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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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