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dennis100
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« on: November 29, 2016, 01:47:43 AM »

Model Number 106
Event Date 09/19/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported on (b)(6) 2016 that during a case for a model m106 implantation, the device was interrogated prior to the case and the patient¿s initials were entered with no problems. The device was connected to the lead outside the pocket and diagnostics were performed. The lead was ok but a low battery message, neos-yes was received. No cautery was used when the device was in the field. System diagnostics were performed again and still a low battery message was received. A backup generator was advised to be used. A review of the design history record showed that the generator passed all functional tests prior to distribution into the field. The device has not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6028183
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dennis100
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« Reply #1 on: November 29, 2016, 01:48:44 AM »

Model Number 106
Event Date 09/08/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
The explanting facility reported that the generator was discarded following explant. Device return to the manufacturer is not expected. No additional pertinent information has been received to date.

Event Description
It was reported that the patient's generator battery registered at 25% capacity in a follow up visit on (b)(6) 2016. The patient was seen 3 months prior ((b)(6) 2016) and it was reported at 75% at that time. The longevity guide predicted the battery to last 1. 9 years at the provided settings. This estimation does not consider the autostimulations or heartbeat detection charge consumption. The internal device data from the patient's generator was reviewed. The lines of interrogation, programming and diagnostics were pulled from (b)(6) 2016 dates. On (b)(6) 2016: the charge consumed values ranged from 36. 272 - 36. 273%. The battery voltage values ranged from 2. 871 to 2. 872 v. The registered indicator was 75% at that time. The minimum battery voltage encountered was 2. 847 v, which indicates the battery meter may have corresponded to the 25% level in the past. On (b)(6) 2016: the charge consumed values ranged from 51. 977 - 51. 978%. The battery voltage values ranged from 2. 844 to 2. 850 v. The registered indicator was 25% at that time. A 31394 autostimulations were completed at the time of this appointment. The generator device history record was reviewed and found all specifications were met prior to distribution. The patient's generator was replaced on (b)(6) 2016. The explanted generator has not been returned to the manufacturer to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5995516
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dennis100
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« Reply #2 on: November 29, 2016, 01:49:37 AM »

Model Number 106
Event Date 09/15/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that during generator replacement surgery the new generator was connected to the lead and the device was interrogated when a low battery vbat's eos message. The generator had been interrogated while still in the packaging and an end of service warning did not present. The generator was then detached from the lead a new generator was implanted. It was noted that electro-cautery equipment was present in the sterile field while the generator was present. The physician was informed by a company representative that the manufacturer does not recommend keeping electro-cautery equipment in the sterile field once the new generator has been introduced to the sterile field. The manufacturing records of the premature end of service generator were reviewed and found that the generator passed quality inspection prior to distribution. Programming data from the day of the attempted implant was reviewed and it confirmed that prior to implant the battery voltage was not at end of service. However a subsequent diagnostic test found that the battery voltage was at end of service. Additionally it was noted that the generator's temperature had increased when the end of service warning was observed. The suspect generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6016730
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dennis100
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« Reply #3 on: November 29, 2016, 01:50:30 AM »

Model Number 106
Event Date 10/04/2016
Event Type Malfunction
Event Description
It was reported on (b)(6) 2016 that the patient had a model 106 implanted in (b)(6) 2015 and only has 25 % battery remaining left per interrogation on (b)(6) 2016. Clinic notes were received on 10/21/2016 from the office visit dated (b)(6) 2016. Battery life was noted to be 25%. There is concern for the low battery indicator since the device was only placed 10 months ago. No additional relevant information has been obtained to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6060787
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dennis100
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« Reply #4 on: November 29, 2016, 01:51:20 AM »

Model Number 106
Event Date 09/26/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the generator's battery indicator was less than 30% after being implanted for approximately a year. The manufacturing records for the m106 generator were reviewed and "trim test tab" was performed (b)(6) 2015. The generator passed quality control inspection prior to distribution. The internal programming history database was reviewed and only found data from the day of implant. The battery life longevity table was referenced with the settings found at implant and it indicated that the generator had approximately 5. 9 yrs from beginning of life to ifi = yes. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6030292
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dennis100
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« Reply #5 on: November 29, 2016, 01:52:16 AM »

Model Number 106
Event Date 08/18/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the nurse practitioner was concerned because the patient's battery life indicator already indicated 25% battery life on (b)(6) 2016. The generator was implanted a little over a year earlier on (b)(6) 2015. The generator device history record was reviewed and found all specifications were met prior to distribution. System diagnostics performed (b)(6) 2016 confirmed that the device was operating within normal limits. The internal device data found that during the final system diagnostic test performed on (b)(6) 2016 the charge consumed was 15. 618% and battery voltage was noted to be 2. 863v, the registered indicator indicated 25% battery remaining at this time. No further relevant information has been received to date.
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6031665
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dennis100
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« Reply #6 on: November 29, 2016, 01:53:07 AM »

Model Number 105
Event Date 09/26/2016
Event Type Malfunction
Event Description
It was reported that a patient's generator had reached end of service, pulse disabled, after being implanted slightly over a year. No recent trauma was noted and the patient was not known to have undergone any surgeries. Clinic notes from (b)(6) 2016 were provided and verified that the generator was interrogated and found at eos - pulse disabled status. A review of the device history record for the generator was performed and showed that the generator passed all electrical and functional tests prior to release for distribution. A battery life calculation was performed and with the available programming history available, the generator was expected to have 2. 0 years until near end of service as of (b)(6) 2016. A review of the available programming history was performed and showed impedance values within normal limits on the date of implant.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6033415
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dennis100
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« Reply #7 on: November 29, 2016, 01:55:37 AM »

Model Number 106
Event Date 09/23/2016
Event Type Malfunction
Event Description
It was reported by the physician to a livanova therapeutic consultant that the patient's generator battery indicator showed 25% battery life remaining on (b)(6) 2016 even though a month prior it was at 100%. After interrogation, the device was noted to be working properly and impedance was within normal range. A review of device history records for the generator shows that no unresolved non-conformances were found. From a review of programming history data retrieved from the therapeutic consultant, the voltage can be seen to be steadily decreasing over time. It did rebound briefly between (b)(6) 2016 and (b)(6) 2016, but the voltage was never measured as less than 2. 85v. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6038446
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dennis100
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« Reply #8 on: November 29, 2016, 01:56:27 AM »

Model Number 106
Event Date 09/26/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient¿s generator battery showed approximately 25% remaining prematurely. It was reported to have previously registered at almost 100% in (b)(6) of 2016. The generator device history record was reviewed and found that all specifications were met prior to distribution. The internal device data was reviewed. The review showed that no anomalies were noted on the date of implant ((b)(6) 2015). The battery indicator at that time was showing 100%. Review of the data on (b)(6) 2016 showed that the battery voltage was between 2. 860v ¿ 2. 865v, and the charge consumed value was between 12. 612 ¿ 12. 613%. The indicator shown at that time was 25% remaining. All impedance values were within normal limits. The data showed 24018 autostimulations had been delivered by that time. The minimum battery registered up until that date was 2. 860v that was recorded on (b)(6) 2016. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6046797
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dennis100
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« Reply #9 on: November 29, 2016, 10:36:34 PM »

Model Number 103
Event Date 09/02/2016
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative

Event Description
It was noted during repositioning a repositioning surgery that the generator showed vbat disabled and was no longer providing stimulation. The company representative stated she had spoken with the surgery about the electro cautery precautions, but it is suspected the device was hit with electro cautery. A new generator was placed during the surgery. The device was interrogated before the surgery and was confirmed to be working correctly. Lead impedance was within normal limits. The device is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5984716
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dennis100
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« Reply #10 on: November 29, 2016, 10:37:17 PM »

Model Number 106
Event Date 10/06/2016
Event Type Malfunction
Manufacturer Narrative
Suspect device udi number: (b)(4).

Event Description
It was reported that a patient's generator showed about "1/3 battery life remaining" on an interrogation on (b)(6) 2016. The patient's device had been implanted on (b)(6) 2016. A review of the device history record for the implanted generator was performed and showed that the generator had passed all inspections prior to release for distribution. Follow-up was later provided that the patient's generator was found at 100% when interrogated on (b)(6) 2016. The battery voltage had rebounded to 2. 871v on (b)(6) 2016. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6067343
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dennis100
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« Reply #11 on: December 09, 2016, 07:33:34 AM »

Model Number 106
Event Date 10/04/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
Clinic notes dated (b)(6) 2016 reported that interrogation of the patient's generator revealed "battery life less than 1/4. The generator device history record was reviewed and found all specifications were met prior to distribution. Through a review of the generator's internal data, it was found that the patient's device was set to a high duty cycle of 71% since (b)(6) 2015. From the only interrogation data available, dated (b)(6) 2016, the battery voltage was 2. 824 v and the charge consumed was 17. 284%. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6091353
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dennis100
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« Reply #12 on: December 09, 2016, 07:34:22 AM »

Model Number 103
Event Date 10/12/2016
Event Type Malfunction
Event Description
Clinic notes were received in regards to the patient's vns generator replacement referral. Within the clinic notes it was found that the physician had to explain to the patient that this device depleted more quickly than her last device because it had a smaller battery and she was set to higher settings. However, a battery life calculation was performed which showed the generator would still have approximately 1. 6 years remaining until neos = yes (near end of service). It should be noted that there is over a year of information that was not available within the manufacturer's internal database which could affect the battery life calculation. The programming history database was reviewed on 10/26/2016. The database contained programming history from 03/10/2014 to 03/16/2015. No anomalies were noted. The diagnostic information showed that the device was performing as intended as the impedance value was within normal limits. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096710
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dennis100
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« Reply #13 on: December 09, 2016, 07:35:02 AM »

Model Number 106
Event Date 10/01/2016
Event Type Malfunction
Manufacturer Narrative
Suspect medical device udi: (b)(4).

Event Description
It was reported that the generator could not be interrogated. The believed cause of the failure to interrogate was battery depletion however the generator had only been implanted for approximately 14 months. Therefore it appeared that if the failure to interrogate was due to an end of service condition it would be premature. A review of manufacturing records indicated that the generator passed quality control inspection prior to distribution. Additionally, it was noted that the generator was laser routed during manufacture. The physician's programming data was received and reviewed. However there was not enough data to determine if the battery voltage of the device was depleting more quickly than expected. The patient underwent a generator replacement. The explanted product has not been received to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6117591
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dennis100
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« Reply #14 on: December 09, 2016, 07:35:36 AM »

Model Number 103
Event Date 11/02/2016
Event Type Malfunction
Event Description
It was reported that the patient had their device replaced due to battery depletion ifi=yes. The patient believes that the battery depleted too quickly. The patient's programmed settings and diagnostics were noted before surgery. These were used to perform a manual battery life calculation along with the available programming history. It indicated 4. 8 years remaining until eos=yes as of (b)(6) 2016. The explanted generator was received on 11/08/2016. Analysis is underway, but hasn't been completed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6122028
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dennis100
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« Reply #15 on: December 09, 2016, 07:36:15 AM »

Model Number 106
Event Date 10/19/2016
Event Type Malfunction
Event Description
It was reported by a medical professional to a company representative that a vns patient¿s generator has had a sudden drop in battery. The battery status indicator was showing 25% on (b)(6) 2016. Review of the dhr for the generator revealed the device met specifications prior to distribution. Systems diagnostics on (b)(6) 2016 were within normal limits. Additional relevant information has not been received to-date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6098291
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dennis100
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« Reply #16 on: December 09, 2016, 07:36:50 AM »

Model Number 106
Event Date 10/13/2016
Event Type Malfunction
Event Description
The physician reported that interrogation of the patient's generator showed a 25% battery indicator even though the patient had been implanted (b)(6) 2015 less than a year ago. A review of device history records for the generator shows that no unresolved non-conformances were found. Per the decoded programming history data, the device seemed to be depleting normally up to the last date of the available data, (b)(6) 2016. Additional relevant information has not been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6084452
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dennis100
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« Reply #17 on: December 09, 2016, 07:37:37 AM »

Model Number 103
Event Date 10/14/2016
Event Type Malfunction
Event Description
It was reported by a company representative that a vns patient¿s generator was interrogated and showed the battery status was at 20%. The physician thought it was strange that the generator was already at 20%. The patient is in referral for replacement. 2 weeks ago the battery status was provided as green, but was found to be at intensified follow-up indicated on (b)(6) 2016. She stated that the patient has a behavior of hitting herself across the chest and it was wondered if that did not cause some damage to the generator. An estimate of battery life calculation with the data available to the manufacturer provided 7. 4 years to near end-of-service condition. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6076885
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dennis100
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« Reply #18 on: December 14, 2016, 10:13:27 AM »

Model Number 250
Device Problems Battery failure; Replace
Event Date 01/31/2008
Event Type Malfunction
Event Description
Reporter indicated that the (b)(6) handheld experienced battery failure in the operating room. (b)(6) handheld was replaced. Attempts for further information are in progress.
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810729
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dennis100
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« Reply #19 on: December 16, 2016, 03:56:10 PM »

Model Number 102
Event Date 11/01/2007
Event Type Malfunction
Event Description
Initial reporter indicated that the pt had their vns generator replaced for being at the end of battery life. The generator was returned to the mfr for analysis and it was confirmed that an anomaly with a c6 compacitor, resulted in excessive current consumption and premature battery drain. The c6 compacitor malfunction lead to the battery being at end of life.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992368
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dennis100
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« Reply #20 on: December 23, 2016, 08:00:11 AM »

Model Number MODEL 250
Event Date 04/09/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
A field rep reported to mfr that the site's handheld computer battery is completely depleted, charging is not possible. Good faith attempts are being made for prod return for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1054281
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dennis100
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« Reply #21 on: January 06, 2017, 06:01:58 AM »

Model Number 106
Device Problem Premature end-of-life indicator
Event Date 09/01/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient¿s generator had reached the 25% indicator despite being at 100% battery life "about 3 months ago". The patient's husband and physician are concerned because the patient has demonstrated great benefit from the therapy but the she lives too far away for any increased follow-up. The husband mentioned he is dissatisfied with how quickly the battery has depleted. A review of device history records for the generator shows that no unresolved non-conformances were found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6194043
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dennis100
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« Reply #22 on: January 06, 2017, 06:02:48 AM »

Model Number 106
Device Problem Premature end-of-life indicator
Event Date 11/28/2016
Event Type Malfunction
Event Description
It was reported by the physician that the patient's m106 generator, which was implanted in (b)(6) 2015, was already showing the ifi = yes (intensified follow-up indicator) condition. The physician elected to program the tachycardia detection off in order to preserve battery life. Of note, the patient had an average of 51 auto-stimulations per day, making up 5% of the total therapy on time. The programming history database was reviewed and no anomalies were noted and the diagnostics were within normal limits, indicating the device was working as intended. The longevity tablet for the m105 generator, located within the physician's manual, was reviewed. The estimated battery remaining for the m105 with similar settings to what the patient had been set to showed that the generator would last approximately 3 years. It should be noted that the patient's duty cycle was set a bit higher than the estimation in the longevity table, which would decrease the battery longevity. Additionally, the longevity table does not take into account the 51 auto-stimulations per day, average, that the patient was having. The auto-stimulations would also decrease the estimated battery life. The dhr for the patient's m106 generator was reviewed and it was confirmed the device was a laser routed device. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6203397
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dennis100
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« Reply #23 on: January 06, 2017, 06:03:40 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 11/09/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
Clinic notes were received in regards to the patient's vns replacement referral. It was noted in the physician's order that the vns had battery failure (battery depletion) and that the patient was referred for vns replacement. It was noted in the physician's note, dated (b)(6) 2016, the patient had a follow-up with the physician and the vns was found to be at end of life. The patient's mother reported the patient has had a few more seizures and that his medications have recently been increased due to the seizures. Clinic notes dated (b)(6) 2016 stated the patient was last seen on (b)(6) 2016 and had only experienced one seizures since that time. It was noted the vns battery has exhausted and the patient would be referred for replacement. It was noted by the mother that the patient's seizures are much better controlled and the patient had no side effects of medication, no regression, doing better in school, special classes, and no toxic habits. He seizures were noted to have decrease in frequency as he is only experiencing about 1 per month. An automatic battery life calculation (blc) was last performed on (b)(6) 2016 and reviewed on (b)(6) 2016. The blc contained information through (b)(6) 2016. Based on the information provided, and the parameters/diagnostic history found in the vns therapy programming history database, the patient has approximately 1 year remaining (0. 8 years minimum) until the neos = yes (near end of service) condition. Impedance values were noted to be within normal limits and no anomalies were noted. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6203411
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dennis100
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« Reply #24 on: January 06, 2017, 06:04:35 AM »

Model Number 103
Device Problem Premature end-of-life indicator
Event Date 11/30/2016
Event Type Malfunction
Event Description
It was reported that a patient went in for vns generator replacement surgery, and the generator that the surgeon intended to implant showed that the battery was already depleted prior to implant. A backup generator was implanted instead. The patient was not reported to have any issues during implantation. Clarification was received that the battery was found to be in the "red" when the generator was connected to the existing lead. There was no mention of electro-cautery used while the generator was in the sterile field. The generator was stored in acceptable temperatures inside the hospital prior to the surgery. The device history record of the generator was reviewed, and the device passed all specifications prior to release. The generator was received on 12/13/2016. Analysis has not been approved to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6204282
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dennis100
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« Reply #25 on: January 06, 2017, 06:05:27 AM »

Model Number 102R
Device Problem Premature end-of-life indicator
Event Date 09/30/2010
Event Type Malfunction
Manufacturer Narrative

Event Description
A generator was explanted and returned due to normal battery depletion. Analysis was performed on the device and it was identified that a supply current parameter measurement was over the upper limit and did not meet the electrical specification. This measurement demonstrated an increased current consumption for the device and could have potentially contributed to an end of the battery life. Analysis confirmed that an electrical component of the device was the root cause of this excessive leakage current. The reason for the component¿s increase in leakage current could not be determined. After the faulty component was substituted, the generator module performed according to functional specifications. Although the device appears to have depleted within expected timeframes based upon the battery life estimation and programming history and clinical history, the faulty capacitor identified during product analysis suggests that it may have also contributed to the battery depletion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6211396
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dennis100
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« Reply #26 on: January 06, 2017, 06:06:10 AM »

Model Number 106
Event Date 07/21/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient's generator showed 100% battery life in (b)(6) 2016 and then showed 25% battery life on (b)(6) 2016. Data from implant, (b)(6) 2015 was received, but no conclusions could be drawn without more recent data. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6142576
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dennis100
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« Reply #27 on: January 06, 2017, 06:07:05 AM »

Model Number 106
Event Date 08/21/2015
Event Type Malfunction
Event Description
It was reported that a patient's device was at ifi=yes, and it was believed that the battery depleted more quickly than expected. Diagnostics were within normal limits, and the device history record of the device showed that it conformed to all specifications prior to release. A battery life estimation was performed using longevity tables, and, based on worst-case-scenario settings, the battery would be expected to reach ifi=yes around 2-4 years. Therefore, the battery was most likely depleting at a faster rate than expected. The patient was referred for generator replacement surgery. No known surgery has occurred to date.

Event Description
The patient had generator replacement surgery due to ifi=yes. The generator was received, but analysis has not been approved to date. The premature battery life indicator was most likely caused by conductive debris from the manufacturing process resulting in leakage paths. The premature battery life indicators are also typically indicative that the generator will reach true end of service earlier than expected. No further relevant information has been received to date.

Manufacturer Narrative
The cause of the premature battery indicator was inadvertently left off the initial report.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6142302
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dennis100
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« Reply #28 on: January 06, 2017, 06:07:50 AM »

Model Number 106
Event Date 11/08/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient's generator was registering approximately 20-30% battery life. Review of the vns physician¿s manual showed that the nominal beginning of life to ifi=yes battery life for the generator at 2ma/30hz/250us, duty cycle of 33% and 3kohm impedance (not accounting for tachycardia detection enabled and autostimulations) is 5. 6 years. The time given the same parameters, except with a duty cycle of 10%, is > 10 years. The generator device history record was reviewed and found that all specifications were met prior to distribution. The internal data for the (b)(6) 2016 appointment was reviewed. The diagaccumconsumed field showed 16. 361% of the available charge had been consumed. The battery voltage was measured between 2. 826 - 2. 855 v. The registered battery indicator was the 25% indicator. The minimum vbat measurement up to the appointment occurred that day and registered 2. 826v. The available internal device data prior to the (b)(6) 2016, appointment was also reviewed and showed battery indicators of 100%.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6143770
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dennis100
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« Reply #29 on: January 06, 2017, 06:08:38 AM »

Model Number 106
Event Date 11/16/2016
Event Type Malfunction
Event Description
It was reported that the generator was displaying a 25% battery indicator. This concerned the physician since it was earlier than expected based on the programmed settings and the implant time of the device. The manufacturing records for the m106 generator were reviewed and the "trim test tab" was performed (b)(6) 2015. The generator passed quality control inspection prior to distribution. The internal programming history database was reviewed and data was found. The battery voltage and percentage of battery consumed are listed below. ((b)(6) 2015) voltage: 3. 384v, % battery consumed = 0. 565%; ((b)(6) 2015) voltage: 3. 385v, % battery consumed = 1. 747%; ((b)(6) 2016) voltage: 2. 898v, % battery consumed = 8. 164%. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6158808
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