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dennis100
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« Reply #1170 on: May 10, 2019, 11:16:57 PM »

Model Number 103
Device Problem No Display / Image
Event Date 12/18/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's battery indicated 18-25% life remaining during an interrogation. It was reported that approximately 3 months later the patient's battery life indicator showed 50-75% remaining. A review of the device history records for the generator was performed and showed that no unresolved non-conformances were found and that the device met all functional specifications prior to distribution. The internal data of the generator from the two interrogation dates mentioned was reviewed. The percent battery remaining, based on the battery voltage when the generator showed 18-25% battery life remaining indicated that there was approximately 24% battery remaining. The percent battery remaining, based on the battery voltage, from 3 months later indicated approximately 60% battery life remaining. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8483157
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dennis100
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« Reply #1171 on: May 10, 2019, 11:17:48 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 06/14/2016
Event Type  Malfunction   
Event Description
The patient's device was explanted and the generator was returned and analysis was approved. The electrical tests performed in the analysis lab found that the device was measured at a voltage of 2. 617 volts confirming that the device was at the ifi = yes condition. However, the memory locations revealed that 30. 817% of the battery had been consumed. Due to this disparity, the pulse generator was opened and further tests were conducted. With the battery still attached to the circuit board (pcba), the voltage was measured at 2. 54 volts confirming the ifi = yes condition. A visual assessment of the pcba showed contaminants on the trimmed edge of the pcba. The device failed several postburn electrical tests; however after the contaminants were removed from the trimmed edge of the pcba, the device passed all but two test which were failed due to the test software requiring updates. The contaminants on the pcba suggest probable electrical paths were established which contributed to the supply current conditions. The analysis therefore concluded that the contaminants on the pcba may have been a contributing factor to the ifi = yes. Therefore there is evidence that the battery is depleting faster than expected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8499145
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dennis100
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« Reply #1172 on: May 10, 2019, 11:18:48 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 03/15/2019
Event Type  Malfunction   
Event Description
It was reported that, during a generator replacement surgery, a new m106 generator showed an ok battery status prior to being placed in the patient; however, after being placed in the patient the battery status was low. The generator was not left implanted as it was replaced. The physician reported that electrocautery was used during the surgery. Diagnostic tests from the surgery confirmed an end-of-service (eos) battery status. 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. Given that the device was at neos/eos, the low output current from both generator diagnostics test is an expected event due to the low battery. Additionally, the neos is likely due to the battery voltage increasing very slightly during the surgery, but again reaching the eos status after programming and diagnostics testing which is expected to further drain the battery. The suspect generator has not been received to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8496073
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dennis100
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« Reply #1173 on: May 10, 2019, 11:19:53 PM »

Model Number 1000
Device Problem Energy Output Problem
Event Date 03/19/2019
Event Type  Malfunction   
Event Description
It was reported that a patient was being interrogated and system diagnostics showed that the patient had low output current. When the patient ran system diagnostics again output current was normal. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8508610
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dennis100
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« Reply #1174 on: May 10, 2019, 11:20:46 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/10/2015
Event Type  Malfunction 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8551798
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dennis100
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« Reply #1175 on: May 10, 2019, 11:21:28 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 03/26/2019
Event Type  Malfunction   

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8520127
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dennis100
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« Reply #1176 on: May 10, 2019, 11:22:05 PM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 03/24/2018
Event Type  Malfunction   

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8558077
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dennis100
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« Reply #1177 on: May 10, 2019, 11:22:48 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/10/2016
Event Type  Malfunction   

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8557374
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dennis100
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« Reply #1178 on: May 10, 2019, 11:23:41 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 03/19/2019
Event Type  Malfunction   
Event Description
The patient's device was prophylactically replaced and the generator was received for analysis. Analysis was completed on the returned device. Visual examination of the device showed markings typical of surgical procedures. Burn marks were observed on the case, which indicated that the device may have been exposed to an electro-cautery tool. The battery was found to be showing intensified follow up indicator = yes (ifi=yes) condition. Diagnostics on the generator showed communication, impedance, and output current to be ok, within normal limits. A visual assessment of the pcba showed contaminants on the trimmed edge of the pcba. The device failed several postburn electrical tests; however after the contaminants were removed from the trimmed edge of the pcba, the device passed all but two test which were failed due to the test software requiring updates. The contaminants on the pcba suggest probable electrical paths were established which contributed to the supply current conditions. The analysis therefore concluded that the contaminants on the pcba may have been a contributing factor to the ifi = yes condition. 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. Programming history was reviewed however data was only available until 02/23/2017. No diagnostics were provided. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8508645
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dennis100
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« Reply #1179 on: May 10, 2019, 11:24:28 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 03/24/2017
Event Type  Malfunction   
Event Description
The nurse reported that the patient's generator had 100% battery and then multiple months later, the battery was at 25%. The nurse believed that the battery depleted too quickly. The nurse also questioned whether or not two hospitalizations for the patient could have been caused by some sort of "surge" with the vns device. A review of the device history record for the generator revealed that the generator passed all functional and electrical requirements prior to release for distribution. No additional relevant information has been received to date.
 
Event Description
Further information was received from the nurse stating there was no surge believed to have occurred. Settings and diagnostics were sent in regarding the alleged premature battery depletion.
 
Event Description
Information was received from the patient's mother that the patient had a recent increase in seizures which she related to the battery depletion of the vns device. However it is known that the generator will provide programmed therapy until it reaches a pulse disabled state due to end of service and the last reported battery indicator was 25%. The patient was now pursuing a generator replacement.
 
Manufacturer Narrative
Date received by manufacturer, corrected date: in mfg report # 2, the date should have been (b)(6) 2017.
 
Event Description
It was reported via clinic notes that the patient's mother felt that the vns magnet was not working as well as before. It also stated that the patient would see the surgeon in anticipation of needing a replacement. A review of the programming data was performed however the premature battery depletion could not be observed with the available information.
 
Event Description
Additional programming data was received and reviewed for the patient. Diagnostics for the patients device were ok however the review of the programming data revealed that the device possibly depleted prematurely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6499191
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dennis100
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« Reply #1180 on: May 10, 2019, 11:25:08 PM »

Model Number 104
Device Problem Premature End-of-Life Indicator
Event Date 03/14/2019
Event Type  Malfunction   
Event Description
It was reported that the patient believed that their vns generator battery depleted more quickly than expected. The patient had high programmed settings since implant. It was stated that tablet data from the implant surgery would not be obtainable as the tablet used was no longer available. The rep was asked to obtain the tablet data from the neurologist's tablet which interrogated the 18-25% battery life. It was further noted that the patient had 51 total magnet activations which may have contributed to the depletion. The rep stated that electrocautery was not used during implant. Data from the generator was reviewed, which indicated that the 18-25% 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 received for review so this case cannot be confirmed. Impedances were within normal limits. Device history records were reviewed an the device conformed to all specifications prior to distribution. No additional, relevant information was received to date. No known surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8495088
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dennis100
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« Reply #1181 on: May 10, 2019, 11:25:41 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 03/15/2019
Event Type  Malfunction   
Event Description
It was reported that the battery of the patient's vns generator was depleting. The patient's treating medical professional suspected the battery had prematurely depleted. The device history records for the generator were reviewed and show that no unresolved non-conformances were found. The device met all specifications for release prior to distribution and was manufactured with a laser routing process. 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=8495994
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dennis100
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« Reply #1182 on: May 10, 2019, 11:26:14 PM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 03/12/2019
Event Type  Malfunction   
Event Description
The generator was returned to livanova as the physician believed that the generator may not have been depleting in an acceptable manner. The generator had been replaced due to battery depletion. Per the physician, the patient had not been exposed to electrocautery or electrical damage. A manual battery life calculation was performed using the settings provided at time of explant. It was assumed that the patient had been at those settings since date of implant as no other information was available. The time to near end of service was 0. 0 years. Device history records were reviewed for the generator, and the device passed all specifications prior to distribution. The device was returned to livanova and product analysis is underway. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8522487
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dennis100
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« Reply #1183 on: May 10, 2019, 11:26:44 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 08/11/2015
Event Type  Malfunction   

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8499478
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dennis100
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« Reply #1184 on: May 10, 2019, 11:27:23 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
Initial report was that a patient was at ifi (intensified follow-up indicator) yes and the physician felt that the device had prematurely depleted. Clinic notes were received for the patient and indicated that the generator was nearly depleted resulting in the physician referring the patient for generator replacement. The device history records for the generator were reviewed and show that no unresolved non-conformance's were found. The device met all specifications for release prior to distribution and was manufactured with a laser routing process. 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=8505849
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dennis100
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« Reply #1185 on: May 10, 2019, 11:28:00 PM »

Model Number 1000
Device Problem Premature End-of-Life Indicator
Event Date 03/19/2019
Event Type  Malfunction   
Event Description
It was reported that the patient¿s battery is getting low and the patient is on very high settings. The neurologist believes the battery has depleted prematurely. The patient's settings were not provided. Programming history was attempted to be reviewed, however there was no history available. Device history records were reviewed and the generator passed all functional specifications prior to distribution. Surgery is likely but has not occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8508633
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dennis100
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« Reply #1186 on: May 10, 2019, 11:28:48 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 10/01/2018
Event Type  Malfunction   

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8539357
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dennis100
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« Reply #1187 on: May 10, 2019, 11:29:27 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 05/18/2016
Event Type  Malfunction   
Event Description
It was reported that patient was referred for replacement due to battery depletion. It was indicated that the patient¿s generator only lasted 2. 5 years. The mother believes that the device did not last very long at only 2. 5 years. The device met all specifications for release prior to distribution and based upon the date of the trim-test tab operation, the device was laser routed the device may be susceptible to premature battery depletion. A review of the generator's internal data verified premature battery depletion. The generator's voltage indicated that the generator had pulse disabled; however, this is inconsistent with the % battery consumed value of 66. 789%, which indicates that around 35% of the battery life should be remaining. No known surgical intervention has 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=8540789
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dennis100
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« Reply #1188 on: May 11, 2019, 01:25:13 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/13/2018
Event Type  Malfunction   
Event Description
It was originally reported through an implant form that a patient's device was explanted due to "battery depletion, unable to interrogate due to battery depletion". Clinic notes were later received stating that the battery level was "already low" per the physician. A review of the device history record indicated that the generator had been laser-routed which has been shown to produce excess debris on the circuit board. This debris may lead to excess current draw from the generator, which can deplete the battery prematurely. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8547842
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« Reply #1189 on: May 14, 2019, 12:56:37 AM »

Model Number 106
Device Problem Communication or Transmission Problem
Event Date 03/16/2017
Event Type  Malfunction   
Event Description
During a patient's generator replacement surgery, it was reported that one of the devices could not be interrogated with. The generator was never taken out of the packaging. The area where the generator was attempted to be interrogated was checked for emi and there was reportedly no emi present. A backup generator was used and that device was interrogated successfully using the same programming system attempted with the generator that was not implanted. A review of the device history record confirmed that the generator had passed all quality inspections prior to release for distribution, including all functional tests. The generator was returned to the manufacturer for analysis, which has not been completed to date.
 
Event Description
The generator was returned for analysis in the unopened packaging. The generator was attempted to be interrogated in the lab, but could not be interrogated. The generator case was removed and the battery voltage was measured with the battery still attached to the printed circuit board assembly (pcba), where it was verified that the voltage was at end of service levels. Visual analysis of the printed circuit board identified contaminated material present on the edge. With the battery removed, the pcba was subjected to a post-burn test were it failed several electrical tests. Fine grit sandpaper and isopropyl alcohol was used to remove the observed contaminates from the pcba and the results of the test after removal of the contaminates verified that they had caused additional supply current drain on the generator during both standby and pulsing modes of operation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6474977
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dennis100
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« Reply #1190 on: May 14, 2019, 12:57:19 AM »

Model Number 102R
Device Problem Premature End-of-Life Indicator
Event Date 09/30/2010
Event Type  Malfunction   
Event Description
The patient experienced an increase in seizures and later underwent a generator replacement. These events were previously reported in mfg. Report #1644487-2016-00845. During product analysis on the generator, it was confirmed that the battery voltage was measured to be 1. 93v and the battery indicator had properly triggered as intended. The generator's output signal was monitored for a 24 hour period while it was in a simulated body environment. It was found that there was gradual reduction in the output current which appeared to have been caused by the depleted battery and current leakage. During electrical testing, it was noted that there appeared to be current leakage at a capacitor component on the printed circuit board assembly. This component was bridged with a known good capacitor component was used. The testing was completed again however this time the generator met functional specifications and there were no signs of current leakage. It was noted that the current leakage may have led to the generator battery depleting sooner than expected. A previous internal investigation determined that a likely cause of current leakage event was related to damage to the capacitor component that occurred during the manufacturing process. Since the increase in seizures was reported to be occurring while the generator was still providing programmed therapy and prior to the battery depleting this report is only capturing the premature battery depletion. It appears that the serious injury of the increase in seizures is not related to the malfunction of the premature end of life. Therefore these events are being reported separately.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6486674
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dennis100
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« Reply #1191 on: May 14, 2019, 12:57:53 AM »

Model Number 1000
Device Problem Premature End-of-Life Indicator
Event Date 04/04/2019
Event Type  Malfunction 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8561080
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dennis100
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« Reply #1192 on: May 18, 2019, 12:36:46 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 05/03/2017
Event Type  Malfunction   
Event Description
It was reported by the nurse practitioner (np) that the physician had interrogated the vns revealing the normal mode, magnet mode, and autostimulation output currents had been set to 0. 0ma. The device showed eos (end of service) and was not supplying stimulation, which is a normal event once the device reached the eos condition. The np felt this was a malfunction since the device had only been implanted 2 years ago. The programming history for the generator was reviewed. No anomalies were noted, but it was confirmed the device had reached eos and that the output currents have been programmed off due to the eos condition. Impedance values were within normal limits indicating the device was working as intended. The device history record was reviewed and it was confirmed the generator had passed all required testing prior to distribution. It was confirmed the device was a laser routed device. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The information in the programming history was decoded and reviewed. The vns diagnostics were within normal limits throughout the available data and it was noted the device had reached the eos = yes (end of service) condition. It was noted the voltage value was only 1. 991v, consistent with an eos = yes condition; however, the percent battery consumed was only 19. 768%. The information observed indicated the device depleted more quickly than expected.
 
Event Description
Information was received indicating the patient had been referred for vns generator replacement surgery due to the generator battery depletion. The vns generator replacement surgery has not occurred to date.
 
Event Description
No surgical intervention has occurred to date. No additional pertinent information has been received to date.
 
Event Description
Generator replacement surgery occurred and the device was received by the manufacturer. Analysis was completed for the returned generator. The septum was not cored. The reported premature end of life was duplicated. During the bench interrogation, the end-of-service warnings were set and the device was automatically disabled. The diagnostic battery voltage calculation confirmed an end-of-service condition. The downloaded data revealed that 20. 215% of the battery had been consumed. Electrical testing showed that the device failed several electrical tests. Fine grit sandpaper was used for the removal of the observed contaminates from the trimmed edge of the printed circuit board assembly. Remaining residual material on the printed circuit board assembly edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption that was out of specification for both standby and pulsing modes of operation, and may have been the contributing factor for the premature end of life.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6592911
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« Reply #1193 on: May 18, 2019, 12:37:23 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 04/19/2017
Event Type  Malfunction   
Event Description
The patient underwent generator replacement due to the low battery status. The generator was returned to the manufacturer however, product analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6604481
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« Reply #1194 on: May 27, 2019, 11:03:47 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/15/2015
Event Type  Malfunction   
Event Description
It was previously reported that the patient¿s generator had reached eos and was pulse-disabled due to the eos condition. Device diagnostics were performed and were noted to be within normal limits. The patient was referred for generator replacement. It was subsequently reported that the patient was experiencing more balance issues and small seizures. The reporter of this information was aware the generator was at end of service and appeared to attribute the experience to the condition of the generator. One of the patient¿s group home providers had questioned why the generator appeared to deplete quickly. Review of the vns physician¿s manual showed a predicted time of 3. 6 years from beginning of life to end of service for settings and diagnostics similar to the patient¿s results. The device history record of the generator was reviewed by the manufacturer. It was found that all quality tests passed prior to distribution. Review of the record also showed that the generator was manufactured using a laser routing procedure. Review of the available internal device data from the date of implant did not reveal any anomalies. The patient¿s vns generator was replaced in surgery. The generator was received by the manufacturer and is undergoing analysis. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted. The unit had failed to interrogate at 1 inch, but successfully interrogated at 0 inch spacing. The bench interrogation showed the generator was disabled from the battery voltage being at end of service (eos) levels. The generator pulse current would not reset. With the generator case removed and the battery still attached to the printed circuit board, the battery measured 1. 641 volts, confirming an eos condition. Contaminants were observed on the edge of the circuit board. The internal device data showed 33. 504% of the battery had been consumed. With the battery removed, electrical testing on the circuit board showed that the several electrical current tests had failed. With the use of fine grit sandpaper and isopropyl alcohol to remove observed contaminates from the trimmed edge of the circuit board, these previously failed tests subsequently passed. Product analysis concluded that the remaining residual material on the printed circuit board edge after the test tab was removed in the manufacturing process resulted in increased current consumption and likely contributed to the premature eos condition. Information from the available programming history and internal device data during the use life of the generator was consistent with these observations. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6647088
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« Reply #1195 on: May 30, 2019, 06:06:07 AM »

Model Number 101
Device Problem Incorrect, Inadequate or Imprecise Result or Readings
Event Date 10/02/2001
Event Type  Malfunction   
Event Description
Analysis was approved for a generator that was explanted and returned due to battery depletion. A visual examination of the generator revealed no external anomalies. A measurement of the battery voltage confirmed that the battery was near end of service. Analysis indicated that the device did not meet specification requirements for current supply due to the resistance value selected during manufacture of the selectable value resistor. When the resistor value was decreased during product analysis, the device performed according to functional specifications. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6612363
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« Reply #1196 on: May 30, 2019, 06:06:51 AM »

Model Number 105
Device Problem Premature End-of-Life Indicator
Event Date 05/10/2017
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing an increase in seizure frequency and intensity. The patient was seen in clinic a week after this increase in seizures and the patient's generator had reportedly been disabled due to the generator reaching end of service (eos - yes). A battery life estimation showed that the generator was expected to have more battery life remaining. The patient was then programmed on during this office visit, but when the patient went back home she felt the device turn itself back off. The patient underwent a generator replacement surgery due to the generator being at end of service. A review of the available programming history showed indications of proper device functionality and diagnostics within normal limits. A review of the device history record showed that the device had passed all quality inspections prior to its release for distribution.
 
Event Description
Data from the generator was received and analyzed. It revealed that the battery voltage was lower than expected for the remaining battery capacity, indicating premature battery depletion. A review of the device history record showed the generator had been laser routed and sent out for distribution. The laser-routing process used in manufacturing of this generator is known to potentially cause conductive debris which cause excess current draw. No further relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6629991
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dennis100
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« Reply #1197 on: May 30, 2019, 06:07:40 AM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Appropriate Term/Code Not Available
Event Date 05/18/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's device could not be interrogated at the patient's initial follow up visit after vns therapy implantation. A generator reset needed to be performed and a message was shown after the rest that the device had been disabled for an unknown reason. The battery level was at 25% and the device was programmed on. At the next follow up appointment, it was reported that the device could again not be interrogated. The patient reported feeling stimulation for a week after the device was programmed on and then not again after that. A generator reset was performed again and when the device was able to be interrogated, an error message was shown that the device had been disabled due to a pulse watchdog timeout. The patient's device was programmed again to the same settings as before. A review of the design history record was performed which showed that the device had passed all functional test prior to distribution. Programming data was received and analysis was performed using the data. Through the analysis, it was shown that there was some form of data corruption. This is believed to be caused by an electrical component failure of the generator. No additional relevant information has been received to date.
 
Event Description
The patient went to the physician's office for another device check and the device showed 50% battery and was able to be interrogated. There was no evidence that the device had not delivered therapy in between the clinic visits however the decision was made to move forward with the replacement. Before the operation, the generator was able to be communicated with and the diagnostics were ok. The generator was replaced and planned to be returned to the manufacturer. The generator was received by the manufacturer however analysis has not been completed to date.
 
Event Description
Product analysis was completed on the generator. Analysis of the device¿s ram and flash data indicated that there were inconsistencies in the values stored in certain locations. The generator was continuously monitored for a time and was able to deliver the programmed output currents. The generator was subjected to the fet which it failed due to a device reset that resulted in a failure to communicate. The device data was reviewed and there were erroneous values noted. After analysis the issues that occurred with the device were isolated to the micro-processor however the cause of the failure could not be identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6632365
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dennis100
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« Reply #1198 on: May 30, 2019, 06:08:26 AM »

Model Number 106
Device Problems Premature Discharge of Battery ; Energy Output To Patient Tissue Incorrect
Event Date 12/01/2016
Event Type  Malfunction   
Event Description
During analysis of a returned generator, it was identified that the device experienced fluctuations in the voltage output during system diagnostic tests. An atypical output waveform occurred when the generator was programmed off, sensing was enabled and a system diagnostic test was performed. The generator can was opened and the printed circuit board assembly failed multiple electrical tests. The supply current drain with sensing enabled was outside of specification, but met specifications when sensing was off. The a2 asic was replaced and the generator then passed all functional specifications. The malfunctioning a2 asic was sent to the vendor for analysis. The asic was returned and the vendor verified the output variation through internal testing. The vendor inspected the units under a microscope and via x-ray imaging and found no visual anomalies. None of the tests performed identified the cause of the amplitude fluctuations.
 
Manufacturer Narrative
(b)(6) 2017.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6640329
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dennis100
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« Reply #1199 on: May 30, 2019, 06:09:13 AM »

Model Number 302-20
Device Problem Fracture
Event Date 05/12/2017
Event Type  Malfunction   
Event Description
It was reported that after the surgeon reviewed the patient's x-rays, he believed that the patient's lead was fractured. The patient's generator was completely depleted. Company representatives reviewed x-ray photos of a small area around the electrodes in the neck. The generator and the majority of the lead were not visible in the photos of the x-rays and so these portions could not be assessed. It was determined that there was a likely a large fracture of the lead in the neck after the patient's second tie-down. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.
 
Event Description
It was reported that the patient underwent revision of their generator and lead due to battery depletion and high impedance. The suspect generator and lead were discarded. No further relevant information was received to date.
 
Event Description
Per the manufacturer's battery life calculator, battery depletion was not expected at time of surgery. High impedance is known to accelerate battery depletion. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6616134
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