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Author Topic: Corrosion/Disintegration  (Read 36841 times)
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dennis100
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« Reply #540 on: February 07, 2019, 01:53:19 AM »

Model Number 302-20
Event Date 01/05/2015
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 vns patient¿s device showed low output current delivered and high lead impedance. The device was disabled and the patient was sent for x-rays. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the explanted generator was completed. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the explanted lead was completed. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil broken ends and strand fragments show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution, mechanical distortion (smoothed surfaces), and /or surface contamination the fracture mechanism cannot be ascertained. Abraded openings of both the outer and inner silicone tubing were also observed near the break location with dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. 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.
 
Event Description
Additional information was received that the patient underwent generator and lead replacement surgery due to prophylactic generator replacement and lead discontinuity. System diagnostics following revision showed normal results without high impedance. The generator and lead were received for product analysis. Analysis is currently underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4460830
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dennis100
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« Reply #541 on: February 07, 2019, 01:54:13 AM »

Model Number 102
Event Date 10/15/2014
Event Type  Injury   
Event Description
It was reported by the treating physician¿s office that the patient¿s caregiver would not leave the wound alone and subsequently caused the infection. Analysis of the generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. Except for an abraded opening in the outer tubing, there were no observed product related issues with the returned lead portions. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant and therefore delivering therapy to the cut leads. Analysis of the lead revealed dried remnants of what appear to have been fluids/betadine solution inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of 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 the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of manufacturing records confirmed sterilization for the lead prior to distribution.
 
Event Description
Although reimplant may occur, it has not occurred to date.
 
Event Description
It was reported that the patient had explant surgery on (b)(6) 2015. The generator and lead were explanted due to wound infection.
 
Manufacturer Narrative
Device available for evaluation, corrected data: the supplemental report #1 inadvertently did not report this data.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
It was reported that re-implant is not being pursued at this time. The physician believes the patient¿s constant scratching at the sites would result in infection occurring again in the future.
 
Event Description
It was reported that the vns patient developed an infection following a recent generator replacement surgery on (b)(6) 2014. The patient was given additional antibiotic medication. No known surgical interventions have occurred to date. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
The patient¿s infected area has still failed to heal completely. The patient will be treated with antibiotic ointment. The electrode portion of the lead was removed on (b)(6) 2015 since the wound was not healing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4293846
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dennis100
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« Reply #542 on: February 07, 2019, 01:55:55 AM »

Model Number 302-20
Event Date 12/23/2014
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for generator and lead replacement due to high impedance. X-rays were taken, but did not reveal any lead discontinuities. It is unknown if any patient manipulation or trauma occurred that may have caused or contributed to the high impedance. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to lead discontinuity. The explanted devices were returned to the manufacturer for analysis. No abnormal performance or any other type of adverse condition was found with the returned pulse generator. The device performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of positive quadfilar coil in the body region of the returned lead portions. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the suspected broken end of the coil. However, due to metal dissolution, a conclusive determination of the fracture mechanism of the coil cannot be made. Though it is difficult to state conclusively the most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant. The lead assembly has punctures in the outer silicone tubing and the inner tubing. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430814
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dennis100
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« Reply #543 on: February 07, 2019, 01:56:39 AM »

Model Number 304-20
Event Date 11/06/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device showed high impedance and was disabled. Clinic notes were received indicating that the patient was experiencing an increase in seizures. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have not been returned to date.
 
Event Description
The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. The reason for explant was listed as patient self-abuse.
 
Event Description
Analysis of the returned generator and lead was completed. 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. Lead discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions. The condition of the lead suggests that patient manipulation caused the lead discontinuity. The inner silicone tubing of the negative coil has what appears to be a punctured opening. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions. Scanning electron microscopy images of the positive coil at the end of the first portion of the lead and the strand segments identified in the vicinity of the positive coil show that pitting or electro-etching conditions occurred on the coil wires.
 
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=4301752
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dennis100
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« Reply #544 on: February 07, 2019, 01:57:29 AM »

Model Number 300-20
Event Date 05/04/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Analysis of the returned generator and lead was completed. The end of service condition of the explanted generator was determined to be the result of normal battery depletion. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portion was confirmed where abraded openings were observed on the outer and both inner silicone tubes and tie down location. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.
 
Event Description
During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2011 and system diagnostic results revealed high impedance (dc dc ¿ 7). Clinic notes from the patient¿s office visit on (b)(6) 2014 indicate that the patient was having as many as 10 seizures per day. It was noted that the patient¿s magnet was not aborting the patient¿s seizures. A battery life calculation using the available programming history show 0 years remaining until eri = yes. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The patient¿s explant device could not be interrogated which was suspected to be due to an end of service condition of the device. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4443052
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dennis100
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« Reply #545 on: February 07, 2019, 08:37:06 PM »

Model Number 300-20
Event Date 12/12/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the vns patient¿s replacement generator was tested with the existing lead and system diagnostics results revealed high impedance. The lead pin was confirmed to be fully inserted into the generator header. Pre-operative diagnostics could not be performed due to the end of service condition. The patient¿s lead was also replaced during the procedure. The explanted devices have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned devices was completed. Analysis of the explanted and opened/unused generators concluded that no abnormal performance or any other type of adverse condition was found. The devices performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of negative quadfilar coil in the electrode region. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. Due to pitting, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be ascertained. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4404879
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dennis100
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« Reply #546 on: February 07, 2019, 08:37:49 PM »

Model Number 302-20
Event Date 12/15/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Event Description
It was reported that the vns patient¿s device showed high impedance. The patient had also been experiencing an increase in seizures. The patient was sent for x-rays and referred for surgery. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis which confirmed discontinuity of negative quadfilar coil in the body region of the returned lead portion. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. Abraded openings of both outer and inner tubing were observed near the break location. The abraded opening and tear 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. There were no performance or any other type of adverse conditions found with the pulse generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4410130
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dennis100
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« Reply #547 on: February 07, 2019, 08:38:33 PM »

Model Number 302-20
Event Date 10/25/2014
Event Type  Malfunction   
Event Description
Additional information was received that no patient manipulation or trauma was known to have occurred which may have contributed to the high impedance. The explanted generator and lead were received for analysis. Analysis of the explanted generator showed proper functionality of the pulse generator in its ability to provide appropriate programmed output currents. 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. Review of the generator's internal data showed that the high impedance occurred sometime on or prior to (b)(6) 2014. Analysis of the explanted lead was completed and confirmed discontinuity of both the positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both the outer and inner tubing were observed as well, which provided paths for the observed fluid leaks. Furthermore, pitting was observed near the break locations. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). It was noted that the patient had been experiencing an increase in seizures. The patient underwent generator and lead replacement surgery on 01/02/2015. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
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=4430468
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dennis100
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« Reply #548 on: February 07, 2019, 08:39:27 PM »

Model Number 302-30
Event Date 12/18/2014
Event Type  Malfunction   
Event Description
Analysis of the returned lead portion was completed which confirmed opening of the inner tubing, exposing conductive quadfilar coils. The openings may have been wear-related and may have contributed to the reported muscle spasms. Scanning electron microscopy images of the connector ring surface show that pitting or electro¿etching conditions have occurred on the surface. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Note that since the lead¿s electrodes were not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not observe any lead discontinuity. Lead discontinuity is suspected in the lead portion not returned, but did not cause or contribute to a death. Device failure occurred, but did not cause or contribute to death.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the fluid leaks found during product analysis.
 
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¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (impedance value ¿ 8180 ohms). The patient presented with an increase in seizure frequency and experienced neck twitching during device programming at the visit. The patient¿s device was disabled and the patient was sent for x-rays. The patient underwent lead replacement surgery on (b)(6) 2014. The replacement lead was tested with the existing generator and diagnostic results showed lead impedance within normal limits (impedance value ¿ 1323 ohms). The explanted lead has been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4426437
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dennis100
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« Reply #549 on: February 07, 2019, 08:40:16 PM »

Model Number 302-20
Event Date 12/22/2014
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 end of service, the surgeon stated that the vns patient¿s lead may be fractured. Operative notes indicate that the setscrew was tightened appropriately and the replacement generator was tested with the existing lead. Diagnostic results consistently provided elevated impedance values. Pre-operative diagnostics could not be performed due to the end of service condition. The patient¿s generator was replaced and the procedure was completed with the device disabled. The patient was referred for lead replacement, but no known surgical interventions for the lead fracture. It was noted that the patient frequently has twisting and jerking neck movements which may have contributed to the lead fracture and that the patient has been having coughing fits.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2015. Preoperative system diagnostic results showed high impedance (dcdc - 6). System diagnostic results with the replacement lead and existing generator showed lead impedance within normal limits (dcdc - 1). The surgeon confirmed that the lead had been completely and securely inserted into the generator header. It was noted that once the neck incision site was opened, it appeared that the anchor tether was out above the carotid sheath where the electrodes were implanted. The explanted generator and lead were returned to the manufacturer for analysis. There was no indication from the returned generator that an end of service or failure to program condition existed. The device communicated normally and performed according to functional specifications. No abnormal performance or any other type of adverse condition was found. Follow-up with the physician's office indicated that the programming system was working fine without any issues. Analysis of the returned lead confirmed discontinuity of quadfilar coil in the electrode region. Pitting was observed on the coil surface. Abraded openings of both inner tubes were observed near the break location. The lead assembly has dried remnants of what appear to have once been body fluids inside the outer and inner silicone tubes.
 
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=4430479
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dennis100
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« Reply #550 on: February 07, 2019, 08:41:50 PM »

Model Number 304-20
Event Date 12/11/2014
Event Type  Malfunction   
Event Description
The patient underwent surgery. During surgery, it was observed that the lead appeared to be corroded. It was reported that the lead appeared to be discolored and device diagnostics resulted in high impedance. Both the generator and lead were replaced. An implant card was received indicating that the generator was replaced due to battery depletion and the lead was replaced due to lead discontinuity. The explanted devices have not been received for analysis to date.
 
Event Description
Clinic notes were received indicating that the vns patient had five seizures in one day. The patient¿s medications were subsequently adjusted. The patient¿s device was noted to be running out of battery life so the patient was referred for surgery. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Corrected data: new information received corrects the suspect device. Corrected data: a device malfunction is suspected to have caused the serious injury. 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=4409566
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dennis100
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« Reply #551 on: February 10, 2019, 03:20:14 AM »

Model Number 302-20
Event Date 12/12/2014
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that high lead impedance was observed on system diagnostics on (b)(6) 2014. The device was not disabled. Although surgical intervention is likely to resolve the high impedance, it has not occurred to date.
 
Event Description
Analysis was completed on the lead and generator. Scanning electron microscopy images of the positive coil end show that pitting or electro-etching conditions have occurred at the end of the coil. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Note that since the a portion of the lead (including portion of electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portions. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
It was later reported that the patient had generator and lead replacement on (b)(6) 2015. The generator was replaced prophylactically, and the lead was replaced due to lead discontinuity. The explanted devices were received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Manufacturer Narrative

Manufacturer Narrative
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=4382825
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« Reply #552 on: February 11, 2019, 01:40:05 AM »

Model Number 300-20
Device Problem High impedance
Event Date 06/01/2014
Event Type  Malfunction   
Event Description
Analysis of the lead identified that there were abraded openings in the outer and inner tubing in one area. For the observed fluid leaks, there were only observed in the inside of the outer tubing (not inner tubing).
 
Event Description
Additional information was received stating that x-rays were taken for the patient and the physician's office was able to visualize a lead fracture in the x-rays. Thus, the patient was referred for revision surgery. The lead fracture is thought to be due to the patient's fall over the summer, though this cannot be confirmed. The patient's recent increase in seizures is thought to be related to a loss of therapy from the high impedance. The increased seizure rate is around pre-vns levels. No known surgical interventions have occurred to date. Good faith attempts for additional relevant information have been unsuccessful.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient¿s device showed high impedance. The patient had experienced an increase in seizures the past summer following a fall. The patient was referred for surgery but no known surgical interventions have occurred to date. The patient had been doing well with vns. It was noted that the patient had also been experiencing chest pain which was attributed to lateral device migration in the chest which occurred shortly after implant surgery.
 
Event Description
Additional information was received that the patient underwent vns generator and lead replacement surgery on (b)(6) 2015 due to high lead impedance. The generator was replaced prophylactically. The explanted generator and lead were received by the manufacturer for analysis. Analysis of the generator concluded that the device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead confirmed a discontinuity of the positive quadfilar coil in the body region of the returned lead portions. The analysis also observed abraded openings of both outer and inner tubing near the break area with associated fluid leaks. Pitting was also observed on the coils at the break location. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.
 
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=4486745
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« Reply #553 on: February 11, 2019, 01:40:51 AM »

Model Number 304-20
Event Date 01/09/2015
Event Type  Malfunction   
Event Description
Product analysis for the patient's lead was completed and approved on 2/9/2015. A break was identified at the end of the positive and the negative lead coils. Scanning electron microscopy images of the positive and the negative lead coils show that pitting or electro¿etching conditions have occurred on the coils¿ ends. However, due to metal dissolution the fracture mechanism cannot be determined. 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 the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Product analysis for the m105 generator was completed and approved on 2/18/2015: in the (b)(6), 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s generator site had pus and was subsequently washed out. Both the generator and lead were explanted due to infection. The patient has not been re-implanted to date. Follow-up revealed that the patient¿s device showed a high impedance condition prior to explant. Attempts for additional relevant information have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Implant card received on 07/02/2015 states that patient had a re-implant surgery on (b)(6) 2015. The original explant had occurred on (b)(6) 2015 with no replacement at that time. The new lead and generator were placed on (b)(6) 2015.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
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=4490139
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« Reply #554 on: February 12, 2019, 02:42:15 AM »

Model Number 302-20
Event Date 01/27/2015
Event Type  Malfunction   
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently indicated the opened but unused generator and lead were returned to the manufacturer for analysis. The issues removing the lead from the opened but unused generator was reported in manufacturer report # 1644487-2015-03985. Device available for evaluation; corrected data: the previously submitted mdr inadvertently indicated that the device was not available for evaluation. Device evaluated by mfr; corrected data: the previously submitted mdr inadvertently indicated that the device was not returned to the manufacturer.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015 due to battery depletion, the vns patient¿s replacement generator was tested with the existing lead and diagnostic results showed high impedance. It is believed that the implanting physician may have damaged the lead while opening the generator pocket; however, preoperative diagnostics were not performed due to failure to interrogate due to end of service so the high impedance condition may have been present prior to replacement surgery. The surgeon had issues removing the lead pin from the replacement generator so he explanted the entire system and implanted a brand new system. The open but unused generator and lead have not been returned to date. The depleted generator was returned to the manufacturer for analysis which confirmed the end of service condition due to normal battery depletion.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the returned lead portion was completed on 10mar2015, which found a coil break at the end of the positive coil. Scanning electron microscopy showed flat surfaces on the coil strands and pitting on the connector ring.
 
Event Description
The opened and unused generator and explanted lead have been returned to the manufacturer where analysis is currently underway. The issues removing the lead from the opened but unused generator was reported in manufacturer report # 1644487-2015-03985.
 
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=4532663
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« Reply #555 on: February 12, 2019, 02:43:05 AM »

Model Number 300-20
Event Date 01/30/2015
Event Type  Injury   
Event Description
It was reported that the vns patient¿s lead was protruding through the patient¿s skin. Patient manipulation is not believed to have caused or contributed to the protrusion. Operative notes were received indicating that the patient¿s lead was well incorporated into the patient¿s skin at the previous generator replacement surgery on (b)(6) 2012. The patient underwent generator and lead replacement surgery on (b)(6) 2015. The notes indicate that at least two loops of the lead were protruding from a defect in the skin of the left neck. There was no pus, erythema, fever or chills. The explanted devices have been returned to the manufacturer where analysis is currently underway.
 
Event Description
The analysis was completed on the patient's explanted generator. The explanted lead analysis is pending completion. 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.
 
Manufacturer Narrative

Event Description
Product analysis for the lead completed on 3/12/2015. Scanning electron microscopy of the positive and negative lead coils show that pitting or electro-etching conditions have occurred on the coil surfaces. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4542004
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« Reply #556 on: February 12, 2019, 02:43:53 AM »

Model Number 302-20
Event Date 10/15/2014
Event Type  Malfunction   
Event Description
The explanted lead and generator were received by the manufacturer for analysis. The lead analysis was completed and a lead break was confirmed as a coil break was identified on what was believed to be the negative coil. Scanning electron microscopy images of the negative coil broken ends show that pitting or electro-etching conditions have occurred at the break locations. Due to pitting, mechanical distortion (smoothed surfaces), and/or surface contamination, the fracture mechanism of the coil could not be ascertained. Generator analysis is expected but has not been completed to date.
 
Event Description
Product analysis for the returned generator was completed. The review of the ram/flash data downloaded from the generator shows an indication of increased impedance from 5267 ohms to 10,013 ohms, and the date of change detection of (b)(6) 2014 (explant date (b)(6) 2016). The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2013 with an impedance value of 2133 ohms (implant date (b)(6) 2012). Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications. The batter voltage indicated an ifi = no condition. There were no performance or any other type of adverse conditions found with the generator.
 
Event Description
Additional information was received stating that the vns patient¿s device first showed a high impedance condition during an office visit on (b)(6) 2015. The patient¿s device was subsequently disabled.
 
Event Description
It was reported that the vns patient¿s device showed a high impedance condition (impedance value >= 10,000 ohms). Diagnostic results for the past year showed normal device function. X-rays were taken and reported to show the lead being ¿angulated. ¿ x-rays 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. 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. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
It was reported the patient was re-implanted with a new vns on (b)(6) 2016; however, this was later confirmed invalid by the physician who noted the patient was re-implanted on (b)(6) 2016. The surgery was a full revision and the patient received a new lead and vns generator. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. 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=4554478
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« Reply #557 on: February 12, 2019, 02:44:48 AM »

Model Number 302-20
Event Date 11/06/2014
Event Type  Malfunction   
Event Description
Analysis of the returned generator and lead was completed. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance. Discontinuity was observed in both positive and negative quadfilar coils in the body region of the returned lead portions where abraded openings were observed on the outer and both inner silicone tubes and tie down location. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient¿s device showed a high impedance condition (impedance value ¿ 9287 ohms) during an office visit on (b)(6) 2015. The patient¿s device was subsequently disabled. X-rays were taken and were reported by the physician to be unremarkable. Clinic notes were received indicating that the patient had been experiencing an increase in nighttime seizures in the past 1-2 months. The notes mention that the increase in seizures may be related to changes in medications that occurred around that time. The patient¿s medications were adjusted on (b)(6) 2015. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4554444
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« Reply #558 on: February 13, 2019, 02:04:50 AM »

Model Number 304-20
Event Date 12/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis was completed on the explanted generator and lead. The lead fracture was not confirmed in the returned lead portion. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the cut/torn end of the coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred on the coil surface. Although not conclusive, the most likely cause for the observed pitting conditions is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Note that since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the generator revealed that the elective replacement indicator (eri) was set. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an eri condition. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion no returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2015. The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date. The reason for product return was documented by the explant hospital as "non-functioning battery and leads. ".
 
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2014 reported that high lead impedance was detected with report of ¿battery failing. ¿ there was mention of ¿scar under electrode¿ and jump in impedance to dcdc ¿ 7. Follow-up with the physician¿s office was performed. It was reported that high impedance was detected on system diagnostic testing. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4521904
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« Reply #559 on: February 13, 2019, 02:05:37 AM »

Model Number 302-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s device also showed high impedance so the lead was also replaced during the procedure. X-rays had been previously taken which showed a bend in the lead approximately 4cm from the anchor tether. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator were received on (b)(6) 2015 and they are currently undergoing analysis.
 
Event Description
Analysis of the lead was completed on (b)(4) 2015 and it identified a break in the negative coil, 2mm from the proximal end of the anchor tether. Evidence of a stress-induced fracture was found at the break area, with mechanical damage and pitting. During the visual analysis the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (-) white electrode ribbon from coming in contact with the vagus nerve. No other discontinuities were identified. The positive electrode ribbon presented remnants of dried body tissue. Findings consistent with an explant procedure were also identified. Analysis of the returned generator was completed on (b)(4) 2015. The battery voltage was 2. 975 volts, which indicates an ifi=no condition. No adverse conditions were found on the generator. The generator performed according to specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4528383
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« Reply #560 on: February 13, 2019, 02:06:31 AM »

Model Number 300-20
Event Date 01/26/2015
Event Type  Malfunction   
Event Description
Analysis of the explanted and returned lead was completed. Note that since a significant 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. Except for slight observed pitting on connector pin(s) and typical wear and explant related observations, there were no observed product related issues with the returned lead portions.
 
Event Description
Analysis of the generator explanted (b)(6) 2015 was completed, and is captured in manufacturer report # 1644487-2014-03067. The downloaded data from this generator showed that the date of high occurrence occurred sometime before (b)(6) 2015, as the impedance value changed from 13139 ohms to 22903 ohms on that day. Additional information was received that the patient underwent generator and lead replacement surgery (b)(6) 2015 due to prophylactic generator replacement and high impedance. The explanted products were received for analysis. Analysis of the explanted generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The last recorded 25% change in impedance was from 12935 ohms to 3957 ohms on date of implant, (b)(6) 2015. Analysis of the lead has not been completed to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Event description; corrected data: the previously submitted mdr inadvertently failed to include information that the patient received generator and lead replacement surgery (b)(6) 2015. Date of explant; corrected data: the previously submitted mdr inadvertently failed to indicate the date of explant.
 
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) 2015 due to low output current, the vns patient¿s replacement generator was tested with the existing lead and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The replacement generator was tested with a test resistor and generator diagnostic results showed lead impedance within normal limits (impedance value ¿ 3900 ohms). The lead pin was reinserted into the generator header but the high impedance condition did not resolve. There was no indication that the lead was damaged during the procedure. Preoperative diagnostic tests were not performed. The lead was not replaced during the procedure. No known surgical interventions for the high impedance condition have occurred to date. The low output current event was reported in manufacturer report # 1644487-2014-03067.

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« Reply #561 on: February 13, 2019, 02:07:40 AM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 01/21/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (5969 ohms). It was reported that x-rays were taken and showed a clear lead break. The device was programmed off after observing the high impedance. The patient suffered a fall 10 days prior to the high impedance reading; however, it was reported that the fall was not significant. It was reported that the impedance has slowly increased over time. The patient has been referred for surgery. No known surgical intervention has been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead was returned to the manufacturer on 08/20/2015 for analysis. Product analysis results confirmed discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portions; also observed abraded openings of both the outer and inner tubing near the break location. During the visual analysis of the returned 316mm portion, the end of the (-) connector pin quadfilar coil appeared to be broken approximately 265mm and the end of the (+) connector ring quadfilar coil appeared to be broken at approximately 266mm from the end of the connector boot. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 265mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 266mm) and identified the area on two of the broken coil strands as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type. The area on the third broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture and no pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 84mm portion quadfilar coil 1 appeared to be broken approximately 2mm and quadfilar coil 2 appeared to be broken at approximately 4mm from the end of the abraded open / outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 2mm) and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The two remaining broken coil strands were identified as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture and no pitting. Scanning electron microscopy was performed on the quadfilar coil 2 coil break (found at 4mm) and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance), mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of these broken coil strands. The area on the fourth broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings and incision mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded openings found on the 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 inner silicone tubes. With the exception of the observed discontinuities and the abraded inner tubing, the condition of the returned lead portions 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 portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015. The suspect lead was explanted and a replacement lead was implanted. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits with 1352 ohms. Return of the explanted lead to the manufacturer is expected but it has not been received to date.

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« Reply #562 on: February 13, 2019, 02:08:39 AM »

Model Number 302-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
Analysis of the lead was completed on 03/16/2015 and it identified a break in the positive coil with pitching and electro-etching at the break location. The appearance of one strand of the positive coil broken end suggest that the fracture could be induced by stress, but it cannot be confirmed due to mechanical distortion, pitting and surface contamination. Additionally, abraded openings of the outer and inner silicone tubing were identified. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.
 
Event Description
It was reported that the vns patient¿s device showed high impedance. The patient had been experiencing an increase in seizures for the past few weeks. The patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Event Description
The explanted lead was received by the manufacturer on 02/23/2015 and is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519312
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« Reply #563 on: February 13, 2019, 02:09:30 AM »

Model Number 302-20
Event Date 01/19/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient was experiencing neck pain. The patient¿s device was tested and diagnostic results revealed high impedance (impedance value ¿ 7012 ohms). The patient¿s device settings were subsequently decreased. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2015. It was noted that the patient¿s lead appeared to be ¿falling apart¿ at the nerve. The explanted devices have not been returned to date.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of negative quadfilar coil in the electrode region. Extensive pitting and evidence of electro-etching were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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=4516900
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« Reply #564 on: February 14, 2019, 01:36:53 AM »

Model Number 302-20
Event Date 02/24/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed. The pulse generator performed according to functional specifications. The battery showed an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 43. 645% of the battery had been consumed. No performance or any other type of adverse conditions was found with the pulse generator.
 
Event Description
The explanted devices were received by the manufacturer on 04/20/2015. Analysis is underway, but it has not been completed to date. Analysis of the lead was completed. Scanning electron microscopy images of the connector pin show that the pitting or electro-etching conditions have occurred on the pin surface at the setscrew marks¿ location. No obvious adverse effect was identified on the device performance as a result of this condition. A portion of the lead including the electrode array was not returned for analysis, rendering an evaluation and resulting commentary on that portion of the lead impossible. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity. The lead impedance with the new system was within normal limits (1793 ohms). The explanted devices are expected to be returned for analysis, but have not been received to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, 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=4641405
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« Reply #565 on: February 15, 2019, 02:55:57 AM »

Model Number 302-20
Event Date 02/12/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes received (b)(4) 2015 and dated (b)(6) 2015 state that the patient is being seen for vns surgery, possible battery replacement. Notes state that the device worked well for several years then ¿stopped. ¿ battery interrogated and battery is dead. The patient was seen to discuss replacing the vns generator and electrodes. The patient underwent a full replacement on (b)(6) 2015. The generator and lead were received on (b)(4) 2015. Analysis is underway but has not been completed to date.
 
Event Description
Clinic notes dated (b)(6) 2015 were received. The notes state that the patient reports breakthrough spells and seizures.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Product analysis for the generator was completed and approved on 06/16/2015. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the lead was completed and approved on 06/25/2015. The lead assembly was returned for analysis and a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends and strand segments found in the organic matter show that pitting or electro-etching conditions have occurred at the break locations. Also, images of the suspected positive coil mating end and some of the strand segments show what appears to be wear (flat surfaces) on the coil strands. An abrasion was noted on the connector boot. White deposits were noted at the end of the connector boot. Abrasions were noted on the outer silicone tubing at multiple locations. The outer silicone tubing has a compressed appearance at multiple locations. A portion of the lead assembly is covered with what appears to be organic matter. The inner silicone tubing of the negative coil is abraded. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
On (b)(6) 2015 programming history was reviewed, and high impedance was observed. On (b)(6) 2004 (adjusted date (b)(6) 2013) the device was interrogated and a system diagnostic was performed and resulted in high lead impedance. No further programming history is available.

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« Reply #566 on: February 16, 2019, 02:11:55 AM »

Model Number 302-30
Event Date 02/06/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). The patient was referred for surgery. The patient underwent generator and lead replacement due to high impedance and end of service. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the explanted devices was completed. The end of service condition of the generator was determined to be the result of normal battery depletion. There was no condition noted during the analysis that would suggest any anomaly with the device. Analysis of the returned lead portions confirmed discontinuity of positive quadfilar coil in the electrode region. Pitting and flat spots were observed on the coil surface on both sides of this lead discontinuity.

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« Reply #567 on: February 16, 2019, 02:12:52 AM »

Model Number 302-20
Event Date 02/13/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
The patient underwent generator replacement surgery on (b)(6) 2015. It was reported that device diagnostics performed three times with the new generator and existing lead were within normal limits. The lead was not replaced. The patient was seen for follow-up with the surgeon at which time device diagnostics results in high impedance (>10,000). The patient was scheduled for lead replacement. The patient underwent lead replacement on (b)(6) 2015. There was no clear evidence of a lead fracture observed during explant. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and diagnostic results revealed high impedance. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in the electrode region. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.

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« Reply #568 on: February 17, 2019, 05:38:05 AM »

Model Number 302-20
Device Problems Break; Crack; Battery Problem
Event Date 01/16/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 the physician reported that high impedance had been observed on a system diagnostics test. The high impedance was first seen on (b)(6) 2015. It was stated that there was no known direct trauma to the device that could have caused or contributed to the high impedance.
 
Event Description
On (b)(6) 2015 it was reported that the patient¿s lead seems to have ¿cracked/broken¿. Per the physician, an x-ray was taken which showed a disruption in one of the leads about 1 cm superior to the generator. It was also reported that the patient¿s battery is at end of life as it has been implanted almost 12 years. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. It was stated that there was no report of high impedance prior to the consult. The patient underwent a full revision surgery on (b)(6) 2015. The explanted products could not be returned for product analysis as the hospital discards them. Good faith attempts for further information from the physician have been unsuccessful.
 
Event Description
On (b)(6) 2015 it was reported that the explanted lead and generator would be returned for product analysis. They have not been received to date.
 
Event Description
Product analysis was completed on the leads on (b)(4) 2015. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 199mm portion the end of the connector pin quadfilar coil appeared to be broken approximately 192mm from the end of the cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on a second broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. The area on a third broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting. The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture and no pitting. Flat spots and pitting was observed on the coil surface. During the visual analysis of the returned 7mm portion the end of the quadfilar coil 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 fine pitting. Flat spots and pitting were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening and abraded open / cut areas found on the outer silicone tubing and the cut ends that were made during the explant process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded open / cut found on one of the inner silicone tubes. With the exception of the observed discontinuities the condition of the returned lead portions 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 portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
On 10/13/2015 the generator and lead were received for product analysis. Product analysis was completed on the generator on 10/27/2015. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. A battery life estimation resulted in 0. 50 years remaining before the eri flag would be set. Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the end-of-service condition is an expected event. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
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=4570324
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