6) 2012, it was reported that the device has been programmed off however the magnet activations increased again to 7048 even with the magnet output current being set to 0 ma. Good faith attempts to obtain additional information are currently being made. Nicole also stated pt has a lot of magnet activations and he stated he does not use his magnet and caregiver also states he does not use magnet. Pt is a little delayed so nicole is not sure. I asked if he recently got ipad or around any speakers or other devices with magnets. She stated no she did not think so. As of today pt had 6913 magnet activations and from (b)(6) 2331 magnet activations. No increase in seizures. Informed her something needs to be activating the device. She acknowledged and will ask the pt.

Event Description
It was reported that during an office visit on (b)(6) 2012 it was noted that several magnet activations were showing up however the patient stated he did not use his magnet. The patient had 6913 magnet activations on (b)(6) 2012 and 2331 magnet activations from (b)(6). There is no increase in seizures. Good faith attempts to obtain additional information including programming history to confirm the magnet activation error have been unsuccessful to date.

Manufacturer Narrative
Magnet activations found in the patient's programming history were reviewed.

Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient does not use the magnet and is not exposed to any magnets in his daily environment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2511259
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dennis100
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« Reply #35 on: February 13, 2017, 04:16:14 AM »

Model Number 102
Event Date 02/25/2012
Event Type Malfunction
Event Description
Product analysis for the explanted generator was completed. 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 pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet functions performed during the output-monitoring test (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet operations for the pulse generator at the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
The patient had prophylactic generator replacement surgery on (b)(6) 2012. Attempts for product return have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative

Event Description
The explanted generator was received by the manufacturer on 07/05/2012. However, product analysis has not been completed to date. The return product form did not provide the reason for replacement.

Event Description
It was reported that during a clinic appointment, the patient and nurse were swiping the patient's vns magnet. However upon interrogation of the generator, no magnet swipes were registered. Follow up with the physician revealed that he has "no dates of this activation" and did not have additional information. A request to the physician's office was made requesting the patient's programming/diagnostic/magnet history. However, the history has not been received to date. The patient was seen at the clinic again on (b)(6) 2012 and the magnet mode reportedly did not pick up the vns stimulation again after trying two additional times. The site feels that the patient needs a new magnet. However, there is evidence that the patient was receiving stimulation with the magnet because the patient felt dizzy when she swiped the magnet, but when the nurse swiped the magnet, the patient did not feel dizzy. The physician's office thought the dizziness was likely related to a sinus infection. A review of the magnet history in the in-house database showed regularly occurring magnet activations. The last available history was on (b)(6) 2010, with 4706 magnet activations.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2511411
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dennis100
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« Reply #36 on: February 14, 2017, 02:39:35 AM »

Model Number 302-20
Event Date 02/20/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(4) 2012, when analysis of the explanted lead was completed. Note that the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Analysis of the explanted generator was completed on (b)(4) 2012 and the end of service condition was confirmed. It was determined that the end of service of the generator was due to normal expected battery depletion. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported on (b)(6) 2012 that while the patient was seen on (b)(6) 2012 the device was interrogated and eos (end of service) = yes. While reviewing the diagnostic data in the handheld device, it was noted that systems diagnostics performed resulted in high lead impedance. The patient was last seen on (b)(6) 2011 and diagnostics at that time were said to be within normal limits. The patient was no longer coughing with magnet activations when previously, magnet swipes would elicit a cough. The patient underwent a full revision in which the lead and generator were explanted and replaced. During surgery, it was noted that the generator could not be interrogated due to end of service. When the surgeon connected the lead to the new generator, he obtained high lead impedance. While removing the lead, the surgeon noted a break in the lead wire. The lead was removed and a new lead was inserted and connected to a new generator. Diagnostics performed indicated normal device function however these results were not provided. The patient's programming history in the manufacturer's in house programming database was reviewed and a battery life calculation was performed which indicated the device is at or near end of service. (b)(4) attempts to obtain additional information as well as the explanted products for analysis are being made.

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

Event Description
Additional information was received on (b)(4) 2012, when the explanted lead and generator were returned to the manufacturer. Product analysis has not been completed at this time. Good faith attempts to obtain additional information from the patient's physician were unsuccessful.

Manufacturer Narrative
Analysis of programming/device diagnostic data performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2500654
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dennis100
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« Reply #37 on: February 15, 2017, 02:08:10 AM »

Model Number 300-20
Event Date 07/17/2011
Event Type Malfunction
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2012. The implant card confirmed the date of surgery and indicated the reason for replacement as battery depletion with neos=yes and lead discontinuity. The explanted products were received by the manufacturer on (b)(6) 2012, however product analysis has not been completed to date.

Event Description
Follow up with the physician was performed which revealed that the patient's increased seizures were believed to be due to loss of vns therapy. The patient experienced coughing with attempted increase in vns settings. The increase in the patient's seizures in 2011, were still below pre-vns baseline levels, and there were no clear causal factors for the increased seizures. The patient experienced painful stimulation during vns programming changes on (b)(6) 2012. To prevent morbidity from seizures, the patient's background medication dosing was adjusted while waiting to address the vns issue, per the physician. No additional information was provided.

Event Description
A physician reported on (b)(6) 2012 that upon interrogation of a patient's model 104 generator, the physician received a warning about low output. The patient's output current was at 1. 0ma, so the company representative instructed the physician to turn the output current up to 1. 5ma. Normal mode diagnostics at 1. 5ma were performed and showed low output current, and then systems diagnostics were performed and showed high lead impedance. On the patient's previous visit on (b)(6) 2012, all diagnostics were reportedly okay. No patient trauma is suspected to have contributed to the high impedance. The patient did pick up a (b)(6) child in (b)(6), and the child wiggled around. The physician was unsure if this may have caused the high impedance. The physician does not suspect that fibrosis would cause the high impedance. The patient has not experienced an increase in seizures. The physician is requesting x-rays be taken of the patient's vns, but it is unclear if the x-rays will actually be taken. Therefore, the x-rays have not been received to date. The physician elected to keep the device programmed on because the patient is doing fine, and he did not want to stop therapy. Although surgery is likely, it has not occurred to date. No additional information was provided.

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

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays received by the manufacturer, no gross lead discontinuities visualized.

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect date of the event, so the patient age was reported incorrectly. Date of event, corrected data: the initial report inadvertently reported the incorrect date of the event. With the additional information received, the patient's symptoms began around (b)(6) 2011 and the impedance began to increase as first captured on this day.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2012, that the patient had x-rays taken in (b)(6). The ap and lateral cervical spine x-rays were later received by the manufacturer on (b)(6) 2012. The radiology report was also received which reported that the leads appeared to be radiographically intact. Due to only neck images being taken, the generator cannot be visualized, and thus, resulting commentary on pin insertion and feed-thru wires being intact cannot be assessed. The electrodes appear to be in alignment. There are no gross lead discontinuities or sharp angles present. However, resulting commentary on the area in the chest that is not visible cannot be assessed. In addition, the presence of an unpronounced lead discontinuity or discontinuity in the portion of the lead not seen in the provided x-rays cannot be ruled out. Therefore, there is no indication from the x-rays that would reveal the cause of the high impedance. Although surgery is likely, it has not occurred to date.

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

Event Description
The patient reported that she "does not like the magnet because it hurts. " however, the company representative followed up with the physician's office. The clinic notes were provided to him to review, and there was no mention of the patient experiencing pain with the magnet in the notes. In addition, there did not seem to be a recent change in magnet settings. Attempts for additional information from the physician's office were unsuccessful.

Event Description
Additional clinic notes were received for the upcoming surgery which has not occurred to date. The notes dated (b)(6) 2011, does not indicate any vns abnormalities or patient adverse events. The vns settings were changed, and there were plans to titrate the settings higher. On the next visit on (b)(6) 2011, it was reported that the patient was "doing somewhat worse since the last visit. " the husband reported that her seizures were slightly worse. He reported a total of eight bigger seizures in the past two months. Her milder, atypical absence episodes are just as long but less intense. There were no recent other changes in the patient's medical history. The patient's vns settings were still titrated up to prior settings, the output currents were increased on (b)(6) 2012. The patient was doing about the same on the (b)(6) 2011, visit. The notes indicated the patient was now reporting about 15-20 seizures in the last 10 weeks on (b)(6) 2012, and the patient was not satisfied with her seizure control. The vns settings were titrated up again. In the notes dated (b)(6) 2012, the patient reported 3 tonic-clonic seizures and four smaller seizures since the last visit. She reported improvement with the vns increase and no side effects, and she was somewhat satisfied with her seizure control at that point. She was doing better since the last visit. An increase in output current was attempted but the patient experienced coughing, so the pulse width was decreased. However, the device indicated high lead impedance from system diagnostics. The physician planned to leave the output current at 1. 0 ma with increased pulse width to 750usec. Attempts for additional information from the physician have been unsuccessful to date. Review of the diagnostic history revealed that a > 25% impedance occurred on (b)(6) 2011.

Event Description
The clinic notes and cover sheet were received from the patient's physician's office. It reported that the patient has been referred for surgical follow up regarding the "lead issues" and the fact that the leads have been implanted for about 12 years. Although surgery is likely, it has not occurred to date.

Event Description
Product analysis of the generator and lead was completed. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. During analysis of the explanted lead, an abraded opening in the outer tubing was observed as well as dried body tissue on the positive electrode ribbon. Note that a portion of the lead assembly (body) was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 87 mm portion pitting was observed on the surface of the marked connector pin. The front portion of the connector boot appeared to be detached from the connector pin. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the marked connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. Of note, suture indentations were observed on the outer silicone tubing. Manufacturer labeling indicates to not use sutures on the lead body. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. During the visual analysis, the (+) white electrode ribbon appeared to be embedded in remnants of dried body tissue. This condition may have prevented the electrode ribbon from coming in contact with the vagus nerve; therefore, contributing to the reported allegations. Other than observed pitting on the marked connector pin and tissue-covered (+) white electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2493494
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dennis100
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« Reply #38 on: February 15, 2017, 02:09:40 AM »

Model Number 250
Event Date 02/28/2012
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report. Analysis of magnet activation history performed.

Event Description
Programming history was received for review. It was noted that the patient's generator had rolled over on (b)(6) 2011 and would have likely attributed to their report of the magnet activation display error although not seen in the history provided. Per the available data the patient had not used their magnet since (b)(6) 2009.

Event Description
A vns treating physician reported that when he was looking at the device history, he noticed that the magnet activations looked weird. He described that the last 15 magnet activations were all the same times but the last time would be left off on the next line and so on. Good faith attempts are underway to see if this is part of a magnet activation display error.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2494047
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dennis100
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« Reply #39 on: February 15, 2017, 02:10:31 AM »

Event Date 02/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
Attempts for the patient's vns model and serial number information were unsuccessful as the site indicated that signed patient consent is required for release of medical records.

Event Description
It was reported by the patient's father that the vns patient had initially experienced a decrease in simple seizures with vns therapy however her complex seizures had increased. The patient then tried deep brain stimulation so the vns was turned off. After some time on deep brain stimulation, the patient had some large seizure episodes which prompted the physician to stop deep brain stimulation and resume vns in (b)(6) 2011. The patient was also noted as having difficulty breathing during magnet stimulation and therefore is reluctant to perform magnet activations to abort seizures. The patient's deep brain stimulator has recently been reactivated as per the patient's father. The patient's settings have been turned down to help with the difficulty breathing. The patient's neurologist office has declined to provide any further information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2487671
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dennis100
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« Reply #40 on: February 16, 2017, 01:10:17 AM »

Model Number MODEL 250
Event Date 12/08/2011
Event Type Malfunction
Manufacturer Narrative
Analysis of magnet activation history performed.

Event Description
While a physician was reviewing a patient's magnet activation history on the handheld computer, it was observed that the magnet activations were occurring at odd times and displayed in an upside down pyramid formation. Good faith attempts to obtain additional information have been unsuccessful to date.

Event Description
Copies of the flashcards belonging to the physician were received and the magnet activation history for each of the flashcards were reviewed however none of the data provided matched the information provided at the time of the initial report. Additionally multiple generators showed magnet activations from (b)(6) 2011, so it is unknown which generator was the one with the magnet activation display issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2479663
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« Reply #41 on: February 17, 2017, 01:19:54 AM »

Model Number 102
Event Date 09/10/2003
Event Type Injury
Event Description
In review of patient's programming history, it was noted that a vns patient's device was disabled on (b)(6) 2003. Follow-up information was obtained from the patient's physician and it was revealed that the patient had been disabled due to an episode of loss of consciousness with magnet use. However, the patient's stimulation was re-enabled on (b)(6) 2008, and there had been no recurrence of the episodes. The generator was later replaced prophylactically for an unrelated reason and was returned to the manufacturer for analysis. The device performed according to functional specifications, and there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Good faith attempts to gain more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032419
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« Reply #42 on: February 18, 2017, 03:26:06 AM »

Model Number 102
Event Date 02/13/2011
Event Type Injury
Event Description
It was reported that the patient, who has dravet syndrome, had her device initially turned on to 0. 25 ma at 9 am. Around noon that same day, the patient had a cluster of myoclonic absence seizures while at a cafe. Her parents swiped the magnet and she immediately went to a generalized convulsion that lasted several minutes. She had previously been free of major motor seizures for more than 12 months and had not missed any of her seizure medications, per physician. The physician has advised the patient to not use the magnet for now. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026040
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« Reply #43 on: February 18, 2017, 09:20:34 AM »

Model Number 102
Event Date 03/11/2016
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2016 indicate that the patient is experiencing a noise in her ear. Additional information was received that the patient woke up on (b)(6) 2016 while sleeping and could hear static and high pitched sound in her ear. Her generator site was hurting and her brain was foggy. The patient then visited the nurse practitioner on (b)(6) 2016. During the visit, the nurse practitioner was testing the magnet by swiping it and the patient felt like getting electrocuted as she had never needed to use the magnet before. Patient had bruising and tenderness in the chest and vomited due to the magnet stimulation. The nurse practitioner noted that the magnet stimulation pulse width was at 500 usec, which was very high compared to the normal stimulation. So the magnet pulse width was decreased down to be the same as normal stimulation. Diagnostics were performed and were within normal limits. X-rays were taken afterwards and no issues were observed. Patient also mentioned that the generator moved around and that it has been a while since this started (prior to (b)(6) 2016). Since the shock with the magnet, patient felt that her heart would beat really fast. This happens about once a day at different times of the day and can last 10-30 min. This heart beat increase is not occurring necessarily with vns stimulation and the vns stimulation doesn't make it better or worse. She never had this happen before and there are no triggers that patient could find. Patient was referred for generator replacement due to end of service of the device battery prior to the occurrence of these events.

Event Description
Additional information was received from the treating nurse practitioner that the patient's chest pain, high pitched sound in ear, and "foggy" brain were not occurring with vns stimulation. No known causes or contributory factors were present. Patient's increased heart rate or palpitations and other events are suspected to be associated with the higher pulse width of the magnet mode stimulation. The pulse width of the magnet mode stimulation was decreased from 500 usec to 130 usec to match the pulse width of the normal mode stimulation. Per the medical profession, there was no device migration as she could not perceive any movement of the generator. The pain in the chest was not due to presence of device or migration. Patient has had her generator replaced since then on (b)(6) 2016 and is doing well. The explanted device has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549412
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« Reply #44 on: February 18, 2017, 09:21:07 AM »

Model Number 102
Event Date 01/07/2011
Event Type Injury
Event Description
Mfr received a report from a vns pt that after vns device magnet was swiped, her heart raced and she started coughing which lead her to shortness of breath. The review of mfr's programming history database showed that sys diagnostics results performed on the day of surgery, (b)(6) 2010, were within normal range. Mfr suggested the pt to see her treating neurologist. Good faith attempts to obtain more info from pt's treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1979704
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« Reply #45 on: February 18, 2017, 09:21:51 AM »

Model Number 102
Event Date 08/23/2008
Event Type Injury
Event Description
Reporter indicated that approximately 5 minutes after a vns pt swiped the vns magnet across her device to initiate vns stimulation, the pt lost her vision for approximately 60-90 seconds. The event has occurred multiple times. The neurologist sent the pt to the er for a ct scan. Nothing has been found, and the pt has been sent home. The neurologist is unsure if the vision loss event is related to vns therapy. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1176198
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« Reply #46 on: February 18, 2017, 09:22:26 AM »

Model Number 103
Event Date 05/03/2010
Event Type Injury
Event Description
A vns pt called and reported that she had been at the hospital on (b) (6) 2010 because the device had been choking her. She had been admitted to the hospital on (b) (6) 2010 because after using her magnet, she felt like her heart was racing. She reported, the hospital treated her like a cardiac pt because they thought she was having a heart attack and believed the vns was the cause. Additionally, she reported that after her initial implant she was unable to eat. Good faith attempts thus far have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1716183
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« Reply #47 on: February 18, 2017, 09:23:25 AM »

Model Number 103
Event Date 01/06/2015
Event Type Injury
Event Description
Additional information was received that the patient's reported episode is not a new seizure type, unknown cause for episode (drop attack with lips turning blue). No interventions were taken. Medications taking at the time of the event. Depakote-6. 25 mg bid / fycompa 8 mg qhs / zonisamide-150 mg qhs / banzel 17. 5 ml in am, 3. 5 ml in afternoon , 7 ml evening / onfi-5 mg bid.

Event Description
It was reported that the vns patient experienced a drop attack and blacked out following a magnet swipe. It was noted that this seizure type was not typical for the patient. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4483657
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« Reply #48 on: February 18, 2017, 09:24:12 AM »

Model Number 103
Event Date 11/01/2009
Event Type Injury
Patient Outcome Life Threatening;
Event Description
It was reported that the pt was recently implanted and recently had his device turned on to 0. 25 ma output current and 0. 5 magnet output current. Per the pt, when he swiped his magnet, he turned blue and passed out. At the time of the report, the physician had not seen the pt since the episode and had no further information regarding the event. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1558272
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« Reply #49 on: February 18, 2017, 09:24:41 AM »

Model Number 101
Event Date 10/10/2013
Event Type Injury
Event Description
On (b)(6), 2013 a vns treating physician reported that a patient suffered bradycardia after swiping the vns magnet. The patient was admitted to the icu ward at the hospital and the physician plans to assess the vns via device diagnostics. It was later stated that the patient had a ¿vt arrest out of hospital after achieving magnet for a focal seizure¿ and that the patient did not have a prior history of cardiac events. It was reported that the arrhythmia event occurred on (b)(6) 2013. The event did not occur following a medication change. The physician noted that the event was not reproduced at diagnostics or higher stimulation setting and that it was unclear if vns or a seizure explains his event. The arrhythmia event has not recurred and the generator is currently programmed on. The patient¿s epileptologist stated that he would not provide any further information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3465822
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« Reply #50 on: February 18, 2017, 09:26:48 AM »

Model Number 103
Event Date 09/17/2012
Event Type Injury
Event Description
A nurse practitioner reported to our field representative that they had a vns patient who had their device implanted in (b)(6). The patient was doing fine with vns, up until 2 days ago, when the patient started complaining of excessive stimulation which then made the patient experience nausea and vomiting. The physician recommended to tape the magnet over the device. The patient did that, which was fine for about an hour, but then started experiencing excessive stimulation again after that. The patient had their vns disabled on (b)(6) 2012. The patient described that when she first started to experience this, she initially taped the magnet over the device and for about 1. 5 hours the device was completely off and she did not experience this. But after that 1. 5 hours, she started to feel nauseous again and vomited. Since disabling the device, the patient has had none of the same problems. The patient just has some minor soreness in her throat which appears to be residual. Diagnostics (normal, system, and magnet) and all the diagnostic results were ok, and within normal limits. The normal mode diagnostic showed communication ok/ lead impedance ok/ 3453 ohms /no. The patient's device is currently disabled, and prior to the disablement the settings were at: 0. 75 output current / 30 hz /500 pw / 30 seconds on time/5, minutes off time ,1. 0 ma / 60 seconds on time / 500 pw. The patient additionally reported that she is supposed to swipe her magnet every day, and after she did so yesterday ((b)(6) 2012) she began experiencing irregular stimulation that was going off anywhere from every 20 seconds to every 1. 5 hours. She was clear that the problems only occurred after she swiped the magnet. She stated that her stimulation is supposed to go off every 5 minutes for 30 seconds so she knew this was not right. The patient explained that with the erratic stimulation, she was experiencing pain at the back left side of her throat, and along with the pain she was vomiting, couldn't breathe, and her heart rate would increase to 150. As she was explaining this, she confirmed that the events were occurring with stimulation, aside from the vomiting that was a result of the pain. The patient reported that she had not had any medication or any external factors changes recently. She also confirmed that no trauma or manipulation had occurred prior to these events. The patient additionally reported on (b)(6) that after having vns implanted she was seizure-free for 4. 5 months, but last week had 2 tonic-clonic episodes. It is likely their device was disabled at this time. Therefore the patient was not receiving vns therapy. The patient's device may be kept off for a couple of weeks and the patient reevaluated to turn it program it back on at a later date.

Event Description
Additional information was obtained on (b)(6) 2012. It was indicated by the patient's neurologist that the anatomical location of the painful stimulation was left neck and the patient had no manipulation or trauma that could have caused or contributed to the painful stimulation. The physician indicated that he was unaware of the arrhythmia occurring and the patient was seen at an emergency for the arrhythmia. The patient had no prior history or family history of any cardiac events. Per the physician the patient did not experience any traumatic events or triggers prior to the onset of arrhythmia. The physician believes that patient's arrhythmia is not due to medication changes and has no information if the arrhythmia is related to vns therapy. On (b)(6) 2012, the patient's vns was irregularly going off as reported by the physician. The patient had a shocking sensation with very high intensity. The patient's device was turned off to preclude a serious injury. On (b)(6) 2012, the patient's device was turned back on and the programmed settings and diagnostic results appeared to be normal however the diagnostic test results were not provided. On (b)(6) 2012, the patient's device was reevaluated.

Manufacturer Narrative

Event Description
On (b)(6) 2012, additional information was received indicating that the patient had been seen three weeks prior and none of the previously reported symptoms had been observed. Per the patient they had all resolved. Follow up with the physician's office indicated that the patient's seizures were well controlled with vns. It was indicated that the pain was believed to be caused by stimulation as it correlated with on times. This pain then caused the patient to vomit. The patient went to the er on (b)(6) 2012 for these symptoms. They met her in the er and turned the device off. When the device was disabled everything resolved. It was indicated that the device may have been stimulating irregularly. The last programming and medication changes occurred in (b)(6). It was also indicated that the patient had no medical history of any of the events and that everything was fine from (b)(6). The physician's office was uncertain if there had been any manipulation or trauma to the device. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2788235
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« Reply #51 on: February 19, 2017, 02:29:56 AM »

Model Number 304-20
Event Date 07/31/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, a nurse practitioner reported that the vns patient's leads were implanted on the right vagus nerve instead of the left. On (b)(6) 2012, the surgeon reported that he could not find any place on the left vagus nerve to place the lead, therefore it was placed on the right vagus nerve. They turned on the device shortly after surgery and programmed the patient to an output current of 2. 0 ma and the patient started experiencing more spasms. The patient's output current was then lowered to 0. 25 ma. Then when the settings were increased up a level, the patient started having spasms again. The surgeon stated that he was considering taking the patient back to surgery as he was wondering if the patient's spasms were due to the lead placement. The surgeon then later reported that he did not think he could get another lead on the left side so they went for right side replacement even though he knows the manufacturer's labeling is for left side placement only. With the device on the left side the patient was able to tolerate settings of up to 2. 5 ma. However, once placed on the right side the patient was only able to tolerate a setting of 0. 25 ma. A setting of 0. 5 ma, which is what the magnet mode was set to, resulted in the patient experiencing significant laryngospasms. The patient was not scoped to make sure it was contraction of the laryngeal cord causing the issue and not something else as the surgeon did not think it was necessary since swiping the magnet, set to 0. 5 ma, resulted in significant choking. The nurse stated that the patient immediately had adverse events with stimulation as the patient had been programmed to his original settings of 2. 0ma without giving the nerve a chance to acclimate to the stimulation. The patient is now being titrated up slowly and all his adverse events have stopped. The nurse later reported that after surgery on (b)(6) 2012, was the first time the laryngospasms/coughing were first observed. The nurse believes that it is due to the high stimulation from vns being turned on to 2. 0 ma after surgery. The events occurred with stimulation. Diagnostic results were within normal limits but the specifics were not provided. The patient does not have a medical history of laryngospasms prior to vns. The laryngospasms ceased after turning the settings down.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2713825
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« Reply #52 on: February 19, 2017, 02:30:47 AM »

Model Number 300-20
Event Date 10/20/2011
Event Type Injury
Event Description
Additional information was received on (b)(4), 2012 when product analysis was completed on the generator. The device performed according to functional specifications. No elective replacement indicator (eri) flags were observed during testing. The device was continuously monitored for 25. 25 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. On (b)(6) 2012 product analysis on the lead was completed. A portion of the lead assembly body, including the unmarked connector pin section, marked connector pin / boot section with model and serial number tag and the electrodes was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity testing could not be performed during the decontamination procedure because the connector pin sections of the returned portion were not returned. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the vns patient was having a full revision surgery that day due to prophylactic reasons. The patient's settings after surgery were going to be output=1. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(4) 2012 that has not yet been completed.

Event Description
On (b)(6) 2011 a vns treating physician reported that he is referring the patient for a prophylactic full revision surgery since he is unable to increase the patient's settings to a 130usec pulse width without her having adverse issues. The patient's device is showing elective replacement indicator=no but the patient is having an increase in seizures. A system diagnostics test performed on (b)(6) 2011 showed output=ok/lead impedance=ok/dcdc=2/eri=no and a normal mode diagnostics test showed output=ok/lead impedance=ok/dcdc=2/eri=no. It was reported that on (b)(6) 2011, when normal mode diagnostics were performed, the patient grabbed her throat, gasped for air, and made an odd coughing noise. A system diagnostics had previously been performed with no adverse events and the results showed an output=ok/lead impedance=ok/dcdc=1/eri=no. The patient's settings were output=1. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The patient's mother reported that some weeks the patient will not have a single seizure and then others she will have a couple of seizures. The physician lowered the patient's pulse width but reported that the patient is more than likely faking the events as she has a past history of falsifying events. A battery life calculation was performed with the patient's programming history and it showed negative years until elective replacement indicator (eri)=yes. The manufacturer's consultant later reported that the patient always has a reaction like grabbing her throat when a lead test is performed or a magnet is swiped. She reported that the physician does not know the cause of the patient's events including the increase in seizures. It is unknown if the cause could be stimulation being higher or a potential lead issue so they are going to prophylactically replace the whole system since it is nearing end of service, the lead has been implanted for so long, and they are unsure why the patient is having these events. The physician has since decreased the patient's pulse width to 130usec. The physician also reported that he believes that the patient is exaggerating the events for attention. Although surgery is likely, it has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2377262
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« Reply #53 on: February 19, 2017, 02:31:56 AM »

Model Number 103
Event Date 06/01/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was unable to turn off the vns with any of the magnets she has. The vns was later disabled. The patient reported that she tried to disable her generator because of severe pain at the time of stimulation. She has had the magnets since 2006, when she was first implanted. The physician turned the 2. 5ma down to output of 2. 25ma, then 2. 0ma, 1. 75ma, and then 0ma and back to 0. 25ma. The planned intervention is for the patient to undergo a generator replacement surgery. The physician stated that the magnet did cause/trigger violent coughing episodes upon application. System diagnostics were performed and no abnormalities were noted and the device was not near eos. No causal or contributory programming changes preceded the onset of the painful stimulation. The surgery was planned to preclude a serious injury, per the physician. The physician further stated that the patient¿s magnet mode stimulation is always off unless it is ¿spontaneously switching¿. The patient later clarified that she had begun to experience painful stimulation when she received her original implant in (b)(6) 2006. The anatomical location of the painful stimulation comes from the vagus nerve, up and down her neck, during stimulation. There has been no trauma to the left side or the vagus nerve. The patient has been using new magnets that she received a few weeks ago. The physician stated that he could not provide clarification on his statement that the device may be ¿spontaneously switching¿; he stated that he has never activated magnet current and no other physician programs the device. He stated that the ¿device is faulty no matter what¿. The physician indicated that the patient was slowly titrated up after implant in order to allow for accommodation to the stimulation. The physician later stated that the patient underwent a cervical rhizotomy soon after the issue began with the generator. The patient stated that she always has had pain with stimulation. She said it is at a low level and has never bothered her. She stated that her current generator has caused her different side effects than with her previous ones. The physician interrogated it at every visit to make sure the generator is functioning at the levels, he has set. She stated that at the end of (b)(6) 204, she suddenly had intense pain. She immediately put the magnet in place and instantly began to cough violently and her throat constricted so much she couldn¿t breathe. The physician set up an emergency visit for her to see him and at that visit she demonstrated what happened when she put the magnet in place over the generator. She again when into a violent coughing attack and her throat constricted as it had when she tried to use it in june. The physician quickly lowered the current down and got the same response. After doing so, a couple of times, he turned the generator off completely. After a bit, he turned the generator back on to 0. 25ma. The physician instructed her to put the magnet in place as he increased the output to 0. 25ma and interrogated it at the same time. The magnet worked normally and the diagnostics of the generator showed it functioning normally as well. The patient clarified that she is fully aware how to use the magnet. The patient stated that before the event in june she had just seen her physician two weeks prior, when her device was interrogated, and the physician did not change anything at that visit. The patient underwent generator replacement on (b)(6) 2014. The explanted generator has not been returned for product analysis to date.

Event Description
On (b)(4) 2014 the explanted generator was returned for product analysis. Product analysis was completed on the generator on (b)(4) 2014. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. No magnet parameters (as received or programming history) available for this generator, magnet current was set to 0. 50ma. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The reported allegations against the generator were not duplicated in the product analysis lab. The battery, 3. 036 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
The patient's magnet was tested with the new generator, and the physician reported that it was working well. It is also noted that the as-received explanted generator frequency parameter was set to 1hz. Per manufacturer labeling, frequencies programmed to <10hz do not ramp and cause excessive battery drain regardless of output current.

Event Description
On (b)(6) 2014 the physician reported that the patient has not yet tried the magnet with her new generator but that they will test it at the next visit.

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4036475
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« Reply #54 on: February 19, 2017, 02:32:47 AM »

Model Number 102
Event Date 02/01/2013
Event Type Injury
Event Description
The implant card was received which reported that the patient had prophylactic generator replacement surgery on (b)(6) 2013. It was reported that the explanted device has been discarded since the device has not been sent back to the manufacturer to date.

Manufacturer Narrative
The initial report inadvertently reported the age incorrectly due to the date of event being reported inadvertently incorrectly. (b)(4).

Event Description
It was reported that the patient's device has been turned off for a few years with perceived lack of efficacy (however, review of the manufacturer's programming history shows the device was programmed on in (b)(6) 2011, the last known date of history programmed by the nurse practitioner). The family requested to have it turned back on as vns therapy may help the patient. Upon turning back on, magnet stimulation caused the patient pain and he became cyanotic. Therefore, the magnet output current was decreased, and the device is currently on with no issue. The physician wants to replace the device due to the length of implant. Follow-up with the nurse practitioner revealed that the cyanosis is believed to be related to the battery nearing end of service although the eri flag is no. The magnet stimulation was only 0. 25 ma above the normal output current, and magnet use caused a violent cough and cyanotic episode. This led the nurse to believe the battery may be dying. The patient does not have a medical history of cyanosis, and there were reportedly no causal or contributory programming or medication changes precede the onset of the events. The patient's mother reported the device had been off for about 3-5 years, but this is not substantiated by the history in the manufacturer's database. Stimulus is on every minute and a half. The nurse indicated that there is suspected potential erratic stimulation as the battery is clearly not completely off as the patient is receiving therapy via witnessed voice vibration and cough, which she noted is just the patient's reaction to stimulation. She is not sure if the patient's symptoms are related to the device being turned off for some time. Both normal and system diagnostics were all okay but the specific results and programming settings were not provided. The patient is referred for generator replacement due to clinical end of service. Although surgery is likely, it has not occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2993702
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« Reply #55 on: February 19, 2017, 02:33:33 AM »

Model Number 304-20
Event Date 03/01/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
Patient had surgery on (b)(6) 2016. The lead had a complete break with multiple knots, indicative that the patient twisted the device. The patient also must have twisted the generator as it was no longer anchored to the fascia. It is believed that the patient's fall as well as manipulation contributed to the break. The lead was received for analysis on 04/21/2016. Product analysis is underway but has not been completed to date.

Event Description
It was reported that the patient is reporting increased seizures, nausea, vomiting with magnet use, increased irritability, extreme voice hoarseness, left throat pain, and incisional pain over the generator. The patient was recently implanted on (b)(6) 2016. The device was turned on to 0. 25ma last week. She returned on (b)(6) 2016 with the above complaints and when system diagnostics was performed it resulted in high impedance over 10,000 ohms. X-rays also show that the generator lead coiled and disconnected from radiopaque structure in left supraclavicular area indicating disrupted vns. It was instructed to turn the device to 0. 0 ma and refer the patient to surgery for replacement. Clinic notes received on (b)(6) 2016 and dated (b)(6) 2016 state that patient believes seizures are worse since the operation. It was mentioned that the patient had a convulsion on (b)(6) and fell, hitting her nose and may have caused trauma to the device as she did mention she could feel it moving in her chest. Post-op symptoms (with device off) included weight loss, nausea, vomiting, increased headaches, and notable negative change in mood. The week prior she was initially activated at the output current of 0. 25 ma with minimal side effects. Over the past week, she has had significant reaction to the device with increasing hoarseness, left throat pain, incisional pain, worsened mood and nausea and vomiting with magnet use. Notes state that from her post-op convulsion, it is suspected that the disconnection of the lead and generator seen on x-rays is likely from her fall and will require surgery to correct the connections. Notes from initial implantation on (b)(6) 2016 also confirm that a non-absorbable suture was used to secure the generator to the pocket. Follow-up showed that the patient is referred for surgery on (b)(6) 2016. The voice hoarseness was stated to sometimes occur with stimulation on times. The left throat pain was occurring both with stimulation and without. It was stated that it is unknown if the increase in seizures is attributed to the high impedance but the level is approximately the same as baseline. It is unknown if the tinnitus, worsened mood, increased headaches, weight loss are attributed to vns therapy or high impedance. X-rays are not available for review.

Event Description
Product analysis for the lead was completed and approved on 05/18/2016. A break was identified in both positive and negative lead coils. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. Scanning electron microscopy images of both positive and the negative coils suggest a stress¿induced fractured (due to rotational forces) occurred. Scanning electron microscopy images of the negative coil at the break located past the anchor tether show that a stress-induced fracture (due to rotational forces) occurred on the coil. The overall appearance of the lead coils past the electrode bifurcation is consistent with patient manipulation of the implanted device, a ¿twiddler. ¿ the inner silicone tubing of the negative coil has dried remnants of what appear to have once been body fluids inside the inner silicone tubing at the break location.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5551724
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« Reply #56 on: February 19, 2017, 02:34:37 AM »

Model Number 105
Device Problem Device operates differently than expected
Event Date 11/12/2015
Event Type Injury
Event Description
It was reported that the patient swiped her magnet and the stimulation was so strong it made her cry. Subsequent device stimulation (normal mode and magnet mode) was painful. The magnet was used to disable the device and the patient was seen by the physician. Device diagnostics were within normal limits and the device was not at end of service. The patient was sent for x-rays. The patient underwent generator and lead replacement due to the painful and shocking stimulation. The explanted devices have not been received for analysis to date.

Event Description
The generator and lead were received for analysis. Analysis of the generator was completed on 01/04/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery showed ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Event Description
Analysis of the lead was completed on 01/11/2016. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5272254
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« Reply #57 on: February 19, 2017, 02:35:03 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1851127
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« Reply #58 on: February 19, 2017, 02:35:29 AM »

Model Number 102
Event Date 06/01/2011
Event Type Injury
Event Description
It was reported by a physician's office that the pt was complaining of chest pain, coughing, and pain in her right arm that started approx two weeks prior. The pt had been to the er and the physicians ruled out "other issues" and told the pt that the symptoms "must be the vns. " the pt was at very low settings and could not tolerate any higher programming. The pt swiped her magnet and had significant cough and tightening of her chest. Also, the pt was unable to tolerate the system diagnostic testing parameters to test device function. The device was disabled to see if the issue resolved. Also, the pt is not currently taking any different medications than in the past. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2201826
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« Reply #59 on: February 19, 2017, 02:35:57 AM »

Model Number 106
Event Date 05/02/2016
Event Type Injury
Event Description
It was reported that a vns patient was complaining of sporadic painful stimulation at the generator site and radiating down through his left arm starting. Clinic notes received indicate the symptoms started on (b)(6) 2016 and were more intense with magnet activation. The condition progressed to constant sensation of tightness in chest and shortness of breath of approx. 1 hour duration until he taped the magnet over the device. The symptoms were alleviated for around 24 hours following pulse width adjustment from 500usec to 250usec and frequency adjustment from 30hz to 20hz on (b)(6) 2016 but then recurred. Full diagnostics were performed on (b)(6) 2016 and lead impedance on (b)(6) 2016 was normal 3,093 ohms. It was stated that the lead impedance was checked in varying neck positions. The physician elected to disable the device on (b)(6) 2016 and the patient was referred to a surgeon for anticipated exploratory surgery to explant and replace generator due to presumed malfunction/bleeding of current of vns system. X-rays were taken but nothing conclusive could be diagnosed by the providers. The x-rays were not provided to the manufacturer for review. The generator was successfully explanted and replaced on (b)(6) 2016 with no complications noted. The explanted generator was discarded by the explanting facility.

Manufacturer Narrative
(b)(4).

Event Description
An implant card was subsequently received for the procedure on (b)(6) 2016 indicating that a normal lead impedance of 3,373 ohms was observed with the newly implanted generator in place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5685905
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