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dennis100
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« Reply #1230 on: July 11, 2019, 12:43:11 AM »

Model Number 105
Device Problem Premature End-of-Life Indicator
Event Date 05/12/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient's device was suspected to be defective due to possible premature battery depletion. Patient's device was interrogated and battery was observed to be at 5-11%. A battery life calculation was performed and the results shows that the device should have greater than 10 years until neos- yes. A review of device history records for the generator and lead shows that no unresolved non-conformance's were found. Based on the decoder data, there appears to be a discrepancy between the battery consumed and the remaining battery capacity. The battery capacity remaining and battery voltage seems to be much less than expected and indicates that the generator battery is depleting prematurely. Results 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7815240
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dennis100
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« Reply #1231 on: July 11, 2019, 12:44:56 AM »

Model Number 106
Event Date 05/29/2019
Event Type  Injury   
Event Description
Implanted device was not working properly. Removed a few months later due to battery defect. Manufacturer took the implanted device that was explanted. New implant placed. Manufacturer response for vns, (b)(4) cyberonics (per site reporter). No response yet.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8695295
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dennis100
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« Reply #1232 on: July 11, 2019, 12:46:15 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/15/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported via clinic notes received by the manufacturer that the patient was referred for vns generator replacement surgery due to battery depletion. It was stated that the device was at end of service, or eos, and not delivering stimulation. It was reported later that the vns was unable to be interrogated. The patient underwent vns replacement surgery and the implant and warranty registration form received indicated that the replacement was prophylactic. Follow up with the company representative revealed that there was concern that the device was going to be depleted and was at an intensified follow-up indicator, or ifi, condition. During attempts at product return, it was revealed that the facility, historically, discards all explanted products after gross examination. Over a year after the explant of the device, the patient's father reported that he believed the vns generator had prematurely depleted as it had only lasted two years. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The device was manufactured using the laser routing process. The patient's internal generator data was reviewed from the manufacturer's programming history database and based on the measured vbat compared to the calculated expected vbat, the battery had depleted faster than expected. The data indicated that the device was at an eos condition as previously alleged and had rebounded back to an ifi condition by the time the surgery had occurred. 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 additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8738539
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dennis100
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« Reply #1233 on: July 11, 2019, 12:47:06 AM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 06/27/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The generator was explanted and returned due to prophylactic replacement. No allegations were made against the vns generator. During product analysis, a visual assessment on the printed circuit board assembly (pcba) showed contaminates on the trimmed edge of the pcba. The contamination that was observed on the trimmed edge of the pcba suggested probable resistive electrical paths were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions. 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. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8727556
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dennis100
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« Reply #1234 on: July 11, 2019, 12:48:04 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 08/13/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
An implant card was received indicating the patient received a prophylactic replacement. The explanted generator was returned for product analysis. Generator analysis was completed and approved. Product analysis verified the battery to be at ifi=yes. The battery, 2. 688 volts (ifi range 2. 41v - 2. 74v) shows an ifi=yes condition. The data in revealed that 46. 019% of the battery had been consumed. Contamination was observed on the trimmed edge of the pcba (printed circuit board assembly) with contributed to the supply current conditions and increased current consumption. This may have been a contributing factor to the low battery condition of the generator. A device history review was performed and confirmed that all parameters passed inspection and the generator of interest is part of the laser routing issue which would cause premature end of service.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8699528
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dennis100
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« Reply #1235 on: July 11, 2019, 12:48:53 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 06/14/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The patient's physician expressed concern that the patient's generator battery has prematurely depleted. The device history record of the generator was reviewed, and the device passed all functional specifications prior to release. It was confirmed that the device was not manufactured during the time that m106 and m105 generators were laser-routed. The physician's office informed that they no longer have access to the programming system used to interrogate the patient's device, and therefore no programming history data is currently available for review. No other relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8676376
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dennis100
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« Reply #1236 on: July 11, 2019, 12:50:08 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   
Manufacturer Narrative
 
Event Description
It was reported that a patient has experienced severe, worsening seizures. Upon interrogation it was found that "5-10%" (ifi=yes) of the battery remained, and that the total on time was 2400 hours. It was noted that the patient has always been at moderate to low settings, and that it is believed that the battery has not performed up to its expectations. It was mentioned that the patient is being referred immediately for battery replacement. The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process. 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. 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=8670843
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dennis100
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« Reply #1237 on: July 14, 2019, 04:09:28 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 08/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the generator had only been implanted for about a month when the 11-25% battery status indicator was seen by the physician. The generator was programmed to very high settings, but the battery would not be expected to be that low within one month. Data from the generator was reviewed, which indicated that the 11-25% battery status may have been related to beginning-of-life battery impedance leading to a false low battery warning. The battery voltage in these cases usually rebounds over time. However, further data has not been reviewed, so this case cannot be confirmed. The device history record of the generator was reviewed, and the device conformed to all specifications prior to release. No further relevant information has been received to date. No surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7812343
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dennis100
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« Reply #1238 on: July 14, 2019, 04:10:11 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 06/05/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Initial report was that a physician was inquiring about whether or not the patient¿s device had prematurely depleted. The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process. 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. Clinic notes were received for the patient. Clinic notes indicated that the vns battery had dropped significantly since the patient¿s last office visit. 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=8744926
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dennis100
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« Reply #1239 on: July 16, 2019, 11:08:06 PM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 05/18/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient's device was unable to be interrogated, even after 10 attempts. It was noted that the patient may have gained weight, though the family did not think so. The company representative was unable to locate the generator despite multiple attempts. The scar and scar tissue could be seen, but the device could not be located. The device was not believed to be dead as it was implanted two years ago and the patient was at relatively low settings that have not been changed. It was further noted that in the past, they have had difficulty interrogating the device, but usually ended up being able to. The physician questioned if the issue was due to implant depth, weight gain, or device migration, and the patient was referred for exploratory surgery to possibly relocate the generator to a "better location". The surgery was not to preclude a serious injury. It was confirmed that non-absorbable suture was used to secure the generator at implant. A battery life calculation was performed and with the data available, it confirmed that it was unlikely that the device had depleted. The patient underwent a battery replacement surgery due to failure to communicate. Pre-operation interrogation was not successful due to suspected deep implant depth. The old generator was explanted and interrogation was attempted multiple times with the device still connected to the leads and the programming wand placed directly on top of the generator. After replacing the generator, interrogation with the same programming system was performed successfully, with impedance within normal limits. The explanted generator was returned for analysis. Analysis was completed and it was found that the generator could not be interrogated when it was received so further diagnostic and electrical testing could not be performed. The battery was measured and confirmed an end of service condition. The pcba was tested with the battery removed, fine grit sandpaper was used to remove observed contaminates form the trimmed edge of the pcba. Based on the test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions and the failure to program. 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 further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7911405
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dennis100
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« Reply #1240 on: July 16, 2019, 11:08:43 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/01/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by the patient's physician that he was unsure if the patient's vns had depleted prematurely. He stated that the patient previously had a seizure and the vns was interrogated and found to have reached end of service, or eos. The patient underwent vns generator replacement surgery. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The generator was found to be laser routed. During attempts at product return, it was revealed that the facility had disposed of the explanted generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7784093
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dennis100
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« Reply #1241 on: July 23, 2019, 12:31:09 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
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=8186309
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dennis100
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« Reply #1242 on: July 23, 2019, 12:31:49 AM »

Model Number 1000
Device Problem Premature End-of-Life Indicator
Event Date 11/16/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that this new and unused generator was interrogated during a patient¿s replacement surgery and the error code stating eos was continuously seen by the surgeon. It was stated that the surgeon has a lot of experience with vns and it was decided to not implant this device. Additional information was received from the operating room staff that the generator was not able to be interrogated at all during the surgery. The unused generator has not been received by the manufacturer to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8150651
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dennis100
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« Reply #1243 on: July 23, 2019, 12:32:30 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
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. It was noted that per the last set of data, the device was disabled. 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=8187455
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dennis100
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« Reply #1244 on: July 23, 2019, 12:33:07 AM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 08/14/2015
Event Type  Malfunction   
Manufacturer Narrative
 
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=8185761
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dennis100
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« Reply #1245 on: July 27, 2019, 12:23:27 PM »

Model Number 302-20
Device Problem Fracture
Event Date 02/18/2018
Event Type  Malfunction   
Event Description
It was reported that the physician that the patient had high impedance, and that the physician believed that the generator was prematurely depleting. The physician had originally attributed the high impedance to the patient's falls. The battery had been implanted for two years and was showing intensified follow up indicator. Data was reviewed for the generator, and the generator had high impedance for over a year. The patient¿s generator had been left on at high settings. A battery life calculation was made using the patient's settings and impedance confirmed the battery depletion was expected. Surgery is likely but has not occurred to date. No additional information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8345713
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« Reply #1246 on: July 27, 2019, 12:24:04 PM »

Model Number 103
Event Date 01/06/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient';s vns generator was unable to be interrogated on two different occasions on (b)(6) 2016. The physician's office suspected that the issue was with their programming system but were unable to rule out the patient's generator as being a cause. The programming wand battery was checked and the power light did not turn on at all during troubleshooting. It is suspected that the 9 v battery might have been depleted, resulting the failure of communication. The battery was changed and the wand was confirmed to be working properly. The programming system worked properly with the demo generator but the patient's generator could not be confirmed. The patient was in a car accident recently and experienced two grand mal seizures since then. The reason for the patient's visit was to check the device function to ensure that there were no lead related issues due to the car accident.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5518753
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dennis100
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« Reply #1247 on: August 09, 2019, 11:00:43 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 06/06/2019
Event Type  Malfunction   
Event Description
It was reported that a m106 generator stored in the hospital's "stock" was dead upon initial interrogation. It was mentioned that over 25 interrogations were performed, and then they attempted several more interrogations with the lead connected. It was noted that they had the wand placed directly over the generator, however they kept receiving a "generator not found" message. Further follow up confirmed that the generator was unable to be interrogated while it was still within the sterile packaging. After three failed attempts with the m106 generator, an interrogation of a m1000 generator was attempted with no issue. It was noted that electro-surgery tools were used to open the patient to remove the old device, however by the time the generator was removed from the sterile packaging and placed in the patient, there were no electro-surgery tools in the field. It was confirmed that the generator was stored in the implant room at the hospital, and the conditions of the room were exceptional, described as room temperature and dry. A review of the device history records confirmed no unresolved non-conformances for the generator, and confirmed that the device met all specifications for release prior to distribution. Additionally, it was confirmed that the device was not manufactured with the laser routing process that left certain devices susceptible to premature battery depletion. The generator was received for product analysis. 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=8754711
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dennis100
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« Reply #1248 on: August 09, 2019, 11:01:28 PM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 06/14/2019
Event Type  Malfunction   
Event Description
A report was received that during a prophylactic generator replacement for a patient, the surgeon found a small slit in the tubing and could visibly see fluid in the lead. However, the physician questioned whether the fluid in the lead could have been the reason for the shorter life span of the generator at the patient's pre-op settings. A full revision was performed at this time. A manual manufacturer's battery life calculation was performed with additional data provided by the sales representative and operating room specialist. The result revealed expected time to neos = 4. 8 years. Device history records were reviewed and the device passed all functional specifications and quality tests and were sterilized prior to distribution. The suspect device has been explanted but has not been received for analysis to date. No additional relevant information has been received to date. The fluid leak is reported in mfg report 1644487-2019-01323 as there is no confirmed relationship between the generator's premature battery depletion and the fluid leaks, as impedance was within normal limits prior to surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8773208
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dennis100
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« Reply #1249 on: August 09, 2019, 11:02:07 PM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 08/18/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's generator was replaced prophylactically. The generator was returned and underwent product analysis where evidence of premature battery depletion was found. Upon opening the generator can, visual analysis identified contaminates on the trimmed edge of the printed circuit board assembly (pcba). The post burn electrical test indicated that the contamination on the trimmed edge of the pcba was suggestive of probable electrical paths that were established between the copper edges, which could contribute to premature battery depletion. No further anomalies were identified with the generator outside of the contaminates and premature battery depletion and the generator performed according to functional specifications. The device history record of the generator were reviewed and indicated that the generator passed functional specifications prior to distribution, and it was confirmed that the device was laser-routed during the manufacturing process. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8762960
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« Reply #1250 on: August 09, 2019, 11:02:47 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 08/19/2015
Event Type  Malfunction   
Event Description
It was reported that the battery was replaced due to low battery ifi = yes condition. During product analysis, it was found that the battery had prematurely depleted contributing to the ifi = yes condition. Product analysis was performed on generator that was explanted and returned due to a low battery status(ifi-yes). A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The generator was interrogated and found to be at an ifi ¿ yes condition. A visual assessment on the pcba (printed circuit board assembly) showed contaminates on the trimmed edge of the pcba. The series resistor voltage 0. 080mv, which translates to 8. 0ua stand by current (supply current off-time (limits 1ua ¿ 5ua)), as measured at the product analysis bench, shows an increased current consumption (out of speciation) for the pulse generator. It was hypothesized that the trimmed edge of the pcba was disturbed during the open can process, removing the resistive paths that were established between the copper edges on the trimmed edge of the pcba. Therefore, the electrical performance of the generator, as measured in the pa bench, will be used to conclude that the contamination that was observed on the trimmed edge of the pcba suggested probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the ifi=yes condition. Other than the noted pcba debris, there were no performance or any other type of adverse conditions found with the pulse generator. 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. The date of the trim test operation indicates the device was manufactured with the laser routing process that left certain devices susceptible to premature battery depletion. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764882
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« Reply #1251 on: August 09, 2019, 11:03:21 PM »

Device Problem Premature End-of-Life Indicator
Event Date 06/27/2019
Event Type  Malfunction   
Event Description
It was reported by the physician that a patient's battery has prematurely depleted in the past but no patient information was provided. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8811433
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« Reply #1252 on: August 09, 2019, 11:03:56 PM »

Model Number 105
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 06/17/2015
Event Type  Malfunction   
Event Description
The patient's physician informed that the generator battery status was ok in (b)(6) 2019, however the battery indicator in (b)(6) 2019 was now registering intensified follow up indicator (ifi-yes) status. It was mentioned that the patient was having increased seizures, which prompted the doctor to check the batter status and discover the ifi indicator. The patient is now being referred for generator replacement. The patient's mother was concerned that the generator battery depleted fast than expected. The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process. 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. 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=8786040
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« Reply #1253 on: August 09, 2019, 11:04:27 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 06/25/2019
Event Type  Malfunction   
Event Description
It was reported that the patient's neurosurgeon and father requested a detailed report of the patient's generator as they believe the generator battery depleted prematurely. The patient was referred for vns generator replacement. 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 and was manufactured with the use of laser routing. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8781095
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« Reply #1254 on: August 09, 2019, 11:05:00 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/01/2019
Event Type  Malfunction   
Event Description
It was reported that the physician believed the patient's vns generator battery was depleting quickly. The physician stated that the patient had been implanted a little over a year. Review of the manufacturer's records indicated the patient as being implanted for almost two years. A review of device history records revealed that the generator passed quality control inspection prior to distribution and was manufactured after the laser routing process was discontinued. The tablet data for the generator was received and reviewed by the manufacturer. No battery status indicator flag was present and there was no indication that premature battery depletion was present. The values indicate that the battery was right around 50%, which also aligns with the measured battery voltage. Based on the battery longevity tables in the vns therapy system epilepsy physician's manual and the programmed settings, as the device has not yet reached the 25% indicator and based on the assessment of pcbr values in the decoder, it appears that the device was depleting as expected. Clinic notes were later received by the manufacturer approximately half a year later and indicated that the patient's vns is at 11-25%. The physician stated that the duty cycle was only 35% and that the battery was depleting rapidly. As a battery status indicator was now observed and the physician was alleging rapid depletion again, a new instance of peol was captured and investigated accordingly. The patient underwent vns generator replacement surgery reported as prophylactic. During attempts at product return, it was revealed that the facility historically discards explanted products per their policy. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8827764
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dennis100
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« Reply #1255 on: August 09, 2019, 11:05:43 PM »

Model Number 103
Device Problem Insufficient Information
Event Date 05/05/2014
Event Type  Malfunction   
Event Description
It was initially reported that a patient was having their device replaced and no information regarding the reason for replacement was received. Information regarding the return of the generator was received and generator was received into analysis, with reason for explant on the return product form noted to be due to"hardware failure". Device history records were reviewed for the generator and any defects and changes that were found during manufacturing of the device were signed off on and approved prior to the product being released. The device ultimately passed all functional specifications and quality tests and were sterilized prior to distribution. Per the explant surgeon, no further details from this replacement are known and it was stated that the only note regarding the patient's generator replacement was that the generator was at end of life. Per the referring physician, the hardware failure was in reference to the generator battery being depleted and the battery life being too short and only lasting two years, when he thought it would last 5 years. However, it was found that the physician was referring to the patient's recent generator which was reported to have prematurely depleted, reported in mfr report# 1644487-2018-00490. The generator has been received into analysis and product analysis has not been completed at this time. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8773479
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dennis100
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« Reply #1256 on: August 09, 2019, 11:06:20 PM »

Model Number 105
Device Problem Premature End-of-Life Indicator
Event Date 06/25/2019
Event Type  Malfunction   
Event Description
It was reported that the patient's generator is thought to be depleting too quickly. Since this device is included in the m105 field action, the device was identified as one that was manufactured using the laser-routing process, which may have led to the premature battery depletion. The device history records were reviewed and confirmed that the device was manufactured when laser-routing was in use. The device met all specifications for release prior to distribution. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8794261
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dennis100
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« Reply #1257 on: August 09, 2019, 11:06:55 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/05/2019
Event Type  Malfunction   
Event Description
It was reported that a surgeon wanted the patient's generator evaluated by the manufacturer as they suspected the battery depleted prematurely. The generator was replaced prophylactically and the battery status showed 11-25% remaining at the time of the replacement. The device history records were reviewed and indicated the generator passed all functional specifications prior to distribution and the generator was not subjected to the laser routing process per the trim test tab date. The suspect product has not been received by the manufacturer for product analysis to date. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8842651
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dennis100
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« Reply #1258 on: August 09, 2019, 11:07:28 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 06/26/2019
Event Type  Malfunction   
Event Description
Physician reported that the patient's generator was depleting faster than expected. 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 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=8809059
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dennis100
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« Reply #1259 on: August 09, 2019, 11:08:05 PM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 06/16/2016
Event Type  Malfunction   
Event Description
The generator was explanted and returned due to battery depletion. No allegations were made against the vns generator at time of explant. During product analysis, a visual assessment on the printed circuit board assembly (pcba) showed contaminates on the trimmed edge of the pcba. The contamination that was observed on the trimmed edge of the pcba suggested probable resistive electrical paths were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions. 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. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8836372
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