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dennis100
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« Reply #1020 on: January 23, 2019, 02:00:18 AM »

Model Number MODEL 250
Event Date 06/03/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The neurologist¿s handheld device was returned to the manufacturer due to issues charging the device. The neurologist previously reported having issues charging the device; however, the he later stated that the handheld device was charging and functioning as expected. Analysis of the returned handheld device is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the handheld was completed on (b)(4) 2014. An analysis of the handheld identified that the returned battery was defective, and unable to hold a charge. No further anomalies were identified using a known good dell battery. Analysis of the flashcard was completed on (b)(4) 2014. 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=3908675
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dennis100
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« Reply #1021 on: January 23, 2019, 02:01:13 AM »

Model Number 302-20
Event Date 06/09/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 due to battery depletion, the vns patient¿s lead was also replaced due to lead discontinuity (dc dc ¿ 0). The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. The generator replacement was reported in manufacturer report # 1644487-2014-01319.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
On (b)(4) 2014, product analysis was completed on the explanted generator. The reported unable to interrogate allegation, was duplicated (not due to eos) in the product analysis laboratory at two orientations. This is addressed in the 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. Bench test verified magnet operation. The generator performed according to functional specifications; during the product analysis there were no anomalies found with the pulse generator. Product analysis on the lead was completed on (b)(4) 2014. A large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis a large portion of the returned lead assembly appeared to be twisted and compressed; the outer silicone tubing appeared to be abraded open and abraded openings were observed on both of the inner silicone tubes, in the abraded open area of the outer silicone tubing. During the visual analysis the (-) connector pin and (+) connector ring quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3912101
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dennis100
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« Reply #1022 on: January 24, 2019, 03:51:58 AM »

Model Number 103
Event Date 10/21/2008
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis of a generator that was returned was completed on (b)(6) 2014. The battery status indicated ifi = yes, the battery is partially depleted. A review of the internal memory locations within the generator suggests the existence of an error in calculating the device's battery voltage. Electrical test results showed that the pulse generator performed according to functional specifications. Other than the noted condition were no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4042218
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dennis100
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« Reply #1023 on: January 25, 2019, 08:47:36 AM »

Model Number 102
Event Date 07/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported on (b)(6), 2014 that the patient thinks the vns device may be depleted because his seizures have increased. The patient said he had four seizures the day before and 3 seizures today. The patient was referred for generator replacement. Although surgery is likely, it has not occurred to date. Although a blc was performed which showed 3. 64 years remaining until eri=yes; for model 100, 101, 102, and 102r pulse generators, frequencies of 5 hz or below for long-term stimulation generate an electromagnetic trigger signal, which results in excessive battery depletion of the implanted pulse generator. Per review of the patient¿s programming history, this generator was programmed to 1hz on two dates; therefore, the generator likely has reached or is nearing eos.
 
Event Description
On (b)(6) 2014 it was reported that the patient underwent generator replacement on (b)(6) 2014. It was reported that the explanted generator was discarded by the hospital and therefore cannot be returned for product analysis. Good faith attempts for further information from the physician have been made but have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4008184
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dennis100
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« Reply #1024 on: January 25, 2019, 08:48:22 AM »

Model Number MODEL 250
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld passed all functional tests prior to distribution.
 
Event Description
Analysis of the returned handheld device and software flashcard was completed. No mechanical anomalies were identified during the analysis. It was identified that the main battery was unable to hold a charge and power the handheld. The cause for the identified anomaly is associated with a defective battery. No further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that the psychiatrist¿s handheld device was unable to be charged for the last several months. The connection between the handheld device and power adaptor would not stay in place and appeared to be damaged. The handheld device has been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4019040
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dennis100
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« Reply #1025 on: January 26, 2019, 03:51:09 AM »

Model Number MODEL 250
Event Date 07/14/2014
Event Type  Malfunction   
Event Description
It was reported that the epileptologist was having issues with his handheld device. While attempting to perform screen alignment, the handheld reportedly froze on the 3rd of 4th step of the screen alignment prompt. A hard reset was attempted but could not be completed as the handheld was unresponsive. The handheld battery was removed and reinserted but the issues continued to occur. Follow-up revealed that the handheld device was now working. No additional troubleshooting was performed but the handheld¿s issues had resolved. The handheld device has not been returned to date as the issues have resolved.
 
Manufacturer Narrative
Type of device, name, corrected data: the initial manufacturer report inadvertently reported the programming software as the suspect device instead of the programming computer. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the epileptologist¿s handheld device ¿just needed a battery¿ and resolved the reported issues. Attempts for clarifying this information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4003452
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dennis100
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« Reply #1026 on: January 28, 2019, 05:49:39 AM »

Model Number HHD, DELL
Event Date 08/26/2014
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 handheld would not power on after being charged for hours. A hard reset was performed and the screen lock was verified to not be engaged. The battery was removed and reinserted; however, no troubleshooting resolved the issue. A new programming tablet was provided to the physician. The handheld is expected to be returned for analysis, but has not been received to date.
 
Event Description
The handheld and flashcard were received for analysis. Analysis of the handheld was completed on 11/18/2014. 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 software was completed on 11/18/2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4113368
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dennis100
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« Reply #1027 on: January 29, 2019, 07:24:00 AM »

Model Number 103
Event Date 08/22/2014
Event Type  Malfunction   
Event Description
Additional programming history was reviewed and decoded which showed that initial interrogation of the device showed 3. 272 volts. Subsequent diagnostics found the device at 1. 937 volts and showing vbat < eos indicating that electrocautery likely struck the device causing it to disable.
 
Manufacturer Narrative

Event Description
The explanted generator was returned to the manufacturer for analysis. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Diagnostic testing indicated the device was operating properly and showed a non-ifi condition. The eos condition was not duplicated once the output was re-enabled. The cause of the eos condition was not determined. Other than the eos condition, there were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that during generator re-implant surgery on (b)(6) 2014, the vns patient¿s replacement generator showed an end of service condition after being placed into the generator pocket. The generator was not tested prior to implant. Another generator was used for the case. The surgeon claims that cautery was not used when the generator was presented into the field. The unused generator has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4102486
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dennis100
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« Reply #1028 on: January 31, 2019, 02:08:51 AM »

Model Number MODEL 250
Event Date 10/01/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was no longer working. The battery appeared to be swollen and the case would not close. A new programming tablet was provided to the physician. The physician had another programming system available so no patient care was affected. The handheld and flashcard were received for analysis. Analysis of the handheld was completed on 10/23/2014. As result of the swollen battery, it was identified that the handheld would not power on. 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 flashcard was completed on 10/23/2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4209541
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dennis100
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« Reply #1029 on: January 31, 2019, 02:09:50 AM »

Model Number 105
Event Date 08/05/2014
Event Type  Malfunction   
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. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated that the battery status was ok. Other than the noted condition, there were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
It was reported that the patient had surgery on (b)(6) 2014 for device repositioning due to patient discomfort, with no replacement planned. It was then reported that during this generator repositioning, a plasma blade accidently made contact with the generator. Diagnostics run in the or then revealed and end of service status, which was not seen prior to surgery. The generator was therefore replaced. Device manufacturing labeling indicates user of electrosurgery [electrocautery or radio frequency (rf) ablation devices] may damage the generator. The product was returned. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4055889
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dennis100
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« Reply #1030 on: February 01, 2019, 12:09:29 PM »

Model Number 102
Event Date 09/23/2014
Event Type  Malfunction   
Manufacturer Narrative
Describe event or problem, corrected data: the initial report did not include information from the patient's clinic notes. This information has been included in this report. Relevant tests/laboratory data: the initial report did not include diagnostic information. This information has been included in this report.
 
Manufacturer Narrative

Event Description
A review of the patient¿s clinic notes revealed that the patient felt the device was at end of service although the physician confirmed it was not however, the device was replaced at the patient¿s request.
 
Event Description
It was reported that the patient's generator was unable to be interrogated due to battery depletion. Clinic notes dated (b)(6) 2014 indicate that the device was at eos - no. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4200329
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dennis100
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« Reply #1031 on: February 02, 2019, 08:27:30 AM »

Model Number MODEL 250
Event Date 06/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of a returned handheld was completed on 09/18/2014. 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. No further anomalies were identified. Analysis of the flashcard was completed on 09/18/2014. 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=4171215
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dennis100
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« Reply #1032 on: February 03, 2019, 03:40:24 PM »

Model Number 103
Event Date 10/20/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns patient¿s device could not be interrogated. Attempts for additional relevant information will be made.
 
Event Description
It was reported that the failure to interrogate the patient¿s generator was due to the physician¿s wand battery being dead. The issue has been resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274221
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dennis100
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« Reply #1033 on: February 04, 2019, 02:55:10 AM »

Model Number 105
Event Date 10/22/2014
Event Type  Malfunction   
Event Description
It was reported that during initial implant surgery, the device diagnostics were run with the generator in the pocket and resulted in vbat less than eos. It was reported that two device diagnostics performed prior to closing the generator pocket were within normal limits, but that after the generator pocket was closed the vbat less than eos message appeared. It was reported that the generator was likely exposed to electrocautery during the surgery. The surgeon replaced then replaced the generator. The explanted 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 which confirmed an output pulse disabled condition due to a perceived low battery voltage. Analysis concluded that the event may be related to high energy exposure during surgery. The pulse generator performed according to functional specifications after output was re-enabled.
 
Manufacturer Narrative
(b)(4). Corrected data: inadvertently did not include the udi on the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4255773
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dennis100
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« Reply #1034 on: February 04, 2019, 02:56:10 AM »

Model Number 201
Event Date 10/31/2014
Event Type  Malfunction   
Event Description
It was known that the failure to interrogate was associated with a depleted 9v battery in the programming wand. Although it was not confirmed that the generator was successfully interrogated, it was known that the wand battery was depleted when the patient's device was checked. It is not expected that the programming system could communicate with a dead 9v wand battery.
 
Manufacturer Narrative

Manufacturer Narrative

Event Description
It was reported that the physician's programming system was unable to interrogate the patient's generator. It was reported that the wand battery was depleted, but there was no backup battery available. The patient left the office without being interrogated. Further follow-up revealed that the issues with the programming system resolved with wand battery replacement. The patient has not been seen again to see if the device is able to be interrogated. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4281667
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dennis100
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« Reply #1035 on: February 06, 2019, 02:35:44 AM »

Model Number 103
Event Date 11/12/2014
Event Type  Malfunction   
Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the generator was connected to the lead and system diagnostic results showed normal device function. The generator was disconnected and the surgeon began creating the generator pocket. The generator was reconnected and placed in the generator pocket; however, subsequent diagnostic results showed a near end of service condition. At the patient¿s follow-up appointment, the patient¿s device showed a pulse disabled message. The physician elected to program on the patient¿s device. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient¿s device had reached the intensified follow-up battery status indicator. Diagnostics were reported to be normal.
 
Event Description
Follow-up was received from the patient¿s new neurologist that the patient was referred for replacement as the battery was low. A review of the manufacturer¿s in-house programming history was performed. On the date of implant (b)(6) 2014, systems diagnostics showed the impedance was within normal limits and the battery voltage was 3. 261 volts. Upon a second diagnostics test during implant surgery the generator showed an end-of-service condition, and the battery voltage dropped to 1. 897 volts. On (b)(6) 2016 diagnostics testing showed the voltage had recovered, and impedance values were within normal limits. The battery voltage reached the 25% indicator on diagnostics performed on (b)(6) 2016 with a voltage of 2. 846 volts. It had been reported by the company representative that electrocautery was used near the generator during the implant surgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative

Event Description
Replacement surgery occurred. The explanted device was provided to be discarded by the hospital.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4326482
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dennis100
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« Reply #1036 on: February 06, 2019, 02:37:34 AM »

Model Number 105
Event Date 11/28/2014
Event Type  Malfunction   
Manufacturer Narrative

Manufacturer Narrative
(b)(4).
 
Event Description
The reported allegation was not duplicated in the pa lab. The pulse generator was interrogated at multiple orientations adjacent to the programming wand. The pulse generator was at a distance of one-inch (spacer block) from the programming wand during the interrogations. The pulse generator interrogated at all orientations. 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 shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
During generator replacement surgery, it was reported that this replacement generator was not used because it ¿did not work. ¿ additional information was received that an error message of ¿checksum error¿ was received on the vns programming system when communicating with the generator. This error message is a communication issue message. The surgeon elected to discard the generator and discard it due to the check sum error message. After the wand 9v battery was replaced, the programming system worked as intended. However, the wand battery was not replaced until after the generator was discarded. Following the replacement of the wand battery, a new generator was placed and interrogated successfully. The generator was 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=4343403
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dennis100
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« Reply #1037 on: February 08, 2019, 12:54:01 AM »

Model Number 105
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 05/12/2015
Event Type  Malfunction   
Event Description
It was reported that the physician asked to investigate this patient's generator as it was on the list of laser routed devices. Additional information was received that the patient's generator was explanted. The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process. Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths. Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected. No further relevant information has been received to date. The explanted generator has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8216773
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« Reply #1038 on: February 08, 2019, 12:54:37 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/18/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by the physician the patient's device was at an eri status already even though the generator was implanted in 2015. The patient is to follow up with the physician again to check the device. A review of the device manufacturing records showed it underwent the laser routing process which makes the device susceptible to premature battery depletion. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8237212
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« Reply #1039 on: February 09, 2019, 12:47:55 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/12/2018
Event Type  Malfunction   
Event Description
It was reported by the surgeon that the patient's generator battery depleted faster than expected. The generator's device history records were reviewed. The generator passed all functional specifications prior to release. The trim test tab operation was performed during a time in which model 106 generators were not being laser-routed. An implant card received indicated that the patient's generator was replaced prophylactically. The suspect product has not been received to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8214907
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« Reply #1040 on: February 09, 2019, 12:48:35 AM »

Model Number 105
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Manufacturer Narrative

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=8241673
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« Reply #1041 on: February 09, 2019, 12:49:16 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/20/2018
Event Type  Malfunction   
Event Description
It was reported that a patient would be having an urgent battery replacement due to low battery. The generator was suspected to have prematurely depleted as the physician's office was notified that the generator may have "shorter than expected battery longevity". The generator was found to have low battery at the patient's last interrogation and it was reported that the patient was also experiencing a sudden increase in seizures. A battery life calculation was performed to estimate remaining battery life with the programming data made available to the manufacturer's, and did not estimate that the device would have reached low battery at this time. Review of the device history records confirmed that the device was laser-routed and is susceptible to prematurely deplete. The device passed all quality inspections prior to distribution. Follow up with the physician's office noted that the increased seizures were first noted a "couple months" before per the patient. The last diagnostics provided were from mid-october and showed that the device was functioning at intended. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8246819
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« Reply #1042 on: February 09, 2019, 12:49:58 AM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 08/14/2015
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
This patient's generator was explanted due to prophylactic replacement and underwent product analysis (pa). During pa, 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 where the results showed that the pcba failed several electrical tests, specifically related to supply current. After the trimmed edge of the pcba was cleaned, an electrical test was performed in which the pcba performed according to functional specifications. 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. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8273849
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dennis100
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« Reply #1043 on: February 09, 2019, 12:50:45 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 01/01/2019
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that this patient's device was showing 80% battery remaining, and then 9 months later was showing 25-50% battery remaining and the doctor was asking if this patient's vns device was one of the devices affected by the premature battery depletion seen in m106 and m105 generators. Additional information was received from the doctor stating that the patient's battery had dropped significantly. The device history record of the generator was reviewed, and the device passed all functional specifications prior to release. It was confirmed that the device was not manufactured during the time that m106 and m105 generators were laser-routed. Multiple attempts for relevant information were made, but no relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8284657
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dennis100
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« Reply #1044 on: February 09, 2019, 12:51:50 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 09/26/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for vns generator replacement surgery. The patient underwent replacement surgery and the implant card received by the manufacturer indicated that the reason was due to battery depletion. The explanted generator was received by the manufacturer. Generator product analysis was completed. The end of service, or eos, allegation was not duplicated in the product analysis, or pa, lab. The battery measured 2. 976 v at the completion of the fet, indicating an intensified follow-up indicator, or ifi, = no condition. The device performed according to functional specifications. A visual assessment of the printed circuit board assembly, or pcba, revealed contaminates on the trimmed edge of the pcba. The data dump was reviewed and at the time of review, the battery voltage measured 2. 710 (ifi = yes). The diagaccumconsumed value was 74. 817%. High impedance was observed on the day after the implantation of the generator. No further high impedance were observed in the lead impedance history until after generator explantation. The high impedance was reported in mfg. Report #1644487-2019-00019. The data in the ¿diagvbat_min¿ memory locations show a value of 2. 674 volts approximately a week and a half post-explant. There were no performance or other adverse conditions found with the generator. Based on the data available through product analysis, it was unclear whether a premature end of life indicator was present at the time of the explant. A review of device history records revealed that the generator passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8223607
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dennis100
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« Reply #1045 on: February 09, 2019, 12:52:29 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/27/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's vns generator battery had reached the 11-25% status, and there was a concern that the battery had prematurely depleted. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8268857
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dennis100
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« Reply #1046 on: February 09, 2019, 12:53:04 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 06/14/2016
Event Type  Malfunction   
Event Description
It was reported by the patient's mother that she believed that the device was prematurely depleting, as the patient's battery was at low after being implanted for two years. Device history records were reviewed for the generator. The device was laser routed, indicating that they are potentially subject to premature end of life. Programming history was reviewed for the patient. Battery voltage consumed and the actual battery voltage did not match, indicating that the device was prematurely depleted. No other anomalies were seen. Surgery is likely but has not occurred to date. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8258571
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dennis100
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« Reply #1047 on: February 09, 2019, 12:53:43 AM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 09/03/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's generator was replaced due to low battery. 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 observed conductive debris suggests probable current leakage paths and premature depletion. After the contaminants were removed the generator passed the same electrical tests. The contamination that was observed on the trimmed edge of the pcba suggest probable electrical and resistive paths were established between the copper edges on the pcba, which contributed to the supple current conditions. 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=8283594
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« Reply #1048 on: February 09, 2019, 12:54:36 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/10/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Physician's office reported that patient's vns generator battery has dropped significantly. The device history record of the generator was reviewed, and the device passed all functional specifications prior to release. It was confirmed that the device was not manufactured during the time that m106 and m105 generators were laser-routed. Multiple attempts for relevant information were made, but no relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8284906
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dennis100
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« Reply #1049 on: February 09, 2019, 12:55:11 AM »

Model Number 104
Device Problem Premature End-of-Life Indicator
Event Date 01/01/2019
Event Type  Malfunction   
Event Description
Initial report was that a generator was explanted due to premature depletion. Design history records were reviewed for the generator. The generator passed all specifications prior to distribution. The explanted product has not been received by product analysis to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8278218
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