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dennis100
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« Reply #600 on: December 01, 2018, 01:23:34 AM »

Model Number 304-20
Event Date 06/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2013 information was received from the reporter that the patient was scheduled to have surgery on (b)(6) 2013, either a lead repositioning or an explant. Follow-up confirmed that both the generator and lead were explanted on (b)(6) 2013. The primary reason for surgery had been reported that over time the white tie-downs that attached to the patient¿s lead had slowly moved to the surface of the skin and had begun to push through the skin. The surgeon, upon fixing the issue during surgery, then explanted the entire vns system due to a reported lack of efficacy in the patient. The patient and family had reported that there was no benefit of the vns and did not want the device replaced because the patient never received a therapeutic effect. The patient had no types of infections, complications, or any other issues with surgery. A review of the manufacturer¿s programming history database showed that there were no anomalies in the generator settings and also that no diagnostic tests had been performed. The explanted generator and lead products have been returned to the manufacturer for product analysis. Additional information is pending further attempts to the reporter and analysis of the products.

Event Description
Product analysis of the explanted generator and lead was performed. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. A lead assembly was returned for analysis in four pieces with the lead connector portion still attached to the pulse generator. Abrasions were identified on the outer silicone tubing at multiple locations. The electrodes were damaged showing bends in the electrode ribbon and partial detachment of the electrode ribbon and suture from the silicone helix. This condition was most likely caused at explant. 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 identified tubing openings and the cut ends of the returned lead portions. Based on the appearance of the returned lead portions, it is believed that the identified punctures, kinks, superficial cuts, etc. Were most likely caused during the explant procedure. Product analysis of the generator verified an end-of-service message was seen and was 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. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Follow up with the physician's office found that the physician stated the reason they had to do surgery was that the lead had eroded through the skin and the patient was not experiencing efficacy with the device. It was stated that "as far as we know" the patient was doing well since explant. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3237070
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dennis100
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« Reply #601 on: December 01, 2018, 01:24:59 AM »

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

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3242310
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dennis100
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« Reply #602 on: December 02, 2018, 01:29:49 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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dennis100
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« Reply #603 on: December 02, 2018, 01:31:16 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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dennis100
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« Reply #604 on: December 03, 2018, 04:08:16 AM »

Model Number 302-20
Event Date 06/07/2013
Event Type  Malfunction   
Event Description
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 193mm portion multiple coil breaks were observed on quadfilar coil 1 in the area of abraded openings observed, past the electrode bifurcation. Scanning electron microscopy was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type. 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 portions is consistent with conditions that typically exist following an explant procedure. 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. 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 portions were performed, during the visual analysis, and no other discontinuities were identified.

Event Description
Additional information was returned on (b)(4) 2013 about the explanted lead. The electrodes around the nerve were removed in ten small pieces without damage to the nerve. The new electrodes were placed in the same place, and the resulting dcdc was 0. The lead body was explanted in two pieces. The lead is to be returned but has not been received to date. An implant card from the lead revision surgery was also received indicating that the lead was explanted due to lead discontinuity.

Event Description
Additional information was received that the lead was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.

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

Manufacturer Narrative
Analysis of programming history. 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 during generator revision for a failure to program due to battery depletion, high impedance was seen upon connecting the new generator. The generator was not programmed off following the high impedance reading. No x-rays were taken. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. On (b)(6) 2103, the patient underwent lead revision. The lead was changed, the dcdc code was 0, and it was stated that everything was perfect. The lead has not been returned to date. The failure to program occurred two months prior. The physician's programming system was in working order, and other generators could be interrogated with the physician's programming system. The explanted generator was discarded after removal.

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dennis100
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« Reply #605 on: December 07, 2018, 08:37:24 AM »

Model Number 300-20
Device Problems High impedance; Device Contamination with Body Fluid
Event Date 08/13/2018
Event Type  Malfunction   
Event Description
It was reported that a patient underwent a full revision surgery. The generator was indicated to be replaced due to battery depletion, and the lead was stated to have been replaced for compatibility with the latest generator model. Both the generator and lead were returned for analysis. Generator analysis was completed and noted an intensified follow-up indicator = no condition. High impedance was detected from a review of the device's internal data. Analysis of the lead noted four sets of setscrew marks were seen on the marked connector pin providing evidence that proper contact between the setscrew and the marked connector pin existed at least once. Abraded openings were noted on the outer silicone tubing. The cause for these abraded openings are unknown; it was noted that a couple of them were the result of tie-downs. The lead assembly had dried remnants of what appeared to have once been bodily fluids inside the inner and outer tubing. No obvious points of entrance were noted other than that the abraded openings in the outer silicone tubing. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions. The last system diagnostics recorded from a review of the manufacturer's available programming data history was from 2016, indicating the device was functioning as intended. No additional relevant information has been received to date.

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dennis100
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« Reply #606 on: December 07, 2018, 08:38:28 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 #607 on: December 08, 2018, 01:29:54 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 10/16/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during surgery, after a m102 generator was replaced due to battery depletion, high impedance was detected on the replacement 106 generator. System diagnostics on the m102 generator prior to surgery indicated that impedance was ok. Intraoperative diagnostics performed on the m106 after the initial lead connection was ok. However, after the surgeon placed the 106 in the pocket and closed it, another diagnostic recorded high impedance ohms with only 0. 5ma current delivered. Repeated diagnostics showed high impedance with differing low output currents. The surgeon then removed the generator from the chest and the pin was reinserted. Pin reinsertion was attempted twice more; however, diagnostics were still high. While performing the pin reinsertion, it was also visually confirmed that the lead pin was past the connector block and then it was confirmed that the setscrew was tightened until it clicked, but impedance did not resolve. Therefore, the lead was replaced, and the high impedance resolved. It was also reported that there was two places where the lead visually looked "abraded". The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8057524
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« Reply #608 on: December 08, 2018, 01:30:27 AM »

Model Number 302-20
Device Problems Mechanical Problem; Device Contamination with Body Fluid
Event Date 10/10/2018
Event Type  Malfunction   
Event Description
It was reported during replacement surgery that the lead had a crack and fluid inside of it. The surgeon saw a crack on the casing of the lead. After the lead site was irrigated, the surgeon observed fluid in the lead. It is unclear if the fluid is the irrigation fluid or patient's body fluid. The diagnostics run during replacement indicated that the device was functioning as intended. The lead was not revised due to the normal diagnostics. A representative had attended the appointment prior to replacement and observed normal diagnostics at that time. No additional or relevant information has been received to date. No known lead revision surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8031252
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« Reply #609 on: December 13, 2018, 04:02:13 AM »

Model Number 300-20
Device Problem Patient-Device Incompatibility
Event Date 08/14/2013
Event Type  Injury   
Event Description
Additional information was received indicating that the cause of the left neck scarring was continued fibrosis that was observed previously in this patient. The deformed/dimpled neck scar was removed during the attempted generator repositioning surgery as part of a lead removal procedure. It was indicated that the intervention was for patient comfort and cosmetics and not to preclude a serious injury. The attempted generator repositioning surgery is reported in mfr. Report #1644487-2015-05251.

Event Description
It was reported that the patient was seen due to a lump at the electrode site that was sensitive, but not painful. There was no fever or pus, but the surgeon ordered x-rays and ct scans to determine what the issue may be. The patient was scheduled for surgery to lance the lump. The surgeon was not sure what the issue was and the cause was unclear as the patient has been implanted for some time. Additional information was received on (b)(6) 2013, during the exploratory surgery. The physician was able to perform interrogation and run diagnostics, which showed the device was within normal limits, during surgery. Per the surgeon, there was a lump of fibrous tissue around the electrodes, which he referred to as a "taboma". The surgeon indicated that he removed the tissue and performed interrogation and diagnostics again. The surgeon noticed that the outer tubing of the lead was cracked; however, the inner tubing was fine. He stated that he would not be performing a lead revision. Review of the lead device history records confirmed all quality tests were passed prior to distribution after being reworked. Follow up with the physician found that the fibrous tissue was likely related to a foreign body response. The notes indicate that there were fibrous, acute and chronic inflammation of focal giant cell reaction. The initial prognosis was "painful mass in the neck around the lead" so the surgery was taken due to the pain. Pain was not related to stimulation. The site did not indicate if the surgery was to preclude a serious injury or not. The patient's outcome is good, and there was no external trauma or manipulation of the electrode area that is believed to have caused the pain/lump. No additional information was provided.

Manufacturer Narrative

Event Description
The explanting facility indicated that the explanted generator and lead portion were discarded and are therefore unable to be returned for product analysis.

Manufacturer Narrative

Event Description
Additional information was received stating that the patient had a neck scar that was deformed and dimpled without any active inflammation in his neck incision the patient's mother asked the surgeon to revise the neck scar during a planned generator repositioning surgery. The repositioning surgery was attempted but it is unknown if the neck scar was revised. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3344698
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« Reply #610 on: December 13, 2018, 04:03:26 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 #611 on: December 14, 2018, 05:53:21 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
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 during generator replacement a lead break was identified and the lead was replaced as well. It was reported that the surgeon indicated that the patient is a "twiddler" and manipulated the lead through the skin which caused the lead fracture. The generator and lead were returned to device manufacturer for analysis on (b)(6) 2013. Analysis of the lead is underway, but has not been completed to date. Analysis of the generator was completed on (b)(4) 2013. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Event Description
Product analysis was performed on the explanted lead. Abraded openings were noted in the outer and inner silicone tubing. The overall appearance of the lead is consistent with patient manipulation of the implanted device, a ¿twiddler¿. 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, typical wear and explant related observations, no anomalies were identified within the returned lead portions.

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« Reply #612 on: December 14, 2018, 05:54:52 AM »

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

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

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

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

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« Reply #613 on: December 14, 2018, 05:56:34 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 #614 on: December 15, 2018, 01:42:57 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 #615 on: December 15, 2018, 01:44:04 AM »

Model Number 300-30
Event Type  Malfunction   
Event Description
An explanted lead was returned and analyzed. The analysis was completed on 09/23/2013. Abraded openings were noted on the inner and outer silicone tubing. A break was identified at the end of the positive and negative lead coil. Scanning electron microscopy images of both coils suggest a stress-induced (fatigue) fracture has occurred at the end of the coils. Also, the positive and negative coils have what appears to be wear in the vicinity of the break. The negative coil has what appears to be voids in the vicinity of the break in two strands. No obvious adverse effect was identified on the device performance as a result of this condition. Also, the negative coil has what appears to be a stress-crack in one strand in the vicinity of the broken end. 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, typical wear and explant related observations, no other anomalies were identified in the returned lead portion. The reason for explant was reported in mfr. Report # 1644487-2013-02921. Review of programming history shows that the patient¿s device was disabled on (b)(6) 2006. There is no record of the device being programmed back on.

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=3421250
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« Reply #616 on: December 16, 2018, 03:40:28 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414511
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« Reply #617 on: December 16, 2018, 03:41:30 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414519
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« Reply #618 on: December 21, 2018, 09:11:15 AM »

Model Number 302-20
Event Date 09/23/2013
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently did not report the correct patient age.

Event Description
On (b)(6) 2013 it was reported that the patient had a lead replacement done the week prior due to high impedance. It was found that the issue was a lead break. Follow up with the physician found that the high impedance was first observed on (b)(6) 2013. The last programming history provided was from (b)(6) 2013 which showed diagnostics were ok and the device was set to 1ma output current, 30 hz frequency, 500 microseconds pulse width, 30 seconds on, 5 minutes off. The device was programmed off on (b)(6) 2013. No patient manipulation or trauma occurred that is believed to have caused or contributed to the event. X-rays were sent to the manufacturer for review. The ability to visualize the generator is not compromised by inconsistency between the contrast and brightness of the images. Placement of the generator is normal in the left chest, and the feedthru wires appear intact. The connector pin appeared fully inserted inside the connector block. The ability to visualize the lead is not compromised by inconsistency between the contrast and brightness of the images. A strain relief bend is present per labeling. Two tie-downs are present, one of which is securing a strain relief bend per labeling. Lead is present behind the generator. There is a gross fracture in the lead. There are not any sharp angles present in the lead. The lead wires appear intact at the connector pins. Based on the x-ray images, the cause for the high impedance is the lead fracture as noted above. A portion of the lead behind the generator cannot be assessed; therefore a fracture in that portion of the lead cannot be ruled out. The presence of microfractures and discontinuities in the lead portion not visible cannot be ruled out either. The explanted lead was returned and product analysis was performed. The lead was returned in one piece with two tie-downs. Four sets of setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. The connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The 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. The positive coil appears to be kinked in the vicinity of the ring/backfill interface. An abrasion was identified on the connector boot. The outer silicone tubing has cut openings at approximately 10. 7cm, 11. 6cm, 12. 2cm, and 14. 1cm from boot. No damage to the inner tubing or the lead coils was noted at these locations. A superficial cut was noted on the outer tubing at approximately 23. 1cm from boot. The outer silicone tubing appears to have been compressed at approximately 8. 8, 17. 7-19, and 25cm from boot. The lead coils are slightly stretched at approximately 0-13. 3cm from boot. Abrasions most likely caused by the presence of a tie-down were noted at approximately 25. 3cm and 31. 1cm from boot. Abrasions were noted on the silicone tubing of the lead coils at approximately 1-1. 5cm and 2. 3-2. 7cm past the electrode bifurcation. No visual anomalies were noted on the anchor tether. Both the closest and the furthest electrode to the bifurcation are damaged showing bends on the electrode ribbon, partial detachment of the electrode ribbon and suture from the silicone helix and partially losing their helical shape. A suspected coil break was identified in the negative coil at the anchor tether. The silicone tubing of the negative coil has abrasions/scratches the break location. The negative coil has a dark/discolored appearance on one of the broken ends. 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. The positive coil appears to be kinked in the vicinity of the ring/backfill interface. Although not conclusive it is believed that the identified kinks, superficial, cuts and cut openings were most likely caused during the explant procedure. No other discontinuities were identified within the returned lead portion. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the broken ends. Due to metal dissolution, surface contamination and or mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. The overall length of the returned lead measured approximately 437mm. The length of the returned lead is within tolerance for a full lead assembly. The reported allegations were 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 broken ends. Due to metal dissolution, surface contamination and or mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Other than the above mentioned observations, typical wear and explant related observations, no other anomalies were identified in the returned lead. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the (b)(4) lead passed all functional tests prior to distribution.

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« Reply #619 on: December 23, 2018, 10:24:25 AM »

Model Number 302-30
Event Date 10/05/2013
Event Type  Malfunction   
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.

Manufacturer Narrative
Initial mfr. Report inadvertently listed the incorrected suspect device.

Event Description
It was reported that the patient underwent generator and lead replacement. Preoperative diagnostics were within normal limits. The physician's assistant reported that diagnostics in the physician's office were also within normal limits. During the surgery, the lead (including electrodes) and generator were removed. The surgeon indicated that the electrodes were wrapped tight around the vagus nerve and a "branch" and that there was a lot of scar tissue. The surgeon was certain that it was not the cardiac branches or the laryngeal branches. A new lead was placed on the vagus nerve and new generator was attached to the new lead. Diagnostic tests were within normal limits with the new system. The explanted devices were sent to the hospital pathology and the operating room nurse indicated that the hospital does not usually send back explanted devices. A returned product kit was given and a request to have the explanted devices was provided. It was reported that a company representative went to the site to assess diagnostics on the device prior to surgery being scheduled. It was reported that device diagnostics were unable to be performed due to the patient's complaints of pain and swelling in the neck area. It was reported that the patient was told by the physician that he recommended system replacement based on the patient';s pain and swelling and not based on "bad" diagnostics. The physician left the patient to decide on replacement. The patient reportedly decided on having the device replaced because it was felt that the device was of benefit to the patient. The generator and lead were received for analysis. Analysis of the generator was completed on 04/01/2014. 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 04/01/2014. The puncture mark 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. 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, chlorine and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.

Event Description
On (b)(4) 2013, it was reported that the patient had the vns device disabled by an unknown doctor in (b)(6) due to chest and neck pain. This was found out by the physician when the patient was hospitalized and admitted to the epilepsy monitoring unit (emu) for an increase in seizures. The physician turned the device back on and performed diagnostics on (b)(6) 2013 (emu admit date) and the results showed low impedance. The patient continued to have chest and neck pain with stimulation. The neurologist turned off the device and it has been off since (b)(6) 2013. Follow up indicates that although the device was implanted since 2004, it was only turned on for the last year or so (per the patient). The patient may be proceeding with device replacement, but no surgery has taken place to date. Attempts for additional information have been unsuccessful. No additional information has been provided.

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« Reply #620 on: December 24, 2018, 08:09:20 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 #621 on: December 24, 2018, 08:10:28 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 #622 on: December 29, 2018, 04:06:34 AM »

Model Number 300-20
Event Date 11/04/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2013 it was reported that the patient underwent a full revision surgery due to a lead break with high impedance greater than 10,000ohms. The patient had a lot of pain at the generator site. It was stated that the x-ray did not show a lead fracture but when explanting the lead, investigation showed some silicone of the lead body had disappeared. It was stated that since there was conductor material in contact with soft tissue, which caused pain during stimulation. It was later reported that the device was programmed off following the high impedance observation. It was stated that the patient did hard work while moving houses which might have caused or contributed to the high impedance. The patient felt painful stimulation some days prior to (b)(6) 2013. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(6) 2013. Product analysis is still underway and has not yet been completed.

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« Reply #623 on: December 29, 2018, 04:08:02 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 #624 on: December 29, 2018, 04:09:12 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 #625 on: December 30, 2018, 05:38:51 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 #626 on: December 30, 2018, 05:39:50 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 #627 on: December 30, 2018, 05:40:43 AM »

Model Number 302-20
Event Date 10/18/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was underwent generator and lead explant due to being seizure free with medication. It was reported that the patient's generator had been programmed off for about 18 months for that reason. The patient requested that the device be explanted. The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The incision mark and abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. Abraded inner tubing openings were observed. With the exception of the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on (b)(4) 2013. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #628 on: January 02, 2019, 02:11:56 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 #629 on: January 04, 2019, 08:45:19 AM »

Model Number 300-20
Device Problem Device Contamination with Body Fluid
Event Type  Malfunction   
Event Description
A patient had a prophylactic full revision surgery, and the explanted devices were returned for analysis. Analysis of the returned lead noted abrasion on the outer silicone tubing at multiple locations. It was also noted that there was an abraded opening identified in the inner silicone tubing of the negative coil. Dried remnants of what appear to have once been body fluids/betadine solution were located inside the inner and the outer silicone tubing due to points of entrance at abraded openings and the cut ends of the returned lead portions. Other than the inner/outer tubing abrasions and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the returned generator identified no anomalies. No additional relevant information was received to date.

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