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dennis100
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« Reply #390 on: January 26, 2019, 04:09:13 AM »

Model Number 302-20
Device Problems Fracture; High impedance
Event Date 07/07/2014
Event Type  Malfunction   
Manufacturer Narrative
Corrected data: the initial mfr. Report reported the incorrect date. The date should have been 07/15/2014. The change of date does not change that the report was submitted prior to the 30 day deadline. The initial report is not late as a result of the changed date.
 
Event Description
The explanted products were received for analysis. Analysis was completed for the returned generator 02/04/2016. 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. The septum was not cored. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed for the returned portion of the lead on 02/16/2016 and the reported event was not verified within the returned lead portion. Note that since a portion of the lead including the electrode array was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that since a lead fracture could not be found at surgery on (b)(6) 2014 the family of the patient decided not to have the lead changed. The device was programmed off to assess whether the patient needed vns before deciding to replace the device. Since the device had been turned off over the year prior, the patient experienced a "major backslide". The patient has been referred again for revision of the lead and generator. No known surgical intervention has occurred to-date.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation and coughing.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was disabled during an office visit on (b)(6) 2014 and the pain subsided. The patient was referred for surgery and seen on (b)(6) 2014 for a surgical consult. Several positional system diagnostic tests were performed, and all showed lead impedance within normal limits except one. When the patient was standing and leaning over with his head on the exam table, the patient¿s device showed high impedance. The high impedance observation was believed to be due to a microfracture. It was reported that the patient may have manipulated the device. The patient¿s seizures had also increased but not above pre-vns baseline levels. X-rays were taken and were reported by the physician to be unremarkable. The patient was scheduled for surgery on (b)(6) 2014. Several system diagnostic tests were performed before and during the procedure which all showed lead impedance within normal limits (dc dc ¿ 2). Thus, the surgeon elected to cancel the procedure. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
The initial report inadvertently did not report that the patient also experienced coughing in addition to the painful stimulation.
 
Manufacturer Narrative
Event description, corrected data: the date of the clinic visit where the device was disabled was inadvertently reported in the initial report as (b)(6) 2014, when the visit had occurred on (b)(6) 2015.
 
Event Description
The generator and lead were replaced on (b)(6) 2015. The reason for replacement was reported as due to a lead discontinuity. The explanted products have not been received to-date. No additional relevant information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4006205
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dennis100
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« Reply #391 on: January 26, 2019, 04:10:06 AM »

Model Number 106
Event Date 05/02/2016
Event Type  Injury   
Event Description
It was reported that a vns patient was complaining of sporadic painful stimulation at the generator site and radiating down through his left arm starting. Clinic notes received indicate the symptoms started on (b)(6) 2016 and were more intense with magnet activation. The condition progressed to constant sensation of tightness in chest and shortness of breath of approx. 1 hour duration until he taped the magnet over the device. The symptoms were alleviated for around 24 hours following pulse width adjustment from 500usec to 250usec and frequency adjustment from 30hz to 20hz on (b)(6) 2016 but then recurred. Full diagnostics were performed on (b)(6) 2016 and lead impedance on (b)(6) 2016 was normal 3,093 ohms. It was stated that the lead impedance was checked in varying neck positions. The physician elected to disable the device on (b)(6) 2016 and the patient was referred to a surgeon for anticipated exploratory surgery to explant and replace generator due to presumed malfunction/bleeding of current of vns system. X-rays were taken but nothing conclusive could be diagnosed by the providers. The x-rays were not provided to the manufacturer for review. The generator was successfully explanted and replaced on (b)(6) 2016 with no complications noted. The explanted generator was discarded by the explanting facility.
 
Manufacturer Narrative
(b)(4).
 
Event Description
An implant card was subsequently received for the procedure on (b)(6) 2016 indicating that a normal lead impedance of 3,373 ohms was observed with the newly implanted generator in place.

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dennis100
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« Reply #392 on: January 26, 2019, 04:10:58 AM »

Model Number 103
Event Date 06/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing an increase in seizures for the past month and was having headaches every five minutes during normal stimulation on-times. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3987030
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dennis100
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« Reply #393 on: January 27, 2019, 10:08:01 AM »

Model Number 102R
Event Date 05/14/2014
Event Type  Injury   
Event Description
It was reported that the patient was still very weak. The device was not checked. It was later reported that the patient was doing better and walking and gaining strength. It was reported that the plan is for the patient to be seen in a few weeks to discuss proceeding forward with the revision. No surgical intervention was performed to date.
 
Event Description
Additional information was received stating that the vns patient¿s seizures had improved but the patient¿s magnet appeared to making the seizures worse. The patient was also experiencing pain in her neck whenever the magnet was used. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the lead revision had been cancelled. Additional information was later received that the patient was referred for generator replacement for an unrelated reason.
 
Event Description
The explanted generator was received on 6/3/2015. In the (b)(4) lab, 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 pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information reported that the patient was scheduled for generator replacement. Generator replacement occurred on (b)(6) 2015 but the lead was not replaced.
 
Event Description
Additional information was received that the patient is now going to have generator replacement and prophylactically replace the lead to prevent a potential revision in the future for patient comfort. No known surgical intervention has occurred to date.
 
Event Description
It was reported that the vns patient was hospitalized due to a seizure she experienced when a system diagnostic test was performed on (b)(6) 2014. The patient had also been experiencing painful stimulation in her chest and neck as well as coughing and facial twitching with stimulation. The patient again experienced a seizure when the next system diagnostic test was performed on (b)(6) 2014 so the patient¿s neurologist stated that the system diagnostic tests were causing the seizures. The patient was given medication and taken to the er. It was noted that the patient¿s device settings were higher than those for system diagnostics and that system diagnostic results showed lead impedance within normal limits (dc dc ¿ 2). Follow-up revealed that the patient¿s seizures were above pre-vns baseline levels. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The notes indicate that the patient had been experiencing an increase in seizures since she began using a hearing aid and that she had three seizures since her last office visit. The patient experienced a seizure the before the office visited which resulted in bruising in the arms. The patient stated that she was unable to tolerate magnet mode stimulation. The patient¿s device was tested during the office visit and the patient again experienced a seizure. Diagnostic results showed lead impedance within normal limits. The patient was sent to the er where the patient¿s device settings were lowered. X-rays were taken and were reported by the physician to be unremarkable. The physician recommended replacement surgery due to concerns with the patient¿s lead. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4052095
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dennis100
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« Reply #394 on: January 27, 2019, 10:08:45 AM »

Model Number 304-20
Event Date 03/07/2014
Event Type  Injury   
Event Description
Further follow-up revealed that the patient was not reimplanted. It was reported that the patient reported neck tightness and pulling at the nerve attachment site of the lead.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis, which did not revealed any anomalies.
 
Event Description
It was reported that the patient underwent generator and lead explant due to painful stimulation. The generator and lead were received for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator was completed on (b)(4) 2014. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. No additional relevant information havs been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4128688
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dennis100
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« Reply #395 on: January 27, 2019, 10:09:31 AM »

Model Number 302-20
Event Date 06/29/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for generator and lead replacement due to shooting pain up to the patient's ear with device stimulation. It was reported that the generator would be replaced prophylactically due to the amount of time implanted. An implant card was received indicating that the patient underwent generator and lead replacement due to prophylactic reasons. The explanting facility discarded the explanted devices; therefore, product analysis cannot be performed. The physician reported that the patient was hit in the neck with something and the pain with device stimulation began. It was reported that device diagnostics were within normal limits prior to explant. The physician believed it would be best to have the entire vns system replaced due to the pain and time the generator had been implanted.

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dennis100
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« Reply #396 on: January 28, 2019, 06:08:35 AM »

Model Number 300-20
Event Date 08/28/2014
Event Type  Malfunction   
Event Description
Product analysis for the generator that was completed on 04/16/2015 concluded that the generator detachment of components was most likely attributed to explant related events. Therefore the possibility of a lead break cannot be ruled out. The patient's lead has not been explanted to date.
 
Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2015. It was stated that the generator was in two pieces as the header was detached from the generator. The lead was not replaced. When the new generator was attached to the old lead impedance values were good at 2825 ohms. The generator was returned for analysis on 03/19/2015. Analysis is currently underway but has not been completed to date.
 
Event Description
Product analysis for the generator was completed and approved on (b)(4) 2015. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. The output exhibited output variations on chart. This condition was due to an intermittent connection on the alligator clip, used to establish an electrical connection to the generator. The pulse generator was monitored again for more than 24-hrs and 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. The reported ¿detachment of components(s)/header¿ allegation, most likely occurred during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator as received photo shows no evidence of bodily fluid remnants in the case/header area. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. The generator performed according to functional specifications. Other than the intermittent connection issue that is not related to the generator and the header anomaly (visual analysis), there were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Corrected data: changed suspect device to lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 6). X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date.
 
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=4115750
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dennis100
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« Reply #397 on: January 28, 2019, 06:09:22 AM »

Event Date 08/27/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient had developed an infection at his neck incision site and was experiencing voice alteration and painful stimulation. The patient had been implanted with vns for over a year. No further information relevant to the event has been received to date.
 
Event Description
It was identified that a duplicate report of this patient's infection was submitted in mfg report #: 1644487-2014-02440. Manufacturer report # 1644487-2014-02440 will house any future information related to the infection.

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dennis100
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« Reply #398 on: January 29, 2019, 08:11:18 AM »

Model Number 302-20
Event Date 08/08/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was having issues with pain and with device migration. Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months. She later reported having a strange tremor in her head that occurred several times per day. It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla. Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck. The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside. An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity. The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4103125
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« Reply #399 on: January 30, 2019, 09:16:24 AM »

Model Number 105
Event Date 05/01/2014
Event Type  Injury   
Event Description
It was reported that the patient started having shoulder pain 1 year after surgery. She saw a physician who turned her device off but this has not subsided the pain. It was later reported that the patient saw the physician again and he turned the device back on and everything is now fine.
 
Event Description
It was reported that the physician was unsure if the pain and migration at the chest were attributed to the patient's fall in (b)(6) 2014. It was reported that the pain is constant and does not occur only with device stimulation. No system diagnostics have been run. The patient has moved to another state and is trying to establish care with a new physician. It is unknown if a non-absorbable suture was used to secure the generator to the facia during implant of the device. No additional relevant information has been received to date.
 
Event Description
It was reported that the vns patient was experiencing intolerable painful stimulation when a diagnostic test was performed during an office visit on (b)(6) 2014. The patient was having sharp pain in the auxiliary region. The patient¿s magnet mode output current was increased, but the patient refused any other changes in device settings. The neurologist stated that the pain was due to the positioning of the device and felt the patient¿s device should be repositioned. It was noted that the patient fell off her bicycle in (b)(6) 2014. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the patient's generator is turned off and she is doing alright. The patient is still searching for a new physician. She does not have a consistent following neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4063923
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« Reply #400 on: January 31, 2019, 02:37:11 AM »

Model Number MODEL 250
Event Date 09/22/2014
Event Type  Malfunction   
Manufacturer Narrative
Brand name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Type of device, name, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Model #, serial #, lot #, expiration date, other, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, these fields are being updated to reflect the suspect medical device. Operator of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the user of the suspect medical device. If implanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. If explanted, give date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Device manufacture date (mo/day/yr), corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Labeled for single use, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device. Usage of device, corrected data: information available to date indicates that the event was the result of an interrupted system diagnostic test; therefore, this field is being updated to reflect the suspect medical device.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient was seen in clinic on (b)(6) 2014 for a vns follow-up visit; system diagnostics were performed and the patient experienced pain at the electrode site with stimulation. No changes were made to the patient¿s device settings during the office visit. The patient reported that when he swipes his magnet, he feels the same pain. The patient returned to the clinic on (b)(6) 2014 and the device magnet current different than what was previously programmed. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4207463
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« Reply #401 on: January 31, 2019, 02:37:49 AM »

Model Number 102
Event Date 09/01/2014
Event Type  Injury   
Event Description
On (b)(6) 2014, product analysis was completed on the explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, 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 pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications, there were no anomalies found with the pulse generator.
 
Event Description
It was reported that the patient was having painful stimulation in his throat that he believed to be due to the generator reaching end of service. The patient stated that something similar occurred when his last generator reached end of service. The patient also reported that the generator was going off more often. The physician confirmed that the generator was not at end of service but the patient was insistent to have it replaced. Surgery is likely but has not occurred to date.
 
Event Description
On (b)(6) 2014 it was reported that the patient underwent prophylactic generator replacement on (b)(6) 2014. The explanted generator was returned for product analysis on (b)(6) 2014. Product analysis is still underway and has not yet been completed.

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« Reply #402 on: January 31, 2019, 02:38:42 AM »

Model Number 303-20
Device Problems Degraded; Unexpected Therapeutic Results
Event Date 08/03/2014
Event Type  Injury   
Event Description
Clinic notes were received for patient's referral for vns implantation. Per notes, patient requests for the vns to be re-implanted due to increased frequency of seizures.
 
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 due to painful stimulation in her neck which was occurring every 10 minutes for the past month. During the patient¿s last office visit in (b)(6) 2014, the device output current was increased from 2. 75ma to 3. 25ma. The patient¿s device was tested during the visit and diagnostic results showed normal device function. The patient underwent surgery on (b)(6) 2014 to explant her generator and lead due to electrode failure and pain. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. The patient has not been re-implanted to date to allow sufficient time to let her vagus nerve heal.
 
Manufacturer Narrative
This information was inadvertently left off of initial mfr. Report.

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« Reply #403 on: February 01, 2019, 12:24:25 PM »

Model Number 304-20
Event Date 04/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
During product analysis is was found that the explanted lead had a lead break. A coil break was identified in both the positive and negative lead coils. Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) occurred at the coil ends. Secondary fractures were observed in at least two strands of the quadfilar coils. The negative coil shows what appears to be wear (flat surfaces) resulting in reduction of the strand diameter. Although not conclusive the appearance of the lead break location is consistent with patient manipulation of the implanted device, a ¿twiddler¿. The patient had reported painful stimulation for months and the identified coil breaks may confirm this to be a contributing factor. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.

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« Reply #404 on: February 02, 2019, 08:50:37 AM »

Model Number 302-20
Event Date 01/01/2014
Event Type  Injury   
Event Description
It was reported that the patient was complaining of a constant ear ache and feels that the lead wire is sticking out at the generator site. The patient was referred to the surgeon. It was reported that the ear pain started with device stimulation and is now constant. Device diagnostics were reported to be within normal limits. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166466
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« Reply #405 on: February 02, 2019, 08:51:39 AM »

Event Date 09/08/2014
Event Type  Injury   
Manufacturer Narrative
Adverse event and/or product problem; additional information indicates that the event was not a product problem but an adverse event. Type of reportable event; additional information indicates that the event type was not a malfunction but a serious injury.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis and discard explants after 30 days; therefore, no analysis can be performed. Clinic notes were received indicating that the patient's device was tested during an office visit on (b)(6) 2014 and diagnostics showed lead impedance within normal limits (impedance value - 3000 ohms). After disabling the patient's device, the er physician prescribed medication for the patient. The notes indicate that the patient's painful stimulation occurred abruptly at her until the device was disabled and subsequently began having breakthrough seizures. A lead issue was suspected because of the patient's painful stimulation and not based on diagnostic results or x-rays. Operative notes for the patient's replacement surgery indicate that there was a significant amount of scarring around the nerve which required an external neurolysis as well as neurorrhaphy to prepare the nerve for placement of the new lead. The notes indicate that following placement of the new devices, the device was programmed on and showed low impedance. It is unclear whether the notes were referring to a low impedance reading or a low numerical impedance value that was within normal limits.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation and went to the er on (b)(6) 2014. The er physician stated that the patient¿s device was ¿misfiring¿. Follow-up revealed that during the er visit, the er physician had concerns of a potential lead break and subsequently disabled the device. The patient was sent for x-rays. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician¿s office that the patient experienced painful stimulation on the left side of the face, neck and chest abruptly on (b)(6) 2014. The patient was seen post- surgery by the physician on (b)(6) 2014 and that the incision sites were reported to be healing well. Attempts were made for product information but were unsuccessful.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, 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=4171248
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« Reply #406 on: February 03, 2019, 04:12:28 PM »

Model Number 102R
Event Date 04/01/2014
Event Type  Injury   
Event Description
Additional information was received that the patient underwent replacement of the generator and lead on (b)(6) 2014. The portion of the lead that was explanted was discarded by the explant facility. The explanted generator was received on (b)(6) 2015. In the pa lab, 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 pulse generator diagnostics were as expected for the programmed parameters. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. During the product analysis, there were no anomalies found with the pulse generator.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient began experiencing pain in her chest during stimulation on-times after falling into a glass table. The pain resolved when the magnet was used to temporarily disable the device. The device was programmed off during an office visit on (b)(6) 2014. Diagnostic results did not indicate any issues with the patient¿s device. The patient previously reported occasional tightness in her chest, erratic stimulation and stimulation on-times not perceived. The patient was referred for surgery but no known surgical interventions have occurred to date.

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« Reply #407 on: February 03, 2019, 04:14:08 PM »

Event Date 09/19/2014
Event Type  Injury   
Event Description
It was reported that the neurologist noted redness at the generator site and thought the surgeon should order antibiotics. The patient denied pain or drainage but indicated that the generator site was warm. The patient later reported that she was seen by her primary care physician for an upper respiratory infection and that the antibiotics she was given for that also decreased the redness to the generator site. The patient has been applying neosporin to the incision sites and the chest incision is now light pink and no longer feels warm.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the patient went to the er on (b)(6) 2014 due to chest pain associated with stimulation. The er physician was advised to use the magnet to temporarily disable the device. Further follow up with the physician's office indicated that the patient had recovered from infection on (b)(6) 2014.

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« Reply #408 on: February 04, 2019, 03:18:19 AM »

Model Number 102
Event Date 01/30/2013
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2014, it was reported that the patient¿s vns was being explanted due to discomfort at the generator site and that the vns has been disabled for 2 years. The patient underwent explant of the device and good faith attempts for the return of the explanted product has not been successful to date. It was previously reported on (b)(6) 2013 that the patient was experiencing pain along the lead site upon stimulation and had been going on at all levels of stimulation (0. 25ma and higher). The patient¿s device was interrogate and turned off. It was then reported on (b)(6) 2013 that the patient complained of pain along the whole lead and generator site, and it came and went with stimulation cycles. The patient has always felt the pain since implantation on (b)(6) 2013. The patient was seen by the physician on (b)(6) 2013 gain and the device was turned back on to output=0. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 25ma/magnet pulse width=250usec/magnet on time=60sec. The patient immediately complained of discomfort along the lead path. Normal mode diagnostics were then performed which showed a dcdc of 0. Then system diagnostics were performed which showed a dcdc of 3. The patient stated that he had discomfort along the lead the entire time and that it subsided once the generator was turned off. It was noted that the patient has had his generator up to output=1. 25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet pulse width=250usec/magnet on time=60sec which is when he was subsequently turned down due to discomfort. The patient was referred for x-rays and noted that if a lead break is observed then he would like the device removed, but if there is no lead break then he wants the device explanted. X-rays were received on (b)(6) 2013. The generator is visible in the left chest and is normally placed. The lead pin appears fully inserted inside the connector block. Feed thru wires appear intact. Lead wires at the connector pin appear intact. Lead is present behind the generator. The lead is visible routing upwards to the left neck. The electrodes appear aligned. A strain relief bend is present and is placed per labeling. One tie-down is present and is securing the bend. The presence of a strain relief loop cannot be assessed due to poor image quality. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. Based on the images available, a cause for the painful stimulation cannot be established. Note that an anomaly in the lead portion not visible cannot be ruled out.
 
Event Description
The explanted lead and generator were received by the manufacturer. Lead product analysis was completed. A section of the lead was returned for analysis with the lead connector still attached to the generator. A continuity check was performed between the set-screw and the end of the lead portion while attached to the generator. Proper contact between the set-screw and the lead pin was present. No discontinuities were identified within the returned lead portion. Set-screw marks were identified on the connector pin, indicating that proper contact between the set-screw and the connector pin was present at one point. Due to a portion of the lead not being returned for analysis, an evaluation cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Generator product analysis was completed. The device output signal was monitored for more than 24 hours with the generator placed in a simulated body temperature environment. There was no signs of variation in the generator's output signal and the device provided the expected level of current. The generator communicated as received and no eri flag was set. The diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. There was no abnormal performance or other adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4242424
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« Reply #409 on: February 04, 2019, 03:19:03 AM »

Model Number 102
Event Date 10/06/2014
Event Type  Injury   
Event Description
It was reported that the vns patient began experiencing painful stimulation from the generator site up to the neck after experiencing a fall. The patient went to the er on (b)(6) 2014 due to intolerable pain and was given pain medication. Clinic notes were received indicating that the patient was referred for surgery although diagnostics showed normal device function at the time. The notes briefly mention that patient¿s painful stimulation. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator was returned to the manufacturer for analysis which concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The device performed according to functional specifications. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the surgical intervention was not taken to preclude a serious injury. It is unknown if the patient's pain with device stimulation has resolved as the patient has not been seen by the physician since generator replacement.
 
Event Description
Additional information was received that the patient has been seizure free for the past two months.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4243940
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« Reply #410 on: February 04, 2019, 03:19:41 AM »

Model Number 102
Event Date 06/28/2013
Event Type  Injury   
Manufacturer Narrative
Previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Event Description
On (b)(6) 2014, it was reported that this patient¿s explanted generator was discarded at the time of explant. Attempts for additional information have been unsuccessful.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation in his neck. The patient¿s device settings were lowered but the patient subsequently experienced an increase in seizures. The patient¿s device settings were programmed back to previous settings and the patient¿s painful stimulation returned. X-rays dated (b)(6) 2013 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported event remains unknown. Follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. The replacement generator was tested with the existing lead and diagnostics showed lead impedance within normal limits (impedance value ¿ 1650 ohms). The patient continued to experience painful stimulation following surgery. The explanted generator has not been returned to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4245608
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« Reply #411 on: February 04, 2019, 03:20:49 AM »

Model Number 102R
Event Date 10/01/2014
Event Type  Injury   
Event Description
It was reported that the patient was experiencing pain at the generator site and wants to have a complete system replacement. It was reported that the pain was occurring with device stimulation. The patient was scheduled for vns system replacement. No surgical intervention has been performed to date.
 
Manufacturer Narrative

Event Description
The explanting facility does not return explanted products unless they are notified beforehand. The explanted devices are therefore not available for return for analysis.
 
Event Description
It was reported that the patient underwent a full replacement on (b)(6) 2014 due to the patient's discomfort. Attempts have been made for product return but the explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274291
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« Reply #412 on: February 04, 2019, 03:21:44 AM »

Model Number 304-20
Event Date 09/09/2014
Event Type  Injury   
Event Description
Additional information was received stating that during an office visit on (b)(6) 2014, the vns patient complained of having shocking sensations in her neck along with dysphagia and muscle spasms. The patient had temporarily disabled her device with her magnet and the physician programmed the device off during the office visit. During an office visit on (b)(6) 2014, the patient¿s device was programmed back on and the patient subsequently had a nose bleed and coughing with stimulation. The patient¿s device was tested and showed normal device function at the time. The patient¿s device was again disabled for comfort. No patient trauma or programming changes preceded the onset of the patient¿s issues. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was subsequently disabled and the patient was referred for surgery. The patient¿s physician was suspecting a potential issue with the lead. No known surgical interventions have occurred to date.
 
Event Description
Follow-up report #1 inadvertently did not include that the patient also experienced difficulty speaking during clinic visit on (b)(6) 2014.
 
Event Description
Information was received that the patient underwent full revision of the generator and lead on (b)(6) 2015. The explanted products were reported to be discarded and could not be returned to manufacturer.
 
Manufacturer Narrative

Manufacturer Narrative
Event description, corrected data: follow-up report #1 inadvertently did not include patient's difficulty speaking during clinic visit on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4132917
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« Reply #413 on: February 04, 2019, 03:22:53 AM »

Model Number 302-20
Event Date 10/30/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was shocked by an electric fence which supplies about 10,000 volts the day prior and since the patient has experienced severe pain with device stimulation. It was reported that the output current was decreased from 2. 5ma to 1. 25ma and that the patient still experienced pain, but that it was lessened. Device diagnostics were within normal limits. The device was programmed off and the physician plans to program the device back on in a few months. The physician indicated that the patient is mentally retarded and can not explain where the pain was felt, but that the patient was red in the face with tears in his eyes and a cough as soon as device stimulation began.

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« Reply #414 on: February 04, 2019, 03:23:46 AM »

Model Number 102
Event Date 08/13/2014
Event Type  Injury   
Manufacturer Narrative
Type of reportable event; corrected data: the initial mdr inadvertently selected malfunction instead of serious injury for this field. This mdr is being submitted to correct this data.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient had been experiencing painful stimulation, dyspnea and coughing with stimulation for the last two weeks. The patient described the pain as beginning at the generator site and then traveling up to the left side of her face to her jaw during stimulation on-times. The patient indicated that the painful stimulation was to the point of wanting the device disabled, so the device was programmed off. A system diagnostic showed normal device function. The patient underwent generator replacement surgery on (b)(6) 2014. The explanted device has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4266673
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« Reply #415 on: February 04, 2019, 03:24:32 AM »

Model Number 103
Event Date 09/01/2014
Event Type  Injury   
Event Description
It was inadvertently reported in the initial mdr that no surgical interventions have occurred to date. The patient underwent explant of the vns device but the explant facility chose not to return the explanted generator. Therefore, product analysis of the explanted generator could not be performed.
 
Manufacturer Narrative
Event description, corrected date: it was inadvertently reported in the initial mdr that no surgical interventions have occurred to date. If explanted, give date (mo/day/yr), corrected data: 11/17/2014. The explant date was inadvertently left off from the initial mdr report.
 
Event Description
It was reported that the vns patient was experiencing increased painful stimulation at the generator site and an increase in seizures since (b)(6) 2014. The patient¿s vns generator was disabled due to pain and the patient was referred for surgery to explant the device. The patient¿s explant surgery was being planned for patient comfort. No known surgical interventions have occurred to date. Follow-up revealed that the patient¿s increase in seizures were worse with vns stimulation. The patient did not have any seizures while the device was disabled. The physician stated that the pain was due to the presence of the device. The patient¿s device was tested and showed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4277380
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« Reply #416 on: February 04, 2019, 09:56:42 AM »

Model Number 302-20
Event Date 01/01/2005
Event Type  Injury   
Event Description
It was reported that the patient had vns explant in 2006 due to cardiac episodes and painful stimulation. The patient had previously had generator replacement on (b)(6) 2006. Review of the generator programming history revealed that the device was programed off on (b)(6) 2007. The explant therefore occurred sometime after that time. The patient had vns re-implant surgery on (b)(6) 2014. During surgery, the surgeon noted that the old lead electrodes were inverted on the vagus nerve (with the positive and negative electrodes inverted). It was reported that in 2005, the patient had a cardiac episode and was hospitalized for bradycardia. Additionally, the patient had painful stimulation. As a result, the device was turned off, and the generator and a portion of the lead in the chest area was explanted. Review of programming history in-house reveals the device was programmed off on (b)(6) 2007. Follow-up with the patient's treating neurologist revealed that there is only limited information regarding the events, as the patient was treated by a different physician at the practice at the time of the events and that physician no longer works at the practice. The currently treating physician's recollection is that there were "big problems" with getting the patient regulated which would be explained by the inverted electrodes, per the physician. The explanted portion of the lead from surgery on (b)(6) 2014 was received by the manufacturer for analysis. Note that a large portion of the lead assembly (body); including the connector pin / boot section with model and serial number tag and the electrodes was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuity in the returned portion of the device which may have contributed to the stated allegations. Additionally for the explanted generator on (b)(6) 2006, analysis was completed. Based on the battery life analysis, the pulse generator approached a normal end of life condition. In addition, the pulse generator was operating at an increased duty cycle (71%) and, as defined in the physician¿s manual, this will deplete the battery faster than a low duty cycle; this may have been a contributing factor. The reported condition of erratic stimulation at that time was not verified in the laboratory. Delivered generator output across an electrical load confirmed a steady output voltage consistent with programmed parameter settings. There were no signs of variation in the output signal. The pulse generator would not interrogate, therefore was opened. The measured battery voltage was below the low battery operation level specified for the pulse generator, which indicates that the pulse generator had reached the end of life. These measurement in the lab demonstrate appropriate current consumption for the device, resulting in normal battery depletion. No performance anomalies were noted.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. However, lead electrodes were noted to be inverted on the nerve.
 
Event Description
The surgeon's office reported that the patient had explant surgery on (b)(6) 2008. It was also reported that the explanted generator and portion of the lead explanted at that time were discarded.

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« Reply #417 on: February 05, 2019, 03:29:37 AM »

Model Number 102R
Event Date 10/03/2013
Event Type  Injury   
Event Description
On (b)(6) 2014, it was reported that the patient¿s device was still disabled and that the patient was referred for full revision due to a report of painful stimulation. The surgery was both for patient comfort and to preclude a serious injury: the patient was now experiencing an increase in seizures due to the device being programmed off. It was initially reported that this patient was experiencing an increase in seizures related to menopause. The patient didn¿t feel stimulation all the time like she used to and only felt it when diagnostics were performed. It was presumed that the patient just became used to the settings. Ap and lateral chest x-rays dated (b)(6) 2013 were received and reviewed on (b)(6) 2013. The reason for the exam, per attached documentation, was vns placement and possible lead breakage. X-rays showed that the generator is visible in the left chest and is normally placed. The lead pins appear fully inserted into the connector blocks. The feedthru wires appear intact. The lead wire at the connector pins appears intact. Lead is present behind the generator and cannot be assessed. The lead wire is seen routing up towards the left neck. The electrodes appear normally placed. No gross fractures, lead discontinuities, or sharp angles are present. Based on the images present, the generator placement appears normal, and no lead discontinuities appear to be present. It was later reported that the patient¿s device was currently off, and the patient was to undergo an mri. The device had been disabled because the device was shocking the patient. When the patient used the magnet, nothing happened, even when she wasn¿t having a seizure. Additional clarification showed that it was unknown if the painful stimulation and magnet events were occurring with stimulation. Sometimes the patient would be sitting or lying down, and would experience the ¿shocking. ¿ the patient¿s device had been disabled since (b)(6) 2013 due to the shocking. The patient didn¿t feel the stimulation from magnet activations (stimulation not perceived). The patent had previously experienced choking with stimulation when she was eating or drinking, but she knew this feeling now, and the shocking was different and painful. The patient¿s father believed that the problem would resolve with replacing the patient¿s whole system with the newest model. Surgery is likely but has not taken place.
 
Manufacturer Narrative
Review of programming history; manufacturer reviewed x-rays of implanted device; x-rays reviewed by the manufacturer, no gross lead discontinuities or anomalies visualized.

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« Reply #418 on: February 05, 2019, 03:30:52 AM »

Model Number 102
Device Problem Programming Issue
Event Date 12/02/2014
Event Type  Malfunction   
Event Description
An implant card was received indicating that the device was still unable to interrogate at the replacement surgery. The reason for replacement was identified as "battery depletion, unable to interrogate due to battery depletion. " the explanted generator has been received by the manufacturer. Analysis is underway , but has not been completed to-date.
 
Manufacturer Narrative

Event Description
It was reported that no further attempts have been made to interrogate the patient's device. Insurance coverage is being obtained for revision surgery. The patient experienced returns of suicidal thoughts which was reported to be related to the progression of the patient's depression. Suicidal ideations are not new for this patient and the return of the suicidal thoughts are unrelated to vns.
 
Event Description
It was reported that the patient has had an increase in depression, and has made suicide attempts. Medication changes were considered. The patient had generator replacement surgery on (b)(6) 2015. The explanted product has not been received to-date.
 
Event Description
Analysis was completed for the returned generator. The reported failure to program was determined to be the result of normal battery depletion. The depletion was an expected event as determined by battery life calculation and battery voltage measurement. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device had been disabled in (b)(6) 2008 due to painful stimulation. It was reported that during an office visit on (b)(6) 2014, the physician was considering programming the device back on due to the patient¿s condition, but was unable to interrogate the patient¿s device despite using two known working programming systems. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Initial reporter: the incorrect contact information for the initial reporter was provided inadvertently. Relevant tests/laboratory data: the available device settings and estimate of battery life calculation were inadvertently not provided in the initial report.

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« Reply #419 on: February 05, 2019, 03:31:58 AM »

Model Number 102
Event Date 07/07/2014
Event Type  Injury   
Event Description
An implant card was received indicating that the patient underwent generator replacement on (b)(6) 2014. Attempts made for the return of the explanted product were unsuccessful. The explanted product could not be located by the explant facility. Analysis of the product could not be performed as the product has not been received to date.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the patient experienced painful stimulation at the generator site. The generator replacement surgery was reported to be planned for patient's comfort and not to preclude a serious injury. There were no known vns setting changes or trauma to the site that could have caused or contributed to the painful stimulation. No known surgical interventions have occurred to date.
 
Event Description
A surgery referral form was received indicating that the patient was referred for generator replacement because of pain with vns stimulation for 2-3 months. It was noted that the generator is likely nearing end of service. Clinic notes dated (b)(6) 2014 indicate that the patient experiences more auras and will be referred for generator replacement because the generator battery is low. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

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