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dennis100
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« Reply #960 on: December 13, 2018, 04:18:52 AM »

Model Number 102
Event Date 08/14/2013
Event Type  Malfunction   
Event Description
Clinic notes dated (b)(6) 2013 were received which indicate the patient's vns could not be programmed and the patient experienced a recent increase in seizure frequency. The patient had drop attacks, general tonic-clonic seizures, and some partial seizures. The notes state that they will replace the vns and suspect that the battery is low. However, an estimated battery life calculation performed with the programming history data in the manufacturer's database found an approximate 10 year estimated years left until end of service. Attempts have been made for additional information; however, they have been unsuccessful. No other information has been provided.

Manufacturer Narrative
Analysis of programming history.

Event Description
The patient underwent generator revision on (b)(6) 2013 due to battery depletion. The explanting site does not return explanted products. Follow-up showed that troubleshooting was performed and everything was okay, but no details were given. The increase in seizures was not believed to be related to vns, but the seizures improved since revision. Programming history was not provided despite attempts.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3345699
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dennis100
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« Reply #961 on: December 17, 2018, 04:07:04 AM »

Model Number 103
Event Date 06/07/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis of an generator that was explanted for prophylactic reasons was completed on (b)(6) 2013. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the pa lab, the battery is partially depleted. The data in the diagaccum consumed memory locations revealed that 86. 219% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. A review of the internal memory locations within the generator suggests the existence of an error in calculating the device's battery voltage.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3408304
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dennis100
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« Reply #962 on: December 18, 2018, 12:34:04 PM »

Model Number 102
Event Date 03/28/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received which indicate the patient had a recent significant increase in seizures in (b)(6) 2011. The notes were dated (b)(6) 2011. Attempts have been made for additional information; however, they have been unsuccessful. A battery life calculation estimates 0 years remaining until eri = yes; however, the final system diagnostics performed on (b)(6), 2011 indicate the following: output current = ok, lead impedance = ok, dcdc = 2, eri = no.

Event Description
A battery life calculation performed up to the time of the event showed 1. 20 years remaining. The previous battery life calculation of 0 showed the calculation up to the date of mdr submission and was inaccurate for the reported event.

Manufacturer Narrative
Corrected data: previously submitted mdr stated that a battery life calculation indicated 0 years remaining to eos; however, this was not accurate at the time of the event. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3388311
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dennis100
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« Reply #963 on: December 20, 2018, 01:46:04 AM »

Model Number MODEL 250
Event Date 10/22/2013
Event Type  Malfunction   
Event Description
It was reported that during device interrogation the handheld read a checksum error. The system automatically tries to interrogate again without the user needing to push anything. It was reported that this has occurred on several occasion, but that there are multiple programming systems and no patient's were affected by this. It was reported that the handheld occasionally is able to interrogate successful, but other times it cannot. Troubleshooting was performed. The handheld was moved away from emi, but the problem still occurred. The wand battery was changed and the interrogation was successful. A diagnostic test was also performed successfully. The physician's office decided to hold on to the handheld since it was working properly after the troubleshooting.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3477070
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dennis100
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« Reply #964 on: December 21, 2018, 09:31:31 AM »

Model Number 104
Event Date 10/10/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, the physician reported that he saw the patient that day and the battery level appeared to be low even though the vns battery was implanted on (b)(6) 2013. The physician was concerned that the battery may be malfunctioning. Follow up found that when diagnostics were performed, no warning messages to indicate a low battery appeared; however, the image of the battery showed a half charged battery. The patient has not had any recent procedures. Review of the generator device history records confirmed all quality tests were passed prior to distribution.

Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this vns patient was seen on (b)(6) 2013 at which time everything was okay with the battery. The battery status indicator was full green. There were reportedly no issues, and the physician is not concerned with the generator or software. Diagnostics were within normal limits, and the battery icon was full.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3459672
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dennis100
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« Reply #965 on: December 21, 2018, 09:32:44 AM »

Model Number 104
Event Date 11/06/2012
Event Type  Malfunction   
Event Description
The treating physician's office does not have any notes of the patient having any procedures performed between (b)(6) 2012.

Manufacturer Narrative
Analysis identified that the vmonitor (circuitry involved in measuring battery voltage) was being loaded down by the microprocessor. The cause was not able to be identified. Device failure caused event, but did not cause or contribute to death or serious injury.

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

Event Description
Additional programming history was received for the patient's device which contained data from an office visit that occurred on (b)(6) 2013. Initial interrogation of the generator on the aforementioned date revealed that the battery voltage was measuring 2. 022v. A diagnostic test was performed at the office visit where the battery voltage was re-measured and revealed that the voltage had reached the eos threshold of less than 2. 0v (measured 1. 950v). Additional analysis has been performed on the returned device to further investigate the low battery voltage readings identified during the initial analysis of the device, and a cause for the behavior has not been identified. Though attempts for additional information from the treating physician have been made, no further information has been received to date.

Event Description
It was reported in (b)(6) 2013 that the patient was being scheduled for surgery to have the generator replaced as the device was nearing end of service (battery depletion). There were no complaints associated with the reason for replacement. The generator was subsequently explanted and returned for product analysis in (b)(4) 2013. As part of the analysis of the returned device, a review of programming history was performed. It was identified in review of programming history that upon interrogation on (b)(6) 2012, the device output current was set to 0 ma, which was not preceded by a programming operation. Therefore the 0 ma output current appeared to be unexpected. Further review of the programming history was performed by reviewing the generator source code, where it was noted that the device experienced a pulse disabled event due to vbat less than eos threshold as noted upon interrogation on (b)(6) 2012, which is the reason the output current was set to 0ma upon interrogation on that date. However, the battery voltage was measuring approximately 2. 9v at the time, which is not a voltage level that is indicative of end of service. Therefore the pulse disablement due to vbat less than eos threshold was unexpected. The device was reprogrammed on (b)(6) 2012 to the previous settings of 2. 5ma output current; 20hz frequency; 250 usec pulse width; 21 seconds on; 0. 5 minutes off with no issues, and device diagnostics performed on this date were within normal limits. Product analysis of the device was completed, where it was identified that the battery voltage that the device circuitry was measuring was lower than the actual battery voltage (measuring approximately 2. 2v; actual battery voltage approximately 2. 5v). Visual analysis of the device revealed burn marks on the can, which is indicative of exposure to an electrosurgical device. It is not known if the burn mark was due to use of electrocautery at the explant procedure, however further investigation is underway to determine if the patient may have had other surgical procedures while the device was implanted. Further analysis was performed to determine the cause of the discrepancy in the battery voltage being measured by the device compared to the actual battery voltage, and it was identified that the circuitry involved in measuring battery voltage was being loaded down by the microprocessor. The cause for this was not able to be identified during product analysis. There were no other anomalies identified during analysis of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3443711
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dennis100
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« Reply #966 on: December 21, 2018, 09:33:36 AM »

Model Number 103
Event Date 09/11/2013
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming and diagnostic history performed.

Event Description
Further internal investigation into this issue has been completed and the exact root cause of the reported event remains unknown.

Event Description
On (b)(6) 2013, it was reported that an ifi indicator with a yellow battery was seen with regards to this patient¿s device on (b)(6) 2013. The patient was referred for generator revision. A pre-operative interrogation on (b)(6) 2013 showed a non-ifi status and a green battery status indicator. Multiple diagnostics were performed to confirm with the same non-ifi results. The patient did not undergo generator revision. Review of programming history shows that the generator was last programmed on (b)(6) 2012, and the settings had not been adjusted since that time. Impedance was within normal limits throughout programming history. Review of device history shows that the device was at 2. 799-2. 8 v on (b)(6) 2013. On (b)(6) 2013, the generator voltage was 2. 919 v.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3444134
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dennis100
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« Reply #967 on: December 21, 2018, 09:36:02 AM »

Type of Device:           Stimulator, Autonomic Nerve, Implanted For Epilepsy
Device Brand               VNS Therapy® SenTiva™ Model 1000 Generator
Name:
 Device                       LIVANOVA USA, INC.
Manufacturer's
Name:
Date of this Report:     01/05/2018
(mm/dd/yyyy)
Describe the Event      The patient had a vagal nerve stimulator battery replaced in surgery. After the
or Problem:                patient was taken to her room for post-care, the nurse noted that the newly
                                 replaced battery showed message which stated: "EOS- End of Service". The
                                 Neurosurgeon was notified and the patient was scheduled to replace the
                                 battery once again. The manufacturer's representative was in surgery during
                                 the battery placement.
the device(s) may
have                          Serious injury
caused or
contributed to:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=57302
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dennis100
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« Reply #968 on: December 22, 2018, 09:58:51 AM »

Model Number 103
Event Date 12/05/2007
Event Type  Malfunction   
Event Description
Product analysis was approved on (b)(4) 2013 for a generator explanted due to a near end of service status. The generator was returned due to low battery and neos=yes. The battery voltage was 2. 692 volts (at ifi), as measured during completion of a test parameter of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 87. 510% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications and that there were no adverse functional, mechanical, or visual issues identified with the returned generator. However, a review of the internal memory locations within the generator suggests the existence of an error in calculating the device's battery voltage. Review of decoder data showed that 87. 510% of the battery capacity was consumed; however, the battery voltage was 2. 581 as-received. No adverse patient events were reported as a result of this.

Event Description
As indicated within the initial report, an analysis of the explanted generator revealed that one of the variables used during generator voltage measurements was out of tolerance based on current test system specifications. This out of tolerance condition has been previously investigation and was found to be due to the presence of a manufacturing test system software issue and the near end of life condition of the relay utilized during the voltage measurement calibration of the generators printed circuit board assembly (pcba) during the production of the device. As a result of this inaccuracy the voltage measurements performed by the generator are lower than the actual voltage of the battery as observed in patient programming history. It should be noted that this issue does not impact the ability of the device to deliver therapeutic stimulation. A safety alert was submitted and acknowledged by the patient¿s treating vns therapy physician (recall number: z-0005-2012).

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

Manufacturer Narrative
Analysis of programming history. Describe event or problem, corrected data: initial report did not include details of the observed failure mode. The information has been included in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3531456&pc=LYJ
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dennis100
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« Reply #969 on: January 02, 2019, 02:39:38 AM »

Model Number MODEL 250
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The physician reported that the battery in the handheld died completely and that the battery is probably bad. The physician reported that he has kept the unit plugged into the outlet. The physician has another programming system so no patients were affected. No additional information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3562829
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dennis100
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« Reply #970 on: January 03, 2019, 08:13:57 AM »

Model Number 103
Event Date 01/24/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during vns implant surgery diagnostics were performed with the generator connected to the lead. It was reported that these diagnostics were within normal limits. The generator was placed in the pocket and the incision was closed and device diagnostics showed end of service. The physician reported that electrocautery was not used "close" to the generator. It was reported that the generator would be replaced with a new generator. A company representative was present during the surgery and reported that the generator diagnostics were within normal limits and the generator did not show end of service until the lead was attached to the generator header. The generator 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=3640512
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dennis100
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« Reply #971 on: January 04, 2019, 08:59:36 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/14/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient reported to be referred for battery replacement. The patient's physician expressed concern that the device may be prematurely depleting due to the manufacturing process. Device design history records were reviewed and indicate that the device may have been laser routed. Device programming history data was reviewed. No programming anomalies were observed that would suggest malfunction. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8181872
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dennis100
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« Reply #972 on: January 04, 2019, 09:00:13 AM »

Device Problem Premature End-of-Life Indicator
Event Date 11/19/2018
Event Type  Malfunction   
Event Description
The generator was replaced prophylactically. The generator was then received into analysis by the manufacturer. Analysis noted during the visual assessment of the pcba that there were contaminates on the trimmed edge of the pcba (tab removed). This prompted a further, can-open investigation of the generator which confirmed the contaminates and that the battery had reached an ifi condition with only 69. 775% of the battery consumed. The battery measured 2. 983 volts though the ifi range is 2. 74v - 2. 41v. The stored memory of the generator showed lead impedance was within normal limits throughout implant. Therefore the battery depleted prematurely. A review of the device history record of the generator showed there were no unresolved non-conformances prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8166566
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dennis100
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« Reply #973 on: January 04, 2019, 09:00:59 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/28/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient's physician believed that the device prematurely depleted due to laser routing. The device was replaced. The explanted generator has not been received for analysis to date. Design history record for the device was reviewed. The generator has the potential to be laser routed. The device passed all specifications. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8169268
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dennis100
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« Reply #974 on: January 05, 2019, 12:57:53 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Event Description
It was reported that the physician believed the patient's generator had prematurely depleted. A review of the available data was unable to assess premature depletion due to lack of more recent data. The generator's device history records were reviewed. The generator passed final quality and functional specifications. The generator was laser-routed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8185823
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dennis100
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« Reply #975 on: January 05, 2019, 12:58:38 AM »

Model Number 104
Device Problem Premature End-of-Life Indicator
Event Type  Malfunction   
Event Description
It was reported that the patient's vns had reached the 25% battery status and it was suspected that this was reached prematurely. A review of device history records for the generator was performed and shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8122643
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dennis100
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« Reply #976 on: January 05, 2019, 02:13:46 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/28/2018
Event Type  Malfunction   
Event Description
Patient underwent generator replacement due to low battery. On the day of device replacement, the patient was complaining that her device only lasted 2 years and was told that it would last 5-8 years. A physician's assessment of the battery depletion has not been received to date. The explanted device has not been received for analysis to date. Device design history records were reviewed and indicate that the device may have been laser routed. Programming history data was reviewed for the device. No diagnostic information was available. No programming anomalies were observed that would suggest malfunction. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8174591
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dennis100
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« Reply #977 on: January 05, 2019, 02:14:30 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 05/21/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for vns generator replacement surgery due to battery depletion. It was later reported that the patient's parents were questions why the battery had depleted after only 3 years since implantation. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The device was found to have been manufactured using the laser routing process. Clinic notes were received indicating that the vns battery status was at 50-75% and then, half a year later, at 11-25%. The tablet data for the generator was received and reviewed by the manufacturer. The discrepancy between the diagaccumconsumed value and the battery voltage in the single line of data provided was an indication that the battery was depleting faster than expected. Impedance was within the normal limits throughout the available programming history. No high impedance was observed in the generator's internal history data. An internal investigation was completed on premature battery depletion events. The results of the investigation observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in leakage paths. This finding is indicative that the generator will reach true end of service earlier than expected. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8164396
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dennis100
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« Reply #978 on: January 05, 2019, 02:15:00 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/05/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's generator was believed to be prematurely depleting as the patient was at 50-75% of battery remaining after being implanted last year. Device history records were reviewed and the device was not laser routed, so it would not be susceptible to premature battery depletion due to laser routing. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8178445
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dennis100
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« Reply #979 on: January 05, 2019, 02:15:28 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 09/28/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's generator was prematurely depleting, as there was a unexpected decrease in the past four months. It was also reported that the patient had high impedance, low output current, and pain with stimulation, which is reported in mfr report #1644487-2018-02285. The patient's device was disabled. The patient's lead and generator were replaced. The devices have not been received into livanova to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8180507
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« Reply #980 on: January 05, 2019, 02:16:03 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 11/27/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient underwent a surgery to move the patient's port to the opposite side from the vns. Prior to the procedure the patient's device was turned off and the battery status showed the 75% indicator. After the procedure, the device showed the neos battery status and a message was seen stating that output current was low. It was stated that bovie (electrocautery) was used during this port surgery. The patient later underwent a vns generator replacement surgery and it was found that the battery status was no longer depleted. System diagnostics at this replacement surgery were reported to be normal. The generator was replaced and has been received by the manufacturer. An analysis is underway but has not been completed to date a review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8180656
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« Reply #981 on: January 05, 2019, 02:16:37 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Event Description
It was reported that the physician believes this generator is prematurely depleting. Programming history was reviewed for the generator. Premature battery depletion was not verified although full programming history was not provided. Device history records were reviewed. The generator was laser routed and was susceptible to premature depletion. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8184030
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« Reply #982 on: January 05, 2019, 02:17:18 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The neurologist alleged that the patient's device is depleting prematurely. Based on available programming data, premature battery depletion is not verified. Additional programming data has been requested but no additional relevant information has been received to date. 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=8187876
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« Reply #983 on: January 05, 2019, 02:17:49 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Event Description
It was reported that the physician felt that the patient's vns had prematurely depleted as it was a laser routed device. It was explained that not all laser routed device exhibit premature depletion, but the physician was adamant that the device had prematurely depleted. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The device was found to have been manufactured using the laser routing process. Based on available data, premature battery depletion was not verified. The percent battery capacity used and percent battery capacity remaining appears to match the expected values. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8186378
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« Reply #984 on: January 05, 2019, 02:18:21 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 10/24/2018
Event Type  Malfunction   
Event Description
It was reported that the patient is being referred for vns generator replacement with the generator battery indicating 8-18%. The patient's mother stated that she was told the device would last 8 to 10 years however the patient was having to undergo replacement 5 years after implant. No other relevant information has been received to date. Surgical intervention has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8130713
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« Reply #985 on: January 05, 2019, 02:18:59 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient's epileptologist expressed concerns regarding this patient who is implanted with a laser-routed device. It was reported that the physician believes this patient's generator is prematurely depleting. The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process. The device met all specifications for release prior to distribution. Data from the patient's device was reviewed and does not confirm that the battery depleted more quickly than expected. The charge consumed (%) did not deplete more quickly than expected as compared to the battery voltage measurements. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8183937
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dennis100
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« Reply #986 on: January 05, 2019, 02:19:35 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 08/26/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient's generator battery indicator showed 25% battery remaining despite the battery life calculation showing roughly 2. 8 years remaining until end of service. Programming data was reviewed and it was confirmed that the device appears to be depleting prematurely. No known surgical interventions have occurred to date to replace the generator. 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=8180274
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dennis100
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« Reply #987 on: January 05, 2019, 02:20:10 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 11/19/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient needed a vns replacement for the second time this year. It was noted that the parameters were set very high and a fairly high duty cycle. The output was lowered as a result. The first event, an allegation of premature battery depletion in the previous generator, was captured in mfg. Report #1644487-2018-00561 and was confirmed invalid. A review of device history records revealed that the generator passed quality control inspection prior to distribution. As the patient's initial settings from date of implant were unknown, the vns therapy system physician's manual could not be utilized to estimate whether the depletion was expected. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8157178
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dennis100
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« Reply #988 on: January 05, 2019, 02:20:41 AM »

Model Number 105
Device Problem Premature End-of-Life Indicator
Event Date 06/11/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's device is depleting prematurely. Patient was referred for generator replacement. A review of device history records for the generator shows that no unresolved non-conformances were found. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8142778
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dennis100
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« Reply #989 on: January 05, 2019, 02:21:13 AM »

Model Number 106
Device Problems Energy Output Problem; Premature End-of-Life Indicator
Event Date 12/07/2018
Event Type  Malfunction   
Event Description
It was reported that upon interrogation, the patient's generator had been reset to 0ma. The device was turned back on and the battery life indicated ifi=yes condition. The physician was concerned that this device had prematurely depletion as is was only a couple years old. A battery life calculation was performed and estimated that the device had 0. 9 years remaining until neos=yes. A review of the device history record indicated that the generator had been laser-routed which has been shown to produce excess debris on the circuit board. This debris may lead to excess current draw from the generator, which can deplete the battery prematurely. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8191091
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