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dennis100
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« Reply #420 on: November 14, 2018, 08:17:41 AM »

Model Number 302-20
Event Date 11/28/2012
Event Type  Malfunction   
Event Description
On (b)(4) 2013 the nurse reported that she had just seen the patient and high impedance and a low output current were observed. It was stated that the patient recently had an injury where he fell on his back and the nurse believes this was the cause of the high impedance. The date of the injury was unknown to the nurse. The patient's device was disabled and he was sent to get x-rays taken. The nurse said that the patient was last seen on (b)(6) 2012 and interrogation showed everything was ok. The patient went in for a full revision surgery on (b)(6) 2013. Diagnostics were performed during surgery which showed the device was ok. Diagnostics were again performed after the patient's head was positioned to the right, which showed it was ok with an impedance value of 967 ohms. When diagnostics were performed with the patient's head positioned to the left, high impedance was observed with a value of 6064 ohms. Both the generator and lead were returned on (b)(4) 2013. Product analysis of the generator indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The lead is pending product analysis. No additional information has been provided.

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.

Manufacturer Narrative
Event date, corrected data: initial mdr inadvertantly included the incorrect event date.

Event Description
A review of the decoder data for the generator indicates that the high impedance was first observed on (b)(6) 2012 16:46.

Event Description
Product analysis on the explanted lead was performed. Setscrew marks were observed on the connector pin. The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead. A half set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. The positive connector ring inter-face backfill appeared to be partially detached. Slice marks were observed on the connector pin and connector ring inner silicone tubes, past the electrode bifurcation. The marks penetrated the insulation and some of the coil strands appeared to be cut in half, in some areas. During the visual analysis the positive connector ring quadfilar coil appeared to be broken approximately 1mm from the end of the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the positive connector ring quadfilar coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy (sem) was performed on the electrode (mating) end of the positive connector ring quadfilar coil break and identified the area as having evidence of a stress induced fracture with mechanical damage and pitting. Determination could not conclusively be made on the fracture mechanism. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity 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 portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portion of the device. Note that since the positive white and negative green electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Note that the (+) white and (-) green electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950033
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dennis100
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« Reply #421 on: November 14, 2018, 08:20:01 AM »

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

Manufacturer Narrative

Event Description
Additional information was received that the product analysis was completed on the lead. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) marked quadfilar coil appeared to be broken approximately 69mm and 73mm from the connector bifurcation and at approximately 10mm from the electrode bifurcation with three broken coil strands at approximately 9mm. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil breaks (found at 69mm and 73mm) and identified the areas as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 10mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. The area on the three broken coil strands was identified as being mechanically damaged. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portion of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
Additional information was received that there was no reported manipulation or trauma. X-rays will not be sent to the manufacturer for review. On diagnostics the dcdc code was 7. Product analysis was completed on the generator but has not been completed on the lead. The generator performed according to functional specifications. During product analysis there were no anomalies found with the pulse generator.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2955719
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dennis100
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« Reply #422 on: November 15, 2018, 07:59:54 AM »

Model Number 300-20
Event Date 01/07/2013
Event Type  Malfunction   
Event Description
Product analysis on the vns lead and generator was performed. 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 portion confirmed a discontinuity of the negative coil. Pitting and residual material were also observed on the coil surface of the vns lead.

Event Description
On (b)(4) 2013 the explanted lead and the other explanted vns generator were returned to the manufacturer for product analysis. An implant card was received indicating that the lead was replaced on (b)(6) 2013 due to lead discontinuity.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury. Corrected data: follow-up report #3 inadvertently listed wrong results and conclusion codes additional manufacturer narrative, corrected data: follow-up report #3 inadvertently stated that analysis did not reveal any anomalies.

Manufacturer Narrative

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient had the vns generator m102r and lead 300-20 replaced on (b)(6) 2013. Additional information revealed that the patient experienced no trauma and there were no manipulation to the vns lead suspected. The generator was turned off after the surgery and the new implanted generator was turned back on (b)(6) 2013. The m101 generator was returned to the manufacturer. Product return for the explanted product is in progress. Analysis of the vns generator m101 in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

Event Description
Reporter indicated a patient was to have a prophylactic vns generator replacement surgery, but during a pre-operative vns diagnostics test high lead impedance was noted. The surgeon opted to move forward with the vns generator replacement since he thought it could resolve the issue, but it did not and high lead impedance was still noted after the resident lead was inserted into the new generator. As the high lead impedance did not resolve after reinserting the lead into the new generator, a lead pin issue has been ruled out, and a lead fracture is more likely the cause of the high lead impedance. The new generator was then turned on to previous settings by the surgeon, despite the manufacturer's recommendation to disable the vns generator when high impedance is noted. The explanted vns generator was returned back to the manufacturer on (b)(4) 2013 and is pending analysis. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2942427
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dennis100
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« Reply #423 on: November 17, 2018, 04:27:39 AM »

Model Number 304-20
Event Date 01/02/2013
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death.

Event Description
On (b)(4) 2013 it was reported that during normal mode diagnostic testing, high impedance was observed. During a normal mode diagnostics test on (b)(6) 2013, high impedance was observed with an impedance value of 9800 ohms. Repeat testing two times came in at 3800 ohms and 3900 ohms, which is unchanged and in the normal range for the patient. The pulse frequency was increased from 10 to 20 hz without any obvious side effects. High impedance was again seen on (b)(6) 2013. It was reported that no trauma had occurred, however the physician believed that patient manipulation may have occurred, but this was not confirmed. The device was disabled on (b)(6) 2013 and the patient was scheduled for revision surgery. Prior to the revision surgery the physician plans to check the lead pin insertion and then perform a full revision if the high impedance issue was not resolved. Additionally, the physician has decided against taking x-rays as surgical intervention has already been planned. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(4) 2013 it was reported that the patient had undergone a lead replacement due to ¿spiraling¿ and maybe some ¿manipulation¿. The generator was not replaced. The manufacturer¿s consultant stated that during surgery two system diagnostics tests were performed prior to surgery and they found high lead impedance with an impedance value of greater than 8,000 ohms. Upon opening the generator pocket, it was found that his generator had broken loose from its 3. 0 prolene anchor and this had caused the generator to spin several times in the pocket which is what was believed to have led to the lead break. The surgeon was not convinced it was due to patient manipulation or if it may have happened when the patient is sleeping and moving in his sleep. However, ti was clear that the generator had spun several times in the pocket. The patient was noted to weigh (b)(6) and does not have much in the line of body fat to help protect the generator from manipulation. The spun wires could be seen in the lead wire. The generator appeared to be functioning properly upon implant of a new lead. System diagnostics with the new lead showed results within normal limits (1550 ohms range). Product analysis on the lead was completed on (b)(4) 2013. Scanning electron microscopy images of the connector pin show that pitting or electro-etching conditions have occurred at the areas where an opaque appearance was noted. The exact reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the end of the returned lead portion. 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 manufacturing records were reviewed. Review of manufacturing records confirmed device passed all functional tests prior to distribution.

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

Event Description
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3081120
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dennis100
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« Reply #424 on: November 24, 2018, 04:36:57 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected and is suspected to have contributed to the patient's increased.

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

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

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

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

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

Event Description
Product analysis of the generator showed no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was also completed. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis an abraded opening was observed on the outer silicone tubing and both of the inner silicones were found to be abraded open in half; therefore determination could not be made between the (-) connector pin and (+) connector ring quadfilar coils past this point. These coils were identified as quadfilar coil 1 and quadfilar coil 2. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 239mm, 242mm and 245mm from the end of the connector boot. The (+) connector ring quadfilar coil appeared to be broken approximately 240mm from the end of the connector boot. Scanning electron microscopy was performed and identified the coil break areas as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis quadfilar coil 1 appeared to be broken approximately 247mm from the end of the connector boot and quadfilar coil 2 appeared to be broken approximately 253mm from the end of the connector boot. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting on the quadfilar coil 1 coil break. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Review of the lead manufacturer history records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950000
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dennis100
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« Reply #425 on: November 26, 2018, 04:31:28 AM »

Model Number 302-20
Event Date 01/15/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient was having a vns full revision for an unknown reason. Information was received that the reason for the revision was due to battery depletion, but no reason for the lead revision was given. The patient had a full revision on (b)(6) 2013 and the products were returned to the manufacturer on (b)(6) 2013 for product analysis. Product analysis was conducted on the lead and a coil break was found in the positive and negative portions of the lead along with corrosion. There was no performance issues found with the vns generator. Attempts to contact the physician have been unsuccessful to date. The device history report for the lead was reviewed and no non conformances were found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3094049
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dennis100
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« Reply #426 on: December 01, 2018, 01:30:35 AM »

Model Number 300-20
Event Date 06/28/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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

Event Description
A break was identified in the positive and the negative lead coils. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the end of coil. Due to metal dissolution the fracture mechanism cannot be determined. Scanning electron microscopy images of the negative coil show that a stress-induced fracture (fatigue) has occurred in at least three strands of the quadfilar coil. Scanning electron microscopy images of coil 1 show that pitting or electro-etching conditions have occurred at the end of coil. However, due to pitting or metal dissolution and mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Scanning electron microscopy verified that secondary fractures exited in the vicinity of the broken end. However, due to mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Scanning electron microscopy images of coil 2 show that a stress-induced fracture (fatigue) has occurred in at least two strands of the quadfilar coil. Also, the early stages of what appears to be a secondary fracture was identified in the vicinity of the broken strands. Note that since a portion of the lead (including the lead¿s electrodes) were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations typical wear and explant related observation, no other anomalies were identified in the returned lead portions.

Event Description
On (b)(4) 2013 it was reported that the patient underwent battery replacement surgery due to the generator being at end of service and upon reconnecting the lead to a new generator, high lead impedance was observed. The issue was not corrected during surgery and the patient was closed up and sent to recovery. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Operative notes from the patient¿s surgery indicated that after the high impedance was observed, the surgeon explored the lead and isolated the electrodes and found that they had actually broken as there was ¿some plastic sheathing in the pocket¿. The surgeon stated that it was very clear that this was an old phenomena and that it may have happened after the generator replacement in 2007. It was stated that there were no diagnostics from prior to the generator being at end of service as the latest neurologist who was treating the patient never performed them. No x-rays will be performed as the surgeon physically observed the lead break during surgery. The surgeon does not believe patient manipulation or trauma caused the lead break. The patient¿s generator was left disabled during surgery due to the high impedance. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(6) 2013, an implant card was received indicating the patient had the vns lead replacement on (b)(6) 2013, due to a lead discontinuity. Product analysis of the explanted generator (from the surgery when the high impedance was initially discovered) due to end of service was performed. It was verified that the end of service condition was the result of normal battery depletion. The depletion was an expected event as determined by battery life calculation 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. On (b)(6) 2013, both the new generator and lead were replaced. The explanted devices were returned for product analysis. Product analysis of the returned generator found that the device performed according to functional specifications. Analysis in the lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3239093
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« Reply #427 on: December 02, 2018, 01:36:55 AM »

Model Number 302
Event Date 06/20/2013
Event Type  Malfunction   
Event Description
Generator and lead were received for analysis on (b)(4) 2013. Analysis of the generator was completed on (b)(4) 2013. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the lead is underway, but has not been completed to date.

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

Event Description
An analysis was performed on the returned lead portions and the reported high impedance and lead fracture were confirmed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 335mm portion the (-) connector pin and (+) connector ring quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 270mm) and identified the area on one of the broken quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting on the coil surface. The area on another broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 284mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, fine pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings and slice marks found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, zirconium, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
On (b)(6) 2013 it was reported that the vns patient¿s device had a lead fracture. A battery life calculation was performed with the available data. The result revealed 0. 0 years remaining until end of service = yes. The manufacturing records for the generator and lead were reviewed and device met all specifications prior to distribution. It was later reported that the lead fracture was identified on (b)(6) 2013 by x-ray. The patient was previously seen in 2012 and no lead impedance issues were noted. No patient manipulation or trauma occurred that is believed to have caused or contributed to the lead fracture. Lead and generator were replaced on (b)(6) 2013. Attempts for return of the explanted devices are in progress.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3231930
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« Reply #428 on: December 02, 2018, 01:38:10 AM »

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

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

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

Event Description
An analysis was performed on the returned lead portion. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 252 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis the end of the (+) connector ring quadfilar coil appeared to be broken approximately 29 mm past the end of the abraded open / cut outer silicone tubing. The (-) connector pin quadfilar coil extended approximately 192 mm past the end of the abraded open / cut outer silicone tubing and determination could not be made as to whether the end of the coil was pulled and cut. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 29 mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil (found at 192 mm) and identified the area on two of the coil strands as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism on these two coil strands. The area on a third coil strand was identified as having evidence of a stress induced fracture (tension overload). The fourth quadfilar coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded opening observed on the connector ring inner silicone tubing. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium and sulphur. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portion of the device. The pulse generator was explanted and returned for product analysis due to prophylactic replacement. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 942 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a-non ifi condition. The data in the diagaccumconsumed memory locations revealed that 21. 081% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

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

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« Reply #429 on: December 07, 2018, 08:44:08 AM »

Model Number 303-20
Device Problems Corroded ; High impedance; Mechanical Problem
Event Date 05/15/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient underwent generator and lead explant surgery due to lack of efficacy. The devices were returned for analysis. In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In the lead assembly returned for analysis, an abraded opening was noted on the silicone tubing resulting in portion of the positive coil being exposed. Scanning electron microscopy images of the connector pin and connector ring show that pitting or electro-etching condition have occurred on both the connector pin and connector ring exposed surfaces. An energy dispersive spectrometry analysis was performed on a sample of the deposits observed on the pin. The analysis showed the presence of elements present in stainless steel 316. The higher percentage of iron in this sample suggests oxidation may have occurred. Though it is difficult to state conclusively the observed condition of the connector pin mentioned above may confirm this to be a contributing factor for the reported ¿high impedance¿ allegation. 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. Internal investigation determined that in the event that the lead becomes compromised through wear or trauma (e. G. An abraded opening in the lead¿s silicone tubing), a charge imbalance may form at this location as a result of the alternate current pathway associated with the original model 105 generator design (e. G. Sn<20000). As a result of this charge imbalance and the low pitting potential of quadfilar coil, coil corrosion can occur resulting in a lead discontinuity.

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« Reply #430 on: December 12, 2018, 01:44:58 AM »

Model Number 302-30
Event Date 07/04/2013
Event Type  Malfunction   
Event Description
It was reported that the patient¿s generator and lead were extruding out of the patient (reported in medwatch 1644487-2013-02101). The day before explant, the lead and generator that were outside of the body broke off "like a stick" from corrosion. The lead was cut at the base of the electrode coils and the electrodes were left on the nerve, with heavy duty antibiotic rinses run and continuing on antibiotics after explant. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution. This medwatch serves to report the lead break. This information was reported in medwatch 1644487-2013-02101 within 30 days of the new information being received.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution. Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #431 on: December 13, 2018, 04:10:31 AM »

Model Number 300-20
Event Date 08/16/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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

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« Reply #432 on: December 14, 2018, 06:05:58 AM »

Model Number 302-20
Event Date 08/09/2013
Event Type  Malfunction   
Event Description
Follow up with the physician found that they will not provide access to the vns programming system to get a copy of the patient's vns programming history. It was reported that the programming system was working and there were no suspected issues with it. No x-rays were taken or planned to be taken. Product analysis was performed on the explanted lead and verified 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. Appearance of the negative coil suggests a stress-induced fracture has occurred in at least three strands of the quadfilar coil. A conclusive determination of the fracture mechanism on one strand of the quadfilar coil cannot be made due to mechanical distortion (smoothed surfaces). Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative
Describe event or problem, corrected data: the supplemental 1 report did not include information regarding the abarded opening in the inner and outer tubing. The information has been included in this report.

Event Description
A review generators memory data extracted from available patient programming history revealed that a large increase (>25%) in system impedance occurred between (b)(6) 2011 (i. E. 1636 ohms to 4285 ohms), which may signify the onset of the stress inducted fracture observed during an analysis of the patient¿s explanted lead. Additionally, silicone tubing abrasion, which penetrated the inner and outer tubing, were observed on lead body as well as remnants of what appeared to be dry body fluids within these areas.

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

Event Description
On (b)(6) 2013, it was reported that the patient was receiving a battery replacement due to end of service. After the battery was removed and a new one connected, diagnostics were performed which showed high impedance. The surgeon made several attempts to remove and reinsert the lead pin to verify it wasn't a lead pin issue. He also made sure that the hex screwdriver was fully inserted when connecting the device; however, diagnostics still showed high impedance. The surgeon elected to replace the lead. Additional information was received that the patient is highly active and frequently agitated, with profound mental retardation. There was no specific manipulation or trauma known related to the high lead impedance. The surgeon examined the lead placement while performing the explant and observed that proper strain relief was present and the electrodes were in correct position. There was no excessive scarring on the vagus nerve noted. Diagnostics performed with the new lead and generator showed no more high lead impedance. Review of the lead and generator device history records confirmed all quality tests were passed prior to distribution. The explanted devices were returned to the manufacturer. Product analysis of the generator indicates high impedance of 8695 ohms (previous recorded impedance value of 6404 ohms) occurred on (b)(6) 2012. Confirmed a battery voltage issue; known electrical design operation caused by a high electrical demand on the circuit requiring >10. 5 output volts; also confirmed a component (c4 - ceramic chip capacitor) that was measured to be out-specification, which could be related to drift; also confirmed an output pulse disabled condition due to a perceived low battery voltage; may be related to high energy exposure during explant process. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. An end-of-service warning message was verified in the pa lab and found to be associated with the pulsedisabled by the pulse generator. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 994 volts, verifying an eos condition. The data in the diagaccumconsumed memory locations revealed that 70. 854% of the battery had been consumed. With the exception for capacitor c4 out of specification, the post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. This is not expected to have an adverse effect on battery longevity. The cause for the out of specification capacitor, c4, (v cpu) value is likely associated with component aging.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #433 on: December 15, 2018, 01:50:19 AM »

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

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

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

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

Manufacturer Narrative
(b)(4).

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

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« Reply #434 on: December 16, 2018, 03:46:36 AM »

Model Number 300-20
Event Date 09/17/2013
Event Type  Malfunction   
Event Description
During generator replacement surgery for end of service it was noted that high impedance was found after attaching a new generator to the existing lead. The lead was then also explanted and a new vns system was implanted. The lead was returned for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 44 mm portion quadfilar coil 1 appeared to be broken approximately 23 mm from the electrode bifurcation. Scanning electron microscopy was performed on the quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting. The remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. The generator decoder found that the high impedance was first observed on (b)(6) 2013 which is the date of explant. Analysis of the generator was reported in mfr. Report # 1644487-2013-03234.

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

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« Reply #435 on: December 16, 2018, 03:47:35 AM »

Model Number 300-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
It was reported that during lead replacement surgery device diagnostic testing resulted in high impedance (>= 10,000 ohms) prior to removing the generator from the lead. The generator was disconnected from the lead and generator diagnostics were within normal limits. The surgeon then replaced the lead and generator. A new system was implanted. The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. The lead analysis was completed on (b)(4) 2013. During the visual analysis of the returned 203 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm from the end of the connector bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening, slice mark and cut out hole found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of explanted due to lead break/high impedance. The generator analysis was completed on (b)(4) 2013. Visual examination performed at the bench revealed scratches on the generator can and header most likely associated with manipulation of the device during the explant procedure. Burn marks were also observed on the pulse generator can and header indicating that the pulse generator may have been exposed to an electro-cautery tool. No other surface abnormalities were noted on this device. The generator is operating within specification. The generator was returned due no malfunction suspected/identified. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #436 on: December 21, 2018, 09:18:04 AM »

Type of Device:                    STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Device Brand Name:             Demipulse
Device Manufacturer's           Cyberonics, Inc.
Name:
Date of this Report:              08/18/2015
(mm/dd/yyyy)
Describe the Event               The patient complained that the device was "shocking" her. Implantation date
or Problem:                         is unknown. Per surgeon's note, there was corrosion on the inside of the lead
                                          of the Vagus Nerve Stimulator.
the device(s) may have
caused or contributed to:      Potential for patient harm

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« Reply #437 on: December 24, 2018, 08:15:25 AM »

Model Number 303-20
Event Date 10/01/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the patient's vns leads were replaced due to high lead impedance. The high lead impedance was first observed on (b)(6) 2013. The patient came in with a generator that was dead and could not be interrogated pre-op. The device was not programmed off after the high impedance was observed. It was unknown if patient manipulation or trauma occurred that may have caused or contributed to the event. The old generator was placed over the scapula and the patient would complain would bang against her clavicle. A lead fracture was observed during surgery on (b)(6) 2013. When the new generator was connected to the old lead, a persistent high impedance was present on multiple tests. X-rays were not taken prior to surgery. The explanted lead was returned to the manufacturer and product analysis was performed. 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 broken coil strands were observed on the (+) connector ring tri-filar coil approximately 260mm-261mm from the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. During the visual analysis the (-) connector pin tri-filar coil appeared to be broken approximately 286mm from the connector boot. 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 fine pitting. The area on the remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis the (+) connector ring tri-filar coil appeared to be broken approximately 329mm from the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (torsional appearance) with mechanical damage and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening, tool / slice 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. 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Note that a break of a few strands would still allow current flow through that portion of the lead. This observation is supported by results of electrical measurements which verified continuity between the ends of this lead section. Note that since the electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Review of the lead device history records confirmed all quality tests were passed prior to distribution. Device was reworked to extend expiration date.

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

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« Reply #438 on: December 24, 2018, 08:16:53 AM »

Model Number 304-20
Event Date 11/18/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, high impedance was observed on the patient's implanted vns device. The device was not disabled at the visit. X-rays were ordered. Attempts are being made for additional information; however, no additional information has been received.

Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Analysis of the returned generator and lead was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead identified two breaks in the negative coil. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils. An abraded/torn opening was noted in the inner tubing of the negative coil at the break location. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break locations and at the discolored portion of the coil. Also, the negative coil has what appears to be wear (flat surfaces) in the vicinity of the break. However, due to metal dissolution and surface contamination the fracture mechanism cannot be ascertained. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead assembly.

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

Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

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« Reply #439 on: December 29, 2018, 03:57:27 AM »

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

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« Reply #440 on: December 29, 2018, 03:58:22 AM »

Model Number 300-20
Event Date 11/06/2013
Event Type  Malfunction   
Event Description
Analysis of the generator was completed on (b)(4) 2013. The device performed according to functional specification. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on (b)(4) 2013. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 309mm portion the unmarked connector pin quadfilar coil appeared to be broken approximately 87mm and 98mm from the connector bifurcation. Scanning electron microscopy was performed on the (-) unmarked connector pin quadfilar coil break (and identified the areas as having evidence of being worn to the point of fracture with flat spots, pitting and residual material on the coil surface. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, iron, aluminum, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
It was reported that the patient underwent generator and lead replacement due to high impedance. It was reported that the generator was programmed off after observing the high impedance. It is unknown if any trauma or patient manipulation occurred that could have caused or contributed to the high impedance. X-rays were not taken. The generator and lead were received by device manufacturer for analysis on 11/21/2013. Analysis is underway, but has not been completed to date. The implant card was received and indicated that the lead was replaced due to a lead break.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #441 on: December 30, 2018, 05:27:29 AM »

Model Number 302-20
Event Date 12/23/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was previously reported that the vns patient was experiencing an increase in seizures and an increase in depression. The patient's device had reportedly been at end of service for some time. Analysis of the returned generator and lead was completed. The end of service condition 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. During the visual analysis of the returned 240mm lead portion, quadfilar coil 1 appeared to be broken approximately 2mm from the end of the abraded open / cut / outer silicone tubing. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strands was 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. 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 and the abraded opening observed on one of the 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. 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 in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Diagnostics performed during the patient's vns generator replacement surgery (due to end of service) found high impedance. Diagnostics could not be performed prior to the surgery, as the vns battery was depleted. After replacement with the new generator, diagnostics performed showed an impedance value of greater than 10,000 ohms. The lead pin was re-inserted into the generator multiple times; however, this did not resolve the high impedance. The lead was replaced and final diagnostics showed normal impedance at a value of 2,315 ohms. Attempts were made for additional information; however, they were unsuccessful. No other information was provided.
 
Event Description
It was reported that the generator and lead were ready to be returned for analysis. The devices were returned to manufacturer on 04/11/2014. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death. Adverse event and/or product problem, corrected data: the initial manufacturer report inadvertently did not include that the report was also an adverse event. Outcomes attributed to adverse event, corrected data: the initial manufacturer report inadvertently did not include the outcomes attributed to the adverse event. Relevant tests/laboratory data, corrected data: the initial manufacturer report inadvertently did not include information regarding the patient¿s increase in seizures and depression.

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« Reply #442 on: December 30, 2018, 05:28:49 AM »

Model Number 302-20
Event Date 12/19/2013
Event Type  Malfunction   
Event Description
The patient underwent generator and lead replacement. The lead and generator were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Analysis of the generator was completed on 01/16/2015. 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 01/25/2015. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 408mm portion the (-) connector pin and the (+) connector ring quadfilar coils appeared to be broken approximately 325mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end of the (-) connector pin quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands. Scanning electron microscopy was performed on the electrode (mating) end of the (-) connector pin quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type. Pitting was observed on three of the broken coil strands. Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of the broken coils strands. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 325mm) 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, residual material and no pitting. During the visual analysis of the returned 408mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 334mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end and electrode (mating) end of the (+) connector ring quadfilar coil break (found at 334mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. What appeared to be melting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. What appeared to be residual material was observed in various locations. 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. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
High lead impedance was observed during a follow-up appointment for the patient on (b)(6) 2013. The physician performed system diagnostics several times at different angles. Two of the diagnostics showed normal results; however, after this the rest of the diagnostics showed high lead impedance. The vns device was disabled (programmed off to 0ma). The physician plans to proceed with a "wait-and-see" approach. Ap and lateral chest and neck x-rays were sent to the manufacturer for review. Based on the images provided, the generator appears to be placed in a normal orientation in the left chest. It appears that the lead pin is fully inserted into the connector block. The filter feed-thru wires appear to be intact. The lead wires appear to be intact at the connector pin, and a portion of the lead wire appears to be located behind the generator so it could not be assessed. The electrodes were visualized in the neck and appear in the proper orientation. There appears to be a strain relief bend present, but no strain relief loop appears to be present. There appears to be 3 tie-downs present. The first two tie-downs appear to be placed per labeling as they are placed parallel to the electrodes. The third tie-down does not appear to be placed per labeling given a lack of a strain relief loop. There does not appear to be any gross discontinuities or sharp angles in the lead. However, due to the image quality and the images provided, the entire lead body and generator could not be fully assessed. Follow up with the physician found that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance event. The patient has returned to his country where he will consult with another physician on replacement of the device. Surgery is likely, but has not occurred to date. No other information has been provided.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #443 on: December 30, 2018, 05:29:44 AM »

Model Number 302-20
Event Date 12/18/2013
Event Type  Malfunction   
Event Description
It was reported that device diagnostics on the physician's handheld showed high impedance. It is unknown if the device was programmed off after observing the high impedance reading. It is unknown if x-rays were taken or if any patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance reading. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
It was reported that the device has been programmed off, and there are no plans to replace vns at this time.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator were received. Analysis has not been approved to date.
 
Event Description
Analysis of the generator and lead were approved. There was evidence of high impedance in the generator memory. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device output signal was monitored, and the pulse generator showed no signs of variation in the output signal and demonstrated 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. The battery, 2. 938 volts as measured, showed an ifi=no condition. The data in memory locations revealed that 51. 929% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Scanning electron microscopy images of the negative coil of the lead showed that pitting or electro-etching conditions occurred on the discolored surfaces of the negative coil wires. Also, one strand of the negative quadfilar coil showed appearance of what appeared to be wear (flat surfaces) and scratches on the surface. The reason for this condition was unknown. Although difficult to state conclusively, the most likely cause for the observed electro-etching condition was a pulse generator attempting to deliver therapy through an exposed coil and/or an open electrical load. However, no openings were noted on the outer or the inner silicone tubing of the lead coils of the returned lead portion of the lead. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
The patient was referred for explant surgery because of the high impedance. The patient had explant surgery on (b)(6) 2016. The explanted product has not been received to date.

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« Reply #444 on: January 02, 2019, 02:16:25 AM »

Model Number 300-20
Event Date 09/01/2013
Event Type  Malfunction   
Event Description
The physician reported that the patient may have an issue with the device, but no additional details were provided. It was later reported that the patient will be referred to surgeon for possible revision because the device showed high impedance and end of service. The patient underwent generator and lead replacement on (b)(6) 2013. The lead and generator were returned to manufacturer for analysis. An implant card was received indicating that the patient underwent lead and generator replacement due to "lead discontinuity". Analysis of the generator was completed on (b)(6) 2013. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on (b)(6) 2013. Note that a portion of the lead assembly was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 344 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm and 3 mm from the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 2 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 3 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and (-) unmarked inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the remnants of what appeared to have once been body fluids found inside the outer and (-) unmarked inner silicone tubing. For the observed (+) marked connector pin inner tubing remnants of what appeared to have once been body fluids found inside, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, zirconium, sulphur and calcium. Refer to attached eds sheet for additional information. The slice and puncture marks observed on the inner silicone tubes (past the electrode bifurcation) appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurre, but did not cause or contribute to a death or serious injury.

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« Reply #445 on: January 03, 2019, 08:25:03 AM »

Model Number 302-20
Event Date 01/24/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the returned lead portion was completed. During the visual analysis the positive connector ring quadfilar coil appeared to be broken approximately 20mm from the electrode bifurcation and the negative connector pin quadfilar coil appeared to be broken at approximately 22mm. Scanning electron microscopy was performed on the positive connector ring quadfilar coil break (found at 20mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on the negative connector pin quadfilar coil break (found at 22mm) and identified the area on two of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, fine pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture on one of the broken coil strands. The areas on the remaining broken quadfilar coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type with fine pitting and residual material. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.
 
Event Description
On (b)(6) 2014 it was reported that the patient underwent a full revision surgery that day due to high lead impedance (impedance of > 10,000ohms) and prophylactic generator replacement. The lead was found completely severed. It was stated that the high impedance was first noticed that day during surgery. No manipulation or trauma was believed to have caused or contribute to the impedance or severed lead. The explanted lead and generator were returned for product analysis. Product analysis on the generator was completed and no abnormal performance or any other type of adverse condition was found. Product analysis on the leads is still underway.

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« Reply #446 on: January 03, 2019, 08:25:51 AM »

Model Number 304-20
Event Date 12/16/2013
Event Type  Malfunction   
Event Description
It was reported that the device was not programmed off after observing the high impedance. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Analysis of the lead was completed on (b)(4) 2014. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil broken ends show that pitting or electro-etching conditions have occurred at the break location. Due to metal dissolution the fracture mechanism cannot be determined. Also, images performed at the vicinity of the discolored region show that pitting or electro-etching conditions have occurred at the discolored area. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that during implant surgery in (b)(6) 2012 a lot of scar tissue was noted. The patient underwent lead replacement. During the surgery the device was interrogated and high impedance was obtained. The lead pin was removed from the generator and then reinserted. System diagnostics again resulted in high impedance. It was reported that the lead was replaced. It was found that the lead was fractured at the bifurcation. The generator was left programmed off after the surgery. The lead was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date. Attempts to obtain additional information have been unsuccessful to date.

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« Reply #447 on: January 05, 2019, 01:20:36 AM »

Model Number 300-20
Device Problem Corroded
Event Date 11/08/2018
Event Type  Malfunction   
Event Description
The patient's lead was explanted and returned for analysis. The lead was returned in one section. There were set screw marks on the connector pin which showed that at one point in time proper contact existed. There was pitting (corrosion) noted in the vicinity of the set screw marks.
 
Manufacturer Narrative
(b)(4).

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« Reply #448 on: January 05, 2019, 01:21:31 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.

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« Reply #449 on: January 07, 2019, 02:10:54 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.

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