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dennis100
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« Reply #630 on: January 04, 2019, 08:45:55 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem; Device Contamination with Body Fluid
Event Date 10/22/2018
Event Type  Malfunction   
Event Description
It was reported that a patient was set to have a generator replacement for battery depletion. On the date of surgery, the surgeon reported that high impedance had been seen previously. The patient underwent a full revision of the lead and generator and upon explanting the lead, an abraded opening with calcification was observed. Product return is not expected. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8168075
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dennis100
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« Reply #631 on: January 04, 2019, 08:46:28 AM »

Model Number 300-20
Device Problem Mechanical Problem
Event Date 11/29/2018
Event Type  Malfunction   
Event Description
During the generator repositioning surgery for lead extrusion reported in mfg report #1644487-2018-02130, it was noted during the surgery that just below one of the lead pins, scar tissue had formed in the shape of a tube around the pin's wire. It was stated that within the tube, the lead wire had a portion that was exposed with the insulation pulled back. Diagnostics were performed outside the pocket noting impedance within normal limits. The generator was then positioned and secured into the pocket. Another diagnostic was performed with ok impedance and the pocket was closed. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8188205
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dennis100
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« Reply #632 on: January 05, 2019, 01:14:51 AM »

Model Number 304-20
Device Problems Fracture; Device Contamination with Body Fluid
Event Date 10/22/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for a prophylactic generator replacement surgery. However, during the day of the replacement surgery it was noted that high impedance was seen on the patient's device during a follow-up appointment prior to the date of surgery. There was no mention of trauma that may have caused the high impedance. It was also stated that the patient experienced an increase in seizures since the patient's corpus colostomy, and the physician believed that the increase in seizures may be related to the high impedance. During the patient's generator replacement surgery, the lead pin was inserted securely into the newly implanted generator to ensure that the high impedance was not related to the pin insertion. High impedance was seen again with the newly implanted device. The entire lead was then removed and replaced. Areas where inner lead had come out of the outer insulation were seen. The surgeon stated that he could not see very clearly, but stated that there may be something like a fluid in the lead further down. No other relevant information has been received to date. The explanted products have not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8130154
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dennis100
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« Reply #633 on: January 05, 2019, 01:15:40 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 11/10/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient wanted to get her vns removed. She stated that she doesn¿t think it¿s working anymore. She says it worked and helped her in the beginning, but stopped working for her later on and has been that way for a while. Information was received that the patient¿s device was fully explanted. The explanted generator and lead were received for analysis. Product analysis for the generator was completed and approved. During the analysis, there was no indication from the device that an end of service condition existed. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Product analysis on the lead was completed and approved. During the visual analysis of the returned 42mm portion quadfilar coil 1 appeared to be broken approximately 9mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. Pitting and residual material was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. No other obvious anomalies were noted. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity with the returned portions of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8125705
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dennis100
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« Reply #634 on: January 05, 2019, 01:16:26 AM »

Model Number 304-20
Device Problem Fracture
Event Date 11/09/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Initial report was that a patient was referred for generator replacement due to desire for latest model. Further information was received on the day of replacement that high impedance was observed on the lead during the surgery. The lead appeared to be sutured down resulting in lead damage and the lead was reported to be opened when the surgeon was assessing the lead in surgery. During the surgeon's assessment of the lead, the lead ripped. Further information was received that a stitch had been used by the previous surgeon to secure the lead to tissue and that the lead was either pierced with a needle or that the stitch wore through the lead overtime resulting in the damage. It is stated that the lead's insulating coating cracked significantly resulting in the high impedance. The surgeon proceeded with lead replacement. The lead was returned and is pending product analysis completion. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8128889
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dennis100
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« Reply #635 on: January 06, 2019, 03:49:15 AM »

Model Number 300-20
Event Date 01/20/2014
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which had a break/tear most likely related to the explant procedure. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the device was programmed off and the patient was referred for x-rays. It is unknown if x-rays will be sent to manufacturer for review. No patient manipulation or trauma occurred that is believed to have caused or contributed to a death or serious injury. Surgery is likely, but has not occurred to date.
 
Event Description
Analysis of the returned generator showed that the device performed according to functional specifications. There were no anomalies found with the pulse generator. Analysis of the returned lead portion found the outer silicone tubing abraded open. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the ends of the returned lead portion. A torn/break was identified at the end of the positive coil. Scanning electron microscopy images of the positive coil show that the positive coil was torn (due to rotational forces) as indicated by the appearance of the coil¿s strands. Although, not conclusive, it appears this observed condition is the result of the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
It was reported x-rays did not show a fracture and the physician believes there is a microfracture. Surgery was scheduled and the patient underwent generator and lead replacement on (b)(6) 2014. The generator and lead were returned 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3630993
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dennis100
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« Reply #636 on: January 07, 2019, 02:06:19 AM »

Model Number 302-20
Event Date 10/26/2013
Event Type  Malfunction   
Event Description
The data dump for the generator identified that the lead impedance changed from 2935 ohms to 13129 ohms on (b)(6) 2013. Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis what appeared to be pitting was observed on the connector pin surface. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the connector pin pit deposit and identified the area as consisting of chromium, iron, nickel, silicon, fluorine, sodium, potassium, aluminum and molybdenum. Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, nickel, silicone and molybdenum. A definite cause for the pitting could not be determined based on the lead portion returned. The slice mark and 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. The condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. The generator analysis will be reported in mfr. Report #1644487-2014-00731.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient will be referred to surgeon for revision surgery. No known trauma or patient manipulation occurred that is believed to have caused or contributed to the high impedance. It is unknown if x-rays were performed. Surgery is likely, but has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the vns patient¿s device was explanted on (b)(6) 2014. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3608939
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dennis100
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« Reply #637 on: January 08, 2019, 07:13:19 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 #638 on: January 08, 2019, 07:14:13 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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« Reply #639 on: January 08, 2019, 07:15:15 AM »

Model Number 105
Event Date 02/25/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s neurosurgery consultation on (b)(6) 2014. The notes indicate that the patient was experiencing a recent increase in seizures along with a shocking sensation at the generator site; therefore, the patient was admitted to the hospital through the emergency room on (b)(6) 2014. The patient stated that his seizure frequency had increased from five seizures a day to a seizure every hour. The baseline seizures appeared to last approximately 15 seconds and were tonic-clonic or absence seizures. Radiology reported that neck x-rays showed that lead wires were ¿off. ¿ chest x-rays were reported to be unremarkable. Operative notes were received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. The notes indicate that the patient was experiencing a shocking sensation in his neck with stimulation. Imaging revealed abnormal placement of the lead electrodes. The generator was replaced during the procedure as it was nearing end of service. An implant card was received stating that the lead was replaced due to lead discontinuity. Diagnostic results with the replacement generator and lead revealed lead impedance within normal limits (impedance value ¿ 1906 ohms). Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts for additional relevant information were made, but have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. Analysis of the returned generator 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. Review of the as-received internal device data showed high impedance never occurred. Analysis of the returned lead portion found abraded openings on the outer silicone tubing which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation 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.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: additional information indicates that a device malfunction did not occur. 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. Date of implant; corrected data: additional information indicates that the suspect device is the generator. Type of reportable event; corrected data: additional information indicates that a device malfunction did not occur. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.

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« Reply #640 on: January 08, 2019, 07:16:08 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.

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« Reply #641 on: January 08, 2019, 07:16:59 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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« Reply #642 on: January 09, 2019, 08:30:53 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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« Reply #643 on: January 09, 2019, 08:31:40 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.

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« Reply #644 on: January 10, 2019, 01:18:36 AM »

Model Number 302-20
Event Date 04/03/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc ¿ 7). The device was not programmed off following the high impedance observation. X-rays were not taken. The patient did not report any injuries. The patient underwent surgery on (b)(6) 2014. Pre-operative diagnostics showed high impedance so the generator was replaced. Diagnostic results with the replacement generator and existing lead showed high impedance. The surgeon reported that there was fibrosis in the patient¿s neck; however, the patient¿s neck was never opened. The patient¿s parent did not want to proceed with lead replacement and elected to wait to see if the patient¿s seizures return. The surgeon removed the replacement generator and a portion of the patient¿s lead without replacement. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils. An abraded opening was noted on the outer silicone tubing. The reported high impedance allegations were not verified within the returned lead portion. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. 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 concluded that no abnormal performance or any other type of adverse condition was found. The device performed according to functional specifications.
 
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.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

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« Reply #645 on: January 10, 2019, 01:19:32 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 #646 on: January 10, 2019, 01:20:19 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 #647 on: January 10, 2019, 01:21:07 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 #648 on: January 11, 2019, 01:52:54 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 #649 on: January 11, 2019, 01:54:06 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 #650 on: January 11, 2019, 01:55:09 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 #651 on: January 11, 2019, 01:56:06 AM »

Model Number 102R
Event Date 03/14/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s office visit on (b)(6) 2014. The notes indicate that the patient was having seizures occasionally. The patient¿s infection had cleared but the patient has not been re-implanted to date.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 the generator was unable to be replaced due to a generator site/pocket condition. It was reported that when the surgeon removed the previous generator to replace it, puss was discovered in the generator pocket. It was reported that cultures were positive. A portion of the lead was also explanted (leaving electrodes). Antibiotics were administered and the patient will return at a later date for reimplant. No reimplant has occurred to date. It was reported that a port was placed to drain the infection site which was removed two weeks post-op. At that time, the patient had no draining and was reported to have improved. It was reported that the patient does not have a past medical history of infections and no medication changes were made that could cause or contribute to the infection. The infection was at the generator site and the infection was noted to not be related to vns therapy. The generator and lead were returned for analysis. Analysis of the generator and lead are underway, but have not been completed to date.
 
Event Description
Analysis of the generator and lead was completed. The generator was at end of service which 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. The returned lead portion has dried remnants of what appear to have once been body fluids inside outer and inner silicone tubes, throughout. 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaint. 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 manufacturing records were removed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

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« Reply #652 on: January 11, 2019, 01:56:59 AM »

Model Number 302-20
Event Date 03/26/2014
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014, the surgeon noted fluid in the patient¿s lead so he replaced it during the procedure. No patient manipulation or trauma was reported to have occurred. The last known diagnostics from (b)(6) 2014 were within normal limits. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. During the visual analysis of the returned lead portion, several abraded openings were observed on the outer silicone tubing. The abraded openings found on the outer silicone tubing, and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since the (+) white electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #653 on: January 11, 2019, 01:57:48 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 #654 on: January 11, 2019, 01:58:35 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 #655 on: January 11, 2019, 01:59:31 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3771292
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« Reply #656 on: January 11, 2019, 02:00:20 AM »

Model Number 302-20
Event Date 04/01/2014
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.
 
Event Description
It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014. Pre-operative diagnostic results showed lead impedance within normal limits (dc dc ¿ 1). During the procedure, the surgeon noted that the lead¿s silicone coating began to detach from the lead when the lead pin was disconnected from the generator header. The patient¿s new generator and existing lead were tested and diagnostic results showed low lead impedance. The surgeon was eventually able to obtain diagnostic results indicating lead impedance within normal limits and the surgery was completed. During an office visit with his neurologist on (b)(6) 2014, the patient¿s device was tested and diagnostic results revealed low impedance (impedance value < 600 ohms). The patient stated that she did not feel any stimulation. The neurologist elected to keep the patient¿s device programmed on. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. The patient underwent lead replacement surgery on (b)(6) 2014 due to low impedance. The explanting facility will not return the explanted device to the manufacturer for analysis; therefore, no analysis can be performed.
 
Event Description
An implant card was received confirming that the lead impedance was "ok" at the conclusion of lead replacement surgery on (b)(6) 2014.
 
Manufacturer Narrative
Lot#; corrected data: the initial mdr provided the wrong lot # for the suspect device. Device manufacture date; corrected data: the initial mdr provided the wrong manufacture date for the suspect device.

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« Reply #657 on: January 11, 2019, 11:35:18 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 #658 on: January 11, 2019, 11:36:24 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 #659 on: January 11, 2019, 11:37:29 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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