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Author Topic: Corrosion/Disintegration  (Read 52089 times)
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dennis100
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« Reply #450 on: January 08, 2019, 07:26:31 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3709847
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dennis100
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« Reply #451 on: January 08, 2019, 07:27:39 AM »

Model Number 302-20
Event Date 11/20/2013
Event Type  Malfunction   
Event Description
Clinic notes were received for the vns patient¿s office visit on (b)(6) 2014. The notes indicate that the patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The device was subsequently programmed off. The patient was experiencing an increase in seizures and worsening behavior so his medication was increased. Additional information was received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. The generator was replaced prophylactically. It is unknown whether patient manipulation or trauma caused or contributed to the high impedance. X-rays were taken prior to surgery and a lead fracture could not be visualized. Review of the lead device history records confirmed all quality tests were passed prior to distribution. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. The explanted generator and lead were returned to the manufacturer for analysis. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Review of internal data showed that the high impedance changed from 2917 ohms to 12583 ohms on (b)(6) 2013. An analysis was performed on the returned lead portions and confirmed lead discontinuity. During the visual analysis of the returned 16mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 4mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area 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. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed 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. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Follow up with the patient¿s treating vns therapy physician revealed that the patient¿s seizure activity was still below pre-vns baseline levels and that only the patient¿s ¿staring spells¿ had increased. The physician also indicated that the patient¿s condition improved following replacement surgery.
 
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 occurred, but did not cause or contribute to death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3710394
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dennis100
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« Reply #452 on: January 08, 2019, 07:28:49 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3606987
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dennis100
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« Reply #453 on: January 08, 2019, 07:29:49 AM »

Model Number 302-20
Event Date 02/27/2014
Event Type  Malfunction   
Event Description
Device programming history identified that a system diagnostics test was performed with a test resistor attached to the generator. The results showed high impedance; therefore the generator was replaced. Device diagnostics with the new generator attached to the existing lead again showed high impedance and the lead was replaced. Testing system diagnostics with a test resistor is expected to yield results that are not within normal limits. System diagnostics tests the continuity of the entire system, whereas the generator diagnostic test the system of the generator by itself (independent of the lead) which is why the test resistor is used.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>8,000 ohms). It was reported that there was no trauma that may have caused or contributed to the high impedance. It was also reported that diagnostics approximately six months prior were within normal limits. The physician reported that the x-rays did not show any obvious lead breaks. The patient was referred for surgery. The patient underwent generator and lead replacement surgery on (b)(6) 2014. It was reported that the surgeon saw a lead fracture and replaced the lead. The high impedance resolved. X-rays reviewed by manufacturer did not identify any gross lead fractures or discontinuities with the vns system. The lead was returned for analysis on (b)(4) 2014. Analysis of the lead 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.
 
Event Description
Analysis of the lead was completed on (b)(4) 2014. An abraded opening were identified in the outer tubing and positive coil inner silicone tubing. A break was identified in the positive coil at two locations. Scanning electron microscopy images of the positive coil show that pitting or electroㅔching conditions have occurred at the break locations. The positive coil shows appearance suggesting that a stress-induced fracture has occurred in at least two strands of the quadfilar coil at the mating end of the break located at 26. 1cm from boot. However, due to metal dissolution and mechanical distortion (smoothed surfaces) a conclusive determination of the fracture mechanism of the other strand cannot be made. Due to metal dissolution and mechanical distortion (smoothed surfaces) a conclusive determination of the fracture mechanism of the break located past the electrode bifurcation cannot be made. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. The generator was also returned and analyzed. 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 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=3709574
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dennis100
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« Reply #454 on: January 08, 2019, 07:30:32 AM »

Model Number 302-20
Event Date 04/02/2013
Event Type  Malfunction   
Event Description
Analysis of an explanted lead was completed and identified a lead discontinuity. Abraded openings were noted at the lead body in the outer tubing and the inner silicone of the positive coil tubing. Also, a suspected coil break was identified at the end of the positive coil of the returned lead portion. Scanning electron microscopy images of the positive coil end show that pitting or electro-etching conditions have occurred at the end of the positive coil. The exact reason for this condition is unknown. Due to metal dissolution the fracture mechanism cannot be determined. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. The information was inadvertently previously reported in mfr. Report # 1644487-2013-02022. Further follow-up revealed that high impedance was not observed prior to the explant procedure. There was no patient manipulation or trauma that could have caused or contributed to the lead break. No x-rays were taken. The surgeon indicated that the device was not interrogated during the surgery and that the lead was intentionally cut during removal.
 
Manufacturer Narrative
Device failure occurred, but did not caused or contribute to a death or serious injury. The lead product analysis results and evaluation codes were inadvertently previously reported in mfr. Report # 1644487-2013-02022. This report will now house any further information regarding the lead break.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3699068
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dennis100
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« Reply #455 on: January 08, 2019, 07:31:21 AM »

Model Number 300-20
Event Date 01/24/2014
Event Type  Malfunction   
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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury. Review of the as-received internal device data showed that the last 25% change in the impedance value on (b)(4) 2014.
 
Event Description
Analysis of the returned generator and lead was completed. 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 the as-received internal device data showed that the last 25% change in the impedance value on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance. During the visual analysis of the returned 180mm lead portion the (+) white electrode quadfilar coil appeared to be broken approximately 4mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Pitting was observed on the coil surface. 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. 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 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, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the reported high impedance. Note that since the (-) green electrode was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). It was reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The patient was referred for surgery. The device was programmed off after observing the high impedance. The patient underwent lead and generator replacement. The generator and lead were received for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date.

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dennis100
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« Reply #456 on: January 08, 2019, 07:32:24 AM »

Model Number 300-20
Event Date 02/28/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was not programmed off. Clinic notes were received stating that the high impedance was first observed during an office visit on (b)(6) 2014. The patient has not experienced any changes in her seizure control. The notes also indicate that the battery appeared to be depleting too quickly even with the high duty cycle. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
The patient underwent generator and lead replacement on (b)(6) 2014. The lead and generator were received on (b)(4) 2014. Analysis is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient did not have any trauma, changes in device settings, or changes in medications that may have contributed to the high impedance. The patient's device was disabled on (b)(6) 2014. The patient was doing well following replacement surgery. Analysis of the returned generator and lead was completed. Monitoring of the generator's 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. 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. During the visual analysis of the returned 385mm lead portion, the (-) green electrode quadfilar coil appeared to be broken approximately 3mm from the electrode bifurcation. Scanning electron microscopy was performed identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine 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. During the visual analysis of the returned 385mm portion the (+) white electrode and ribbon appeared to be embedded in remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the tissue-covered (+) white electrode and ribbon the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Abrasions were observed in various locations, possibly caused by wear. Coils appeared slightly stretched, kinked and wavy in some areas which most likely occurred due to manipulation of the lead during the explant process. 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 other discontinuities identified. Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. However, the positive electrode condition may have contributed to the reported high impedance.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3710150
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dennis100
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« Reply #457 on: January 09, 2019, 08:37:12 AM »

Model Number 302-20
Event Date 02/14/2014
Event Type  Malfunction   
Event Description
During generator replacement surgery high lead impedance was observed after a new generator was connected to the existing lead. It was reported that no diagnostics were performed prior to surgery. It was reported that several diagnostics were performed after ensuring that the lead pin was fully inserted into the generator header; however, the high impedance remained. The surgeon reported that he saw a kink in the lead along with fluid in the tubing. The lead was explanted and a new lead and generator were then implanted. The explanted lead and generator were received for analysis. Analysis of the generator was completed on (b)(4) 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 is underway, but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received stating that there was no patient manipulation and trauma that could have caused a lead break. It is uncertain if diagnostic testing was completed prior to surgery. The patient is only seen once a year by the office and is currently doing well. The surgery was prophylactic, and the high impedance was discovered at surgery. Analysis of the returned lead portions was completed. During the visual analysis abraded openings were observed on the outer silicone tubing and on one of the inner silicone tubes. The lead assembly had dried remnants of what appear to have once been body fluids inside outer and inner silicone tubes, in some areas. During the visual analysis of the returned 46mm portion quadfilar coil 1 appeared to be broken approximately 10mm and 16mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the coil break areas as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. During the visual analysis of the returned 46mm portion quadfilar coil 2 appeared to be broken approximately 16mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with no pitting on two and pitting on one of the coil strands. 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. The slice marks 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. For the observed inner silicone tubing 1 fluid remnant, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The abraded opening found on inner silicone tubing 2, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the reported high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
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=3680028
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dennis100
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« Reply #458 on: January 09, 2019, 08:38:02 AM »

Model Number 302-20
Event Date 02/12/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was experiencing an increase in seizures. The device could not be interrogated so the reported event was suspected to be due to end of service. Additional information was received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. Prior to the case, diagnostic results revealed high impedance (dc dc ¿ 7) and end of service. The generator was replaced first and diagnostic results with the existing lead revealed high impedance (impedance value >= 10,000 ohms). The lead was then replaced and diagnostic results revealed lead impedance within normal limits. The surgeon noted that fluid appeared from the explanted lead when it was transected. Additionally, the surgeon stated that one of the wires looked rusted. The explanted generator and lead have not been returned. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.
 
Event Description
Additional information was received stating that the neurologist did not have any issues communicating with other patients¿ devices and that his programming system was functioning normally. The neurologist was unaware of the reported high lead impedance so x-rays were not taken and the patient¿s device was not programmed off. No patient manipulation or trauma was reported. Attempts for product return have been unsuccessful.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. Based on the bench analysis and the electrical test results, the generator exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. 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. With the exception of the parameters that associated with a low battery condition, the device performed according to functional specifications. Analysis determined normal functionality and normal electrical performance of the pulse generator, which will be used to conclude that no abnormal performance or any other type of adverse condition was found with this device. Analysis of the returned lead portion is currently underway.
 
Event Description
Product analysis was completed on the lead. Note that a large portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the stated allegation of high impedance. Note that since a large portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677778
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« Reply #459 on: January 09, 2019, 08:38:49 AM »

Model Number 300-20
Event Date 02/07/2014
Event Type  Malfunction   
Manufacturer Narrative
Supplemental manufacturer report #01 inadvertently did not include dried remnants and abraded openings observations from product analysis.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 03/17/2014. Note that a portion of the lead assembly 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 the (+) and (-) marked connector quadfilar coil appeared to be broken approximately 154mm and 158mm from the connector bifurcation. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting on one of the broken coil strands. 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. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during generator replacement surgery high lead impedance was observed when the new generator was connected to the existing lead. A new lead and compatible generator were then implanted. The lead and generator were returned for analysis on (b)(4) 2014. Analysis of the generator was completed on (b)(4) 2014. 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. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
The lead assembly has dried remnants of what appear to have once been body fluids inside the outer and inner silicone tubes in some areas. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3668055
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« Reply #460 on: January 10, 2019, 01:26:44 AM »

Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient needs a lead replacement because the lead is "malfunctioning". It was reported that the patient went through a metal detector and now the lead is "malfunctioning". Clinic notes dated (b)(6) 2014 note that the patient went through a metal detector on (b)(6) 2014 and after that the patient experienced some vague soreness which intensified into severe pain on (b)(6) 2014. The patient described the pain as burning in the neck/chest area. It was noted that the magnet was placed over the generator with no improvement, but gradually subsided. It was noted that the patient still feels very sore and there was no trauma to the neck and no infectious symptoms. The device output current was decreased and the pulse width increased. The notes indicate that the patient will be referred to surgery. The surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. The physician reported that x-rays were taken, but will not be sent to manufacturer for review. The pain was reported to be with device stimulation. The patient underwent generator and lead replacement on 02/14/2014. An implant card was received that indicated that the patient underwent generator and lead replacement due to "adverse event - pain in left neck". The generator and lead were returned for analysis. Analysis of the generator was completed on (b)(4) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
The initial mfr. Report stated "the surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. " this sentence is being corrected to "the surgeon reported that in the lead revision in 2011 that there was a significant amount of scar tissue but was able to remove the electrodes from the nerve and replace with the new (current) lead. " device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 03/17/2014. Note that a portion of the lead assembly including the (-) green electrode 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 43mm portion quadfilar coil 1 appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, fine pitting and evidence of a stress induced fracture (torsional appearance) on two of the broken coil strands, 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. 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 #461 on: January 10, 2019, 01:27:37 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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« Reply #462 on: January 10, 2019, 01:28:25 AM »

Model Number 102R
Event Date 03/28/2014
Event Type  Malfunction   
Event Description
It was reported that during generator replacement for end of service high impedance (>10,000 ohms) was seen with the new generator attached to the existing lead. It was reported that the explanted generator was unable to be interrogated due to end of service; therefore, the high impedance was not observed prior to generator replacement. The lead pins were removed and reinserted into the generator header several times; however, device diagnostics still resulted in high impedance. The surgeon decided to remove the lead and while removing the lead broke and the coils were left on the vagus nerve. A new lead and compatible generator were implanted. Device diagnostics with the new vns system was within normal limits (1,928 ohms). The generator and lead were received for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date. The physician reported that it is unknown if any patient manipulation or truama occurred that is believed to have caused or contributed to the high impedance. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on (b)(4) 2014. Three broken strands were identified in the negative coil; one strand remained intact. Although not conclusive, the three identified broken strands may confirm this to be a contributing factor for the high impedance allegation. Scanning electron microscopy images show that pitting or electroㅔching conditions have occurred at the broken strands location. Also, the appearance of two strands suggests that a stress-induced fracture has occurred on the strands. However, due to metal dissolution and/or mechanical distortion (smoothed surfaces) a conclusive determination of the fracture mechanism cannot be made. The early stages of secondary stress-fracture fractures were noted on the fourth strand. Also, scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the surfaces of the unmarked connector pin. The exact reason for this condition is unknown. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Abrasions most likely caused by the presence of a tie-down were identified at approximately 25. 5cm from the end of the connector bifurcation. The lead coils are kinked at approximately 0. 4cm past the electrode bifurcation. The silicone tubing of the coils has what appear to be punctures at this location. A suspected coil break was identified in three strands of what is believed to be the negative coil at approximately 0. 3cm past the electrode bifurcation. The silicone tubing of the negative coil has tubing openings at this location. Abrasions were identified on the silicone tubing of the lead coils past the electrode bifurcation. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions. Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils. Analysis of the generator was completed on (b)(4) 2014. 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.

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« Reply #463 on: January 10, 2019, 01:29:14 AM »

Model Number 302-20
Device Problem High impedance
Event Date 01/23/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent surgery to explant the generator and lead due to high impedance on (b)(6) 2014. Pre-operative diagnostic results showed high impedance (impedance value ¿ 7641 ohms). The patient¿s generator was replaced and diagnostic results with the replacement generator and existing lead also showed high impedance. When the surgeon went to replace the lead, it was noted that the patient may have manipulated the device as one electrode had broken/slipped off the nerve and was slightly corroded. The surgeon observed significant scar tissue and fibrosis when explanting the lead. The patient was not re-implanted as the surgeon was unable to find adequate space on the nerve to place the new lead. Attempts to have the product returned for analysis were made but the product has not been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of programming history. Review of manufacturing records for the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected but did not cause or contribute to a death.
 
Event Description
Patient underwent surgery on (b)(6) 2015 and was implanted with vns generator and lead.
 
Event Description
It was reported by the neurologist that diagnostic results of the vns patient¿s generator revealed high impedance (6433 ohms) but was not programmed off. The patient was referred for x-rays and surgery. Surgery is likely but has not taken place. Clinic notes were received for the vns patient¿s office visit involving increasing lead impedance values on (b)(6) 2014. The notes indicate that the patient experienced an increase in breakthrough seizures so the surgeon increased the patient¿s settings on (b)(6) 2014. The patient has autism and his aggressiveness is believed to have contributed to the reported lead impedance. Review of the available programming and diagnostic history showed normal diagnostic results through 2011. Attempts for additional information have been unsuccessful.

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« Reply #464 on: January 10, 2019, 01:29:57 AM »

Model Number 302-20
Event Date 02/07/2014
Event Type  Malfunction   
Event Description
Analysis of the generator was completed on (b)(4) 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 (b)(4) 2014. An abraded opening was noted at the end of the silicone tubing of the positive coil. A break was identified at the ends of the positive and the negative lead coils. Scanning electron microscopy images of the positive and the negative coil show that pitting or electro-etching conditions have occurred at the broken ends. However, due to metal dissolution and surface contamination the fracture mechanism cannot be determined.
 
Event Description
It was reported by the neurologist that vns patient¿s diagnostic results revealed high lead impedance (dc dc = 7) so the generator was programmed off. Clinic notes were received for the patient¿s office visit with her neurologist on (b)(6) 2014. The notes indicate that the patient¿s condition is deteriorating. The notes also indicate that magnet stimulation was no longer effective in aborting the patient¿s seizures. Additional information was received stating that patient manipulation or trauma is not believed to have caused or contributed to the high impedance. X-rays were taken and lead discontinuity was found. The patient underwent generator and lead replacement surgery for lead discontinuity on (b)(6) 2014. During the procedure, the surgeon observed a lead fracture near the sternocleidomastoid. The surgeon stated that the anchor tether was missing from the lead and that he could not find any tie downs on the explanted lead. Review of the available programming and diagnostic history showed normal diagnostic results through 2009. The explanted generator and lead were returned to the manufacturer on (b)(4) 2014 and analysis is currently underway.
 
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 for 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 #465 on: January 11, 2019, 01:40:36 AM »

Model Number 302-20
Event Date 03/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturing device history records were reviewed. Review of the lead device history records confirmed all quality specifications were passed prior to distribution. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. The explanted devices were returned for analysis. Analysis was completed on the generator. The device performed according to functional specifications. Analysis concluded that no abnormal performance or any other type of adverse condition was found with the generator. Analysis of the lead has not been completed to date.
 
Manufacturer Narrative

Event Description
An analysis was performed on the returned lead portions. During the visual analysis of the returned 200mm portion quadfilar coil 1 appeared to be broken approximately 174mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 174mm) and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the second broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The two remaining broken coil strands were identified as being pitted with mechanical damaged which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 174mm) and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. The remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer, no gross lead discontinuities visualized.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It is unknown if any patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. It was later reported that x-rays were performed and would be sent to manufacturer for review. It is unknown if the device was programmed off per manufacturer's recommendations. No surgical intervention has been performed to date. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Attempts for additional information have been unsuccessful.
 
Event Description
X-rays were received and reviewed by manufacturer. Based on the x-rays received, the cause for the reported events are unable to be determined. There was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out. As the lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Due it image quality the lead that were difficult to visualize and fully assess.

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« Reply #466 on: January 11, 2019, 01:41:30 AM »

Model Number 302-20
Event Date 03/31/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014, the surgeon found a break in the patient¿s lead. The generator was being replaced due to end of service. Interrogation of the patient's device prior to replacement surgery was attempted twice but was unsuccessful. The surgeon elected to replace the lead during the procedure. No patient manipulation or trauma was reported. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator found that the device was at end of service due to normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the two returned lead portions was completed. In the first lead portion, the (+) connector ring quadfilar coil appeared to be broken approximately 218mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 218mm) and identified the area as having pitting and residual material in the broken surface areas and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 218mm) and identified the area as being pitted and mechanically damaged which prevented identification of the coil fracture type. The (+) connector ring quadfilar coil extended approximately 3mm past the end of the cut outer silicone tubing and the end appeared to be broken. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. Three of the broken coil strands appeared to have been worn to the point of fracture. Pitting was observed on the coil surface. The (-) connector pin quadfilar coil extended approximately 15mm past the end of the cut outer silicone tubing and the end appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture and no pitting. In the second lead portion, quadfilar coil 1 appeared to be broken approximately 5mm from the end of the abraded open outer silicone tubing. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots and pitting on the coil surface. Quadfilar coil 2 appeared to be broken approximately 7mm from the end of the abraded open outer silicone tubing. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting. The end of quadfilar coil 1 appeared to be broken approximately 29mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being pitted with mechanical damage which prevented identification of the coil fracture type. The remaining broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. The end of quadfilar coil 2 appeared to be broken approximately 29mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. The area on the two remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings, there is evidence to suggest a discontinuity existed in the returned portions of the device. Note that since the anchor tether, (+) white electrode and a small portion of the outer silicone tubing were not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #467 on: January 11, 2019, 01:42:18 AM »

Model Number 302-30
Event Date 03/24/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead explant. A new vns system was not implanted. The generator and lead were received for analysis. Analysis 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.
 
Event Description
Analysis of the generator was completed on 08/06/2014. 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. Analysis of the lead was completed on 08/11/2014. Abraded openings were noted on the outer and the inner silicone tubing. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. Also, the negative coil shows that a stress-induced (fatigue) fracture occurred in one strand of the quadfilar coil. However, due to pitting and mechanical distortion (smoothed surfaces) the fracture mechanism of the other strands cannot be determined. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. Further follow-up revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The physician programmed the device off on (b)(6) 2014. The physician reported that x-rays were performed and the patient was referred to surgery. The plan is to have the device explanted if insurance approves. Surgical intervention has not occurred to date.

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« Reply #468 on: January 11, 2019, 01:43:05 AM »

Model Number 302-20
Device Problem High impedance
Event Date 01/04/2014
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.
 
Event Description
The patient's mother reported that she is not going to proceed with surgery. The device has been programmed off for a couple of months and the patient is doing fine with her seizures. The patient's mother reported that the seizures are below pre-vns baseline.
 
Event Description
Analysis was completed on the returned lead and the report of lead fracture was confirmed. The lead was returned intact and a discontinuity was identified. Scanning electron microscopy identified three of the broken coil strands and surface had pitting. The remaining broken coil strand was mechanically damaged. The mating end of the electrode and one of the broken coil strands had evidence of a fatigue stress induced fracture with mechanical damage, fine pitting and a rotational stress induced fracture. The area on the remaining broken coil strands had evidence of a stress induced fracture with mechanical damage. With the exception of the observed discontinuity, no other anomalies were noted. Analysis for the generator was completed on (b)(4) 2015. The device was automatically disabled (pulsedisabled) and end-of-service warnings were set. The pulsedisabled byte would not reset. The measured battery results, confirmed an end-of-service condition. Review of the generator data showed increased impedance, from 2912 ohms to 13,088 ohms, and the date of change detection was (b)(6) 2014. The electrical test results showed that the pulse generator module performed according to functional specifications.
 
Event Description
It was reported that the vns patient was scheduled for lead replacement surgery. Additional information was received stating that diagnostic results revealed high lead impedance and that the patient was experiencing an increase in seizures for several months. The patient¿s device was programmed off on (b)(6) 2014. Surgery has not occurred to date. Review of the available programming and diagnostic history only found diagnostic results from the day of implant which revealed normal device function at that time.
 
Event Description
The patient had revision surgery for the lead and generator due to high impedance. The products were received and analysis is underway, but has not been completed to-date.

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« Reply #469 on: January 11, 2019, 01:43:55 AM »

Model Number 300-20
Device Problem High impedance
Event Date 03/05/2014
Event Type  Malfunction   
Event Description
Further information was received indicating that system diagnostics were run on the vns system which returned a low impedance result and that the generator was disabled.
 
Event Description
Additional information was received stating that the vns patient¿s surgery has not been planned and has not occurred to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegation of high impedance was confirmed. Note that portions of the (+) white and (-) green electrode quadfilar coils, the anchor tether and (+) white electrode were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. 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. Visual analysis of the returned lead portion found two places of broken coil strands. Both breaks having evidence of stress induced fracture (fatigue appearance). It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. 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 high impedance. The abraded inner tubing openings, exposed coils in adjacent areas, and the tissue-covered (-) green electrode ribbon the condition of the returned lead portions are consistent with conditions that typically exist following an explant procedure. There is no evidence to support the low impedance condition. No other obvious anomalies were noted.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance during an office visit on (b)(6) 2014. The device was subsequently programmed off. The patient was experiencing an increase in seizures above pre-vns levels. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
An implant card was received indicating that the patient underwent generator replacement for end of life on (b)(6) 2014. The implant card noted that the lead impedance was high (>10,000 ohms). The physician reported that the high impedance was observed after the new generator was placed on the existing lead. The new generator was not disabled as the physician believed there were no adverse events reported. The patient is scheduled for lead replacement surgery. No surgical intervention has been performed to date.
 
Event Description
Further information was received indicating that the patient underwent full revision surgery on (b)(6) 2015. The patient's vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with 1930 ohms. Return of the explanted lead and generator to the manufacturer is expected but it has not been received to date.
 
Event Description
It was reported that full revision surgery is expected but it has not occurred to date.
 
Event Description
The explanted lead and generator was returned to the manufacturer on (b)(6) 2015. Analysis of the lead is underway but it has not been completed to date. Analysis of the generator was completed and there were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #470 on: January 11, 2019, 01:44:44 AM »

Model Number 303-20
Event Date 03/18/2014
Event Type  Malfunction   
Event Description
A physician reported high lead impedance. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to the manufacturer to date.
 
Event Description
Additional information was received that the lead was returned to the manufacturer for evaluation. During the visual analysis of the returned 27mm portion the (-) green electrode tri-filar coil appeared to be broken approximately 14mm from the distal end of the anchor tether. A portion of the coil appeared to be dissolved. Scanning electron microscopy was performed on the (-) green electrode tri-filar coil break and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type and evidence of electro-etching on the coil surface. Scanning electron microscopy was performed on the spot-weld / slug area and identified evidence of electro-etching and pitting on the weld connection. 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 puncture marks found on the bilumen tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the bilumen tubing. During the visual analysis of the returned 27mm portion what appeared to be a remnant of dried body tissue was observed on the surface of the ribbon. This condition may have prevented the (-) green electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the partially tissue-covered (-) green electrode ribbon 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, with no other discontinuities identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #471 on: January 11, 2019, 11:56:32 PM »

Model Number 302-20
Event Date 03/20/2014
Event Type  Malfunction   
Manufacturer Narrative
The supplemental report #2 inadvertently did not report this information.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014 due to lead fracture. The explanted lead was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death. However, the confirmed discontinuities have the potential for being a possible contributing cause to the increased seizures.
 
Event Description
An analysis was performed on the returned lead portions. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 333mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 203mm and 222mm from the end of the connector boot. Scanning electron microscopy (sem) was performed on the (+) connector ring quadfilar coil break (found at 203mm) and identified the area on three of the broken coil stands as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. The broken coil strand was identified as having evidence of being worn to the point of fracture. Sem was performed on the (-) connector pin quadfilar coil break (found at 222mm) and identified the area as having evidence of being worn to the point of fracture with flat spots and pitting on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on some of the quadfilar coil breaks. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The abraded openings found on the outer and inner silicone tubes of the leads and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The physician reported that the patient's seizures have recently worsened. It is unknown if the worsening of seizures is above the patient's pre-vns baseline frequency. It was reported that the patient has been referred for surgery. Surgery is likely, but has not occurred to date. Attempts to obtain additional relevant information have been unsuccessful to date.

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« Reply #472 on: January 11, 2019, 11:57:45 PM »

Model Number 302-20
Device Problem High impedance
Event Date 06/23/2005
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7; eos - yes). It was reported that the patient was referred to surgery. The device was not programmed off after observing the high impedance. Clinic notes dated (b)(6) 2014 note that high impedance was observed and that the vns is still working. Device settings were adjusted. The notes indicate that the patient was referred for surgery. The physician's office reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. No x-rays were performed. Surgery is likely, but has not occurred to date.
 
Manufacturer Narrative
Brand name; corrected data: additional information indicates that the suspect device is the generator. Type of device, name; corrected data: additional information indicates that the suspect device is the generator. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.
 
Event Description
The generator was replaced on (b)(6) 2014. The patient had a full replacement on (b)(6) 2015. The surgeon stated he observed an obvious break in the lead wire approximately 3-4 inches away from the generator but did not know what might have caused it. The explanted lead has not been received to date.
 
Event Description
High impedance was detected on (b)(6) 2015, and a decrease in seizure control was reported. The patient has been referred to a surgeon for lead revision, but no surgical intervention has occurred to-date. Clinic notes received indicate that systems diagnostics was performed with lead impedance >=10000 ohms. The output current was lowered from 2. 0 ma to 1. 5 ma. The patient's generator was replaced on (b)(6) 2015.
 
Event Description
The generator and lead were received for analysis on 01/15/2016. Product analysis for the lead was completed and approved on 02/02/2016. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 81mm portion the end of the connector ring quadfilar coil appeared to be broken approximately 37mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having extensive pitting which prevented identification of the coil fracture. The remaining two broken coil strands were identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting. Pitting and residual material was observed on the coil surface. During the visual analysis of the returned 135mm portion the connector ring quadfilar coil appeared to be broken approximately 20mm from the end of the cut / torn outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having extensive pitting which prevented identification of the coil fracture. The remaining broken coil strand was identified as being mechanically damaged (smooth surfaces) 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. 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. Product analysis for the generator was completed and approved on 02/04/2016. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. 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.
 
Event Description
Additional information was received indicating that the vns patient underwent surgery on (b)(6) 2014. During the procedure, the patient¿s generator was replaced due to end of service. The replacement generator was tested with the existing lead and system diagnostic results showed lead impedance within normal limits. The lead was not replaced. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Age at time of event, corrected data: supplemental manufacturer report #01 inadvertently did not update this information. Date of event, corrected data: supplemental manufacturer report #01 inadvertently did not update this information. Operator of device, corrected data: supplemental manufacturer report #01 inadvertently did not update this information. Evaluation codes, conclusions, corrected data: supplemental manufacturer report #01 inadvertently did not update this information to report user error caused event.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently reported that the patient's generator was replaced on (b)(6) 2015, when the replacement surgery occurred on (b)(6) 2015. Relevant tests/laboratory data, corrected data: the diagnostics performed on (b)(6) 2014 were inadvertently not provided in detail as provided by the clinic notes. The diagnostics also were inadvertently not identified as systems diagnostics. Brand name, corrected data: the brand name of the device was inadvertently reported for the generator in supplemental mfr report#01. Type of device, corrected data: the type of the device was inadvertently reported as the generator in supplemental mfr report#01 when intended to be for the lead. Model#, serial#, lot#, expiration date, corrected data: the device product information was inadvertently reported for the generator in supplemental mfr report#01 when intended to be for the lead. Explanted date, corrected data: the device was inadvertently reported explanted in supplemental mfr report#01 when intended to be for the lead, which has not been explanted to-date. Device evaluation, corrected data: the suspect device was inadvertently reported as the generator, when intended to be for the lead, which has not been returned as it has not been explanted to-date. Device manufacture date, corrected data: the suspect device manufacture date was inadvertently reported for the generator, when intended to be for the lead.
 
Event Description
The septum and setscrew were not returned with the generator. The end of service condition of the generator was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
Describe event, corrected data, mdr #3 inadvertently stated that patient had generator replaced (b)(6) 2015 instead of (b)(6) 2014.
 
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 #473 on: January 11, 2019, 11:58:50 PM »

Model Number 302-20
Event Date 08/31/2013
Event Type  Malfunction   
Event Description
The generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury. Date of event, corrected data: additional information indicates that the date of event is at least (b)(6) 2013.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that x-rays did not show an obvious break in the lead. The patient was referred for surgery. The patient underwent generator and lead replacement on (b)(6) 2014. During the surgery, a lead break was identified at the portion of the lead coiled behind the generator. Further follow-up revealed that the patient's device was not programmed off after observing the high impedance. The explanted devices are expected to be returned for analysis, but have not been received to date.
 
Event Description
Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2013. Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. During the visual analysis of the returned 62mm lead portion, quadfilar coils 1 and 2 appeared to be broken approximately 60mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 60mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. Extensive pitting was observed on one of the broken coil strands and pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 2 coil break (found at 60mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the reported high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

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« Reply #474 on: January 11, 2019, 11:59:46 PM »

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

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« Reply #475 on: January 12, 2019, 12:00:40 AM »

Model Number 300-20
Event Date 09/28/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The generator was programmed off on (b)(6) 2014. An emg was performed which showed an immediate drop of electrical load during stimulation which reflects a possible break of the lead. X-rays were taken and sent to manufacturer for review. X-rays did not identify any obvious discontinuities within the vns system. It was reported that surgery is likely; however, surgery has not occurred to date.
 
Event Description
During the product analysis there were no anomalies found with the pulse generator. The generator performed according to functional specifications. During the visual analysis of the returned lead portion, the (+) marked and (-) unmarked quadfilar coils appeared to be broken in the body area of the returned lead assembly. Scanning electron microscopy was performed and identified evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting on both of the broken coils. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. The abraded openings and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded opening found on the (+) inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubing. For the observed (-) inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the reported high impedance. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement on (b)(6) 2014. The generator and lead were received for analysis. Analysis is underway, but has not been completed to date. The surgeon indicated that there were white spots on the lead at the contact area.

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« Reply #476 on: January 12, 2019, 12:01:54 AM »

Model Number 302-30
Event Date 03/17/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 04/22/2014. During the visual analysis the (+) white electrode quadfilar coil appeared to be broken approximately 1. 5mm from the proximal end of the anchor tether. Scanning electron microscopy was performed identified the area as being mechanically damaged with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy, provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance and the patient was referred for surgery. The patient underwent generator and lead replacement on (b)(6) 2014. Pre-operative device diagnostics resulted in high impedance. The explanted generator and lead were returned for analysis on (b)(6) 2014. Analysis of the generator was completed on (b)(6) 2014. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found; however, during decontamination an elective replacement indicator was observed. Analysis of the lead is underway, but has not been completed to date. Further follow-up revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Attempts to obtain additional information have been unsuccessful to date.

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« Reply #477 on: January 12, 2019, 01:49:14 AM »

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

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« Reply #478 on: January 13, 2019, 03:45:59 AM »

Model Number 302-20
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
Clinic notes dated (b)(6) 2014 note vns nearing end of service and lead impedance increased. The notes indicate that the patient will be referred for vns replacement. The physician reported that on interrogation of the device two messages were received indicating that the device was nearing end of life and the lead impedance had increased. Review of device labeling showed that there is not a message that can be received upon interrogation of a model 102 generator that indicates anything about increased impedance. It appears that the physician performed device diagnostics, but is misinterpreting the results. The patient underwent generator and lead replacement and it was reported that device diagnostics were performed without error. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The generator was received with its battery depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. The device performed according to functional specifications. No abnormal performance or any other type of adverse condition was found with the generator. The returned lead portion has dried remnants of what appear to have once been body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the end of the returned lead portion. Incisions in the silicone tubing of the negative coil were necessary to perform proper inspection of the coil. A break was identified at the end of the negative coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the broken strand and the coil end. Also, a secondary break was identified in one strand of the quadfilar coil in the vicinity of the broken end. However, due to metal dissolution and/or surface contamination the fracture mechanism of the broken wires cannot be determined. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
The generator and lead were returned for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3727274
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dennis100
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« Reply #479 on: January 13, 2019, 03:46:55 AM »

Model Number 302-20
Event Date 03/10/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms) during an office visit on (b)(6) 2014. The patient stated that she had a seizure and fell. The patient¿s arm was bruised but she is unsure if the fall caused or contributed to the reported high impedance. Additional information was received stating that the patient underwent generator and lead replacement surgery due to high impedance on (b)(6) 2014. The explanted products have not been returned to manufacturer to date.
 
Event Description
The explanted generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2014. Scanning electron microscopy images of the positive coil show that pitting or electro¿etching conditions have occurred at the end of the positive coil. Due to metal dissolution the fracture mechanism of the coil cannot be determined. Scanning electron microscopy images of the negative coil show that a stress-induced fracture (due to rotational forces) has occurred on the negative coil. Also, the early stages of secondary fractures noted in the vicinity of the broken strands appear to indicate the stress-related primary fractures were most likely created during the explant procedure. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Analysis of the generator was completed on (b)(4) 2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
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=3723807
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