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Author Topic: Fluids Within Lead  (Read 47493 times)
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dennis100
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« Reply #450 on: January 11, 2019, 01:49:30 AM »

Model Number 302-20
Event Date 03/26/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Relevant tests/laboratory data, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Evaluation codes, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history.
 
Event Description
Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.
 
Event Description
It was reported that during generator replacement for end of service, high impedance (9225 ohms) was seen when the new generator was attached to the existing lead. It was reported that interrogation of the device prior to surgery was unsuccessful and the high impedance was not observed until the new generator was attached. The surgeon went to explant the lead and observed that the tubing was "stripped back and exposed down to the wire". The surgeon was unclear if any trauma caused the damage. It was reported that the patient was recently mugged which resulted in bruising; however, it is unknown if this may have caused or contributed to the high impedance. The lead was explanted (leaving electrodes) and a new lead was placed. Diagnostics with the new generator attached to the new lead were within normal limits (1556 ohms). The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that the (+) white and (-) green electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 292mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 282mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, no pitting and residual material. The two remaining broken coil strands were identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. One of the broken coil strands was identified as having evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. During the visual analysis of the returned 146mm portion the end of the (-) green electrode quadfilar coil appeared to be broken approximately 31mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Determination could not conclusively be made on the fracture mechanism. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. 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. The abraded openings 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 inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur and calcium. With the exception of the observed discontinuities and abraded openings, 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. Analysis of the generator was completed on (b)(4) 2014. 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
Failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3771292
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dennis100
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« Reply #451 on: January 11, 2019, 01:50:19 AM »

Model Number 302-20
Event Date 03/26/2014
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014, the surgeon noted fluid in the patient¿s lead so he replaced it during the procedure. No patient manipulation or trauma was reported to have occurred. The last known diagnostics from (b)(6) 2014 were within normal limits. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. During the visual analysis of the returned lead portion, several abraded openings were observed on the outer silicone tubing. The abraded openings found on the outer silicone tubing, 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 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. With the exception of the observed abraded openings, 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 discontinuities were identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since the (+) white electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
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
Device manufacturing records and available programming and diagnostic history 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3761499
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dennis100
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« Reply #452 on: January 11, 2019, 01:51:12 AM »

Model Number 302-20
Event Date 03/31/2014
Event Type  Malfunction   
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, the surgeon found a break in the patient¿s lead. The generator was being replaced due to end of service. Interrogation of the patient's device prior to replacement surgery was attempted twice but was unsuccessful. The surgeon elected to replace the lead during the procedure. No patient manipulation or trauma was reported. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator found that the device was at end of service due to normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the two returned lead portions was completed. In the first lead portion, the (+) connector ring quadfilar coil appeared to be broken approximately 218mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 218mm) and identified the area as having pitting and residual material in the broken surface areas and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 218mm) and identified the area as being pitted and mechanically damaged which prevented identification of the coil fracture type. The (+) connector ring quadfilar coil extended approximately 3mm past the end of the cut outer silicone tubing and the end appeared to be broken. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. Three of the broken coil strands appeared to have been worn to the point of fracture. Pitting was observed on the coil surface. The (-) connector pin quadfilar coil extended approximately 15mm past the end of the cut outer silicone tubing and the end appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture and no pitting. In the second lead portion, quadfilar coil 1 appeared to be broken approximately 5mm from the end of the abraded open outer silicone tubing. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots and pitting on the coil surface. Quadfilar coil 2 appeared to be broken approximately 7mm from the end of the abraded open outer silicone tubing. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting. The end of quadfilar coil 1 appeared to be broken approximately 29mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being pitted with mechanical damage which prevented identification of the coil fracture type. The remaining broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. The end of quadfilar coil 2 appeared to be broken approximately 29mm from the electrode bifurcation. Scanning electron microscopy was performed 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 fine pitting. The area on the two remaining broken coil strands was identified as being mechanically damaged 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. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities, the condition of the returned lead 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 pins 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. Based on the findings, there is evidence to suggest a discontinuity existed in the returned portions of the device. Note that since the anchor tether, (+) white electrode and a small portion of the outer silicone tubing were not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
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=3767029
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dennis100
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« Reply #453 on: January 11, 2019, 11:48:29 PM »

Model Number 300-20
Event Date 09/28/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. 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
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The generator was programmed off on (b)(6) 2014. An emg was performed which showed an immediate drop of electrical load during stimulation which reflects a possible break of the lead. X-rays were taken and sent to manufacturer for review. X-rays did not identify any obvious discontinuities within the vns system. It was reported that surgery is likely; however, surgery has not occurred to date.
 
Event Description
During the product analysis there were no anomalies found with the pulse generator. The generator performed according to functional specifications. During the visual analysis of the returned lead portion, the (+) marked and (-) unmarked quadfilar coils appeared to be broken in the body area of the returned lead assembly. Scanning electron microscopy was performed and identified evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting on both of the broken coils. 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. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. The abraded openings and slice marks found on the outer silicone tubing 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 found inside the outer silicone tubing. The abraded opening found on the (+) inner silicone tubing 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 found inside the inner 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. 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 pins 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. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the reported high impedance. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement on (b)(6) 2014. The generator and lead were received for analysis. Analysis is underway, but has not been completed to date. The surgeon indicated that there were white spots on the lead at the contact area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3741207
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dennis100
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« Reply #454 on: January 11, 2019, 11:49:41 PM »

Model Number 302-20
Event Date 03/06/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Event Description
The generator and lead were returned 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 and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently disabled. The patient had been experiencing an increase in seizures. The patient had multiple seizure types and all have increased. X-rays were taken and were reported to be unremarkable. X-rays were provided to the manufacturer for evaluation. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pins appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Based on the images provided, the cause of the high impedance cannot be determined. The entire lead was not visible on x-rays and therefore continuity in the portions of the lead that were not able to be assessed cannot be confirmed. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known interventions have occurred to date.
 
Event Description
Analysis of the returned generator and lead was completed. The generator analysis will be reported in the next quarterly remedial action exemption report. 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. Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils. A break was identified in one of the lead coils. Abraded openings were noted in the outer silicone tubing resulting in a portion of the positive coil being exposed. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the exposed portion. Scanning electron microscopy images of the broken coil (coil 1) suggest a stress-induced fracture (fatigue) on at least two strands of the quadfilar coil as well as pitting or electro-etching conditions at the break location. Due to pitting and mechanical distortion (smoothed surfaces) the fracture mechanism of the other strands cannot be determined. Also, the broken coil shows what appear to be superficial voids in the vicinity broken coil wires at the mate end. No obvious adverse effect was identified on the device performance as a result of this condition. 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 the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative
Adverse event and/or product problem, corrected data: supplemental mdr #01 inadvertently did not update this field based on the additional information reported in the report. Outcomes attributed to adverse event, corrected data: supplemental mdr #01 inadvertently did not update this field as interventions had taken place. Additional information was received stating that the patient was also hospitalized.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received stating the vns patient was in the hospital when he began experiencing the reported increase in seizures, which was believed to be due to the lead fracture identified during analysis of the returned lead portion.
 
Event Description
It was reported that the patient was scheduled for revision surgery. The patient underwent surgery on (b)(6) 2014. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3740655
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dennis100
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« Reply #455 on: January 11, 2019, 11:50:31 PM »

Model Number 302-30
Event Date 03/17/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 04/22/2014. During the visual analysis the (+) white electrode quadfilar coil appeared to be broken approximately 1. 5mm from the proximal end of the anchor tether. Scanning electron microscopy was performed identified the area as being mechanically damaged with pitting. 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. 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 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 inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy, provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity, 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.
 
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
It was reported that device diagnostics resulted in high impedance and the patient was referred for surgery. The patient underwent generator and lead replacement on (b)(6) 2014. Pre-operative device diagnostics resulted in high impedance. The explanted generator and lead were returned for analysis on (b)(6) 2014. Analysis of the generator was completed on (b)(6) 2014. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found; however, during decontamination an elective replacement indicator was observed. Analysis of the lead is underway, but has not been completed to date. Further follow-up revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3751483
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dennis100
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« Reply #456 on: January 11, 2019, 11:51:35 PM »

Model Number 302-20
Event Date 03/21/2014
Event Type  Malfunction   
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.
 
Event Description
An implant card was received indicating that the vns patient underwent lead and generator replacement surgery on (b)(6) 2014 due to lead discontinuity. Patient trauma is believed to have caused or contributed to the high impedance. X-rays were taken to verify lead pin insertion but were not provided for review. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
During the product analysis there were no anomalies found with the pulse generator. The generator performed according to functional specifications. During the visual analysis of the returned 215mm portion of the lead the (-) connector pin quadfilar coil appeared to be broken approximately 161mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. During the visual analysis of the returned 197mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 3mm from the end of the abraded open / torn / outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. The area on one of the broken coil strands had evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the connector pin coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded opening and slice 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 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 inside the inner silicone tubes. During the visual analysis of the returned 27mm portion the (+) white electrode and ribbon appeared to be partially embedded in what appeared to be dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuities and the partially tissue-covered (+) white electrode and ribbon the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no other discontinuities identified. Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the reported event. Note that since one of the inner silicone tubes and quadfilar coils between the electrode bifurcation and anchor tether was not returned for analysis, an evaluation cannot be made on that portion of the lead. However, the positive electrode condition may have contributed to the reported event.

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« Reply #457 on: January 11, 2019, 11:52:22 PM »

Model Number 302-20
Event Date 08/31/2013
Event Type  Malfunction   
Event Description
The 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. Date of event, corrected data: additional information indicates that the date of event is at least (b)(6) 2013.
 
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
It was reported that device diagnostics resulted in high impedance. It was reported that x-rays did not show an obvious break in the lead. The patient was referred for surgery. The patient underwent generator and lead replacement on (b)(6) 2014. During the surgery, a lead break was identified at the portion of the lead coiled behind the generator. Further follow-up revealed that the patient's device was not programmed off after observing the high impedance. The explanted devices are expected to be returned for analysis, but have not been received to date.
 
Event Description
Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2013. Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. During the visual analysis of the returned 62mm lead portion, quadfilar coils 1 and 2 appeared to be broken approximately 60mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 60mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. Extensive pitting was observed on one of the broken coil strands and pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 2 coil break (found at 60mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. 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. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. The abraded openings 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 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. 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. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the reported high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3754586
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« Reply #458 on: January 11, 2019, 11:53:14 PM »

Model Number 302-20
Event Date 03/20/2014
Event Type  Malfunction   
Manufacturer Narrative
The supplemental report #2 inadvertently did not report this information.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014 due to lead fracture. The explanted lead was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death. However, the confirmed discontinuities have the potential for being a possible contributing cause to the increased seizures.
 
Event Description
An analysis was performed on the returned lead portions. Note that 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 333mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 203mm and 222mm from the end of the connector boot. Scanning electron microscopy (sem) was performed on the (+) connector ring quadfilar coil break (found at 203mm) and identified the area on three of the broken coil stands as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. The broken coil strand was identified as having evidence of being worn to the point of fracture. Sem was performed on the (-) connector pin quadfilar coil break (found at 222mm) and identified the area as having evidence of being worn to the point of fracture with flat spots and pitting 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 on some of the quadfilar coil breaks. 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. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.
 
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 abraded openings found on the outer and inner silicone tubes of the leads 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 found inside the outer and inner silicone tubes.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The physician reported that the patient's seizures have recently worsened. It is unknown if the worsening of seizures is above the patient's pre-vns baseline frequency. It was reported that the patient has been referred for surgery. Surgery is likely, but has not occurred to date. Attempts to obtain additional relevant information have been unsuccessful to date.

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« Reply #459 on: January 12, 2019, 01:51:24 AM »

Model Number 300-20
Event Date 12/01/2012
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
It was reported that the patient¿s lead was breaking through the skin on the patient¿s neck in (b)(6) 2012. On (b)(6) 2013, the patient underwent surgery to reposition the patient¿s lead. During the procedure, the neurosurgeon noted that there was excessive lead coiled in the patient¿s neck around the vagus nerve believed to be due to erosion. The patient was seen by his physician on (b)(6) 2014 and it was reported that the lead erosion had not been resolved. The patient was referred for surgery. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
It was reported that the patient underwent generator and lead explant due to infection. The patient was admitted for intervention of the eroding lead, but also showed signs of granulation at the generator site. It was reported that after excavating the lead, there was pus found around the generator with infection in the surrounding tissue. It was decided to abandon the planned replacement and resolve the infection. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned generator and lead was completed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Electrical test results showed that the pulse generator performed according to functional specifications. The abraded open / cut and slice marks found on the outer silicone tubing of the returned lead portion. 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 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 slice marks observed on the (+) unmarked inner silicone tubing. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the setscrew marks found near the end of the (+) marked and (-) unmarked connector pins indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pins 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, with no discontinuities identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the (-) unmarked connector inner silicone tubing and quadfilar coil, a portion of the (+) marked inner silicone tubing and outer silicone tubing including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #460 on: January 13, 2019, 03:42:52 AM »

Model Number 302-20
Event Date 03/11/2014
Event Type  Malfunction   
Event Description
Additional information from the treating physician revealed there had been no patient manipulation or trauma that could have contributed to the high lead impedance results. Diagnostics from (b)(6) 2012 and (b)(6) 2013 were noted to be ¿unremarkable¿ by the physician.
 
Event Description
It was reported that device diagnostics during generator replacement resulted in high impedance. It was reported that the high impedance was discovered pre-operatively and that both the lead and generator were replaced. The surgeon reported that there was fluid in the lead insulation when the lead was explanted. It was reported that the high impedance was not know prior to surgery. There is no trauma or patient manipulation known that may have caused or contributed to the high impedance. It was reported that the explanting facility discarded the explanted devices and they would not be returned for analysis.
 
Manufacturer Narrative
Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr inadvertently omitted the high impedance value.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3734823
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« Reply #461 on: January 13, 2019, 03:43:53 AM »

Model Number 302-20
Event Date 03/06/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on 09/05/2014 due to lead discontinuity. The explanted lead has been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history 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
Additional information was received indicating that the patient underwent surgery. During the surgery, a new generator was attached to the existing lead and device diagnostics were within normal limits (3767 ohms). It was reported that the patient's head and neck were placed in different positions and subsequent diagnostics were within normal limits. The surgery was finalized with only generator replacement. It was later reported that device diagnostics again resulted in high impedance (>10,000 ohms). The generator was programmed off and the patient was referred for lead replacement. No known surgical intervention have been performed to date. The generator was received for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the generator was completed on 08/07/2014. Results of the analysis will be reported on the quarterly remedial actions exemption report.
 
Event Description
Analysis of the returned lead was completed. During the visual analysis, connector pin and connector ring quadfilar coils appeared to be broken. Pitting was observed on the coil surfaces. Remnants of dried body tissue were observed wrapped around a portion of helical and green electrode ribbon. This condition may have prevented the green electrode ribbon from coming in contact with the vagus nerve. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities and the tissue-covered green electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results showed high lead impedance (impedance value - 6709 ohms) during an office visit on 03/06/2014. X-rays were taken but have not yet been provided to manufacturer for evaluation. The device was not disabled. The patient is often injured because she has drop attack seizures, which may have caused or contributed to the reported high impedance. However, no definitive conclusions can be made with the available information. Review of the available programming and diagnostic history showed normal diagnostic results through 08/01/2013. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful 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=3733255
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« Reply #462 on: January 14, 2019, 03:45:10 AM »

Model Number 300-20
Event Date 05/06/2014
Event Type  Malfunction   
Manufacturer Narrative
Brand name; corrected data: product information was received.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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
The explanted devices were returned to the manufacturer for analysis and product information was obtained. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. The device performed according to functional specifications. There was no indication from the device that an end of service condition existed. Analysis of the returned lead portion is currently underway.
 
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 (dc dc ¿ 7). The device was retested with the same results. The last normal diagnostic results were six months prior to this office visit. X-rays were taken and the images showed the lead tangle approximately 8cm from the patient¿s generator that was approximately 2cm in diameter. Patient manipulation is not believed to have caused or contributed to the high impedance. The patient was referred for surgery but no known interventions have occurred to date.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted generator and lead have not been returned to date.
 
Event Description
Analysis of the returned lead portion was completed. Note that a large portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The slice marks and abraded opening found on the outer silicone tubing 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 found inside the outer silicone tubing. Except for the abraded opening in the outer tubing, there were no observed product related issues with the returned lead portion.

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« Reply #463 on: January 14, 2019, 03:45:52 AM »

Model Number 302-20
Event Date 11/01/2013
Event Type  Malfunction   
Event Description
During generator replacement surgery, the surgeon observed fluid in the lead insulation along with a hole in the tubing. The surgeon then explanted the vns system and indicated that the patient would be reimplanted at a later time to give the patient time to heal. The generator and lead were returned to manufacturer for analysis. Analysis of the generator was completed on (b)(4) 2014. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on (b)(4) 2014. Abraded openings were noted on the outer silicone tubing and in the inner silicone tubing of the negative coil. 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
Device failure occurred, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3722666
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« Reply #464 on: January 15, 2019, 02:09:24 AM »

Model Number 302-20
Event Date 03/22/2014
Event Type  Malfunction   
Event Description
Clinic notes dated (b)(6) 2014 note that device diagnostics resulted in high impedance. It was noted that the patient suffered a fall on (b)(6) 2014. The notes indicate that x-rays will be performed and the patient will be referred to surgery. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.
 
Event Description
Additional information was received that the patient had a full revision. The physician added the new generator to the existing lead and system diagnostic were run and the patient had still had high impedance. The lead was then explanted and a new lead implanted system diagnostics were within normal limits. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
Additional information was received that x-rays were performed but they have not been returned to the manufacturer for review. The generator was not turned off following the high impedance being seen.
 
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
Additional information was received that product analysis was completed on the generator and lead. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The slice mark found on the outer silicone tubing 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 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. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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 discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. 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, 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
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=3813072
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« Reply #465 on: January 15, 2019, 02:10:14 AM »

Model Number 302-20
Event Date 11/20/2013
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a suspected lead discontinuity. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that during lead replacement surgery on (b)(6) 2014, the surgeon confirmed that the high impedance was not due to incomplete lead insertion into the generator header.
 
Event Description
The explanted lead was returned to the manufacturer for analysis. The abraded opening found on the outer silicone tubing 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 silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the high impedance. Note that since a large portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
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 device diagnostics resulted in high impedence (10,000 ohms). It was reported that the patient had recently undergone generator replacement and that device diagnostics with the new generator attached to the existing lead were within normal limits. The patient was seen and device diagnostics again resulted in high impedance. The generator was programmed off and the patient was referred for x-rays. It was reported that no patient manipulation or trauma is believed to have occurred that could have caused or contributed to the high impedance. X-rays were sent to manufacturer for review. X-rays identified that the lead pin was fully inserted into the generator header; however, a suspect area was identified on the lead near the tie-down. A lead fracture is suspected. The patient was referred for surgery and underwent lead replacement. The lead has not been received for analysis to date. Clinic notes dated (b)(6) 2014 note that the patient has experienced nocturnal seizures several night per week. Device diagnostics showed high impedance (10,000 ohms).
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

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« Reply #466 on: January 15, 2019, 02:11:03 AM »

Model Number 302-20
Event Date 04/15/2014
Event Type  Malfunction   
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. Abrasions were noted on the returned lead portions. The lead assembly has dried remnants of what appear to have once been body fluids/betadine solution inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the cut ends of the returned lead portions. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils. A suspected coil break was identified in the positive coil end at the 1st portion of the returned lead. Scanning electron microscopy images of the positive coil end show that pitting or electro¿etching conditions have occurred at the coil end of the first portion. Due to metal dissolution, surface contamination and mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Based on the overall appearance of the returned lead portions the most likely cause for the observed pitting condition is that the generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load. However, the exact point in time of when this occurred is unknown. 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 the above mentioned observations and typical wear and explant related observations, no other 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 the generator and lead were explanted due to probable lead fracture. It was reported that the generator was explanted due to end of life. Further follow-up with the neurologist revealed that no high impedance was observed prior to surgery. Further follow-up with the surgeon revealed that the lead fracture was identified during generator replacement for end of service. The surgeon reported that no x-rays were performed and no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The 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.

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« Reply #467 on: January 16, 2019, 01:52:25 AM »

Model Number 300-20
Event Date 04/08/2014
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
On august 18, 2014 product analysis was completed on the explanted generator. Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab. The battery voltage was 2. 895 volts (not at ifi) as measured during completion of the final electrical test. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The review of the device's internal memory showed the impedance went from 9799ohms to 12299ohms on (b)(6) 2014, both of which are high impedance. Product analysis was completed on the lead on 9/2/14. Except for slight observed pitting on the negative connector pin and one abraded outer tubing observation, there were no observed product related issues with the returned lead portions. Scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the connector pin surface at the areas where reddish-brown deposits were noted. An energy dispersive spectrometry (eds) analysis performed on the sample of the reddish-brown deposits observed on the pin showed the presence of some elements typically observed on stainless steel 316/316l. The higher percentage of iron observed in this sample suggests that an oxidation process may have occurred. The exact impact of this condition on any on the reported "high impedance" allegation is unknown. 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. The outer silicone tubing is abraded open and the lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing of the second portion of the returned lead. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.
 
Event Description
On (b)(6) 2014 it was reported that the generator and lead would be returned for product analysis. A full revision surgery had taken place on (b)(6) 2014 due to the high impedance. The generator and lead were received for product analysis on (b)(4) 2014. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative
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
It was reported that a vns patient received a high impedance warning during diagnostic testing and that the patient¿s generator was disabled as a result. Last successful diagnostic results were reportedly obtained seven (7) months earlier. Surgery has not occurred to date.

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« Reply #468 on: January 17, 2019, 02:03:03 AM »

Model Number 302-20
Event Date 05/22/2014
Event Type  Malfunction   
Manufacturer Narrative
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.
 
Event Description
It was reported that the vns patient¿s device showed high impedance during an office visit on (b)(6) 2014. The patient¿s device was not disabled. X-rays were ordered and the patient was referred for surgery. No known surgical interventions have occurred to date. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The notes indicate that the patient had approximately 1-2 seizures per month since her last office visit three months ago which she described as ¿light. ¿ the patient reported recently having a grand mal seizure and going to the er. The neurologist increased the patient¿s medication during the office visit due to the recent seizure. The patient denied any changes in vision and noted that stress and excessive heat can trigger seizures. Further follow-up revealed that the vns patient had a history of grand mal seizures prior to vns. The physician attributed the patient¿s recent seizure to the reported high impedance and subsequent loss of therapy. X-rays were taken and were reported by the physician to be unremarkable. The patient¿s last good diagnostic results were from (b)(6) 2014.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the generator and lead was completed. In the 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. In addition, 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. Note that a large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis, three broken coil strands were observed on the (-) connector pin quadfilar coil approximately 120mm-122mm from the end of the connector boot. Scanning electron microscopy was performed identified the area as having evidence of being worn to the point of fracture with flat spots and pitting on the coil surface. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 119mm and 131mm from the end of the connector boot. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 119mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Flat spots and pitting were observed on the coil surface. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 131mm) and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting. It is 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 found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Note that a break of a few strands would still allow current flow through that portion of the lead. This observation is supported by results of electrical measurements which verified continuity between the ends of this lead section. Note that since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death. It may have contributed to the change in seizure pattern.

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« Reply #469 on: January 17, 2019, 02:03:55 AM »

Model Number 105
Event Date 05/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Analysis of the explanted generator and lead was completed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead found abraded openings on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since a large portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2014 to explant her generator and lead. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Further follow-up revealed that the patient¿s device had to be explanted due to generator and lead extrusion. The patient had been picking at her devices which caused them to extrude inferiorly and laterally to the original incision sites. The patient went to the er on (b)(6) 2014 due to device extrusion at the axillary incision site. Prior to explant, there was a noticeable breakdown of the patient¿s skin due to the extrusion. There were no signs of infection or abscess, but the patient was antibiotics as a precaution. The patient is expected to be re-implanted once her incision sites are healed. The patient has not been re-implanted to date.

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« Reply #470 on: January 17, 2019, 02:04:51 AM »

Model Number 304-20
Event Date 05/30/2014
Event Type  Malfunction   
Event Description
The explanted generator and lead were received by the manufacturer on 12/17/2014. However, analysis has not been completed to date.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Manufacturer Narrative
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
It was reported that the vns patient¿s device showed high impedance. The patient was sent for x-rays. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful 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.
 
Event Description
Analysis of the explanted devices was completed. There were no performance or any other type of adverse conditions found with the pulse generator that occurred during implant. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening and tool marks found on the outer silicone tubing 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 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. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device.

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« Reply #471 on: January 17, 2019, 02:06:09 AM »

Model Number 302-20
Event Date 08/14/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
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 patient was hospitalized on several occasions recently due to seizures with high lead impedance. X-rays were performed and assessed by the treating vns physicians, and no obvious lead issues were observed.
 
Event Description
The neurology office reported that the patient was being referred for surgical evaluation due to high impedance. X-rays performed in (b)(6) 2014 did not show any lead break issues per the neurology office. It was reported that the device has not been disabled. Additional information received from the nurse revealed that the high impedance was first observed on (b)(6) 2013. No patient manipulation or trauma is believed to have contributed to the high lead impedance. No known surgical intervention has occurred to date.
 
Event Description
The treating physician reported that he does not attribute the patient's worsened seizures to vns. The worsened seizures were described as a possible increase in frequency that was not worse than prior to vns implant. X-rays were unremarkable.
 
Manufacturer Narrative

Event Description
Analysis of the suspect device and generator was completed. Abraded opening were noted in the outer and the negative inner silicone tubing, and two breaks were identified in 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 and on the coil surfaces with dark appearance. Scanning electron microscopy images of the negative coil breaks show appearance suggesting that a stress-induced fracture has occurred in at least two strands at the break located at ~17. 9cm from boot. However, due to metal dissolution, surface contamination, and mechanical distortion the fracture mechanism of the other strands and the second coil break located at approximately 18. 8cm from boot 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 end of the returned lead portions. Note that since the anchor tether silicone helix 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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. 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.
 
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(4) 2014. It was reported that after the generator was replaced, high lead impedance still resulted with the existing lead. Therefore, the lead was also replaced. The suspect device was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient underwent generator replacement several months ago due to high impedance, but that the high impedance resolved with generator replacement (mfr. Report # 1644487-2013-01609). The implant card from the generator replacement surgery confirmed that the lead impedance was ok with the new generator and existing lead (3342 ohms and 3589 ohms). Further follow-up revealed that x-rays were taken. Attempts to obtain additional relevant information have been unsuccessful to date. Surgery is likely, but has not occurred to date.

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« Reply #472 on: January 19, 2019, 02:59:53 AM »

Model Number 302-30
Event Date 05/15/2014
Event Type  Malfunction   
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.
 
Event Description
Additional information was received stating that no trauma was reported prior to the high impedance observation. Analysis of the returned generator and lead was completed. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the generator. The end of service condition of the returned generator was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. During the visual analysis of the returned lead portion, quadfilar coil 1 appeared to be broken approximately 86mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed 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 areas on the remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. Quadfilar coil 1 also appeared to be broken approximately 172mm from the end of the abraded open / 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 areas on the remaining broken quadfilar coil strands were identified as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Quadfilar coil 2 appeared to be broken approximately 122mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken quadfilar coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Quadfilar coil 2 also appeared to broken at approximately 171mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Determination could not conclusively be made on the fracture mechanism. 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. The abraded openings 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 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. 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 except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional 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 and no other discontinuities were identified. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the reported high impedance. Note that since the (+) white and (-) green electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
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 diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). Troubleshooting was performed multiple times including lead pin re-insertion. The patient¿s lead was replaced during the procedure. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2008.
 
Manufacturer Narrative
(b)(4).

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« Reply #473 on: January 19, 2019, 03:01:08 AM »

Model Number 302-20
Event Date 05/15/2014
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (impedance value ¿ 9083 ohms). The patient¿s device was not disabled following the high impedance observation. The notes indicate that the patient played rough with another family member and was hit in the chest while wrestling. The patient was sent for x-rays and referred for surgery. No known surgical interventions have occurred 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 returned lead portion was completed. Based on the findings, there is evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the reported allegation. During the visual analysis, the (-) connector pin quadfilar coil appeared to be broken approximately 257mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end of the (-) connector pin quadfilar coil break (found at 257mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed on the electrode (mating) end of the (-) connector pin quadfilar coil break (found at 257mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. 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. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. The abraded openings and tool and tear marks 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 tear marks 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 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. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed and no other discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was reported that the patient underwent generator and lead replacement. The generator and lead were returned for analysis. An implant card indicated that the devices were replaced due to lead discontinuity. Analysis of the generator was completed on (b)(4) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead is underway, but has not been completed to date.

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« Reply #474 on: January 20, 2019, 01:55:13 AM »

Model Number 302-20
Event Date 07/01/2014
Event Type  Malfunction   
Event Description
The suspect device is the lead and diagnostics available at that time were within normal limits. No suspected malfunction of the generator exists, and as such, the follow-up report #1 should not have referenced that product analysis of the generator is underway as it is irrelevant information.
 
Event Description
Analysis of the returned lead was completed. 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 ends of the returned lead portions. Incisions in the silicone tubing of the lead coils were necessary to perform proper inspection of the lead. A high impedance condition was identified in the positive coil. Openings were noted on the outer and the inner silicone tubing in the vicinity of the coil discontinuity. Scanning electron microscopy images of the outer silicone tubing suggest the tubing was in contact with some type of electro-cautery tool. Scanning electron microscopy images of the positive coil ends at the coil discontinuity location show that the coil was most likely cut using some type electro-cautery tool as indicated by the fused coil wires in one of the coil ends. 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 returned generator is currently underway.
 
Manufacturer Narrative
Describe event or problem; corrected data: the suspect device is the lead and diagnostics available at that time were within normal limits. No suspected malfunction of the generator exists, and as such, the follow-up report #1 should not have referenced that product analysis of the generator is underway as it is irrelevant information.
 
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
It was reported that during prophylactic generator replacement surgery on (b)(6) 2014, the vns patient¿s replacement generator was tested with the existing lead and diagnostic results revealed high impedance (dc dc ¿ 7). The lead pin was reinserted into the generator header and diagnostic results continued to show high impedance. The patient¿s lead was replaced during the procedure. Pre-operative diagnostic results showed lead impedance within normal limits. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

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« Reply #475 on: January 20, 2019, 01:56:04 AM »

Model Number 302-20
Event Date 07/08/2014
Event Type  Malfunction   
Event Description
The lead and generator were received for analysis. The implant card confirmed that the lead and generator were explanted due to lead discontinuity and the lead impedance with the new system was within normal limits. Analysis of the generator was completed on 09/03/2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on 09/04/2014. During the visual analysis of the returned 329mm portion the (+) white electrode quadfilar coil appeared to be broken approximately 23mm and 24mm from the electrode bifurcation. Scanning electron microscopy was performed on the (+) white electrode quadfilar coil break (found at 23mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the (+) white electrode quadfilar coil break (found at 24mm) 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 area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. During the visual analysis of the returned 329mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 23mm and 25mm from the electrode bifurcation. Scanning electron microscopy was performed on the (-) green electrode quadfilar coil break (found at 23mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the (-) green electrode quadfilar coil break (found at 25mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. 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. 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 found on the outer silicone tubing 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 found inside the outer silicone tubing. 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.
 
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 was tested during an office visit on 07/08/2014 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). No trauma is suspected to have caused or contributed to the reported high impedance; however, it was noted that the patient is in a wheelchair with straps going across his chest and that he is frequently picked up from his wheelchair. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted generator and lead have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #476 on: January 20, 2019, 01:56:57 AM »

Model Number 302-20
Event Date 07/08/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on (b)(6) 2014. Abraded openings were noted in the outer and the inner silicone tubing. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred on the coil broken end. Due metal dissolution and surface contamination the fracture mechanism of this end cannot be determined. Scanning electron microscopy images of the positive coil at the suspected mating end show what appears to be wear (flat surfaces) on the coil strands resulting in reduction of the diameter of the quadfilar coil strands up to the point of break. 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. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils. 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 the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance. It was noted that the high impedance observation may have been due scarring or fibrosis formation. X-rays were taken and showed that the superior electrode was disconnected from the remainder of the lead. The patient¿s device was subsequently disabled during an office visit on (b)(6) 2014. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the patient underwent generator and lead replacement due to lead discontinuity. The generator was replaced prophylactically. The explanted devices were received for analysis. Analysis of the generator was completed on 09/25/2014. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #477 on: January 23, 2019, 01:30:31 AM »

Model Number 300-20
Event Date 06/02/2014
Event Type  Malfunction   
Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. Product analysis was completed on the generator but has not been completed on the lead. 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, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 945 volts, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 14. 910% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a 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 that product analysis was completed on the lead. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening found on the outer silicone tubing 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 found inside the outer silicone tubing. The slice mark found on the (-) unmarked connector inner silicone tubing 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 found inside the inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, sulphur, chlorine and calcium. Refer to eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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 discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was reported that device diagnostics resulted in high impedance (> 10,000 ohms). It was reported that the patient was reporting an increase in seizures. It was noted that the patient suffers from drop attacks which are believed to be due to the high impedance. It was reported that the drop attacks are normally controlled with vns. There was no recent trauma and the patient did not manipulate the device through the skin. The patient underwent generator and lead replacement. The explanted devices are expected to be returned for analysis, but have not been received to date.

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« Reply #478 on: January 23, 2019, 01:31:22 AM »

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

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« Reply #479 on: January 23, 2019, 01:32:15 AM »

Model Number 302-20
Event Date 06/02/2014
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that x-rays were taken and did not identify any lead discontinuity; however, a portion of the lead was not visible. The patient was seen again and subsequent device diagnostics resulted in high impedance (dc dc code - 7). The device was programmed off and the patient was referred for surgery. No surgical intervention has been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator were received for analysis. Analysis of the generator was completed on 01/07/2015. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on 01/09/2015. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 233mm and 241mm from the end of the connector boot. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 233mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 241mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. 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 found on the outer and 1 inner 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 and inner silicone tubing. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, zirconium, magnesium, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Follow-up revealed that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. The explanted devices have not been returned to date.
 
Event Description
Additional information was received stating that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 7).

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