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dennis100
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« Reply #60 on: September 15, 2018, 01:24:25 AM »

Model Number ASKU
Event Date 10/12/2011
Event Type  Malfunction   
Event Description
Product analysis of the explanted lead was completed on (b)(6) 2012. During the visual analysis of the returned 151 mm portion the ends of the marked and unmarked quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area on both quadfilar coils as being mechanically damaged which prevented identification of the coil fracture type with pitting on the marked quadfilar coil break area. 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 silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids / tissue and white deposits 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. 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 unmarked 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. Note that since the marked connector boot, and a large portion of the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Additional information received revealed that the patient underwent full revision surgery in which the lead and generator were explanted and replaced. The explanted lead was discarded and will not be returned for analysis. Good faith attempts to obtain the explanted generator are in process.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator have been returned to the manufacturer and device evaluation of the explanted generator has been completed. The generator performed according to functional specifications and there was no abnormal performance or any other type of adverse conditions found. Product analysis of the explanted lead has not been completed at this time.
 
Event Description
It was reported that during a prophylactic generator revision surgery, a lead break was identified and the surgery was cancelled as the patient would need a full revision. Follow up with the site revealed that x-rays were not taken prior to surgery and at the time of surgery, a dcdc of 7 was obtained (unknown which mode). No device diagnostics were performed prior to surgery per the physician however the patient was not reporting any issues to the physician which would indicate there was an issue with the lead. Revision surgery to address the high lead impedance will likely occur but has not to date.
 
Manufacturer Narrative
Describe event or problem, corrected data - previous report stated that the lead was discarded however it was not. The information has been corrected on this report. Conclusions, corrected data - previous report stated that the lead was discarded however it was not. The information has been corrected on this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2323681

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dennis100
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« Reply #61 on: October 08, 2018, 01:25:41 PM »

Model Number 102R
Event Date 03/30/2012
Event Type  Malfunction   
Event Description
Initially a battery life calculation was requested on a vns patient's generator. The patient's settings were 2. 5/30/250/30/3. Their system diagnostic testing was dcdc 3, eri no. The battery life calculation was negative. The patient went to surgery for a prophylactic generator replacement. In preop a system diagnostic test was performed that resulted in the following: high lead impedance with an ok output status, dcdc=6 and eri=yes. The patient was programmed at 2. 75ma. It was noted in the or that the patient's generator had a detached header. There was no specific trauma that was reported preceding the event. The header detachment did not occur during the explant. The explanted generator has been returned for analysis. Analysis is pending completion.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report. Type of report corrected data follow-up # 3 on last emdr should have been a #2. (b)(4) , version no: 2 corrected data: the last emdr was sent version 3 when it should have been version 2. Therefore this emdr being sent version 2.
 
Manufacturer Narrative

Manufacturer Narrative
Operator of device corrected data: updated to patient.
 
Manufacturer Narrative
Device malfunction occurred but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis was completed , the elective-replacement-indicator (eri) was set. A window was cut into the pulse generator case to access the feed-thru output connections on the substrate. Bench test connectors were attached to the negative and positive feed-thru wires, at the substrate, to perform a final electrical test. The generator passed all final electrical testing evaluations with the exception of a single test parameter related to the partially depleted condition. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. The reported detachment of the header at explant was confirmed. The location of the white deposits observed on the pulse generator case suggests that header delamination/separation had occurred. The observed header anomalies found in the visual analysis may have been the contributing factor to their high impedance. The failure mechanism could not be determined; however poor adhesion and tool marks in the header area were observed on the returned product.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2546638
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dennis100
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« Reply #62 on: October 09, 2018, 12:24:02 PM »

Model Number 300-20
Event Date 04/21/2012
Event Type  Malfunction   
Event Description
Good faith attempts were made and no further information was attained.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.
 
Event Description
Neurology reported that they had a vns patient with high lead impedance. A system diagnostic test resulted in 8393 ohms/limit/high. The patient had their generator replaced on (b)(6) 2012 and no diagnostics have been performed since that date. It is unknown if the patient experienced any trauma to the site. The patient did start to experience pain at the generator site a few days prior to this clinic visit when their vns activated. The site is aware to program their vns off. It is unknown if this has been done. The patient at this time has no surgery planned because they are seizure free. X-rays were received for review. Lateral neck and ap chest x-rays via disc and were reviewed. The generator is visualized in the left upper chest in a normal orientation. Filter feedthru wires appear to be intact and the lead pins appear to be fully inserted into the header of the generator. The lead body is intact at the lead pins. The lead body and electrode site were able to be visualized. The electrodes appeared to be possibly not be in alignment. It is possible the anchor tether is displaced, but cannot be visualized. There is lead behind the generator that cannot be assessed. A strain relief bend is present but not per labeling. The strain relief loop does not appear to be adequate. One tie-down is present but is within the loop. Most of the lead was visible and no obvious lead discontinuities or anomalies were identified. Some lead is behind the generator and this portion cannot be assessed. Based on the x-ray review, no obvious lead discontinuities or anomalies were observed in the x-ray images that may be contributing to the allegation of high lead impedance. It is possible there is an issue with the lead behind the generator that cannot be visualized or a lead break that cannot be seen on x-ray. Good faith attempts are underway for further information.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuity visualized. Device malfunction suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent generator and lead replacement surgery on (b)(6) 2013. The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) marked connector quadfilar coil appeared to be broken approximately 246mm and 248mm from the connector boot. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 246mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 248mm) and identified the area as having flat spots on the coil surface with pitting and mechanical damage. Evidence of a stress induced fracture was observed, but 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 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 what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. 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, zirconium, sulphur and calcium. 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 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 other discontinuities were identified. The abraded openings observed on the outer and inner silicone tubes have the potential for contributing to the painful stimulation allegation. Analysis of the generator was completed on (b)(4) 2013. Although the septa were cored, but no bodily fluid remnants were observed in the header septa cavities, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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 shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
New information received identified the date of event. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that the patient's device was disabled (b)(6) 2012. The patient after their device was disabled started to have increased seizures with the loss of therapy. The patient now wants to have full revision surgery. No surgery date planned at this time as the patient has broken ribs that need to heal first.

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dennis100
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« Reply #63 on: October 10, 2018, 02:39:20 AM »

Model Number 300-20
Event Date 04/19/2012
Event Type  Malfunction   
Event Description
A fax was received from the physician on (b)(6) 2012. It is unknown if patient manipulation or trauma occurred that caused or contributed to the event. A product malfunction was indicated. The physician also noted that the patient's device was an older model and would be replaced with a newer model when the lead is replaced. It was also indicated that the patient had not yet undergone surgery has the patient had not kept an appointment with the surgeon. Surgery is still likely but has not taken place to date.
 
Manufacturer Narrative
Manufacturer review x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Only a portion of 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
Pa for the generator was approved on (b)(4) 2012. During the analysis, there was no indication from the device that an end of service condition existed. 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.
 
Event Description
Ap chest, lateral chest, and ap neck x-ray images were received on (b)(6) 2012. The generator is visible in the upper, left chest. The generator is placed normally. The connector pins appear to be fully inserted inside the connector blocks. The feedthru wires appear intact. Lead is present behind the generator and cannot be assessed for continuity. No sharp angles are present. Lead wires appear intact at the connector pins. There is a suspect area of continuity in the lead body. A gross lead discontinuity is suspected at the bottom of the strain relief bend. Based on the x-rays images received there appears to be a suspected lead discontinuity. As the entire lead could not be assessed, continuity in the obstructed portion of the lead cannot be confirmed. On (b)(6) 2012, the patient underwent lead and generator explant due to high impedance and a dead battery. The explanted devices were received on (b)(6) 2012. Product analysis for the explanted lead showed that a 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. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found 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. 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, with no discontinuities identified. Based on the findings in the product analysis lab, 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 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.
 
Event Description
On (b)(6) 2012, a physician reported high impedance readings from systems diagnostics performed on (b)(6) 2012 for a vns patient. The patient did have any serious falls and has not experienced any increase in seizures. X-rays were taken; however, the physician could not see a lead break in the area of the chest that was imaged. Additional x-rays were scheduled; however, it is unclear if they were actually taken. No images were provided for manufacturer review. A battery life calculation was performed with results of 1. 28 years until eri to yes. Surgery is likely but has not taken place to date.
 
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=2581839
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dennis100
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« Reply #64 on: October 11, 2018, 06:29:28 AM »

Model Number 302-20
Event Date 01/26/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012, the explanted lead was received by the manufacturer for product analysis. Product analysis was completed on (b)(6) 2012. The connector pin / boot section with model and serial number tag and electrodes were not returned; therefore it was not possible to verify the model and serial number during this analysis. During the visual analysis quadfilar coil 1 appeared to be broken approximately 277mm and 285mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 277mm) and identified the area as having evidence of a stress induced fracture with mechanical damage, residual material and no pitting. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 285mm) and identified the area on two of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism of the remaining quadfilar coil strands. 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 and calcium. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. What appeared to be remnants of dried body fluids were observed inside one of the inner silicone tubes, in some areas. 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. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
Additional information was received on (b)(6) 2012 when it was discovered that the vns patient underwent a full revision surgery on (b)(6) 2012. The lead was replaced due to high impedance noticed on (b)(6) 2012. Prior to surgery, x-rays showed that the lead was fractured. There has not been any accident or trauma which could have caused the breakage. It was also reported that only the lead will be returned for product analysis, as the generator was disposed of by the hospital. The lead impedance after the new vns system was implanted was noted to be "ok". Attempts have been made for the return of the lead however it has not been received for product analysis to date.
 
Event Description
It was reported by a company representative that high impedance was reported at a follow-up appointment. X-rays were performed and the surgeon was able to see a lead discontinuity. The last known good system diagnostics were from (b)(6) 2011. No patient manipulation or trauma was reported to have contributed to the reported high impedance. X-rays were received and evaluated by the manufacturer. Review of x-rays indicated the generator was visualized in the left upper chest. The filter feed-through wires appeared to be intact. The lead connector pin seemed not to be fully inserted into the generator connector block. There is part of the lead placed behind the generator and could therefore not be assessed. Electrodes seemed correctly aligned on the vagus nerve. A lead discontinuity was visible on the lead body in the neck area. At the moment revision surgery is likely.
 
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=2603919
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dennis100
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« Reply #65 on: October 13, 2018, 04:32:00 AM »

Model Number 302-20
Event Date 06/22/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that a patient underwent total revision on this date and that the explanted devices would be returned to the manufacturer. The generator was replaced due to end of service, and the lead was replaced due to high impedance. A manufacturer's consultant also indicated that these physicians may not be willing to provide additional information. On (b)(6) 2012, the explanted generator and lead were returned and are currently undergoing product analysis. A returned product form received on (b)(4) 2012, indicated that the lead came out in pieces and the largest piece was returned. A battery life calculation was performed on (b)(4) 2012. The results indicated negative years to eri = yes. On (b)(6) 2012, it was reported that the physician would not provide any additional information regarding these events.
 
Manufacturer Narrative
Analysis of programming history. 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
Product analysis for the explanted generator and lead was approved on (b)(6) 2012. The near end of service flag was set (n eos = yes) for the generator. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Only a section of the lead was returned for product analysis. The lead's electrodes were not returned. Two tie-downs were returned with the lead. Two sets of setscrew marks were seen on the connector pin, providing evidence that contact between the setscrew and the lead pin existed at least once. One of the setscrew marks is located toward the end tip of the connector pin. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time when this occurred is unknown. Based on the location of the setscrew marks on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator "+" and "-" terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. White deposits were identified on the outer silicone tubing at various locations. The lead assembly has remnants of what appears to be dry body fluid 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. An energy dispersive spectrometry analysis performed on a sample of the white deposits identified si, p, ca, na, and mg as the composition for the substance. The exact reason for the presence of the substance is unknown. The lead assembly was returned for analysis due to high impedance. The reported high impedance allegation was not verified within the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2647472
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dennis100
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« Reply #66 on: October 19, 2018, 11:21:23 AM »

Model Number 302-20
Event Date 08/14/2012
Event Type  Malfunction   
Event Description
Additional information was received indicating that x-rays were taken; however, the device was not visible. Attempts to obtain new images were unsuccessful. The patient's increase in seizures was attributed to the high impedance. The patient underwent revision on (b)(6) 2012. The new device was successfully implant and verified to be working properly. The generator was replaced prophylactically. After re-implant, the patient responded to treatment. The lead and generator were received on (b)(6) 2012. Product analysis for the explanted lead showed that the reported "high impedance" allegation was not verified within the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Four sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is unknown. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. White deposits were identified on the connector boot in the vicinity of the ring/backfill interface. Abrasions were identified on the connector boot. The outer silicone tubing has what appear to be abrasions/imprints. The outer silicone tubing appears to have been compressed at three locations. Abrasions most likely caused by the presence of a tie-down were identified; the outer silicone tubing is cut open at approximately 33 cm from boot. No obvious damage to the lead coils or the inner tubing was noted at this location. The outer silicone tubing has what appear to be internal abrasions at multiple locations. Abrasions were identified on the silicone tubing of the lead coils. The lead assembly has remnants of what appears to be body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. No discontinuities were identified within the returned lead portion.
 
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.
 
Event Description
On (b)(6) 2012, it was reported that normal mode and system diagnostics for a vns patient indicated high impedance. Diagnostics were repeated with the same results. The device subsequently programmed off. The physician requested a new generator due to the fact that this generator was implanted in 2008. The event was reported to be continuous, of moderate severity, and possibly related to stimulation. Device parameters were changed as intervention. It was also noted that the patient had an increase in seizures over the previous seizure rate. The patient reportedly has generalized tonic-clonic seizures and atonic seizures. The patient's settings and diagnostics from this date were provided. Additional information was received that x-rays were taken and would be provided for manufacturer review; however, they have not been received to date. The patient had not had any fall, injury or manipulation of her vns lead that could be attributed to the high impedance. The increase in seizures was over thee pre-vns seizure rate at baseline rate two months prior. The physician attributed the loss of therapy to the high impedance. Adjustments to mediation were made to treat seizures and to preclude a serious injury. Surgery is likely, but has not occurred.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Product analysis for the explanted generator was completed on (b)(6) 2012. The pulse generator was explanted/returned due to prophylactic replacement. 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. A battery life calculation on (b)(6) 2012 indicated 6. 49 years remaining.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2744314
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« Reply #67 on: October 31, 2018, 01:28:05 AM »

Model Number 300-20
Event Date 10/18/2012
Event Type  Malfunction   
Event Description
Additional information was received that on (b)(6) 2012 that the patient had a full revision surgery on (b)(6) 2012. No other information was provided at this time. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received that the lead was also returned to the manufacturer for evaluation. Product analysis is planned but has not been completed to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that product analysis was completed on the generator and lead. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found with the 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. 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, molybdenum and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since a large portion of the lead assembly (body) including the electrode array section.
 
Event Description
It was initially reported that the patient was having a full revision due to the generator being at end of service and the lead due to high impedance. The patient has been having an increase in seizures unknown if above or below pre-vns baseline. The physician felt that the seizures were due to both the high impedance and medication adjustments. There is no known trauma or manipulation that could have caused the issue. Surgery if likely but has not occurred to date. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.
 
Manufacturer Narrative
 
Event Description
Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.

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dennis100
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« Reply #68 on: November 14, 2018, 08:22:32 AM »

Model Number 302-20
Event Date 12/21/2012
Event Type  Malfunction   
Event Description
Product analysis of the explanted devices 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. The device was not turned off as a result of the high impedance. An analysis was performed on the returned lead portions and the reported allegation of high impedance was confirmed. 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. During the visual analysis of the returned 207mm portion the end of quadfilar coil 1 appeared to be broken approximately 150mm from the end of the cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on two of the coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining quadfilar coil strands was identified as being mechanically damaged and pitted 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 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 what appeared to be remnants of dried 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. What appeared to be white deposits were observed on the outer silicone tubing. 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 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, during the visual analysis, and no other discontinuities were identified.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported that the patient was referred for generator replacement due to an unknown reason. On the date of surgery on (b)(6) 2013, the company representative became aware that high lead impedance was observed on (b)(6) 2012 by the referring vns physician. Per the most recent clinic notes on (b)(6) 2012, the notes stated that high lead impedance and limited output status was observed, "suggesting either weak battery (but still functioning) or lead impedance. X-rays were obtained and showed no disconnect". The patient reported to be seizure free for two years. He was reportedly doing well and having no problems, per the physician's notes. The surgeon was not aware of any trauma that may have contributed to the high impedance. Intra-operatively, the surgeon replaced the generator which still resulted in high lead impedance. Therefore, the lead was replaced and retested. Two system diagnostic tests were performed and were within normal limits. The explanted generator and lead were received by the manufacturer for analysis; however, product analysis has not been completed to date. The return product form indicated the reason for replacement as lead discontinuity. Ap and later views of the neck and the chest were received and reviewed by the manufacturer. The generator was visualized in the left side of the patient's chest and placement appeared to be normal. The connector pin appeared to be seen past the connector block and filter feed thru wires were intact. The lead appeared intact at the connector pin. There was a small portion of the lead behind the generator and continuity in that portion of the lead body could not be assessed. Leads were visualized towards the left side of the neck area. There were no sharp angles or lead discontinues seen in the portions of the lead that were able to be visualized based on the x-ray image provided, a cause for the high lead impedance could not be identified however the presence of a micro fracture in the lead or a lead discontinuity in the portion of the lead that could not be assessed cannot be ruled out.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2949056
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« Reply #69 on: November 14, 2018, 08:23:39 AM »

Model Number 302-20
Event Date 09/23/2012
Event Type  Malfunction   
Event Description
Reporter indicated that during a vns generator replacement surgery, high lead impedance was noted with the resident lead and new generator. The patient received a new lead and generator. As a lead pin issue was ruled out, a lead fracture is the more likely cause of the high impedance. Attempts for additional information are in progress. The explanted vns generator and lead were returned. Analysis of the generator did not reveal any anomalies, and the generator performed per specifications. The generator was at end of service. Review of internal programming data from the generator indicated an impedance change from normal to high impedance occurred on (b)(6) 2012. Analysis of the lead is pending.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
All attempts to the reporter for additional information have been unsuccessful to date. Analysis of the vns lead was completed. During the visual analysis of the returned 39mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 1mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area on one of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on three of the quadfilar coil strands was identified as being mechanically damaged with 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 which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. 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 and calcium. 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 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, during the visual analysis, and no other discontinuities were identified. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2955092
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« Reply #70 on: November 14, 2018, 08:25:07 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
The vns treating physician reported that high lead impedance was found during an office visit on (b)(6) 2013. The patient was last seen on (b)(6) 2012 at which time the lead impedance was within normal limits. The physician reported that an x-rays confirmed a distal fracture. The patient was for replacement surgery as soon as possible to prevent more seizures. Clinic notes from the patient's visit on (b)(6) 2013 were received which indicated the patient continued to do well. However, the patient had a breakthrough seizure earlier in (b)(6), followed by brief myoclonic jerks involving his upper limbs. Since then, he has not had any further seizures. He is seizure free on the ketogenic diet. Also on the last office visit, his seizure medications were being weaned off and had been over of seizure medications for about 8 months. The patient had breakthrough seizures that seem to be related to vns lead fracture. Given the good seizure control, the plan was to continue to wean the patient off of seizure medications. Attempts for additional information from the physician's office have been unsuccessful to date, including to obtain a copy of the x-rays. Although generator and lead replacement surgery is likely, it has not occurred to date.

Manufacturer Narrative
Device failure occurred, and it was believed to have contributed to the patient's increased seizures.

Event Description
Additional information was received from the hospital reporting that the patient had generator and lead replacement surgery on (b)(6) 2013 and the explanted products were available for return. The explanted products were received by the manufacturer on (b)(6) 2013 for analysis. The return product form indicated the reason for replacement as prophylactic generator replacement and due to lead discontinuity. The implant card was also received and confirmed the date of surgery and indicated the reason for generator replacement as battery depletion with near end of service marked. Product analysis has not been completed to date.

Event Description
Operative notes from the patient's revision surgery on (b)(6) 2013 were received which indicated the diagnosis as placement of new lead due to fracture and generator secondary to end-of-life due to length of implant. The patient was doing well but began to lose efficacy with vns. Imaging was obtained which showed a fracture of the lead, explaining the device's 'failure to work. ' during the procedure, an incision was made over the old scar in the neck and dissection was carried down to remove the lead and the anchors. There was significant scar tissue surrounding the sternocleidomastoid, which was carefully dissected free by the surgeon. The lead dove directly posterior at this point, and the surgeon worked through the scar tissue to identify the connecting portion of the electrode. However, the nerve was scarred-in quite heavily, and the surgeon was unable to locate and free up all three of the components that held the nerve. The nerve was traced superiorly into the cicatrix and he tried to free up enough to again identify the previous electrodes, but the scar tissue was so heavy so the surgeon did not feel that he could 'safely dissect the nerve free without some type of injury to it. ' at this point, the surgeon felt that 'removal of the old electrode component was probably not worth the risk of injury to the nerve, and again try to free up as much nerve as possible, although the amount of exposure was very limited. ' the new set of electrodes were then successfully wrapped around the nerve. The surgeon felt that he had adequate contact of the two superior components of the lead, and the third electrode was able to be adequately wrapped around the nerve by laying it down inferiorly. Upon disconnecting the previous lead from the generator, a fracture was observed in the lead. The replacement lead was connected to the replacement generator which resulted in normal impedance upon diagnostics. He noted in the notes that the two electrodes appeared to have good relationships with the nerve. Attempts for additional information from the surgeon have been unsuccessful to date.

Event Description
The surgeon's office reported that there was noted to be scarring around the electrode and vagus nerve. However, the believed cause/relationship to vns was not provided. It may be reasonably assumed that it was related to presence of the electrode on the nerve.

Event Description
Product analysis of the generator showed no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was also completed. Note that a 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 an abraded opening was observed on the outer silicone tubing and both of the inner silicones were found to be abraded open in half; therefore determination could not be made between the (-) connector pin and (+) connector ring quadfilar coils past this point. These coils were identified as quadfilar coil 1 and quadfilar coil 2. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 239mm, 242mm and 245mm from the end of the connector boot. The (+) connector ring quadfilar coil appeared to be broken approximately 240mm from the end of the connector boot. Scanning electron microscopy was performed and identified the coil break areas as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis quadfilar coil 1 appeared to be broken approximately 247mm from the end of the connector boot and quadfilar coil 2 appeared to be broken approximately 253mm from the end of the connector boot. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting on the quadfilar coil 1 coil break. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. 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. 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. Review of the lead manufacturer history records confirmed all quality tests were passed prior to distribution.

Manufacturer Narrative

Manufacturer Narrative
Device failure is suspected and is suspected to have contributed to the patient's increased.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950000
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« Reply #71 on: November 14, 2018, 08:26:13 AM »

Model Number 300-20
Event Date 01/14/2013
Event Type  Malfunction   
Event Description
It was initially reported that the patient had high impedance. The patient was sent for x-rays but they had not been provided to the manufacturer for review. The patient had their output current turned down to 0. 5 ma and the physician does no plan to turn the patient off. The patient also reported that he was experiencing a shocking sensation at the same appointment where the high impedance was discovered. The patient has a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned but has not been complete.

Manufacturer Narrative

Event Description
Additional information was received that the product analysis was completed on the lead. 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 the (+) marked quadfilar coil appeared to be broken approximately 69mm and 73mm from the connector bifurcation and at approximately 10mm from the electrode bifurcation with three broken coil strands at approximately 9mm. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil breaks (found at 69mm and 73mm) and identified the areas as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 10mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. The area on the three broken coil strands was identified as being mechanically damaged. 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 what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. 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 and calcium. Refer to attached eds sheet for additional information. 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 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 other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portion of the device. 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
Additional information was received that there was no reported manipulation or trauma. X-rays will not be sent to the manufacturer for review. On diagnostics the dcdc code was 7. Product analysis was completed on the generator but has not been completed on the lead. The generator performed according to functional specifications. During product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2955719
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« Reply #72 on: November 17, 2018, 04:30:09 AM »

Model Number 300-20
Event Date 02/05/2013
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.

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 confirmed device met all specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

Event Description
Product analysis on the leads was completed on (b)(4) 2013. 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. What appeared to be white deposits were observed in various locations. 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 half set of setscrew marks found near the end of the marked connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the marked 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 in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. Product analysis of the generator was completed on (b)(4) 2013. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the pa lab. The battery is partially depleted, 2. 808 volts (near 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 internal memory of the device stated that the impedance value went from 91 ohms to 22152 ohms on (b)(6) 2013 which is after explant.

Event Description
On (b)(4) 2013 it was reported that the vns patient has high impedance. Diagnostics indicated that the device was only able to deliver 1. 0 ma despite being programmed to 3. 5 ma. It was also reported that the patient is experiencing an increase in seizures. Clinic notes dated (b)(6) 2013 were received. The clinic notes mention that the patient has vns and "sometimes it does work and there are other times where it will not work". The physician later clarified that this means that sometimes the magnet does not work to abort the patient's seizures and sometimes it does. High impedance was noted during this visit and the patient was having an increase in seizures. The clinic notes also mention that the patient's tremor is back, but not as severe as they used to be. The patient's guardian reported that the patient's seizures have changed and the patient has been experiencing more tremors in the last 2 years that the neurologist states are seizures. She states that sometimes the magnet works and sometimes it does not seem to help with breakthrough seizures. She did state that the patient is using different magnets than those provided for the vns. The caregiver mentioned that she believes that his seizures are overall better than baseline. The patient was referred for x-rays and surgery. The manufacturing records were reviewed for the lead and the device met all specifications prior to distribution. The physician later indicated that the increased seizures were first observed a couple of months ago but the high impedance was first observed on (b)(6) 2013. The physician stated that the increased seizures could be related to the vns. The physician has decided to have the device checked. The increase in seizures were noted to be below pre-vns baseline levels. The patient has been experiencing an increase in staring seizures. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures. No patient manipulation or trauma occur that is believed to have caused or contributed to the event. The device was not disabled. Good faith attempts for the patient's lead product information from the implanting hospital were unsuccessful. Additional clinic notes were received dated (b)(6) 2013 that indicate the patient is having multiple seizures daily which include multiple different types of seizures. Vimpat was added along with depakote and keppra but despite these medications, the patient continues to have increased seizures. The patient underwent a full revision surgery on (b)(6) 2013 due to the high impedance and prophylactic generator replacement. The explanted generator and lead were returned for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed. A/p and lateral x-rays of the chest were received. The lead pins appeared to be fully inserted into the header of the generator. There was a portion of the lead located behind the generator that could not be assessed. There did not appear to be any lead discontinuities or sharp angles in the lead portion that was able to be visualized. Based on the x-ray images provided, an exact cause for the report of high impedance could be determined. However, a small portion of the lead could not be visualized in the chest due to it being behind the generator and a portion of the lead in the neck could not be visualized in the views available. Also, the presence of a micro-fracture in the lead cannot be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2986519
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« Reply #73 on: November 27, 2018, 07:53:20 AM »

Model Number 102R
Event Date 05/20/2013
Event Type  Death   
Event Description
It was reported that the cause of death was due to seizure disorder as a result of a blunt force trauma from a motor vehicle accident. It was reported that the patient was still experiencing seizures at the time of death. It was unknown if the death was a result of a terminal seizure. The generator and lead were returned for analysis on (b)(6) 2013. The generator analysis was completed on (b)(4) 2013. 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. The lead analysis was completed on (b)(6) 2013. Note that 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. 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, zirconium and calcium. Refer to attached eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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, with no discontinuities identified.

Manufacturer Narrative

Event Description
A coroners office called to obtain a returned goods number for an explanted generator. It was reported that it can take up to a month to have the product returned. Thus far it has not been returned. At this time it is unknown the cause of the patient's death. Autopsy results are pending completion. The death was non traumatic but no other information known at this time. Good faith attempts will be made for more information as it becomes available for release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3188401
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« Reply #74 on: December 01, 2018, 01:32:36 AM »

Model Number 302-20
Event Date 06/21/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013 it was reported that the vns patient¿s vns lead was referred for replacement due to high lead impedance. Battery life calculations revealed that the vns generator had 0. 0 years left til end of service. Good faith attempts have been performed and it was later reported that the high impedance issue was first observed on (b)(6) 2013. The patient did not experience pain or any other adverse events. The office reported that their patient¿s vns devices are not turned off unless they are in pain. Thus, the patient¿s device was not changed to 0 ma. No x-rays were taken. No patient manipulation or trauma is believed to have caused or contributed to the high impedance. However, the physician was not able to provide a reason as to why the high impedance issue occurred.

Event Description
On (b)(6) 2013, it was reported that the patient had the vns generator and lead replaced on (b)(6) 2013. Diagnostics were performed which were all ok and the patient was interrogated prior to leaving the operating room to ensure the device was programmed off. However, when the patient came back into the office for a follow up visit, it was found that the device was turned on (reported in mfr #: 1644487-2013-02883). No other information was provided. The explanted device has not been returned.

Event Description
The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. The lead analysis was completed on (b)(4) 2013. During the visual analysis the white (+) and green (-) ribbons appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the electrode ribbons from coming in contact with the vagus nerve; therefore contributing to the reported allegations. With the exception of the observed tissue-covered (+) white and (-) green electrode ribbons 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 slice marks found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur, chlorine and calcium. 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 in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. However the "as-received" condition of the helicals suggest they were not mounted on the vagus nerve during some portion of the implant life. The generator analysis was completed on (b)(4) 2013. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3242310
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« Reply #75 on: December 02, 2018, 01:40:17 AM »

Model Number 302
Event Date 06/20/2013
Event Type  Malfunction   
Event Description
Generator and lead were received for analysis on (b)(4) 2013. Analysis of the generator was completed on (b)(4) 2013. 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 lead is underway, but has not been completed to date.

Manufacturer Narrative
Device failure is suspected, but did not contribute to a death or serious injury.

Event Description
An analysis was performed on the returned lead portions and the reported high impedance and lead fracture were confirmed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 335mm portion the (-) connector pin and (+) connector ring quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 270mm) and identified the area on one of the broken quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting on the coil surface. The area on another broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 284mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, fine pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. 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 openings and slice marks found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. 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, zirconium, 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 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 marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device. 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
On (b)(6) 2013 it was reported that the vns patient¿s device had a lead fracture. A battery life calculation was performed with the available data. The result revealed 0. 0 years remaining until end of service = yes. The manufacturing records for the generator and lead were reviewed and device met all specifications prior to distribution. It was later reported that the lead fracture was identified on (b)(6) 2013 by x-ray. The patient was previously seen in 2012 and no lead impedance issues were noted. No patient manipulation or trauma occurred that is believed to have caused or contributed to the lead fracture. Lead and generator were replaced on (b)(6) 2013. Attempts for return of the explanted devices are in progress.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3231930
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« Reply #76 on: December 02, 2018, 01:41:26 AM »

Model Number 302-20
Event Date 05/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013 it was reported that the patient has high impedance and x-rays were performed that showed a clear lead break. The x-rays were not sent to the manufacturer for review. The patient underwent revision surgery that day. It was later reported that the high impedance was first observed in (b)(6) 2013. The patient¿s device was not programmed off despite the high impedance. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The explanted lead and generator were returned to the manufacturer on (b)(4) 2013 for product analysis. Product analysis is underway and has not yet been completed.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
An analysis was performed on the returned lead portion. 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. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 252 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis the end of the (+) connector ring quadfilar coil appeared to be broken approximately 29 mm past the end of the abraded open / cut outer silicone tubing. The (-) connector pin quadfilar coil extended approximately 192 mm past the end of the abraded open / cut outer silicone tubing and determination could not be made as to whether the end of the coil was pulled and cut. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 29 mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil (found at 192 mm) and identified the area on two of the coil strands as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism on these two coil strands. The area on a third coil strand was identified as having evidence of a stress induced fracture (tension overload). The fourth quadfilar 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 silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded opening observed on the connector ring inner silicone tubing. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium and sulphur. Refer to attached eds sheet for additional information. 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. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portion of the device. The pulse generator was explanted and returned for product analysis due to prophylactic replacement. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 942 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a-non ifi condition. The data in the diagaccumconsumed memory locations revealed that 21. 081% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Review of manufacturing records confirmed sterilization for lead prior to distribution. No nonconformances were observed.

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« Reply #77 on: December 12, 2018, 01:47:08 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient would have a full vns revision surgery due to high lead impedance. The device was replaced due to "malfunction of vns device and high lead impedance" on (b)(6) 2013, per the hospital. Device manufacturing records were reviewed and no unresolved non conformances were found. Attempts have been made for additional information; however, they have been unsuccessful.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications 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 the high impedance was seen (b)(6) 2013 and the patient was turned off that day. The last good diagnostics was (b)(6) 2013 however results were not provided. X-ray were taken but will not be sent in to manufacturer for review. During surgery there was a lot of scar tissue that was seen and there were no lead breaks or other issue visualized. It was unknown if this was the cause of the high impedance but it was felt that it may have contributed. The cause of the fibrosis/scar tissue was unknown. Product analysis was completed on the generator and lead. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery is 2. 889 volts (not at ifi). The data in the diagaccumconsumed memory locations revealed that 65. 153% of the battery had been consumed. 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. Review of internal memory shows that the high impedance occurred (b)(6) 2013. During the visual analysis of the returned 390mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 331mm from the end of the connector boot. Scanning electron microscopy was performed and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage 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. 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, zirconium, sulphur and calcium. 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.

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« Reply #78 on: December 13, 2018, 04:12:12 AM »

Model Number 300-20
Event Date 08/16/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards 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 patient had a full vns replacement surgery on (b)(6) 2013 due to a lead fracture. Device manufacturing records were reviewed. Review of manufacturing records confirmed both the generator and lead passed all functional tests prior to distribution. The explanted devices were returned for product analysis. Visual examination noted tool marks on the pulse generator case and header, most likely associated with manipulation of the device during the explant procedure. No other surface abnormalities were noted on this device. The septum was not cored. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. The lead was returned for the allegation of fracture of leads/explanted/due to lead break/high impedance. The lead assembly was returned in two portions and the electrodes and tie downs were not returned. Due to the condition of the lead as ¿ received, determining the marked connector verses the unmarked connector quadfilar coils could not be made during the visual analysis of the returned 132mm portion. Setscrew marks were observed on the marked and unmarked connector pins, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connect pin. White deposits were observed on the marked connector boot and what appeared to be remnants of dried body fluids were observed inside the outer silicone tubing in some areas. An abraded opening was observed on the outer silicone tubing approximately 43mm-45mm from the connector bifurcation. A slice mark was observed on the outer tubing and penetrated the outer insulation, but the inner tubing did not appear to be damaged. On the returned 132mm portion what appeared to be remnants of dried body fluids were observed inside the outer silicone tubing in some areas and quadfilar coil 1 appeared to be broken approximately 20mm from the electrode bifurcation. Incisions were made to allow for sem photos. Continuity testing could not be performed during the decontamination procedure because the returned lead was not connected to a generator when received into pa. During the visual analysis of the returned 132mm portion quadfilar coil 1 appeared to be broken. Scanning electron microscopy was performed on the connector end of quadfilar coil 1 coil break (found at 20mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been received.

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« Reply #79 on: December 14, 2018, 06:08:37 AM »

Model Number 302-20
Event Date 08/09/2013
Event Type  Malfunction   
Event Description
The generator and lead were returned for product analysis. The lead was returned for the allegation of high impedance and explanted due to lead break/high impedance. A section of the lead assembly was returned for analysis in one piece. The lead¿s electrodes were not returned for evaluation. Two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. An opaque appearance was noted on the connector pin in the vicinity of the end tip. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The connector ring has what appears to be flash extending from the small o-ring boot to the connector ring exposed area 0. 029 inches (max: (b)(4)). This was measured using calipers and a reticle. However, no adverse effect was identified on the device performance as a result of this condition. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were noted on the connector boot. Abrasions were noted on the outer silicone tubing at multiple locations. The outer silicone tubing has what appear to be internal abrasions at multiple locations. White deposits were identified on the outer silicone tubing at approximately 5. 6cm and 32. 6-32. 9cm from the end of the connector boot. The cut ends of the lead coils are located approximately 31. 5cm from the end of the connector boot. Abrasions most likely caused by the presence of a tie-down were identified at approximately 32. 6cm from boot. The outer silicone tubing appears to have been cut at approximately 33. 3cm from boot. The lead coils have a wavy appearance along the lead body. The outer silicone tubing appears to have been compressed at approximately 5. 6, 26. 6, and 27. 1cm from boot. The lead coils are kinked at approximately 25. 6cm from boot. The lead assembly has remnants of what appear to be dry body fluids inside the inner silicone tubing of the positive coil. No obvious point of entrance was identified other than the cut end of the returned lead portion. No discontinuities were identified within the returned lead portion. No obvious pitting was noted. No adverse effect was identified on the device performance as a result of this condition. The returned portion of the lead (connector included) measured approximately 37. 7cm in length. An analysis was performed and the allegations were not verified within the returned lead portion. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observation, no anomalies were identified in the returned lead portion. The generator was returned for the allegation of device disabled due to a product issue and due to prophylactic replacement. Visual examination noted tool marks/dents on the pulse generator case most likely associated with manipulation of the device during the explant procedure. No other surface abnormalities were noted on this device. The septum was not cored. The generator performed according to functional specification. During the product analysis there were no anomalies found with the pulse generator.

Event Description
On (b)(6) 2013, it was reported that the patient was seen on (b)(6) 2013 and that high lead impedance was noted. Clinic notes dated (b)(6) 2013 state the patient's vns was turned off and it was recommended to obtain x-ray images. The notes also indicate that the patient's seizures have increased lately. A report for cervical x-rays performed on (b)(6) 2013 indicates the following: a left-sided neurostimulator is noted with the wires projected over the soft tissues of the left aspect of the cervical spine at the line of the c5 vertebral body. The visualized wires appear to be intact without evidence of fracture. Further impression include that there is no acute displaced fracture in the visualized portion of the cervical spine and that a short segment of the wires posterior to the stimulator are not well visualized. A report for chest ap/pa and lateral x-rays performed on (b)(6) 2013 notes that a neurostimulator is over the left chest and that the visualized wires appear to be intact. It is noted; however, that the proximal extent of the stimulator wires are not included on the radiograph. The wires posterior to the stimulator are not well visualized. The nurse practitioner followed-up to state that the x-rays report was normal. These x-ray images were not sent to the manufacturer for review. Replacement surgery was completed successfully on (b)(6) 2013. The device was programmed on to the prescribing physician's specifications. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

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.

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« Reply #80 on: December 15, 2018, 01:52:39 AM »

Model Number 302-20
Event Date 07/03/2013
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: the initial report indicated the high impedance occurred in (b)(6) 2013 however, additional information received revealed that the date of the high impedance is (b)(6) 2013. The information has been corrected in this report.

Event Description
A review of the data contained within the explanted generators memory revealed that a >25% change in system impedance was estimated to have occurred on (b)(6) 2013 (2442 ohms to 10199 ohms) signifying the start of the high impedance event.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, it was reported that the patient was showing high lead impedance on diagnostics performed that day. The patient's settings were disabled during the visit after the high impedance was observed. The patient was referred for x-rays and the surgeon for replacement. Replacement surgery occurred on (b)(6) 2013. Clinic notes dated (b)(6) 2013 confirm that high impedance was seen. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Manufacturer Narrative
(b)(4).

Event Description
The explanted generator and lead were returned on 09/12/2013. Visual examination performed at the bench revealed scratches on the generator can and header most likely associated with manipulation of the device during the explant procedure. Burn marks were also observed on the pulse generator can and header indicating that the pulse generator may have been exposed to an electro-cautery tool. No other surface abnormalities were noted on this device. The generator was subjected to and successfully completed a final electrical test. The generator is operating within specification. Results of diagnostic testing indicated that the battery status indicated ifi=no. The data in the diagaccum consumed memory locations revealed that 36. 384% of the battery had been consumed. 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 lead was returned for analysis due to allegation of high impedance/lead break. A section of the lead assembly was returned for analysis in one piece. The lead's electrodes were not returned for evaluation. Four sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. The outer silicone tubing has what appear to be internal abrasions at multiple locations. The outer silicone tubing appears to have been compressed at multiple locations. The negative coil is covered with what appears to be organic matter in the vicinity of the anchor tether location. The organic matter was removed to perform proper inspection of the lead. White deposits were noted on the silicone tubing of the negative coil at approximately 0. 6cm past the anchor tether. A break was noted on the negative coil at approximately 0. 2cm past the electrode bifurcation. The negative coil has an opaque appearance at approximately 0. 1cm prior to the broken end. The lead assembly has remnants of what appears to be dry body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portion. The reported high impedance/lead breaking allegations were verified. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil broken ends (including portion with an opaque appearance) and strand segments show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be determined. Note that since the closest and furthest electrode to the bifurcation were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion.

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« Reply #81 on: December 16, 2018, 03:49:43 AM »

Model Number 300-20
Event Date 09/17/2013
Event Type  Malfunction   
Event Description
During generator replacement surgery for end of service it was noted that high impedance was found after attaching a new generator to the existing lead. The lead was then also explanted and a new vns system was implanted. The lead was returned for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 44 mm portion quadfilar coil 1 appeared to be broken approximately 23 mm from the electrode bifurcation. Scanning electron microscopy was performed on the quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting. The remaining broken coil strands were 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. 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 silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found 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, sulphur and calcium. 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 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. The generator decoder found that the high impedance was first observed on (b)(6) 2013 which is the date of explant. Analysis of the generator was reported in mfr. Report # 1644487-2013-03234.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #82 on: December 16, 2018, 03:50:41 AM »

Model Number 300-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
It was reported that during lead replacement surgery device diagnostic testing resulted in high impedance (>= 10,000 ohms) prior to removing the generator from the lead. The generator was disconnected from the lead and generator diagnostics were within normal limits. The surgeon then replaced the lead and generator. A new system was implanted. The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. The lead analysis was completed on (b)(4) 2013. During the visual analysis of the returned 203 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm from the end of the connector bifurcation. Scanning electron microscopy was performed 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 which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening, slice mark and cut out hole found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. 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 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 in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of explanted due to lead break/high impedance. The generator analysis was completed on (b)(4) 2013. Visual examination performed at the bench revealed scratches on the generator can and header most likely associated with manipulation of the device during the explant procedure. Burn marks were also observed on the pulse generator can and header indicating that the pulse generator may have been exposed to an electro-cautery tool. No other surface abnormalities were noted on this device. The generator is operating within specification. The generator was returned due no malfunction suspected/identified. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. 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.

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 occurred, but did not cause or contribute to a death or serious injury.

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« Reply #83 on: December 29, 2018, 03:54:40 AM »

Model Number 300-20
Event Date 11/06/2013
Event Type  Malfunction   
Event Description
Analysis of the generator was completed on (b)(4) 2013. The device performed according to functional specification. 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) 2013. 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. During the visual analysis of the returned 309mm portion the unmarked connector pin quadfilar coil appeared to be broken approximately 87mm and 98mm from the connector bifurcation. Scanning electron microscopy was performed on the (-) unmarked connector pin quadfilar coil break (and identified the areas as having evidence of being worn to the point of fracture with flat spots, pitting and residual material on the coil surface. 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 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. 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, iron, aluminum, sulphur and calcium. 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.
 
Event Description
It was reported that the patient underwent generator and lead replacement due to high impedance. It was reported that the generator was programmed off after observing the high impedance. It is unknown if any trauma or patient manipulation occurred that could have caused or contributed to the high impedance. X-rays were not taken. The generator and lead were received by device manufacturer for analysis on 11/21/2013. Analysis is underway, but has not been completed to date. The implant card was received and indicated that the lead was replaced due to a lead break.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
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.

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« Reply #84 on: December 29, 2018, 03:55:27 AM »

Model Number 302-20
Event Date 11/06/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
On (b)(6), 2013 it was reported that the patient underwent generator replacement that day and during surgery, high impedance was discovered. The patient was scheduled for a lead revision surgery on (b)(6) 2013. It was reported that the patient¿s generator had been prophylactically replaced on (b)(6)2013 and the lead replaced on (b)(6) 2013 due to the high impedance observed during the prophylactic generator replacement surgery. After replacement, system diagnostics showed results within normal limits. The explanted products have not been returned for product analysis to date. Generator replacement captured on mfr. Report # 1644487-2011-01493. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on (b)(4) 2014. 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 the (-) connector pin quadfilar coil appeared to be broken approximately 172mm from the end of the connector boot. 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. What appeared to be pitting was observed on one of the broke coil strands. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on one of the broken coil strands. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening and slice 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 inside the outer silicone tubing. The abraded opening found on the (-) connector pin inner silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing. There was no obvious path found for the fluid ingress observed inside the (+) connector ring inner silicone tubing. What appeared to be white deposits were observed on one of the inner silicone tubes. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium, sulphur and calcium. 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, during the visual analysis, and no other discontinuities were identified.

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« Reply #85 on: December 30, 2018, 05:24:33 AM »

Model Number 302-20
Event Date 10/18/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was underwent generator and lead explant due to being seizure free with medication. It was reported that the patient's generator had been programmed off for about 18 months for that reason. The patient requested that the device be explanted. The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The incision mark and 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, zirconium, sulphur and calcium. Abraded inner tubing openings were observed. With the exception of the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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 discontinuities identified. Analysis of the generator was completed on (b)(4) 2013. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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dennis100
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« Reply #86 on: January 02, 2019, 02:18:11 AM »

Model Number 300-20
Event Date 09/01/2013
Event Type  Malfunction   
Event Description
The physician reported that the patient may have an issue with the device, but no additional details were provided. It was later reported that the patient will be referred to surgeon for possible revision because the device showed high impedance and end of service. The patient underwent generator and lead replacement on (b)(6) 2013. The lead and generator were returned to manufacturer for analysis. An implant card was received indicating that the patient underwent lead and generator replacement due to "lead discontinuity". Analysis of the generator was completed on (b)(6) 2013. 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 (b)(6) 2013. Note that a portion of the lead assembly was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 344 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm and 3 mm from the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 2 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 3 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine 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 (-) unmarked inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the remnants of what appeared to have once been body fluids found inside the outer and (-) unmarked inner silicone tubing. For the observed (+) marked connector pin inner tubing remnants of what appeared to have once been body fluids found inside, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. 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, zirconium, sulphur and calcium. Refer to attached eds sheet for additional information. The slice and puncture marks observed on the inner silicone tubes (past the electrode bifurcation) appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. 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.
 
Manufacturer Narrative
Device failure occurre, 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=3551516
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dennis100
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« Reply #87 on: January 08, 2019, 06:16:48 AM »

Model Number 300-20
Event Date 03/03/2014
Event Type  Malfunction   
Manufacturer Narrative
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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed 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 was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 197mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 25mm and 29mm from the end of the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 25mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 29mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting on two of the broken coil strands. Pitting was observed on the coil surface. 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 inside the outer silicone tubing. The abraded openings found on the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes. 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, sulphur and calcium. 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. 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.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 8620 ohms) during an office visit on (b)(6) 2014. The patient recently had some slips and falls. The patient underwent generator and lead replacement surgery due to high impedance on (b)(6) 2014. The generator was also replaced as diagnostic results revealed near end of service. The surgeon noted that there was a lot of scar tissue present. 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) 2013.

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dennis100
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« Reply #88 on: January 08, 2019, 06:17:51 AM »

Model Number 302-20
Event Date 12/01/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The explanted devices are expected to be returned to manufacturer for analysis, but have not been received to date.
 
Event Description
An implant card was received that corrected the date of explant.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). It was reported that the diagnostics were within normal limits in (b)(6) 2013 and that the patient started to experienced an increase in seizures in (b)(6). The device was programmed off and the patient was sent for x-rays. It was reported that it is unsure if any trauma occurred that could have caused or contributed to the high impedance, but that the patient experiences drop attacks and the high impedance may be trauma related. It was reported that the seizures were back to pre-vns baseline frequency. The patient was referred to surgery. Surgeon noted that x-rays did not identify a clear lead break, but that the images would be sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the lead. Surgery is likely, but has not occurred to date.
 
Event Description
Analysis of the returned generator was completed. Monitoring of the device 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.
 
Event Description
The generator and lead were received for analysis. Analysis of the lead was completed on 06/12/2014. The lead assembly was returned intact. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 322mm 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 322mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 322mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type 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 which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. 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 and calcium. 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 portions were performed, during the visual analysis, and no other discontinuities were identified. Analysis of the generator is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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dennis100
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« Reply #89 on: January 10, 2019, 01:12:24 AM »

Model Number 302-20
Event Date 03/28/2014
Event Type  Malfunction   
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.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include that x-rays were received that were pending review.
 
Event Description
Analysis of the generator was completed on 09/23/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 09/23/2014. 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 portions of the returned lead assembly appeared to be compressed and twisted and numerous abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 216mm portion quadfilar coil 1 appeared to be broken approximately 32mm and 36mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 32mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Determination could not conclusively be made on the fracture mechanism. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 36mm) 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. 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 openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. 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, sulphur and calcium. 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.
 
Event Description
It was reported that the vns patient visited the hospital due to an increase in seizures above pre-vns baseline levels. The physician reported that the event was related to vns stimulation. The patient¿s device was tested and system diagnostic results revealed high lead impedance (dc dc ¿ 6). The patient¿s device was not programmed off. X-rays and emg were planned but it is unknown it they have been taken to date. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient had multiple seizure types that all increased. The seizure type, duration of the seizures, post-ictal period, and auras did not change. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
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 which was reportedly visualized near the lead pin. It was noted that the patient¿s generator was not fixed with a non-absorbable suture, so the generator may have turned while implanted. The patient¿s replacement device was programmed on to previous device settings. The explanted generator and lead were returned to the manufacturer where analysis is currently underway.
 
Event Description
X-rays were provided to the manufacturer on (b)(6) 2014. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause high lead impedance remains unknown. No known interventions have occurred to date.

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