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dennis100
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« Reply #990 on: January 05, 2019, 02:21:47 AM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 08/21/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's battery status indicated 11-25% remaining, and there was a concern his generator had prematurely depleted. Per a review of the manufacturer's device history records, the generator passed final quality and functional specifications prior to release. The generator was laser-routed. A review of the generator's internal data verified premature battery depletion. The generator's voltage indicated that the generator had 11-25 % of its battery life remaining; however, this is inconsistent with the % battery consumed value of 27. 789%, which indicates that around 70% of the battery life should be remaining. From a previous internal investigation, it is known that some laser-routed devices may be susceptible to premature battery depletion. The observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in current leakage paths and premature depletion. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8162718
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dennis100
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« Reply #991 on: January 05, 2019, 02:22:20 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 11/27/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's device was found to be at the neos battery status; however, the patient returned to the clinic the next week and it was found that the battery showed the 50-75% status. A review of the 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=8190425
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dennis100
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« Reply #992 on: January 05, 2019, 02:22:58 AM »

Model Number 105
Device Problem Premature End-of-Life Indicator
Event Date 11/01/2018
Event Type  Malfunction   
Event Description
It was reported by the patient that she felt that her depression was worsening. The patient was to follow-up with her physician in order to get the vns checked as she felt that the depression was a result of a low vns generator battery. Clinic notes were received by the manufacturer showing that the vns was pulse disabled, or programmed off due to the vbat being less than the end of service, or eos, threshold. The tablet data for the generator was received and reviewed by the manufacturer. The device was confirmed pulse disabled. The discrepancy between the diagaccum consumed value and the battery voltage on the date in the clinic notes provided is an indication that the battery was depleting faster than expected. It is unknown whether this is the result of an asic latch-up condition caused by exposure to electrocautery. A review of device history records revealed that the generator passed quality control inspection prior to distribution and was manufactured well before laser routing was utilized. 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=8144303
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dennis100
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« Reply #993 on: January 05, 2019, 02:23:32 AM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 07/02/2015
Event Type  Malfunction   
Event Description
Product analysis of a product replaced prophylactically was completed. Evidence of premature battery depletion due to contaminants of the pcba from the laser-routing manufacturing process were identified. A visual assessment of the pcba showed contaminates on the trimmed edge of the pcba. The pcba failed several tests of the post-burn electrical tests. The contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to an excessive supply current conditions. After the trimmed edge of the pcba was cleaned, the generator performed according to specifications with no further anomalies identified. Note that the internal data of the generator also showed evidence of premature depletion with the battery voltage being inconsistent with the % battery consumed. The manufacturer's device history records were reviewed and it was verified that the generator passed final quality and functional specifications prior to release. The generator was confirmed to have been laser-routed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8123346
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dennis100
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« Reply #994 on: January 05, 2019, 02:24:04 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/06/2018
Event Type  Malfunction   
Event Description
It was reported that a patient's device was suspected to be at end of service condition as the device could not be interrogated despite several different programming systems attempting interrogation. The patient was referred for battery depletion. A battery life calculation was performed and did not support the allegation of the device reaching end of service condition. The patient's husband believed the device had prematurely depleted. It was noted that the patient was last seen in (b)(6) by the epileptologist however the device was not interrogated at this appointment. 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 battery replacement surgery had occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8123316
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dennis100
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« Reply #995 on: January 05, 2019, 02:24:41 AM »

Model Number 105
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 06/11/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was initially reported that this patient's generator was on the list of suspected devices that were laser routed. The physician therefore requested data analysis as a generator replacement was needed only about 3 years after the generator was implanted. 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. Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths. Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected. The patient received a generator replacement, and the explanted product has been received by the manufacturer where analysis is underway but has not been completed to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8124214
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dennis100
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« Reply #996 on: January 06, 2019, 04:03:50 AM »

Model Number 104
Device Problem Premature End-of-Life Indicator
Event Date 05/21/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A message was received from the patient indicating that their current implant has only been in for 2 years, but it is dying. Review of the manufacturing records for the generator confirmed the device met specification prior to distribution. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7893855
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dennis100
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« Reply #997 on: January 06, 2019, 04:06:21 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/20/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A physician's assistant stated that a patient's battery had reached a 25% battery indicator and questioned whether the device was depleting as expected. A review of device history records for the generator shows that the device was potentially laser routed. The device met all specifications for release prior to distribution. A battery life calculation and programming history review were performed and no programming anomalies were observed that would suggest malfunction. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8157453
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dennis100
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« Reply #998 on: January 07, 2019, 03:02:51 AM »

Model Number MODEL 250
Event Date 01/10/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld would not power on after being charged. It was also reported that the handheld wouldn't connect. The physician was provided with a new programming tablet. The handheld is expected to be returned, but has not been received to date.
 
Event Description
The handheld, flashcard and wand were received for analysis. Analysis of the wand was completed on (b)(4) 2014. ¿as received¿ the programming wand did not communicate, which analysis on the pa lab test bench determined was caused by a depleted battery. After the battery was substituted with a known good bench battery, the programming wand passed all communication testing at various orientations. Passing electrical tests demonstrated that current consumption rates were within specification, thereby eliminating any possibility of a condition where a battery might be prematurely depleted by the wand circuitry. Continuity testing of the serial data cable and the battery cable passed. No mechanical or visual anomaly was identified. After the battery was substituted, the programming wand performed according to functional specifications as evaluated through 38-0004-3600. Analysis of the handheld was completed on (b)(4) 2014. No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. Analysis of the handheld was completed on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3611359
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dennis100
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« Reply #999 on: January 07, 2019, 03:03:51 AM »

Model Number 201
Event Date 01/16/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the programming wand's 9v battery was depleted and caused the reported event.
 
Manufacturer Narrative

Manufacturer Narrative
Brand name, corrected data: supplemental report #1 did not update the product to the programming wand. The product has been updated in this report. Type of device, name, corrected data: supplemental report #1 did not update the product to the programming wand. The product has been updated in this report. Model #, corrected data: supplemental report #1 did not update the product to the programming wand. The product has been updated in this report. Operator of device, corrected data: supplemental report #1 did not update the product to the programming wand and therefore the user would be the physician. The operator of the device has been updated in this report.
 
Event Description
The physician reported that the handheld showed the following error message: "error initiating programming" when he tried to interrogate the patient's vns generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3630089
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dennis100
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« Reply #1000 on: January 07, 2019, 03:04:40 AM »

Model Number MODEL 250
Event Date 01/13/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician's handheld has a swollen battery. It was reported that the physician experienced issues with the display and removed the battery to reset, but that when the battery was removed, it was noticed to be swollen. A new programming tablet was provided to the physician and the handheld and flashcard were returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
An analysis of the handheld verified that the main battery was swollen, but that the handheld performance was not affected. No performance anomalies associated with the main battery were identified during the analysis. The handheld performed according to functional specifications. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
Additional information was received stating that the nurse¿s handheld device was stored in a drawer. It was reported that no mishandling had occurred.
 
Manufacturer Narrative
Device failure occurred, 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=3622544
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dennis100
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« Reply #1001 on: January 08, 2019, 07:36:02 AM »

Model Number 300-20
Event Date 02/28/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was not programmed off. Clinic notes were received stating that the high impedance was first observed during an office visit on (b)(6) 2014. The patient has not experienced any changes in her seizure control. The notes also indicate that the battery appeared to be depleting too quickly even with the high duty cycle. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
The patient underwent generator and lead replacement on (b)(6) 2014. The lead and generator were received on (b)(4) 2014. Analysis is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient did not have any trauma, changes in device settings, or changes in medications that may have contributed to the high impedance. The patient's device was disabled on (b)(6) 2014. The patient was doing well following replacement surgery. Analysis of the returned generator and lead was completed. Monitoring of the generator's device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator. During the visual analysis of the returned 385mm lead portion, the (-) green electrode quadfilar coil appeared to be broken approximately 3mm from the electrode bifurcation. Scanning electron microscopy was performed identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. During the visual analysis of the returned 385mm portion the (+) white electrode and ribbon appeared to be embedded in remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the tissue-covered (+) white electrode and ribbon the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Abrasions were observed in various locations, possibly caused by wear. Coils appeared slightly stretched, kinked and wavy in some areas which most likely occurred due to manipulation of the lead during the explant process. 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, with no other discontinuities identified. Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. However, the positive electrode condition may have contributed to the reported high impedance.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. 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=3710150
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dennis100
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« Reply #1002 on: January 08, 2019, 07:37:13 AM »

Model Number 103
Device Problems Failure to Interrogate; Battery Problem
Event Date 03/03/2014
Event Type  Malfunction   
Manufacturer Narrative
Evaluation codes, corrected data: the evaluation conclusion code inadvertently was reported on the initial report.
 
Event Description
It was reported that the vns patient¿s device could not be interrogated. Generator replacement surgery was scheduled due to suspected end of service. Additional information was received stating that the neurosurgeon¿s wand battery needed to be replaced. After the battery was replaced, the wand was functioning properly which indicates that the wand battery likely caused the failure to communicate. Additionally, the doctor¿s office planned to contact the patient to inform him surgery was no longer required. With the available information, no definitive conclusions can be made. The patient has not been seen to confirm that the generator could be communicated with since the initial report. Review of the available programming history showed that the last known settings were from (b)(6) 2013.
 
Event Description
It was reported that the patient was seen by the physician and the device was successfully interrogated. The battery status was reported to be at ifi=yes on (b)(6) 2015. The patient was referred for prophylactic battery replacement. The patient underwent prophylactic generator replacement on (b)(6) 2015. Explanted product has not been received to-date.
 
Event Description
It was reported that the battery was at near end-of-service = no. The explanted generator was discarded and will not be returned for analysis.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3710780
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dennis100
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« Reply #1003 on: January 09, 2019, 08:57:32 AM »

Model Number 103
Event Date 03/18/2008
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis of a generator that was returned was completed on (b)(4) 2014. The battery showed a non-ifi condition. A review of the internal memory locations within the generator suggests the existence of an error in calculating the device's total consumed energy. This error results in an incorrect device longevity estimate. This event was previously investigated and this generator was found on the list of devices for this error. In addition, a review of the vns programming history database printout (shows ifi) and the internal memory locations within the generator verified the existence of an error in calculating the device's battery voltage. Additional monitoring of the device was requested. The pulse generator was programmed to the last known parameters from the vns programming history database (no as received parameters) and to the as received percent of battery capacity to monitor diagvbat for a period of time. The pulse generator showed no anomalies during the period that diagvbat was monitored. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specification. Other than the noted errors, there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3675337
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dennis100
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« Reply #1004 on: January 10, 2019, 01:51:30 AM »

Model Number 103
Device Problem Device Displays Incorrect Message
Event Date 04/03/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was programmed off prior to having an mri. The nurse stated that when the device was programmed back on after mri, the handheld device displayed a warning message indicating ¿pulse disablement with vbat < eos threshold¿. After proceeding through the warning message, the battery icon was fully green and diagnostic testing performed revealed that the eos status was no and the lead impedance within normal limits (impedance value ¿ 2191 ohms). No adverse events were reported. No known interventions have occurred to date. Attempts to obtain additional information are in progress.
 
Manufacturer Narrative
Review of decoder data and programming and diagnostic history.
 
Manufacturer Narrative

Event Description
It was reported that the patient underwent generator replacement due to eos - yes. The explanted generator was received for analysis. The returned product form indicated that the generator was replaced due to neos - yes. The implant card was received also indicating that the generator was replaced due to battery depletion, near eos/ neos - yes. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: additional information indicates that the warning message appeared prior to the mri.
 
Manufacturer Narrative
Corrected data (conclusion code): the supplemental 02 report inadvertently included the incorrect conclusions coding. The conclusion coding has been updated to no conclusion can be drawn.
 
Event Description
A copy of the software flashcard was obtained. Programming and diagnostic history from the date of the mri was reviewed. Prior to the mri, the device was interrogated, disabled, and interrogated again. Following the mri, the device was interrogated and programmed back on. System diagnostic results performed on that day revealed normal device function. Review of the decoder data confirmed that the generator was disabled due to vbat < eos threshold upon initial interrogation on the date of the mri. Review of the battery voltage from this date revealed 3. 065v from the last 24hr voltage measurement.
 
Event Description
Analysis of the generator was completed on 07/16/2015. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications the battery shows an ifi=yes condition. In the pa lab there were no performance or any other type of adverse conditions found with the pulse generator. The generator decoder identified that the generator was at a near end of service.
 
Event Description
Additional information was received stating that vns patient¿s device showed the pulse disablement message prior to the mri. The patient¿s device was programmed on back to her previous device settings after the mri. Attempts for additional relevant information, including a copy of the software flashcard, have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3782239
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dennis100
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« Reply #1005 on: January 10, 2019, 01:52:36 AM »

Model Number 103
Event Date 12/17/2013
Event Type  Malfunction   
Event Description
Additional information was received that the patient the patient had a generator replacement. The generator was returned to the manufacturer for evaluation. Product analysis is un process but has not been completed.
 
Manufacturer Narrative

Event Description
It was reported that the physician was planning on replacing the patient's generator because it's "indicating the need for replacement". The physician indicated that this seems odd. It was later reported that the generator showed ifi and surgery was cancelled. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
On (b)(6) 2014, it was reported that the current device was programmed to 3 ma output current, 1. 8 minute off time, and 500 usec pulsewidth. The patient is implanted with a model 103 generator. Review of battery longevity tables show that if the device was programmed to the above output current and pulsewidth at a 33% duty cycle, the device would likely reach ifi status (from beginning of life) in 1. 4 years.
 
Manufacturer Narrative
Brand name , corrected data: previously submitted mdr indicated that this was unknown; however, the device appears to be a model 103 generator information. Model #, corrected data: previously submitted mdr indicated that the model was unknown; however, this should be 103. This report is being submitted to correct this information. If implanted, give date (mo/day/yr), corrected data: previously submitted mdr indicated that this was unknown; however, the device was originally implanted in 2012. This report is being submitted to correct this information.
 
Event Description
Additional information was received that the patient is scheduled for generator replacement on (b)(6) 2014. No information has been received indicating whether or not surgery was performed as scheduled.
 
Event Description
Additional information was received that the product analysis was completed on the generator. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2. 035 volts, indicating a neos condition. However, during a diagnostic test attempt, the battery voltage dropped less than 2. 00 volts, which shows that the battery is depleted (eos) when the device attempts to enter a functional mode. The data in the diagaccumconsumed memory locations revealed that 93. 431% of the battery had been consumed. The post burn-in electrical test results show that the pulse generator module performs according to functional specifications. Other than the noted events, there were no additional performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3658664
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« Reply #1006 on: January 10, 2019, 01:54:07 AM »

Model Number 103
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
The explanted generator has been returned to the manufacturer where analysis is currently underway. An implant card was received indicating that the generator replacement surgery was prophylactic due to ifi = yes.
 
Event Description
Additional analysis was completed on the generator on 01/27/2015. The generator was opened for additional testing. The battery voltage measured 2. 855 volts with the module attached to the battery. The current drain was 3. 22 micro amps. No visual anomalies were noted during visual examination. The battery voltage and the input to the a/d, that measures the battery voltage, were assessed while performing a vbat test. The battery voltage measured 2. 765 and the input measured 934mvolts. The input measured approximately one-third of the battery voltage, which according to design indicates the properly level for the input to a/d. All testing was performed at room ambient temperature. The module was removed from the battery and connected to a power supply. Vbat measure tests were performed with the power supply set to various voltages between 2. 0 and 3. 0 volts (the vbat trim values had not been changed from the as received values). Results of testing indicate that the vbat measurements are being read correctly by the module. The post burn-in electrical test results show that the pulse generator module performs according to functional specifications. Summary: results of testing indicate that the module is reading the battery voltage properly. No excessive current drain was noted when the current drain was measure while attached to the battery or during post burn-in test.
 
Event Description
Addendum product analysis was completed and approved on (b)(6) 2015: additional testing was requested on the pulse generator to monitor the battery status and voltage calculation. The pulse generator was re-assembled with the original battery. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Interrogation and system diagnostic tests were performed at various intervals in order to monitor battery and ifi status. Results of the additional testing indicate that the pulse generator is reading the battery voltage properly. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional programming and diagnostic history was received on (b)(4) 2014. Review of the available programming and diagnostic history confirmed ifi = yes upon interrogation on (b)(4) 2014. Additional information was received from the surgeon stating that electrocautery was used only to open up the generator pocket to explant the previous generator during the generator replacement surgery that occurred in (b)(6) 2013. Diagnostic results with the replacement generator and the existing lead revealed normal device function when tested both inside and outside of the generator pocket. The surgeon noted that he did not use electrocautery after the replacement generator was implanted. Review of the device data revealed the device's battery voltage decreased from 3. 281v on (b)(6) 2013 to 2. 772v on (b)(6) 2014, indicating there was a drop of battery voltage that occurred in between these office visits with no other contributory factors such as increased lead impedance. The patient was referred for surgery by his neurologist to have the device replaced, primarily because the patient was experiencing an increase in seizures and the ifi condition of the device. There were no changes to medication which may have caused or contributed to the increase in seizures. Surgery has not occurred, and no known interventions have occurred to date.
 
Event Description
It was reported that the patient was seen on (b)(6) 2014 and that the device is still showing ifi = yes. It was reported that the patient is high functioning and is of a personality that is "mischievous". The physician reported the patient experienced an increased level of seizure activity with no medication changes. It was reported that the neurologist would like to wait about three months and to reassess the patient at that time. However, it was reported that the surgeon is anxious to get the generator replaced due to situation and wanting to know what happened with the device. It was later reported that the patient was scheduled for generator replacement. Generator replacement occurred on (b)(6) 2014. The generator is expected to be returned for analysis, but has not been received to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: follow-up report #7 inadvertently listed incorrect date received. Date should have been 05/11/2015.
 
Event Description
Analysis of the returned generator was completed. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed the device¿s battery voltage decreased from 2. 772v on (b)(6) 2014 to 2. 59v on (b)(6) 2014. Using the generator battery longevity table at the patient¿s last known programmed settings on (b)(6) 2014, the approximate battery life from beginning of life (bol) to end of service is 1. 9 years.
 
Manufacturer Narrative

Event Description
It was reported that during additional testing of the generator, diagnostics have been performed each week and all behavior has been as expected. The original battery was reattached and battery voltage measurements have been taken showing nothing out of the ordinary.
 
Event Description
It was reported that the patient's generator showed ifi = yes upon interrogation. The physician indicated that this was not expected as the generator was just implanted in (b)(6) 2013. It was reported that the patient was admitted over the weekend for seizures. The physician reported that a system diagnostic test was ok and that the patient has been ok since generator replacement. The physician believes that something may have happened after the surgery. Clinic notes dated (b)(4) 2014 note that the ifi is on. It was later reported that the surgeon is refusing to take the patient back for surgery as he does not believe there is anything that he could have done to warrant the patient to go back in for surgery. The surgeon reported that electrocautery is not used on the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3661074
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« Reply #1007 on: January 11, 2019, 02:29:27 AM »

Model Number 103
Event Date 03/26/2014
Event Type  Malfunction   
Event Description
Analysis of the generator was completed on 10/28/2014. The pulse generator was placed at a distance of one-inch (spacer block) from the programming wand and interrogated at multiple orientations adjacent to the programming wand. The pulse generator interrogated at all orientations. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. The patient¿s generator could not be interrogated during the procedure prior to replacement. The programming system is not expected to have caused or contributed to the event as it has successfully interrogated with other generators following the replacement surgery. A battery life calculation using the available programming history and prediction tables showed approximately 4. 8 years from beginning of life to end of service. The explanted generator has been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3761647
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« Reply #1008 on: January 12, 2019, 03:52:35 AM »

Model Number 105
Event Date 03/11/2014
Event Type  Malfunction   
Event Description
An implant card was received indicating that the vns patient¿s generator was replaced due to neos = yes. Additional programming and diagnostic history was received showing normal diagnostic results through (b)(4) 2013.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
It was reported that the vns patient's generator showed ifi - yes. The physician reported that the generator must be faulty as it was implanted in (b)(6) 2013. It was reported that the patient underwent another surgery in (b)(6) 2013. It was reported that device diagnostics were within normal limits. The patient was referred for generator replacement. The patient underwent generator replacement on (b)(6) 2014. The generator is expected to be returned for analysis, but has not been received to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the explanting facility will not returned explanted devices without patient consent; therefore, device analysis cannot not be performed.
 
Manufacturer Narrative

Event Description
Follow-up with the surgeon was performed, and he reported that electrocautery was not used during the repositioning surgery on (b)(6) 2013 or during any other procedures between implant in (b)(6) 2014. It is known and addressed in device labeling that exposure of electrocautery or rf device can damage the generator and cause premature depletion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3734824
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« Reply #1009 on: January 14, 2019, 03:24:04 AM »

Model Number 103
Event Date 04/22/2014
Event Type  Injury   
Event Description
It was reported that the patient underwent generator replacement due to battery depletion. The explanted generator was received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the explanted generator was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The reported ifi=yes battery status was duplicated. There are no performance or any other type of adverse conditions that would have effect on battery longevity found with the pulse generator.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 and (b)(6) 2014 were received indicating that the vns patient was experiencing seizures daily. Notes dated (b)(6) 2014 indicate that the patient was having breakthrough seizures. The neurologist stated that the patient¿s device may not be working. The patient¿s device settings and medication were increased. The patient¿s device was at an ifi condition. The patient was referred for surgery but no known surgical interventions have occurred to date. Using the generator battery longevity table at the patient¿s last known programmed settings on (b)(6) 2014, the approximate battery life from beginning of life (bol) to end of service is 2 years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3827970
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« Reply #1010 on: January 15, 2019, 01:39:30 AM »

Model Number MODEL 250
Event Date 04/16/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was hard to power on after being charged. Once the handheld powered on an interrogation was attempted at which time the handheld powered off. Upon restarting the handheld an error message was obtained indicating that the battery door latch was open. Troubleshooting confirmed that the latch was closed; however, it was noted that the door appeared to be bowed. The battery was confirmed to be normal in size and the handheld was stored at normal recommended temperatures. The battery confirmed to be at 100% and again shut down with the same error message being received upon restarting a second time. A new programming computer was provided to the physician and the handheld and flashcard were returned for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The handheld analysis was completed on (b(4) 2014. No anomalies associated with the battery latch were identified. During the analysis it was identified that the main battery was swollen. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus causing the handheld to power off. No further anomalies were identified. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3812355
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« Reply #1011 on: January 16, 2019, 01:22:36 AM »

Model Number 102R
Event Date 07/11/2006
Event Type  Malfunction   
Manufacturer Narrative
The generator was found to have a leaky capacitor, potentially contributing to a premature end of service condition.
 
Event Description
Analysis of a generator explanted for end of service was completed on (b)(4) 2014. The supply current tests did not meet functional specifications. These measurements demonstrate an increased current consumption for the device, potentially contributing to a premature end of life condition. The increased current consumption was isolated to a leaky capacitor (c4). A battery life estimation resulted in 0. 48 years remaining before the eri flag would be set. However, an incomplete programming history indicates the estimation does not use all the data required to make an accurate estimation. With the capacitor substitution for c4, the pulse generator module performed according to functional specifications. The most probable root cause for the premature end of life condition was identified to be a leaky capacitor, c4. The cause for the c4 capacitors increase in leakage could not be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800932
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« Reply #1012 on: January 16, 2019, 01:23:22 AM »

Model Number 102
Event Date 04/02/2014
Event Type  Malfunction   
Event Description
The physician reported that the programming system issue has resolved and no further issues have been observed. The physician reported that the patient does not have an appointment scheduled until (b)(6) 2014 and that the patient has not had any complaints or concerns.
 
Event Description
It was reported that the patient's device was unable to be interrogated. The physician performed troubleshooting and identified that an error message indicated "procedure failed, error in communication". The physician's office indicated that this is the first occurrence that this message had been received. The physician ensured that the programming system was not plugged into the wall and that all cables were secure; however, the issue still occurred. The physician requested that a company representative come troubleshoot the programming system. A company representative performed troubleshooting on the physician's handheld. It was reported that the handheld was not recognizing the new version software that was installed in the handheld. The company representative performed and hard reset and loaded the new software successfully. It was also determined that the wand battery was depleted, which was replaced. The handheld and wand successfully interrogated and performed diagnostics on demo generators. The patient has not been seen again since the troubleshooting on the programming system; therefore, it is unknown whether or not the patient's generator is now able to be communicated with.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3787195
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« Reply #1013 on: January 17, 2019, 01:31:03 AM »

Model Number MODEL 250
Event Date 04/29/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that there were battery issues with the handheld device. A hard reset was performed and the handheld device was fully charged; however, the battery issues did not resolve. The handheld device has not been returned to date.
 
Manufacturer Narrative
Date of event; corrected data: additional information updated the date of event. Name and address, title, first name, last name, facility name, address, city; corrected data: additional information updated the initial reporter. Occupation; corrected data: additional information updated the initial reporter.
 
Event Description
Additional information was received stating that the handheld device will not be returned to the manufacturer for analysis. A replacement battery is expected to be utilized to resolve the reported issues with the handheld.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3888538
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« Reply #1014 on: January 18, 2019, 02:33:24 AM »

Model Number 201
Event Date 05/14/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Additional information received revealed that the issue was actually with the programming wand not holding a charge, not the handheld computer. The site thought that charging the handheld device also charges the wand and did not realize the wand used a 9v battery. A company representative provided the physician¿s office training on how to replace the 9v battery and the site has not experienced any further issues. Nothing will be returned at this time as all the components of the programming system are functioning properly.
 
Event Description
It was reported that the physician's handheld will not hold a charge. The physician reported that the handheld screen would "fade" shortly after being unplugged from the wall. The physician requested a new programming computer. The handheld and flashcard are expected to be returned for analysis, but have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3869933
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« Reply #1015 on: January 19, 2019, 03:29:15 AM »

Model Number 103
Event Date 05/30/2014
Event Type  Malfunction   
Event Description
The unused generator has been returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported that during lead replacement surgery on (b)(6) 2014 due to high impedance, the vns patient¿s replacement generator was interrogated and showed pulse disablement. The generator was not used and a different generator was implanted. The pulse disablement is believed to be due to electrocautery that was used during the procedure. The unused generator has not been returned to date. The high impedance was reported in manufacturer report # 1644487-2014-01214.
 
Event Description
On (b)(4) 2014 product analysis was completed on the explanted generator. Review of the data indicated that the pulse disabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3892636
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« Reply #1016 on: January 20, 2019, 01:41:09 AM »

Model Number 105
Event Date 05/22/2014
Event Type  Malfunction   
Event Description
On (b)(6) 2014, it was reported that this vns patient's generator was explanted on (b)(6) 2014 because the generator failed during testing. Follow-up showed that no troubleshooting was recorded in the operative note. Per the surgeon's office, the device was successfully communicated with on (b)(6) 2013 (date of implant) at which time, the device was not programmed on. The explanted generator has been returned to the manufacturer where analysis is currently underway. Review of manufacturing records confirmed that the suspect device passed all functional tests prior to distribution.
 
Event Description
Analysis of the returned generator was completed. A failure was noted in the output circuit of the generator to deliver a pulse between the positive and negative electrodes. The no output condition was due to a failure of the asic to deliver a pulse on the positive output pin. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant. The no output condition is possibly due to damage by the use of electro-cautery. It also noted that the battery was swollen, indicating that the generator was in a high current state at one point. Review of the available programming and diagnostic history along with the decoder data from the generator replacement procedure on (b)(4) 2013 showed that the final system diagnostic test performed that day had the pulse status as enabled, indicating that the pulse disablement likely occurred due electrocautery used during the explant procedure on (b)(4) 2014.
 
Manufacturer Narrative
Review of the available programming/diagnostic history and decoder data.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Manufacturer Narrative
Describe event or problem, corrected data: previously submitted mdr indicated that burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant; however, this should have reflected that the exposure occurred at device explant. This report is being submitted to correct this information.
 
Event Description
The information available indicates that the exposure to electrocautery occurred at the time of explant, not implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3965041
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« Reply #1017 on: January 20, 2019, 01:42:18 AM »

Model Number 103
Event Date 06/27/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the recently implanted vns patient¿s device was interrogated during an office visit on (b)(6) 2014. The device showed a message stating ¿vbatt < eos threshold. ¿ the neurosurgeon stated that electrocautery was not used during the implant procedure. The patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator was completed. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The device showed a non-ifi condition. Other than the noted event, there were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3963735
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« Reply #1018 on: January 21, 2019, 11:11:06 AM »

Model Number 103
Event Date 06/18/2014
Event Type  Malfunction   
Event Description
Analysis of the handheld was completed on (b)(6) 2014. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. Analysis of the flashcard was completed on (b)(6) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Programming history from the handheld showed that device interrogation on 06/18/2014 showed the battery status as ok.
 
Manufacturer Narrative

 
Manufacturer Narrative
New information corrects the date of event. This was inadvertently left off of follow-up mfr. Report #01.
 
Event Description
The programming history decoder identified that the interrogation performed on (b)(6) 2014 identified no problems with the device. The lead impedance was within normal limits (2465 ohms). No anomalies were identified.
 
Manufacturer Narrative
Corrected data: initial and follow-up mfr. Report inadvertently reported on the incorrect suspect device.
 
Event Description
It was reported that while attempting interrogation on a vns patient's generator the handheld showed a "check sum" error and showed the generator at 50% battery life. It was reported that the patient's generator had been recently implanted. Another handheld was utilized and the interrogation was successful and no longer showed 50% battery life. A new programming tablet was requested and the handheld was returned for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3938452
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« Reply #1019 on: January 22, 2019, 04:50:50 AM »

Model Number 201
Event Date 06/18/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the programming system was able perform interrogations without any issues after replacing the 9v battery of the programming wand.
 
Manufacturer Narrative
Brand name; corrected data: additional information indicates that the suspect device is the programming wand. Type of device, name; corrected data: additional information indicates that the suspect device is the programming wand. Model #, serial #, lot#, other; corrected data: additional information indicates that the suspect device is the programming wand. Device manufacture date; corrected data: additional information indicates that the suspect device is the programming wand.
 
Manufacturer Narrative

Event Description
It was reported that the handheld was successfully used to interrogate several patient's devices. It was determined that once the unit was unplugged from the electrical outlet no further issues were observed.
 
Event Description
It was reported that the physician's handheld is giving the physician problems. It was reported that there is no connection with the generator and the handheld. The physician attempted to change the battery and check connections without result. The physician requested a new programming computer. The handheld 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=3936485
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