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Author Topic: Corrosion/Disintegration  (Read 58971 times)
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dennis100
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« Reply #510 on: January 27, 2019, 05:07:28 AM »

Model Number 103
Event Date 07/02/2014
Event Type  Malfunction   
Event Description
Initially, it was reported that high impedance was observed and the patient was experiencing an increase in seizures. It was reported that the patient had recently suffered a fall during ice skating. The physician assistant believes the device was damaged during the fall. X-rays were taken and sent to manufacturer for review. X-rays identified that the lead pin did not appear to be fully inserted into the generator header. The patient underwent surgery. The surgeon opened the chest pocket to check the connection and when the generator was removed the lead pin fell out of the header confirming a generator/lead connection issue. The surgeon implanted a new generator and lead. The explanted lead and generator were received for analysis. Analysis of the lead was completed on (b)(4) 2015. During the visual analysis of the returned 289mm portion what appeared to be rust-like deposits and pitting were observed on the connector pin surface. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the connector pin. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the connector pin rust-like deposit and identified the area as consisting of chromium, iron, nickel, silicone and phosphorus. Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, nickel, sodium, manganese, silicone and sulphur. A definite cause for the pitting could not be determined based on the lead portion returned. 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 at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Analysis of the generator was completed on (b)(4) 2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no additional performance or any other type of adverse conditions found with the pulse generator. The generator decoder identified that the high impedance occurred prior to (b)(6) 2014.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4576543
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dennis100
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« Reply #511 on: January 28, 2019, 05:04:05 AM »

Model Number 302-20
Event Date 08/21/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Analysis of the lead was completed on 09/22/2014. Multiple breaks were confirmed in the negative coil of the returned lead portions. Mfr. Report # 1644487-2014-02711 will house the lead analysis. Analysis of the generator was completed on 09/25/2014. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Event Description
Based on the information available to date, the reported left scapular abscess appears to be the result of lead dissolution: when a lead fracture occurs and a small length of the lead is exposed to extracellular fluid, the broken end of the lead acts as the electrode. The current delivered by the pulse generator is conducted through the very small surface area of the fractured lead. The result of this event is the pitting at the broken end of the coil wire. Adverse events associated with this event can include infection-like symptoms including inflammation, pain, or edema of abscess. The adverse events reported here appear to be the result of the lead malfunction reported in mfr report #1644487-2014-02711.
 
Event Description
It was reported that the patient underwent an incision and drainage of a left scapular abcess and complete removal of the vns system. Both lead and generator were explanted. The explanted devices were returned for analysis. Analysis is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.

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dennis100
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« Reply #512 on: January 28, 2019, 05:04:52 AM »

Model Number 302-30
Event Date 08/14/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The generator and lead were received for analysis. Generator analysis was completed on 12/08/2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Event Description
Analysis of the lead was completed on 12/11/2014. 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 2. 5mm from the electrode bifurcation (and the coil appeared to be kinked). The (+) connector ring quadfilar coil appeared to be broken approximately 3mm from the electrode bifurcation. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 2. 5mm) and identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and 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 3mm) 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 opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2014 note that interrogation of the device showed high impedance and was verified with a second interrogation. The patient was referred for surgery. No known surgical intervention has been performed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4106898
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dennis100
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« Reply #513 on: January 28, 2019, 05:05:42 AM »

Model Number 302-20
Event Date 08/27/2014
Event Type  Malfunction   
Manufacturer Narrative
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. There were no performance or any other type of adverse conditions found with the pulse generator. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on the date of explant, where the impedance value changed from a normal limits range to high lead impedance. Prior to this change, lead impedance was within normal limits. Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in both the electrode and body regions. Abraded openings of both outer and inner tubing were observed near the break area. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results showed high impedance (impedance value ¿ 5571 ohms). The neurologist stated that the high impedance observation may be indicative of an issue with the lead or fibrosis. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Pitting was observed on the coil surface.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on 10/30/2014. The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on the date of replacement surgery, where the impedance value changed from a normal limits range to high lead impedance. Analysis of the lead is currently underway.
 
Manufacturer Narrative
Describe event or problem: corrected data: the previously submitted mdr inadvertently did not include information regarding the pitting that was observed during analysis of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4115707
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dennis100
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« Reply #514 on: January 29, 2019, 06:57:08 AM »

Model Number 302-20
Event Date 06/11/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results were ¿abnormal¿ indicating a potential lead fracture. The patient refused to have her device disabled. It was noted that there was no change in the patient¿s seizure frequency. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(4) 2014. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin could not be confirmed to be fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received clarifying that the reported ¿abnormal¿ diagnostic results were referring to diagnostic results from (b)(6) 2014 which revealed high impedance (dcdc ¿ 7). The suspected cause of the high impedance condition of the patient¿s device is believed to be due to trauma experienced from the patient¿s seizure activity. The physician attributed that the patient¿s increase in seizures was due to the high impedance condition of the device. Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. The generator performed according to functional specifications. Analysis of the returned lead portions confirmed discontinuity of positive quadfilar coil in the electrode region. Scanning electron microscopy images of the positive coil broken ends show that pitting or electro-etching conditions have occurred at the break locations. The silicone tubing of the negative coil was found to be punctured open. 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 cut ends of the returned lead portions.
 
Event Description
An implant card was received noting that the patient underwent lead and generator replacement due to lead discontinuity and an increase in seizures. The explanted lead and generator were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4082477
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dennis100
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« Reply #515 on: January 29, 2019, 06:58:01 AM »

Model Number 302-20
Event Date 07/29/2014
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed on 10/14/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 10/29/2014. A break was identified in the positive coil. Scanning electron microscopy images suggest pitting or electro-etching conditions at the suspected broken end of the positive coil of the second portion of the returned lead. Due to metal dissolution the fracture mechanism cannot be determined. Scanning electron microscopy images of the suspected positive coil (mate end to the second portion) located at the 3rd portion of the returned lead indicate a stress-induced fracture (fatigue) in at least three strands of the quadfilar coil. Also, the coils wires have mechanical distortions (smoothed surfaces) in the vicinity of the break. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
It was reported that the patient underwent generator and lead replacement surgery. The generator was reported to be replaced prophylactically. It was reported that pre-operative system diagnostic resulted in high impedance (dc dc code - 7). Pre-operative device settings showed that the device had not been programmed off. The generator was replaced and device diagnostics again resulted in high impedance (>10,000 ohms). The lead was then replaced. Device diagnostics with the new vns system were within normal limits. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (dc dc ¿ 7). X-rays were not taken. The patient was referred for surgery but no known surgical interventions have occurred to date. The notes showed normal device diagnostic results through (b)(6) 2013.

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dennis100
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« Reply #516 on: January 30, 2019, 08:53:34 AM »

Model Number 302-20
Event Date 07/17/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead has been returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported that during generator replacement for battery depletion, high impedance was observed with the new generator attached to the existing lead. The patient was referred for lead replacement at a later time. An implant card was received indicating high impedance. The explanted generator for analysis. Analysis was completed on (b)(4) 2014. The device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no abnormal performance or any other type of adverse condition was found with the generator. The patient underwent lead replacement. It was reported that device diagnostics with the new lead and existing generator was within normal limits (1275 ohms). The explanted lead has not been received for analysis to date.
 
Event Description
Analysis of the returned lead portion was completed. During the visual analysis, the coil appeared to be broken 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. The slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4074618
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« Reply #517 on: January 30, 2019, 08:54:14 AM »

Model Number 302-20
Event Date 08/11/2014
Event Type  Malfunction   
Event Description
The explanted lead was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to near end of service and lead discontinuity. Follow-up revealed that the procedure was originally scheduled for only generator replacement due to near end of service. Diagnostic results showed lead impedance within normal limits prior to surgery and high impedance was first observed during the procedure. The surgeon elected the replace the patient¿s lead and stated that the explanted lead was kinked. The explanted generator and lead have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the returned lead portion was completed which confirmed discontinuity of negative quadfilar coil in the body region. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. Abraded openings were observed on both the outer and inner tubing near the break location. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils.

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dennis100
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« Reply #518 on: January 31, 2019, 01:44:16 AM »

Model Number 302-20
Event Date 09/24/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Event Description
Operative notes were received indicating that the vns patient¿s generator was tested with a test resistor and generator diagnostic results showed normal device function. Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. The generator performed according to functional specifications. Analysis of the returned lead portion confirmed discontinuity of both positive and negative quadfilar coils in the electrode region. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (dc dc -7). The patient¿s device was not disabled following the high impedance observation. X-rays were taken and reported by the physician to be unremarkable. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The generator was replaced prophylactically. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

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« Reply #519 on: January 31, 2019, 01:45:04 AM »

Model Number 302-20
Event Date 02/03/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and multiple system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently disabled. The patient¿s device was last tested on (b)(6) 2012 and system diagnostic results showed lead impedance within normal limits (impedance value ¿ 3225 ohms). X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin cannot be confirmed to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. A suspect area was identified distal to the positive electrode. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the patient underwent generator and lead replacement. Device diagnostics with he new vns system were within normal limits. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis of the generator did not confirm the reported battery depletion and revealed that the device had not reached the ifi point and just under 25% of the battery had been consumed. Review of the internal device information shows an indication of increased impedance consistent with the initial report. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead confirmed discontinuity of positive coil at two locations in the electrode region of the returned lead portions. Scanning electron microscopy images of the positive coil breaks show that pitting or electro-etching conditions have occurred at the break locations. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be ascertained. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead. Based on the appearance of the returned lead portions, it is believed that identified punctures, kinks, tubing cuts, were most likely caused during the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210668
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« Reply #520 on: January 31, 2019, 01:45:46 AM »

Model Number 302-20
Event Date 09/02/2014
Event Type  Malfunction   
Event Description
Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. The generator performed according to functional specifications. Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in the electrode region. Some of the broken coil strands was identified as having 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. The abraded opening found on the outer silicone tubing and the cut ends made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the patient moved states and has not been seen by a physician in 8 months. The patient reported that he feels a sensation in his chest area and is experiencing an increase in seizures. The patient was seen by a physician and device diagnostics resulted in high impedance (dc dc code - 7). The patient was referred to surgeon. The patient underwent generator and lead replacement (including electrodes). The explanted lead and generator were received for analysis. Analysis is underway, but has not been completed to date.

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« Reply #521 on: February 01, 2019, 11:22:05 AM »

Model Number 302-20
Event Date 06/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent lead replacement on (b)(6) 2015. Device diagnostics on the surgery date returned impedance within normal ranges (1440 ohms). Further information was received indicating that the outcome for the patient was satisfactory and that new device diagnostics returned impedance within normal ranges (2959 ohms). The explanted lead has not been returned to the manufacturer to date.
 
Event Description
The returned lead was analyzed. Visual analysis of the returned portion found that the positive connector ring quadfilar coil appeared to be broken approximately 1. 5mm from the electrode bifurcation. Scanning electron microscopy identified that the area was mechanically damaged, which prevented identification of the coil fracture type. Pitting was observed on the coil surface, which evidences that stimulation was present for a certain period of time. Low magnification scanning electron microscopy 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 and 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. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to patient death.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). X-rays were taken and sent to manufacturer for review. It was reported that the patient's increase in seizures was being managed by optimisation in medication. Radiology report indicated that no break in the lead was seen. Review of x-rays by manufacturer did not identify any suspected lead discontinuity. The lead pin appeared to be fully inserted into the generator header. The cause of the high impedance was unable to be determined based on the x-ray images received. It was reported that the device was programmed off after observing the high impedance. There was no patient manipulation or trauma that is believed to have caused or contributed to the high impedance. No known surgical intervention has occurred to date.
 
Event Description
It was reported that the lead became twisted and coiled during explant. The lead was received for analysis. Analysis is underway, but has not been completed to date.

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« Reply #522 on: February 01, 2019, 11:22:48 AM »

Model Number 300-20
Event Date 09/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient had high impedance at a recent appointment. The patient¿s generator was turned off and the patient was referred for surgery. The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 986 volts as measured shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 2. 444% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a large portion of the lead assembly (body) including the (+) white electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 91mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 238mm past the end of the cut / torn / connector silicone / inner silicone tubes. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity 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 and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum 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. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of high impedance. Note that since a large portion of the lead assembly (body) including the (+) white electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #523 on: February 01, 2019, 11:23:29 AM »

Model Number 302-20
Event Date 09/29/2014
Event Type  Malfunction   
Event Description
It was reported that during surgery device diagnostics showed high impedance with the new generator attached to the existing lead. The generator was tested with the test resister which showed the generator was within normal limits. The surgeon then dissected the lead coils off of the nerve and placed a new lead. An implant card was received confirming that both the generator and lead were replaced and that lead impedance with the new system was within normal limits. The explanted lead was received for analysis. Analysis of the lead was completed on (b)(4) 2014. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil broken ends show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution and surface contamination the fracture mechanism cannot be determined. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). The patient was referred to neurosurgery. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #524 on: February 01, 2019, 11:24:23 AM »

Model Number 302-20
Event Date 05/12/2014
Event Type  Malfunction   
Event Description
Additional information was received that product analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 941 volts as measured shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 57. 124% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a portion of the (-) green electrode quadfilar coil was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 455mm portion the end of the (-) connector pin quadfilar coil appeared to be broken at the distal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. 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 stated allegation of 'fracture of 'high impedance' note that since a portion of the (-) green electrode quadfilar coil was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Date of event, corrected data: the supplemental report #1 inadvertently did not report this data. Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report this data.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient had high impedance. The patient had their generator turned off and was schedule for surgery. The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned, but has not been completed.
 
Event Description
Per internal data obtained through product analysis from the explanted generator revealed that there was a change in impedance reading from 2209 ohms to 10000 ohms on approximately (b)(6) 2014.

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« Reply #525 on: February 02, 2019, 08:26:17 AM »

Model Number 302-20
Event Date 09/10/2014
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanted generator and lead were received for analysis. The returned product form indicated that generator and lead replacement was performed due to lead discontinuity. Analysis of the generator was completed on 01/21/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on 01/23/2015. 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 81mm portion an abraded opening was observed on inner silicone tubing 1 approximately 9mm-10mm from the end of the electrode bifurcation and quadfilar coil 1 appeared to be exposed. The surface of quadfilar coil 1 appeared to be pitted in this area. Scanning electron microscopy was performed on the quadfilar coil surface and identified the area as having extensive pitting. With the exception of the abraded inner tubing opening and coil pitting, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient had recently undergone generator replacement surgery on (b)(6) 2014. The patient was going to be scheduled for surgery, but the patient's mother wants to wait. No surgical intervention has been performed to date. No relevant information has been received to date.

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« Reply #526 on: February 03, 2019, 03:27:39 PM »

Model Number 302-20
Event Date 10/28/2014
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostics revealed high impedance. At the patient¿s previous office visit on (b)(6) 2013, system diagnostics showed lead impedance within normal limits. X-rays were taken and were reported by the physician to show possible looping/interruption in the lead behind the 3rd rib. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. The as-received generator was completely detached from the header which occurred during and after explant surgery. Other than the header anomaly, there was no performance or any other type of adverse condition found with the pulse generator. Lead discontinuity was confirmed in both positive and negative quadfilar coils in the body region of the returned lead portions. Scanning electron microscopy images show that at pitting or electro-etching conditions have occurred at the break location. Abraded openings were observed in both outer and inner tubing near the break locations. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.
 
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.

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« Reply #527 on: February 04, 2019, 01:36:01 AM »

Model Number 302-20
Event Date 10/23/2014
Event Type  Malfunction   
Event Description
Analysis of the lead was completed and confirmed the reported lead discontinuity. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil suggest a stress-induced fracture (fatigue) occurred in at least two strands of the quadfilar coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions occurred at the broken mate end. Due to mechanical distortion (smoothed surfaces) and/or metal dissolution, the fracture mechanism of the remaining strands cannot be ascertained. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had lead replacement surgery on (b)(6) 2014 due to lead fracture. The lead was returned to the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
It was reported that when the patient underwent a generator replacement due to end of service, when the new generator was placed interrogation showed a high lead impedance warning. No lead revision was performed at that time. Although surgery is likely, it has not occurred to date.

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« Reply #528 on: February 04, 2019, 01:36:50 AM »

Model Number 300-20
Event Date 10/20/2014
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the patient underwent a full revision surgery due to high impedance and end of service. It was reported that the generator was unable to be interrogated due to end of service. The generator and lead were received for product analysis on 02/10/2015. Product analysis is underway and has not yet been completed.
 
Event Description
On (b)(6) 2014 it was reported that the patient had high impedance during a system and normal mode diagnostics test. It was also noted that the patient¿s battery is near end of service. The patient was referred for a full revision surgery. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On 02/25/2015 product analysis was competed on the generator. The generator was found to be at end of service and was determined to be the result of normal battery depletion. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. A battery life estimation resulted in 3. 00 years remaining before the eri flag would be set. However, an incomplete programming history (8. 5-year gap) indicates the estimation does not use all the data required to make an accurate estimation. Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the eos condition is an expected event. The pulse generator module performed according to functional specifications; there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Product analysis on the lead was completed on 03/04/2015. Which confirmed discontinuity of the positive quadfilar coil in the body region of the returned lead portions; also observed abraded openings of the inner tubing near the break location. A break was identified in the positive coil at two locations. Scanning electron microscopy images of the positive coil end, positive coil segment, and strands segments show that pitting or electro-etching conditions have occurred at the break locations. However, due to metal dissolution and/or surface contamination the fracture mechanism cannot be ascertained. The inner silicone tubing of the lead coils has abraded openings at the ends. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. Since a portion of the lead (including the unmarked connector and the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #529 on: February 04, 2019, 01:37:34 AM »

Model Number 303-20
Event Date 10/29/2014
Event Type  Malfunction   
Event Description
On (b)(6) 2014 the explanted generator and lead were returned for product analysis. Product analysis is still underway and has not yet been completed.
 
Event Description
Product analysis was completed on the lead on (b)(6) 2014. The (+) white and (-) green electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 125mm portion the end of the (-) green electrode tri-filar coil appeared to be broken approximately 15mm from the distal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type. Fine pitting was observed on two of the broken coil strands. Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on the remaining broken coil strand. Pitting and flat spots were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Product analysis was completed on the generator on 12/22/2014. An end-of-service warning message was verified in the pa lab. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 971 volts, indicating an eos condition. The data from the generator shows an increase of impedance to 9434 ohms, which occurred on (b)(6) 2014. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient was supposed to undergo generator replacement due to end of service on (b)(6) 2014 but pre-operative diagnostics showed high impedance. The surgery was therefore cancelled for the day. Although surgery is likely, it has not occurred to date.

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« Reply #530 on: February 04, 2019, 01:38:32 AM »

Model Number 302-20
Event Date 10/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(4) 2014, product analysis was completed on the generator. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the battery was partially depleted. The partially depleted battery condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis on the lead was completed on 12/3/2014 which confirmed discontinuity of quadfilar coil (unknown polarity) in the electrode region of the returned lead portions; also observed abraded openings of both outer and inner tubing in body region of lead. A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 41mm portion quadfilar coil 1 appeared to be broken approximately 18mm from the end of the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 18mm) 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 being mechanically damaged which prevented identification of the coil fracture type with pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 18mm) 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 having extensive pitting which prevented identification of the coil fracture type with mechanical damage. 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 open / cut and slice marks observed 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 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 phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
Clinic notes dated (b)(6) 2014 reported that the patient's device was unable to be interrogated due to "not-functioning. " the physician¿s office attributed the failure to interrogate to normal end of service which was substantiated by battery life calculation results of 0 years remaining until neos condition at that time in (b)(6) 2014. The notes also reported that the patient¿s seizures were ¿recurring. ¿ it was noted that sometimes the patient does not take her anti-seizure medication regularly. The patient was seen for surgical consult for generator replacement on (b)(6) 2014, and the surgeon was able to perform diagnostics at which time high lead impedance was discovered. The patient had surgery on (b)(6) 2014. Pre-operatively, system diagnostic test was performed and results were high lead impedance. After the generator was replaced, high lead impedance still was observed. Therefore, the lead was also replaced. After the lead was replaced, diagnostics were within normal limits. The explanted devices were returned to the manufacturer for analysis, but analysis has not completed to date.

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« Reply #531 on: February 04, 2019, 01:39:31 AM »

Model Number 302-20
Event Date 10/01/2014
Event Type  Malfunction   
Event Description
On (b)(6) 2014 it was reported that the patient has high impedance on all diagnostics, so they turned the device off and ordered x-rays for the patient. The patient¿s last visit was in (b)(6) 2014 and the diagnostics were normal at that time. The patient¿s caretaker said she hadn¿t noticed the patient¿s voice go hoarse with stimulation in a while so thinks it may not have been working properly for a few months. They have not had any major falls or injuries. Although surgery is likely, it has not occurred to date. An x-ray assessment was performed on the x-ray images for the patient. The generator was visualized in the patient¿s left chest. The lead appeared to be intact at the lead pin. The filter feed thru wires appeared to be intact. The lead pin appeared to be fully inserted into the connector block. The electrodes appeared to be in alignment; however, the electrodes appear to be inverted on the patient¿s vagus nerve. Based on the x-rays received, the cause of the high impedance cannot be determined. However, a micro-fracture cannot be ruled out.
 
Event Description
The patient had lead revision surgery on (b)(6) 2016. The generator was not replaced. System diagnostics were performed during the surgery, and high impedance was identified prior to the lead replacement. Once the lead was replaced, there was normal impedance. The explanted lead has not been received to date.
 
Event Description
The device history record of the lead was reviewed, and the device conformed to all specifications prior to release. The explanted lead was received on 05/09/2016. Analysis was approved on 06/02/2016. A break was identified in the positive coil. The positive coil showed that pitting of electro-etching conditions have occurred at the break location. One strand of the positive quadfilar coil showed minor appearance suggesting that a stress-induced fracture occurred in at least one strand. However, due to pitting and mechanical distortion (smoothed surfaces) the fracture mechanism of strands could not be ascertained. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #532 on: February 04, 2019, 01:40:16 AM »

Model Number 302-20
Event Date 10/16/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 7). The patient device was not disabled as the patient did not complaint of any discomfort. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
The patient underwent a full replacement on (b)(6) 2016 due to battery depletion, unable to interrogate due to battery depletion and lead discontinuity. The generator and lead were received for analysis on 06/13/2016. Product analysis for the generator was completed and approved on 06/22/2016. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at a low battery condition (depleted). Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. With the exception of the parameters that are associated with a low battery condition, the device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no abnormal performance or any other type of adverse condition was found with the generator.
 
Event Description
It was also reported that the patient is anxious about not having vns as it has helped her in the past.
 
Event Description
Product analysis on the lead was completed and approved on 07/01/2016. A small portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During product analysis abraded openings were found on the inner tubing. Abrasions were observed in various locations, possibly caused by wear. Connector pin and connector ring coil breaks were observed with abraded openings on the inner tubes. 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 356mm) and identified the area as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type with pitting on three of the broken coil strands. Pitting and residual material were 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. No other obvious anomalies were noted.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

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« Reply #533 on: February 05, 2019, 02:36:55 AM »

Model Number 302-20
Event Date 10/22/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
An implant card was received indicating that the patient under vns re-implantation surgery. The implant card had a notation stating the removal of the old lead occurred. This was determined to be in reference to the remaining lead not explanted as previously noted in this report. Attempts at product return revealed that pathology in the facility did not receive any explanted products for the patient. The recently explanted portion of the lead has not been received by the manufacturer to date. Any additional information regarding re-implant is not relevant to this report.
 
Event Description
There is no plan for vns re-implant at this time. Although re-implant may occur in the future, it has not occurred to date.
 
Event Description
Clarification was received from the currently treating physician that a note dated (b)(6) 2014 from the treating physician at that time reports that his vns was explanted, and the fractured lead previously mentioned in (b)(6) 2016 was in reference to the remaining lead not explanted. Any additional information regarding re-implant is not relevant to this report. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was implanted. No additional relevant information has been reported.
 
Event Description
It was initially reported that the patient had generator and lead explant on (b)(6) 2014 due to an unknown reason. The explanted devices were returned to the manufacturer for analysis. The generator showed that the device was at end of service condition as result of expected normal battery depletion. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the returned lead portion was completed on (b)(6) 2014. Note that the lead assembly (body) including the section of the connector boot containing the model and serial number tag and the electrode section was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. During the visual analysis, the (-) connector pin quadfilar coil appeared to be stretched and kinked and extended approximately 3mm past the end of the connector ring. Two strands of the (+) connector ring quadfilar coil appeared to be stretched and kinked and extended approximately 1mm past the end of the connector ring. Determination could not be made as to whether the ends of the quadfilar coils were broken. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 3mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and a secondary break line. Scanning electron microscopy was performed on the two coil strands of the (+) connector ring quadfilar coil break (found at 1mm) and identified the areas as having extensive pitting which prevented identification of the coil fracture type. The area on one of the remaining two broken coil strands found inside the connector ring area was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The remaining broken coil strand found inside the connector ring area was identified as having evidence of a stress induced fracture (fatigue 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. 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 except for the half set of setscrew marks observed on the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. The observed location of the canted spring marks suggests there may have been intermittent contact with 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. Based on the findings in the product analysis lab, there is evidence of discontinuities in the returned portion of the device. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The surgeon¿s office reported that the patient was referred for generator replacement surgery due to end of service, but during surgery, the surgeon found that there were ¿fractured electrodes. ¿ as a result, they did not move forward with replacement of the system because the patient had not consented for lead replacement. Although re-implant may occur in the future, it has not occurred to date.

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« Reply #534 on: February 06, 2019, 01:50:23 AM »

Model Number 302-20
Event Date 11/13/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the returned lead was completed which confirmed discontinuity of the negative quadfilar coil in the electrode region. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. However, due to pitting, mechanical distortion (smoothed surfaces) and surface contamination the fracture mechanism cannot be determined. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions. Based on the appearance of the returned lead portions, it is believed that the identified punctures, kinks, superficial cuts/scratches, and tubing cut openings were most likely caused during the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the vns patient device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently disabled. X-rays dated were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin cannot be confirmed to be fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. Follow-up revealed that the patient underwent surgery on (b)(6) 2014. Pre-operative system diagnostics showed high impedance (impedance value >= 10,000 ohms). A replacement generator was connected to the existing lead tested with the existing lead and system diagnostic results showed lead impedance within normal limits (impedance value ¿ 3708 ohms and 4111 ohms). The surgeon believed that incomplete lead pin insertion was the cause of the high impedance condition so the lead was not replaced during the procedure. When the patient was closed and dressed, the surgeon tested the device multiple times and high impedance was observed (impedance value >= 10,000 ohms). It was noted that the patient¿s body position remained mostly unchanged during the procedure. The patient was referred for additional surgery, but surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4326952
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dennis100
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« Reply #535 on: February 06, 2019, 01:51:09 AM »

Model Number 300-20
Event Date 11/13/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was scheduled for generator replacement surgery on (b)(6) 2014 due to end of service. Pre-operative system diagnostic results showed lead impedance within normal limits (dcdc ¿ 2). After the patient¿s generator was replaced, the replacement generator was tested with the existing lead and diagnostic results revealed high impedance (impedance value -10,000 ohms). The lead was replaced and another generator was implanted due to device compatibility. It was noted that the surgeon handled the patient¿s lead somewhat roughly prior to its replacement. Operative notes were received indicating that the surgeon observed damage to the lead during the procedure so the lead was also replaced. The explanted devices and the opened but unused generator have not been returned to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
The explanting facility discarded the explanted devices; therefore, no analysis can be performed.
 
Event Description
The explanting facility did not discard the devices. The explanted products and opened but unused generator were returned to the manufacturer for analysis. No abnormal performance or any other type of adverse condition was found with the explanted and unused generators. The devices performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of negative quadfilar coil in the body region. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Abraded openings were observed on both the outer and inner tubing near the break area. The abraded openings found on the (-) unmarked connector pin inner silicone tubing and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4326527
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dennis100
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« Reply #536 on: February 06, 2019, 01:51:54 AM »

Model Number 304-20
Event Date 11/21/2014
Event Type  Malfunction   
Event Description
It was reported that the patient has a shocking sensation since (b)(6) 2014 and his generator was disabled due to it. X-rays were taken and the physician confirmed that the lead had come apart 3cm away from the end of the distal lead, high impedance had been observed during diagnostics. No accidents were reported to have occurred. The patient was referred for a full revision surgery. The patient underwent a full revision surgery on (b)(6) 2014. The explanted lead and generator were returned for product analysis. Product analysis is still 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On 12/22/2014 product analysis was completed on the generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 938 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on the leads on 01/05/2015 which confirmed discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions. A break was identified at the end of both positive and negative coils in the single returned lead portion. Scanning electron microscopy images of the positive and negative coil ends show that pitting or electro-etching conditions occurred at the break locations. Appearance of the lead coils suggests a stress-induced fracture occurred in at least one strand of the quadfilar coils. In addition, the appearance of one strand of the positive coil suggests a stress-induced fracture due to rotational forces occurred. Also, the early stages of secondary stress fractures and what appear to be stress fissures were identified in the vicinity of the break locations. Due to mechanical distortion (smoothed surfaces) and/or pitting a conclusive determination of the fracture mechanism of other strands cannot be made. The negative coil has what appears to be pitting at the area where the coil is discolored. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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dennis100
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« Reply #537 on: February 06, 2019, 01:52:46 AM »

Model Number 300-20
Event Date 10/23/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement on (b)(6) 2014 due to lead discontinuity. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the lead was completed on 01/13/2015. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil at the suspected torn end located at the 1st portion of the returned lead show that a stress-induced fracture (due to rotational forces) has occurred on the coil wires. Although not conclusive secondary fractures noted in the vicinity of the broken end suggest the stress-related primary fractures were most likely created during the explant procedure. Scanning electron microscopy images of the negative coil at the second portion show that pitting or electro-etching conditions have occurred at the coil end and at the area where a dark appearance was noted. Due to metal dissolution and surface contamination a conclusive determination of the fracture mechanism cannot be made. 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 portions. Analysis of the generator was completed on 01/19/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient was seen by the nurse practitioner due to an increase in seizure activity. It was reported that device diagnostics resulted in high impedance. The device output current was decreased from 2ma to 1. 5ma. The patient was sent for x-rays. Further follow-up revealed that device diagnostics on (b)(6) 2014 were within normal limits. The patient underwent generator replacement on (b)(6) 2014 and post operative device diagnostics were within normal limits. It was reported that the increase in seizures is thought to be due to a loss of vns therapy. The seizures were not back to the patient's pre-vns baseline frequency. There were no external factors that are believed to have caused or contributed to the high impedance. Clinic notes dated (b)(6) 2014 note that device diagnostics showed high impedance. Surgical clinic notes dated (b)(6) 2014 note that the patient had been doing very well with decreased seizure frequency until more recently and that high impedance was observed by the neurologist. It was noted that device diagnostics were again performed which indicated high impedance (6475 ohms). It was noted that the patient will undergo lead replacement with possible generator replacement due to device compatibility. The device was programmed off. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Corrected data: this information was inadvertently left off of follow-up mfr. Report #02.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4319221
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dennis100
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« Reply #538 on: February 07, 2019, 01:51:49 AM »

Model Number 302-20
Event Date 12/22/2014
Event Type  Malfunction   
Event Description
X-rays were taken and were reported by the physician to be unremarkable. It was reported that the patient underwent full revision surgery on (b)(6) 2015 to replace the lead. The generator was replaced prophylactically. The explanted devices were returned to the manufacturer. Analysis of the devices is currently underway.
 
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 portions was completed on 02/27/2015 and it identified pitting on the pin surface; reddish deposits on the pin surface were found with a high percentage of iron that suggests that oxidation may have occurred, but the impact of this condition cannot be determined. No other anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead. Analysis of the generator was completed on 03/04/2015 proper functionality of the pulse generator was verified. The device provided the expected level of output current. The battery showed an ifi=no condition. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred during replacement surgery on (b)(6) 2015, where the impedance value changed from high lead impedance to a normal limits range. No adverse conditions were identified for the generator.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the assessment of the x-rays by the health professional.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient had recently undergone generator replacement on (b)(6) 2014 for end of service. It was reported that device diagnostics in the operating room were within normal limits (2000 ohms). It was reported that the lead impedance increased gradually following surgery and that on (b)(6) 2014 the high impedance was first observed. It was reported that x-rays were scheduled and surgical revision was planned. No known surgical intervention has been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death. Only a portion of the lead was returned for analysis which did not reveal any lead fractures. A lead fracture is suspected in the lead portion not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430709
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dennis100
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« Reply #539 on: February 07, 2019, 01:52:37 AM »

Model Number 300-20
Event Date 12/30/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Describe event or problem; corrected date: the previously submitted mdrs inadvertently did not provide the correct type of surgery that occurred. All products were implanted/explanted. There were no products that were opened but not used.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that, during generator replacement surgery on (b)(6) 2014 due to end of service, the vns patient¿s replacement generator was tested with the existing lead and system diagnostic results showed high impedance. The patient underwent lead replacement surgery on (b)(6) 2015. No x-rays were taken. The physician attributed the high impedance condition to the age of the lead. The explanted products have not been returned to date.
 
Event Description
The patient underwent generator and lead replacement surgery on (b)(6) 2015 due to high impedance. The explanted devices from (b)(6) 2015 were returned to the manufacturer for analysis.
 
Event Description
The opened but unused generator and explanted lead were returned to the manufacturer for analysis. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is currently underway.
 
Event Description
Analysis of the returned lead was completed which confirmed discontinuity of negative quadfilar coil in the electrode region and positive coil in the body region. One strand of the positive coil show that pitting or electro- etching conditions have occurred at the break location.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4444903
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