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dennis100
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« Reply #1050 on: February 09, 2019, 12:56:07 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by the patient that she had severe pain on the right side of her brain that radiated down through her body into her legs. The patient reported everything twitched and that it was not a seizure. The patient continuously felt like her head was pounding and pain would not go away. The patient did not take medication and saw physician later in the day who stated battery had dropped. The patient stated her and the physician could not understand why her battery had dropped drastically and caused that pain. The patient stated that she stays away from any electronics that may cause accidental magnet stimulation and did not believe this to be the cause of the pain. The tablet data for the generator was received and reviewed by the manufacturer. No battery status indicator was flagged in the data available, which was from approximately half a year prior to the allegation. As no recent data is available, it was unable to be assessed whether the alleged premature depletion was present. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The device was found to have been manufactured using the laser routing process. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8268943
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dennis100
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« Reply #1051 on: February 09, 2019, 12:56:45 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Event Description
It was reported that this patient's device battery was suspected to be depleting prematurely. A review of device history records for the generator shows that no unresolved non-conformances were found. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8241667
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dennis100
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« Reply #1052 on: February 09, 2019, 12:57:18 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/19/2018
Event Type  Malfunction   
Event Description
It was reported that the physician believed that the patient's generator depleted very quickly and that the generator should have lasted longer. The patient's generator has been implanted for approximately 2. 5 years and the battery status indicator is showing 11-25%. A review of the device history records for the generator showed that no unresolved non-conformances were found and that the device met all specifications for release prior to distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8242322
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dennis100
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« Reply #1053 on: February 09, 2019, 01:42:06 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/14/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by the patient's physician that their generator had depleted to 25% since their replacement surgery on (b)(6) 2018. The physician indicated that the patient's generator had depleted quicker than expected, and that the patient was programmed to high settings and used the magnet with each seizure. A review of the device history records for the generator showed that no unresolved non-conformances were found and that the device met all specifications for release prior to distribution. The manufacturer's battery life calculation tool indicated that if the patient was set to the highest setting since implant, a 25% battery status indicator is possible. It was reported that the patient experienced an increase in seizure frequency and that their seizures were occurring at a different time of the day. The physician indicated that the patient's seizure frequency can fluctuate. The physician indicated that the patient's increase in seizures was worse than their pre-vns seizure rate baseline and the patient's mother indicated that no external factors were involved. The physician indicated that the patient's seizures were either related to low battery or was not related to the vns. No known 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=8229152
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dennis100
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« Reply #1054 on: February 10, 2019, 03:46:24 AM »

Model Number MODEL 250
Event Date 10/30/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the physician's programming system was unable to interrogate a known working generator. Troubleshooting was performed which identified that the physician's programming system was found to not interrogate. The physician was provided a new programming system and the handheld and wand were returned for analysis. Analysis of the handheld was completed on (b)(4) 2014. During the analysis an intermittent power connection associated with the serial cable was identified. The cause for the anomaly is associated with a bent serial cable plug leaf spring that prevented electrical contact with the ac adapter barrel connector. The cause for the bent spring is unknown, but is most likely associated with mishandling of the device. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Analysis of the wand was completed on (b)(4) 2014. The returned battery was depleted and was not the recommended type per labeling (battery type labeling recommends alkaline). After the battery was substituted, the programming wand performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4392435
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dennis100
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« Reply #1055 on: February 12, 2019, 03:09:06 AM »

Model Number 103
Event Date 01/22/2015
Event Type  Malfunction   
Event Description
It was reported that during initial implant surgery, device interrogation resulted in vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532404
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dennis100
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« Reply #1056 on: February 12, 2019, 03:10:09 AM »

Model Number 103
Event Date 01/28/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's device was at eos - yes due to suspected electrocautery from the procedure in 2015. The generator was replaced however the explanted generator has not been received by the manufacturer to date.
 
Manufacturer Narrative

Event Description
It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement device was hit by electrocautery which resulted in a low battery condition of the device. The surgeon elected the implant the device. Follow-up revealed that the patient¿s device was functioning normally.
 
Event Description
Additional information was received that the explanting facility would not return the explanted generator so product return is not expected.
 
Manufacturer Narrative
(b)(4). The initial mdr inadvertently did not include the suspect device udi. This report is being submitted to correct this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4536309
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dennis100
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« Reply #1057 on: February 13, 2019, 01:37:45 AM »

Model Number 103
Event Date 01/23/2015
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery device diagnostics with the new generator and existing lead were within normal limits both inside and outside of the generator pocket and once the incision was closed device diagnostics showed ifi - yes. It was reported that electrocautery was not brought back into the field during incision closure; however, it was on the table near the patient which may have discharged during incision closure. A new generator was then implanted. A device programming decoder showed that the battery voltage changed from 3. 354v to 2. 022v between 9:04:31 and 10:00:41 on (b)(6) 2015. The generator was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Event Description
Analysis of the returned generator was completed. An end-of-service warning message was verified and 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 may have been exposed to an electro-cautery tool during device implant or explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The battery of the returned generator was measured as 3. 095 volts showing an ifi=no condition. The downloaded data revealed that 1. 629% of the battery had been consumed. Other than the observed pulse disablement and burn marks, 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=4532316
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dennis100
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« Reply #1058 on: February 13, 2019, 01:38:28 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 this patient was referred for a generator replacement due to near end of service (neos) = yes. The patient received a generator replacement and the explanted generator was returned for product analysis. The generator underwent product analysis and a the vns programming history database shows that the neos=yes was set on the day of explant. A visual assessment on the printed circuit board assembly (pcba) showed contaminates on the trimmed edge of the pcba. The battery was removed. The pcba was subjected to an electrical test and results show that the pcba failed several electrical tests. After the trimmed edge of the pcba was cleaned, an electrical test was performed and the generator passed all electrical tests. Based on the 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 both standby and pulsing modes of operation, and may have been the contributing factor for the reported allegation of replacement due to battery depletion (neos = yes). The dhr of the generator was reviewed, and the device passed all functional specifications prior to release. It was also confirmed that this device was manufactured during the time that m106 generators were laser-routed. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8211956
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dennis100
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« Reply #1059 on: February 13, 2019, 01:39:33 AM »

Model Number 103
Device Problems Device Displays Incorrect Message ; Battery Problem
Event Date 01/19/2015
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement device was implanted and programmed on to previous device settings. The patient¿s device was then tested and showed a near end of service condition. Electrocautery was not used during the procedure. Pre-operative diagnostic results of the replacement generator showed ok battery status. The patient¿s device was tested again the next day and showed pulsedisabled due to ¿vbat
 
Manufacturer Narrative

Event Description
Analysis was completed on the explanted generator and shows a pulse disabled condition had occurred and confirms the pulse generator was programmed out of the event on (b)(6) 2015 (implant (b)(6) 2015). The battery, 2. 701 volts as measured during completion of test parameter (measured diagvbat) of the final electrical test, shows an ifi=yes condition. The data in the diag accum consumed memory locations revealed that 18. 203% of the battery had been consumed. A battery life calculation resulted in 4. 9 (minimum 4. 0) years remaining before the near-end-of-service (neos) flag would be set to a neos=yes condition. Other than the noted event (pulse disabled), there were no performance or any other type of adverse condition found with the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor for the hardware reset condition. No device failure found during product analysis, the premature end of life condition was confirmed by product analysis as due to the pulse disabled event from an electro-cautery tool usage at implant.
 
Event Description
Additional information was received that at the follow up visit on (b)(6) 2015 the battery was showing 100% of charge; on the (b)(6) 2015 that battery was showing 30% of charge remaining. Review of the decoder data provided showed on the interrogation on (b)(6) 2015 the battery voltage (vbat) was 3. 545volt; however the "pulse disabled" incorrectly showed vbat< eos threshold which was not the case as the currently measured vbat 3. 545v is > to 2. 0v. The battery status indicator is 100%, in line with the measured vbat 3. 545v. On the next programming step on (b)(6) 2015, the measured voltage was the same, vbat 3. 545v with "pulsedisabled" showing "enabled" with no eos flag. No further eos flag showed on the next visits.
 
Event Description
Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015. It was reported that the generator was explanted due to device failure. The explanted generator was returned to the manufacturer on 12/15/2015. Analysis is underway but it has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519027
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dennis100
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« Reply #1060 on: February 13, 2019, 01:40:30 AM »

Model Number MODEL 250
Event Date 01/22/2015
Event Type  Malfunction   
Event Description
It was reported that the physician¿s programming handheld was freezing, and the back battery door was missing. A replacement tablet was provided. The suspect handheld was received by the manufacturer for analysis. The handheld battery was received with the battery backwards, in addition to the battery cover missing. However, the analysis has not been completed to date.
 
Event Description
An analysis was performed on the returned handheld, and the reported allegation was verified. Visual analysis verified that the handheld was returned without a battery cover. As a result, the handheld would not power on. Additionally, it was also identified that the main battery was inserted backwards. As a result, the handheld was unable to be powered using battery power. Once the main battery was inserted correctly, and a known battery cover was installed, the handheld performed according to functional specifications. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519676
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dennis100
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« Reply #1061 on: February 13, 2019, 01:41:42 AM »

Model Number 105
Event Date 01/26/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during generator replacement surgery on (b)(6) 2015 due to an increase in seizures, the vns patient¿s replacement generator was tested with the existing lead which showed normal device function and battery status. After the patient was closed, the device was tested again and showed an end of service condition. The patient was reopened and another generator was used for the procedure. Follow-up revealed that electrocautery was used for the subcutaneous tissue during the procedure while the generator was inside the generator pocket. There was no indication that electrocautery had contacted or damaged the generator upon removal. Gloves were worn throughout the surgery to prevent potential static discharge to the generator. The suspect generator has been returned to the manufacturer where analysis is currently underway. The increase in seizures event was reported in manufacturer report # 1644487-2014-03183.
 
Event Description
Analysis of the returned generator was completed. Review of the downloaded data indicated that the pulse disabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532198
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« Reply #1062 on: February 14, 2019, 01:57:12 AM »

Model Number 201
Event Date 03/04/2015
Event Type  Malfunction   
Event Description
Additional information was received from the physician reporting that the communication issue was related to a depleted 9v wand battery. After 9v wand battery replacement, the programming system now functions.
 
Manufacturer Narrative

Event Description
On (b)(6) 2015 it was reported that the physician was having difficulty interrogating the patient's device, it kept giving ¿procedure failed, checksum error" messages. He reported that he had just recently interrogated several other patients without issue. No further information was received as the physician ended the call. Good faith attempts for further information from the physician were unsuccessful.
 
Manufacturer Narrative
(b)(4). The initial mdr inadvertently did not include the udi for the suspect device at the time. The suspect device for the event was updated from the generator to the programming wand in supplemental mdr #01.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4637643
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« Reply #1063 on: February 15, 2019, 03:23:35 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 08/26/2015
Event Type  Malfunction   
Event Description
The patient was replaced and the explanted generator was returned to the manufacturer. Product analysis was performed on the returned generator. Based on the results, the generator prematurely depleted. The pulse generator performed according to functional specifications. Based on the postburn electrical test, 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. The design history record was reviewed for the generator. The device passed all specifications prior to distribution. The time of the trim test tab indicated this generator underwent laser routing and is susceptible to premature depletion. No additional or relevant information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8206707
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« Reply #1064 on: February 15, 2019, 03:24:15 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/01/2018
Event Type  Malfunction   
Event Description
It was reported that this patient¿s generator had a very short battery life and therefore it is believed to have prematurely depleted. No other relevant information has been received to date.
 
Event Description
The dhr of the generator was reviewed, and the device passed all functional specifications prior to release. The trim test tab operation was performed during a time in which model 106 generators were not laser-routed. The patient received a generator replacement, stated to be due to battery depletion, and the explanted generator has been received by the manufacturer. Product analysis is underway but has not been completed to date. Multiple attempts for relevant information were made, but no information has been received to date. No other relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7776398
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« Reply #1065 on: February 16, 2019, 02:01:26 AM »

Model Number 103
Event Date 11/03/2014
Event Type  Malfunction   
Manufacturer Narrative
Device history records were reviewed. No device failure occurred; however, the device did reach an end of life condition earlier than expected due to the generator remained programmed to a high output state during manufacturing. The event did not cause or contribute to a death or serious injury.
 
Event Description
On 11/07/2014, it was reported that this vns patient underwent generator revision on (b)(6) 2014 due to end of service. The generator was returned on (b)(4) 2014 and underwent product analysis. On (b)(6) 2015, this generator was identified as having been affected by a manufacturing error that led to the generator remaining programmed on to a high output state for several months. During the time that the device remained programmed on, the generator is believed to have used a significant amount of battery capacity. The calculated projected life accounting for the time that the device remained on did not meet the design requirements for battery longevity. As a result of this, the generator reached an ifi status indicator earlier than expected. Product analysis was approved on (b)(6) 2015. In the pa lab, the pulse generator diagnostics were as expected for the programmed parameters, and a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The device was found to be an ifi-yes battery status. Product analysis confirmed that the generator reached a ifi-yes state sooner than expected based on a battery life calculation and an analysis of the generator¿s charge consumption counter. Other than this noted condition, 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=4618238
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« Reply #1066 on: February 16, 2019, 02:02:27 AM »

Model Number 102R
Event Date 01/29/2015
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2015 reported status epilepticus was on the new problem list. The chief complaint was seizures with dead vns battery. The patient moved residences the week prior and had her first seizure in a while. The physician assessed that the patient experienced recurrent seizures since. Additionally, it was noted that some of her medications were previously discontinued by the previously treating physician. The patient¿s generator was unable to be interrogated due to suspected end of service by the physician. The physician reported in the notes that the patient is sensitive to the vns and reports having seizure when being tested. The patient developed complex partial status epilepticus in the clinic. The patient was transferred to the medical care center. No known surgical intervention has occurred to date. Good faith attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanted generator was received for analysis. However, analysis has not been completed to date. The reason for replacement was reported to be prophylactic n the return paperwork.
 
Event Description
Additional information reported that the patient was scheduled for generator replacement due to the device not working. Generator replacement occurred on (b)(6) 2015. It was reported that the explanted device could be interrogated pre-operatively. It was reported to not be at end of service condition and diagnostics were within normal limits (dcdc-2). The lead was not replaced. The explanted generator has not been received by the manufacturer for analysis to date.
 
Manufacturer Narrative

Event Description
Analysis of the generator was completed. The reported failure to program was duplicated (not due to end of service of the battery) in the analysis laboratory at two orientations. This is addressed in the vns physicians manual by instructing the user to reposition the wand. Since product labeling addresses these situations and provides instructions to easily remedy the events (wand position and system operation), it is not considered a device malfunction. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information was received from the treating physician¿s office. It was reported that they have not had any vns programming system issues since the patient's device could not be interrogated. They elected to refer the patient for generator replacement surgery due to battery depletion and prophylactic lead replacement. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4621721
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« Reply #1067 on: February 16, 2019, 02:03:14 AM »

Model Number 104
Event Date 06/23/2014
Event Type  Malfunction   
Manufacturer Narrative
Programming history and device history records were reviewed. No device failure occurred; however, the device did reach an end of life condition earlier than expected due to the generator remained programmed to a high output state during manufacturing. The event did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2014, it was reported that this vns patient was referred for generator revision for an unknown reason. On (b)(6) 2014, a tc present at the patient¿s appointment preformed diagnostics: diagnostics were within normal limits. The generator was reported to be being replaced due to generator nearing end of service. The patient underwent generator revision on (b)(6) 2015. The generator was returned and underwent product analysis. Analysis was approved on (b)(6) 2015 and identified that the generator had reached a near end of service state sooner than expected based on a battery life calculation and an analysis of the generator¿s charge consumption counter. A review of the generator¿s device history record revealed that it was likely left programmed on to a high output state as a result of an incomplete final electrical test (fet) at the time of manufacture. The generator likely stayed in this high output state for months before being subjected to fet again, effectively programming the generator off. During the time in between fet tests, the generator is believed to have used a significant amount of battery capacity, resulting in the discrepancy identified in product analysis. There were no additional performance or any other type of adverse conditions found with the pulse generator. Review of the dhr shows that the device did pass all functional specifications prior to distribution. Review of in-house programming history shows that the ifi-indicator was first seen on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4618213
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« Reply #1068 on: February 17, 2019, 06:07:22 AM »

Model Number 105
Event Date 02/10/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the unused pulse generator showed an ifi condition while still in the packaging. The suspect generator has not been returned to date.
 
Event Description
Analysis of the returned generator was completed. After a brief period (30 minutes) at 9°f (-12. 8°c), in an environmental chamber, the packaged generator interrogations and system diagnostic tests showed ifi yes and neos yes after 90 minutes. When the packaged generator had time to stabilize at room temperature (74°f (23. 4°c)), the packaged generator interrogations and system diagnostic tests showed ifi no. The pulse generator was not removed from the original package. There were no performance or any other type of adverse conditions found with the pulse generator. Based on correspondence in the issue file, it appears that only interrogations were performed. It is possible that despite recovery of the battery voltage during the attempted implant, the ifi flag did not clear because a diagnostic test was not performed. Only a diagnostic test will clear/update the battery status flag to reflect the current battery condition.
 
Manufacturer Narrative
(b)(4). Corrected data: inadvertently did not include the udi on the initial report.
 
Event Description
Additional information was received that the generator premature battery depletion was not thought to be due to cold temperatures, which could cause an inaccurately low battery voltage reading. The generator had been stored inside at room temperature and another generator stored in the exact same conditions showed normal battery voltage. The generator has been received by the manufacturer for analysis. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4577750
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