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dennis100
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« Reply #1140 on: April 07, 2019, 02:19:20 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 02/14/2019
Event Type  Malfunction   
Event Description
Physician reported that the patient's generator was prematurely depleting. The patient underwent generator replacement due to depleting battery. The explanted product has not been received by product analysis to date. A review of device history records for the generator shows that no unresolved non-conformances were found. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8443443
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dennis100
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« Reply #1141 on: April 07, 2019, 02:19:54 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 10/22/2018
Event Type  Malfunction   
Event Description
Patient underwent prophylactic generator replacement due to ifi (intensified follow-up indicator)=yes. The explanted generator was received by product analysis. Product analysis for the generator was completed. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator, due to the pulse generator remaining ¿on¿ post explant. A visual assessment on the pcba showed contaminates on the trimmed edge of the pcba. Based on the postburn electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions. Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for the pulsing mode of operation, and may have been the contributing factor for the battery depletion. Design history record was reviewed for the generator. The generator passed all specifications prior to distribution. The device was laser routed. No other relevant information has been received to date,.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8416012
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dennis100
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« Reply #1142 on: April 07, 2019, 02:20:24 AM »

Model Number 105
Device Problem Premature End-of-Life Indicator
Event Date 01/16/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's generator was suspected to be at end of service condition as the device could not be interrogated. The patient's physician reported that the patient's generator battery prematurely depleted. A manufacturer's battery life calculation was performed with the available programming data and it supported the generator reaching end of service condition. A review of the device history records indicated that the generator had passed functional specifications prior to distribution and had not been subjected to the laser-routing process. The patient's generator was replaced due to battery depletion. It was reported that the facility is traditionally a no return site and therefore return of the suspect product is not suspected to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8414793
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dennis100
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« Reply #1143 on: April 07, 2019, 02:20:59 AM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 08/12/2015
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 residual material, contaminates, on the printed circuit board assembly (pcba) resulted in increased current consumption for standby and pulse modes of operation. Due to the presence of the contaminates, the generator failed several electrical tests due to out of specification supply currents. The visually observed conductive debris suggests probably current leakage paths and premature depletion. After the contaminates were removed the generator passed the same electrical tests. The contamination that was observed on the trimmed edge of the pcba suggests probable electrical and resistive paths were established between the copper edges on the pcba, which contributed to the supply current conditions. The device history records 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=8436065
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dennis100
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« Reply #1144 on: April 07, 2019, 02:21:33 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/14/2015
Event Type  Malfunction   
Event Description
The patient's generator was replaced due to reported prophylactic battery replacement. The explanted product was received by the manufacturer at end of service condition. Product analysis was completed on the returned generator and found evidence of premature battery depletion. 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. The manufacturer's device history records were reviewed. The generator passed final quality and functional specifications prior to release. The generator was subjected to laser-routing process.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8409943
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dennis100
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« Reply #1145 on: April 07, 2019, 02:22:16 AM »

Model Number 104
Device Problem Premature End-of-Life Indicator
Event Date 02/12/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for vns replacement due to a low battery. The specific battery indicator was not provided. The patient¿s father was concerned that the battery had only lasted approximately one year and two months and believed the battery prematurely depleted. A estimation of the device's remaining battery life as performed with the programming data currently available to the manufacturer and the results did not support that the battery would have reached an elective replacement indicator (i. E. Ifi, neos, eos). 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. A review of the decoded programming data from the date of implant revealed no sudden drops in voltage. The percentage of battery consumed aligned with the voltage and no anomalies were identified. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8403722
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dennis100
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« Reply #1146 on: April 08, 2019, 02:27:33 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/08/2018
Event Type  Malfunction   
Event Description
A generator was returned after a prophylactic generator replacement surgery. Product analysis was completed on the device. A visual assessment of the pcba board showed contaminates on the trimmed edges of the pcba. The contamination that was observed suggest probable electrical paths were established between the copper edges on the trimmed edge of the pcba which contributed to the supply current conditions. Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) and may have been the contributing factor for the reported allegation of ¿low battery - intensified follow-up indicator=yes". A review of the device history record indicated that the generator had been laser-routed which has been shown to produce excess debris on the circuit board. This debris may lead to excess current draw from the generator, which can deplete the battery prematurely. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8386029
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dennis100
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« Reply #1147 on: April 09, 2019, 12:35:40 AM »

Model Number 103
Event Date 05/09/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A report was received indicating that following pocket closure during a device implant an end of service message was observed. Diagnostics performed prior to pocket closure revealed normal battery status and normal lead impedance. It was stated that electrocautery was not used between the first and second diagnostic measurements. The device was then successfully explanted and replaced with no issues. Manufacturing records were reviewed for the device and no unresolved nonconformances were identified prior to device distribution. Data from the programmer used at implant has been obtained and is currently under review. The explanted device has been returned to the manufacturer and is currently undergoing product analysis.
 
Event Description
Data obtained and decoded from the user's programming system confirmed that an end of service indicator had been observed following normal readings. An end-of-service warning message was verified during testing and was found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator was likely exposed to an electro-cautery tool during device implant/explant. A reset of the pulsedisabled bit in the pulse generator memory was performed to allow for an output to once again be provided by the pulse generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 066 volts as measured during testing shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 3. 082% of the battery had been consumed. Other than the noted event (pulsedisabled), there were no additional performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5697599
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dennis100
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« Reply #1148 on: April 10, 2019, 01:25:04 AM »

Model Number MODEL 250
Event Type  Malfunction   
Event Description
A handheld computer and the flashcard were returned to the manufacturer due to exchange for a new motion tablet. During the physical inspection of the returned handheld, it was noticed that the main battery appealed to be swollen. No performance issue was reported from the facility. Review of manufacturing records confirmed all tests passed for the concerned handheld computer prior to distribution. Analysis of the returned handheld computer was completed and the "main battery swelling" allegation was verified. During the analysis it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently). No further anomalies were identified. Analysis of the returned flashcard was completed and no anomalies associated with flashcard software or databases were identified during the flashcard analysis. During the analysis it was identified that the flashcard contained a (b)(6) operating system file and folders. The presence of the file and folders is an indication that the flashcard was inserted into a device using the (b)(6) operating system. The file and folders had no impact on the vns software performance. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5805032
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dennis100
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« Reply #1149 on: April 10, 2019, 01:25:51 AM »

Model Number 106
Event Date 05/09/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the patient who was implanted with a model 106 in (b)(6) 2015 already has 1/3 of battery life remaining. It was indicated that system diagnostics have been performed and the battery is coming back with less than 1/3 battery life left. There are no events reported which could explain the depleted battery life like additional exposure to cautery or other types of electrical exposure. A battery status indicator is visible which shows a battery level consistent with a 2. 74v < vbat = < 2. 87v range considered to be in the bottom 25% of the generator's battery life. The battery gauge is green, indicating pre-ifi status. The design history record for the m106 was reviewed on 06/02/2016. Records shows that the generator passed all functional tests including r-wave configuration prior to distribution into the field.
 
Event Description
It was reported on (b)(6) 2016 that the generator was replaced on (b)(6) 2016. The decoder was reviewed on 06/29/2016 for the patient's m106 device. History was available on (b)(6) 2015, (b)(6) 2016. From the decoder, on 1(b)(6) 2015 the device had consumed 2. 645% of the battery and the diagvbat was at a value of 3. 359 volts. On (b)(6) 2016 the device had consumed 4. 257% of the battery and the diagvbat was at a value of 3. 347 volts. On (b)(6) 2016 the device had consumed 10. 174% of the battery and the diagvbat was at a value of 2. 793 volts. Based on the battery gauge status for m105/m106, the battery voltage from (b)(6) shows 2. 793 which falls in the range of 2. 74v< vbat<= 2. 87v which would show a 25% remaining green indicator on the battery gauge. The explanted generator was received for analysis on 07/06/2016. Analysis is underway but has not been completed to date.
 
Event Description
Product analysis for the model 106 generator was completed and approved on 08/08/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 783 volts as measured during completion of test parameter of the final electrical test, shows an ifi=yes condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the implant procedure, which may have been a contributing factor. Other than the noted event (eos condition), there were no performance or any other type of adverse condition found with the pulse generator. Updated decoder with implant date information was reviewed: no new information showing electrocautery usage is seen from the decoder. It is still possible that cautery was used after this data was obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5695118
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dennis100
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« Reply #1150 on: April 11, 2019, 02:26:19 AM »

Model Number MODEL 250
Event Date 06/01/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the physician's programming handheld is not working correctly. It was reported that the battery cover is bowed out and will not close correctly causing a message to pop up about closing the latch. The physician was provided a new programming handheld. The faulty handheld is expected to be returned for analysis, but has not been received to date.
 
Event Description
The suspect handheld product information was obtained. The handheld was later received by the manufacturer for analysis. However, analysis has not been completed to date. Review of the handheld device history records confirmed that all quality inspections were passed prior to distribution with no non-conformances.
 
Event Description
An analysis was performed on the returned handheld and the reported allegation was verified. A visual analysis of the handheld was able to verify that the main battery was swollen. During the analysis, it was also identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently). No further anomalies were identified with the handheld or software.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5780434
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dennis100
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« Reply #1151 on: April 11, 2019, 02:27:20 AM »

Model Number 106
Event Date 06/15/2016
Event Type  Malfunction   
Manufacturer Narrative
Suspect device udi#: (b)(4).
 
Event Description
It was reported by the surgeon that while in the operating room he was receiving a "pulse disabled vbat less than eos" error message (eos - end of service). The physician noted that he did use cautery to open the patient and removed the old generator; however, he stated he did not use cautery after the 106 generator was opened. The surgeon was able to complete the patient's surgery using a new 106 generator. It was explained to the surgeon that the generator would need to be sent to the manufacturer for further analysis. At this time, it is unknown whether or not the generator will be sent back to the manufacturer for analysis. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the hospital would be sending the generator back to the manufacturer for analysis; however, the device has not been received to date.
 
Event Description
The generator was returned to the manufacturer for analysis. Product analysis (pa) for the returned generator was approved on 09/19/2016. Review of the data download from the generator indicated the pulsedisabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5793428
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dennis100
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« Reply #1152 on: April 12, 2019, 01:10:44 AM »

Model Number MODEL 250
Event Date 06/13/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the handheld programmer and wand were being returned due to the facility receiving a new tablet and wand. It was noted that the handheld programmer was not holding it's charge long enough to complete a memory download. The handheld had been adequately charged to gain a full battery when the issues with the battery life were observed. The handheld programmer and wand were received. Product analysis was completed on the wand and the flashcard containing the software. Analysis found that both performed according to functional specifications. Product analysis on the handheld found that the battery was swollen which caused the battery cover to bend. As a result the battery cover could not make sufficient contact with the battery latch switch. This caused the handheld device to be inoperable. The cause of the swollen battery is not clear however it appears that it may be related to the usage of the battery. The handheld device was powered on using the ac power supply and the handheld device was successfully charged. The handheld then successfully performed interrogations and system diagnostic tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5777393
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dennis100
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« Reply #1153 on: April 13, 2019, 04:40:32 AM »

Model Number MODEL 250
Event Date 06/22/2016
Event Type  Malfunction   
Event Description
A nurse at a physician's office reported that their handheld programmer was not holding a charge. When the device was plugged in it would start, but then only displayed the windows background. The nurse was instructed to turn off the device, remove the software card and re-insert it, which resolved the issue however, the battery would still not hold a charge. The programmer has not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Event Description
The handheld programmer was received for analysis, which is underway but has not been completed to-date.
 
Event Description
Analysis was completed on the returned handheld. During the analysis, the main battery was able to hold a charge and power the handheld for over an hour. It was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on. This condition can also cause the handheld to power off intermittently. No further anomalies were identified. No anomalies were identified with the flashcard and the software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5801539
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dennis100
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« Reply #1154 on: April 14, 2019, 01:36:07 AM »

Model Number MODEL 250
Event Date 07/15/2016
Event Type  Malfunction   
Event Description
It was reported by a company representative that a physician's handheld was unable to stay powered on for more than a few seconds whether it was plugged in or not. The handheld programmer is showing a message that the battery latch is open, even though it is closed. It was state the battery cover seems to be bulging out slightly, but it still gives the same warning message when it is held down. The representative stated the battery did not appear to be swelling. Additional relevant information has not been received to-date. The handheld has not been received by the manufacturer to-date.
 
Event Description
The handheld programmer was received with the serial cable, flashcard and power supply adapter on (b)(6) 2016. Analysis is underway for the returned products but has not been completed to-date.
 
Event Description
Analysis was completed for the handheld and no anomalies associated with the battery latch were identified during the analysis. During the analysis, it was identified that the handheld would not power on due to a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on. This condition can also cause the handheld to power off intermittently. No further anomalies were identified. Analysis was completed for the flashcard. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5869949
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dennis100
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« Reply #1155 on: April 14, 2019, 01:36:52 AM »

Model Number 104
Event Date 07/12/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the patient reported an increase in seizures the week prior. The patient saw the physician on (b)(6) and stated that ifi-yes was seen. The patient has a model 104 generator and he has had it implanted just over one year and the battery is at ifi-yes due to rapid cycling. The physician wants the patient to be replaced with a m102r.
 
Event Description
The generator was replaced on (b)(6) 2016. The explanted device has not been received to date.
 
Event Description
The generator was received for analysis on 10/26/2016. Product analysis is underway but has not been completed to date.
 
Event Description
Product analysis for the generator was completed and approved. The device output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The final electrical test, shows an ifi=yes condition. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5872940
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dennis100
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« Reply #1156 on: April 15, 2019, 12:36:04 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 08/26/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes from a visit on (b)(6) 2016 were received regarding a replacement referral where it was noted that the patient's generator was showing an end-of-life message. The specific message was not provided in the notes. A change in the patient's seizure frequency was noted. Follow-up from the physician provided that the device settings, but was not able to provide the specific battery status indicator. Diagnostics were provided to have been performed february 2016, but results were not provided. Additional relevant information has not been received to-date. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted generator was received for analysis, which is underway but has not been completed to-date. It was reported by the company representative present at the surgery that the device was not able to be interrogated during surgery, or in the physician¿s office.
 
Event Description
A review of downloaded data from the date of surgery, (b)(6) 2015 provided the battery voltage was 3. 300 volts and 0. 87% of the battery had been consumed. Seizure detection had been turned on and the heartrate was being detected.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed for the returned generator. The report of end-of-service and failure to program were duplicated during analysis. The generator would not interrogate and as a result, several tests were unable to be performed. With the pulse generator case removed, and the battery still attached to the printed circuit board assembly, the battery measured 0. 055 volts confirming an end-of-service condition. The battery was removed and the printed circuit board assembly was subjected to an electrical test. Results show that the pulse generator module failed several electrical tests. Fine grit sandpaper and isopropyl alcohol were used for the removal of observed contaminates from the trimmed edge of the printed circuit board assembly. After the trimmed edge of the printed circuit board assembly was cleaned, an electrical test was performed. Remaining residual material on the printed circuit board assembly edge after the test tab removal manufacturing process resulted in increased current consumption out of specification for both standby and pulsing modes of operation, and may have been the contributing factor for the reported allegations of end-of-service and failure to program.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5980465
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« Reply #1157 on: April 16, 2019, 12:21:10 AM »

Model Number MODEL 250
Event Date 08/28/2016
Event Type  Malfunction   
Event Description
Information was received indicating that the physician was having difficulties with their handheld device. The handheld was continuously rebooting when the wand was plugged in. The handheld was able to hold a charge and no specific screens were seen prior to the hand held rebooting itself. The flashcard was inserted correctly and no patient therapy was affected. The issues first began on (b)(6) 2016. No other relevant information has been received to date. The hand held is expected to be returned but has not been received for analysis to date.
 
Event Description
The physician's handheld and software were received on (b)(6) 2016 for product analysis which was completed on (b)(6) 2016. No anomalies were identified with the software in the physician's handheld. Product analysis was then performed on the physician's hand held device and an anomaly was identified. The battery of the handheld was swollen causing the battery cover switch to register that the latch was unlocked, thus causing the handheld to power off intermittently. No other anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5969525
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« Reply #1158 on: April 21, 2019, 03:39:17 AM »

Model Number 104
Device Problems No Display / Image; Premature End-of-Life Indicator
Event Date 05/17/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes were received for the patient indicating replacement was planned. The patient has been implanted for less than a year. Per the referral request, the reason for the surgery was lead impedance change. Per the clinic notes, on office visit dated (b)(6) 2016, the vns battery was found to be at ifi=yes. The clinic notes stated there was low impedance, however, the impedance value was 4793 ohms, which is within normal limits. It was also noted that the patients settings were at 2. 0ma but the device was only delivering 1. 75ma of therapy. It is believed that when the physician stated there was low impedance, he was actually referring to the low output current. The device programmed to 2. 0ma was likely unable to deliver the intended current. After applying ohms law with the tolerance of the lead impedance measurement, it is likely the device would not be able to deliver that programmed output current with the given lead impedance and =/- 25% tolerance for lead impedance. No additional relevant information has been received to date. No surgery has occurred to date.
 
Event Description
Patient underwent surgery. During the surgery, the surgeon repaired the patient's lead. No devices were reported to have been explanted. No additional relevant information has been received to date.
 
Event Description
A battery life calculation was performed with the last known device settings from the clinic notes. The results revealed 2. 2 years of battery life remaining.
 
Event Description
The patient's father reported that his son has had problems with his current vns generator since its implant in 2016, including the complaint that magnet mode stimulation did not seem to have its expected impact on the patient. The father also suggested there may be a problem with the generator battery longevity. Per the patient's father, the physician did not identify issues with the impedance of the vns system at a recent clinic visit; however, the battery life remaining indicator appeared to switch between 25% and 50% within the same clinic visit. A company representative reported that the physician was concerned about the battery status of the generator because of the changing battery status indicator during the most recent clinic visit. The physician also believed that the battery had depleted faster than expected based on the date of implant and the patient's current vns settings. Clinic notes from the patient's two most recent visits indicated that the battery life indicator displayed 25% life remaining upon interrogation at the beginning of the clinic visit, and 50% life remaining at the end of the visit. The intensified follow-up indicator = yes was not observed at either clinic visit. Diagnostics for the generator were within the normal limits. The patient was referred for surgery. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
Programming history was reviewed for the patient's device. System diagnostics tests indicated that impedance was within the normal limits throughout the available history; however, several diagnostic tests showed instances of elevated impedance, resulting in the device delivering a lower output current than programmed due to the increased impedance. This is expected behavior of the generator. The settings were adjusted to a deliverable output current several times over the available programming history in response. A further review of the available programming history did not indicate that the battery was depleting faster than expected. The device was never observed to have reached the intensified follow-up indicator battery status. No additional relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6112562
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« Reply #1159 on: April 22, 2019, 01:32:16 AM »

Model Number MODEL 250
Event Date 11/27/2016
Event Type  Malfunction   
Event Description
It was reported that a tablet won¿t hold a charge. It will work if kept plugged in but once unplugged, it turns off. The malfunctioning tablet has not been received for analysis to date.
 
Event Description
The tablet was received for analysis on (b)(6) 2016 with the serial adapter and power supply. Product analysis for the tablet was completed and approved on (b)(6) 2016. An analysis was performed on the returned tablet and during the analysis it was verified that the main battery was defective and no longer able to hold a charge. It was attempted to charge the main battery overnight, but was unable. After 24 hours of charging the battery gauge button was still flashing amber. Once the main battery was replaced with a known good battery, no anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.

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« Reply #1160 on: April 22, 2019, 01:35:00 AM »

Model Number 106
Event Date 10/18/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that during a replacement surgery the old generator was removed and the new generator 106 was implanted and it was noted to be at end of service. (eos). It was stated that the generator was not at eos in the package and no cautery was used after the vns was introduced into the sterile field. When the new generator was initially interrogated it showed that output current was at 0 and the generator was fully charged. After the vns was plugged into the patient's lead system outside of the pocket it showed eos condition. This was noted after performing system diagnostics. A backup generator was used. The design history record for the generator showed that it passed all functional tests prior to distribution. No additional relevant information has been received to date.
 
Event Description
The generator was received for analysis on 11/15/2016. Product analysis is underway but has not been completed to date.
 
Event Description
Product analysis was completed on the generator. It was noted that the ¿pulsedisabled¿ byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6095886
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« Reply #1161 on: April 24, 2019, 01:41:27 AM »

Model Number MODEL 250
Event Date 10/18/2016
Event Type  Malfunction   
Event Description
It was reported that a handheld at a facility had a swollen battery. The physicians were concerned about using the handheld in that condition. No patient therapy was reportedly affected. The handheld and its software were both returned for analysis. Per the analysis, the battery was verified as swollen and the handheld would not power on. The swollen battery bent the battery cover, causing the latch switch to register that the latch was unlocked, preventing the handheld from powering on. Additionally, the handheld showed that the main battery was unable to power the handheld on for longer than 30 minutes. The analysis on the returned software verified that there were no anomalies associated with the programming software.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096031
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« Reply #1162 on: April 24, 2019, 01:42:57 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 11/01/2016
Event Type  Malfunction   
Event Description
It was reported that after a surgery that was taking place for lead repositioning purposes, the generator was found near end of service. The generator was not near end of service before the surgery. Electrocautery was reportedly used in the lead repositioning surgery. Due to the generator being found at near end of service after the lead repositioning surgery, the generator was explanted during that surgery. A lead discontinuity was identified during this surgery. The lead discontinuity has been reported under mfr. Report #1644487-2016-02708. System diagnostics both pre-operatively and post-operatively were within normal limits. The explanted generator has not been received to date.
 
Event Description
The explanted generator was received for product analysis. Analysis has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The generator was returned and had product analysis completed. The generator data was reviewed and showed that the pulse disabled byte had been activated. Additionally, the generator had visible burn marks on its case. The pulse disabled byte was reset and the generator was able to adequately provide the intended therapy when it was monitored in a simulated body environment for a period of over 24 hours. The generator diagnostics were as expected for the programmed parameters and a comprehensive electrical evaluation showed that the generator performed according to functional specifications. The measured battery voltage and the measured charge consumed did not indicate an end of service condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6120646
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« Reply #1163 on: April 26, 2019, 06:38:31 AM »

Model Number MODEL 250
Device Problem Mechanical Problem
Event Date 12/05/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the physician has tablet issues. The serial cable was swapped with a known good cable and the communication issues with the tablet persisted. The sales representative then used her own tablet with the physician¿s wand and serial cable and stated that the entire system functioned properly. Since this isolated the issue to the tablet it was believed that the usb port may be broken thus causing the programming issues. A hard reset was performed on the tablet however the problem still occurred. It was stated that no patient¿s therapy was affected. The serial cable was stated not to be loose in the port but through isolation of components the tablet was suspected to have the issue. The tablet has not been received for analysis to date.
 
Event Description
The company representative then returned for further troubleshooting and found that the physician had replaced the depleted 9 v battery with another depleted 9v battery so she placed a new 9v battery into the physician's wand and used it with her programming system. The wand was then able to communicate. The company representative then replaced the physician's white serial adapter with a black serial adapter. The company representative then used the wand and the serial adapter along with the physician's tablet to communicate with a demo generator. It was determined that the previous troubleshooting steps did not fully resolve the communication issues but after testing each component of the physician's programming system with a known good component the issues were identified and resolved. Since this troubleshooting was performed no other communication issues persisted with the physician's device. The white serial cable was then disposed of. The serial cable does not require return, as the failure mode is understood to be a failure of the serial cable associated with a disconnected wire connection no other relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6181465
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« Reply #1164 on: April 26, 2019, 06:39:26 AM »

Model Number MODEL 250
Event Date 10/13/2016
Event Type  Malfunction   
Event Description
It was reported that a medical professional could not interrogate generators when using her programming system. The handheld computer could not work anymore. They tried to reset the device at multiple times without success. It was reported that there was an issue with the stylus (pointer pen) and the screen. Review of manufacturing records confirmed that the handheld computer passed all functional tests prior to distribution. The return of the suspected handheld computer is expected but it has not been received to date.
 
Event Description
The suspected handheld computer and flashcard were returned to the manufacturer on 11/07/2016. Analysis is underway but it has not been completed to date.
 
Event Description
Analysis of the returned flashcard was completed. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Analysis of the returned handheld computer was completed and the reported allegation was verified. During the analysis it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently). Also during the analysis it was identified that the handheld was unable to advance past the screen alignment utility. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. No further anomalies associated with the handheld performance were identified during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6081404
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« Reply #1165 on: May 07, 2019, 07:08:49 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 02/16/2017
Event Type  Malfunction   
Event Description
It was reported during the patient's replacement surgery that the patient was going to be replaced with a new m106 generator. The new m106 generator was removed from the packaging and placed on the patient's lead. When diagnostics were run, the generator already showed an eos = yes (end of service) condition. It was noted that electro cautery was used during the explant procedure, but it was not used near the new m106 generator. The surgeon did not believe the electro cautery and the new m106 were in the sterile field at the same time. The m106 was not used due to the generator showing the eos = yes condition. The programming history database was reviewed and found to contain information from the date of the patient's surgery. The device was interrogated, followed by a programming, then the device was interrogated 2 more times. During the programming, no settings were changed and all output currents remained programmed to zero. System diagnostics were also performed. The first system diagnostics showed the device was already at the eos = yes status. The dhr for the m106 generator was reviewed and the generator was found to have passed all testing prior to distribution. The generator information from the programming system was decoded and reviewed. Upon initial interrogation, the battery capacity consumed showed 0. 587% and the generator had 3. 315 v with a battery status of ok. On the date of surgery, it was found that the voltage value experienced a sharp, unexpected decline down to 1. 912 v, while the battery capacity had only depleted slightly, and expectedly, up to 0. 590%. Additionally, the "diagvbat_min" showed that 1. 912 v was the minimum voltage observed during the life of the battery. The minimum voltage measured was the same date of the surgery, indicating the date of surgery was the date the lowest battery voltage throughout the life of the device was observed.
 
Manufacturer Narrative
"the generator was received by the manufacturer for analysis. " this information was inadvertently left off of the initial mfr. Report. Device available for evaluation; corrected data: this information was inadvertently left off of the initial mfr. Report.
 
Event Description
The generator was received by the manufacturer for analysis. Product analysis (pa) for the returned generator was completed. The generator product had been opened but not used due to the reported pulse disablement. Pa performed a review of the data downloaded from the generator, which indicated the "pulse disabled" byte was set to a value that represents a "vbat

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« Reply #1166 on: May 07, 2019, 07:09:34 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/02/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Patient underwent prophylactic generator replacement due to ifi - yes. The explanted device was received and analysis was performed. In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The battery, 2. 619 volts, shows an ifi=yes condition. The data in the generator memory locations revealed that 67. 738% of the battery had been consumed. An ifi=yes condition is not typically observed at 67. 738% of battery consumption. With the pulse generator case removed and the battery still attached to the printed circuit board assembly (pcba), the battery measured 2. 592 volts confirming an ifi condition. The battery was removed. The pcba was subjected to a postburn electrical test and results show that the pcba failed several electrical tests. Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption for both standby and pulsing modes of operation, and may have been the contributing factor for the low battery indicator. 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. A review of device history records for the generator shows that no unresolved non-conformances were found.

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« Reply #1167 on: May 10, 2019, 11:14:00 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=8469374
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« Reply #1168 on: May 10, 2019, 11:15:14 PM »

Model Number 105
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 05/29/2015
Event Type  Malfunction   
Event Description
It was originally reported that the physician wanted an analysis of the patient's device as the patient was planning on receiving an explant procedure of their generator due to the fact that the generator serial number was on the list of affected devices that were laser routed. The device history records were reviewed and confirmed that the generator was manufactured when laser-routing was in use. The device met all specifications for release prior to distribution. Internal data analysis was performed on the received tablet data and it was found that the charge consumed (%) did not deplete more quickly than expected as compared to the battery voltage measurements. According to this data, there is no evidence that suggests the device prematurely depleted. The generator was explanted and sent back for product analysis. During product analysis the generator was interrogated, and system diagnostics returned results within the normal limits. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications, and therefore premature battery depletion was not duplicated at this point during testing. The pulse generator was then opened due to possible contaminates on the trimmed edge of the printed circuit board assembly (pcba). With the pulse generator case removed, the battery voltage measured 2. 947 v. Analysis found contaminants on the trimmed edge of the pcba inside the generator, which created paths for current leakage. Electrical testing was performed on the pcba, and the pcba failed several electrical tests related to current consumption. After the trimmed edge of the pcba was cleaned and the contaminates were removed, the pcba passed electrical testing and performed according to functional specifications. Review of the complete product analysis of the returned generator confirmed that the generator exhibited premature battery depletion caused by the laser-routing manufacturing process. No further relevant information has been received to date.

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« Reply #1169 on: May 10, 2019, 11:16:08 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 03/18/2019
Event Type  Malfunction   
Event Description
It was reported that the patient's generator was unable to be interrogated due to battery depletion. The patient's physician indicated that the battery should not have depleted as quickly as it did. A review of the device history records revealed that the generator passed all quality and functional specifications prior to distribution. The device was found to have been manufactured using the laser routing process. 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=8489960
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