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dennis100
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« Reply #750 on: June 13, 2019, 03:02:04 AM »

Model Number 302-20
Device Problems Corroded ; High impedance
Event Date 10/26/2017
Event Type  Malfunction   
Event Description
A call was received (b)(6) 2017 from a hospital providing that a patient had full revision due to battery depletion and ¿bad¿ impedance. The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date. Additional relevant information has not been received to-date.
 
Event Description
Analysis was completed for the returned generator. Measurement of the battery voltage determined that the battery was depleted and was the result of normal, expected battery depletion. The device performed according to functional specifications and analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis was completed for the returned lead. A break was identified at the ends of both lead coils. Scanning electron microscopy images of both coils show that pitting or electro-etching conditions have occurred at the break locations. Since the electrode array portion was not returned for analysis, an evaluation 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. Follow-up from the physician provided that system diagnostics were performed indicating high impedance, suggestive of electrode fracture. The physician stated the lack of efficacy was suspected to be due to the lead fracture.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7051849
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« Reply #751 on: June 15, 2019, 11:08:13 PM »

Model Number 302-20
Device Problems Fracture; Appropriate Term/Code Not Available
Event Date 01/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During a consult for generator replacement due to battery depletion, a lead fracture was observed in x-rays. The generator battery was reported to be dead. Both the generator and lead were replaced. The explanted lead was received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative

Event Description
During the visual analysis, multiple quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture. Determination could not conclusively be made on the fracture mechanism. Pitting and residual material were observed on the coil surface. Scanning electron microscopy identified an area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on one and residual material on the other two broken coil strands. 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 / torn areas 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 on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7042802
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dennis100
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« Reply #752 on: June 17, 2019, 04:14:53 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem; Premature End-of-Life Indicator
Event Date 04/27/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received that a generator battery depleted more quickly than anticipated. The generator was to be returned to the manufacturer for analysis. The generator has not been received to date and no other relevant information has been obtained.
 
Event Description
Further information was received from the nurse that the initial report of a generator not having the expected longevity was inaccurate. It was reported that the issue was actually a lead that did not function as expected. Further information indicated that high impedance was found on the patient's lead and first generator. This generator was replaced with a second generator on a later date, but the lead remained implanted. System diagnostics were run and high impedance was still reportedly present after this generator replacement. The second generator and lead were later replaced with a new vns system. The second generator and connected lead were returned to the manufacturer, but have not been received to date. The programming history on the first generator was not available at the time of the high impedance. There was no programming history available for the second generator. No further relevant information has been received to date.
 
Manufacturer Narrative
Corrected data, device manufacture date: supplemental mdr #1 inadvertently did not include the manufacture date for the lead.
 
Event Description
Further information was received that the patient's most recent generator and lead were received by the manufacturer. Analysis has not been completed to date. It was also reported that the explant date was initially reported incorrectly. The correct date was provided. No further relevant information has been obtained to date.
 
Manufacturer Narrative

Event Description
Further information was received that product analysis was completed on the generator. There were no visual anomalies observed. All diagnostic tests performed on the generator showed that lead impedance and current delivered was normal. The generator performed according to all functional and electrical specifications. The data from the generator provided measured impedance values throughout the time the generator was connected to the lead. This data showed that high impedance was present when the generator was first implanted but had resolved at a later date. After it had resolved, high impedance returned indicating the high impedance may have been intermittent. Product analysis was later completed on the lead. The lead was returned in three pieces, but portions of the lead were not returned and an evaluation could not be made on that part. Two sets of set screw marks were seen on the connector pin providing evidence that proper contact was made between the set screw and connector pin. Abrasions were noted on the silicone tubing of the lead coils past the electrode bifurcation. Abrasions were noticed along the outer silicone tubing at multiple locations. Abrasions caused by tie-downs were also noted. These abrasions were likely caused by normal wear and not the surgical procedure. A suspected coil break was identified in the positive coil past the anchor tether. A single broken strand was identified in the positive cold prior to the break location. Scanning electron microscopy images of the positive coil break and single broken strand show that pitting or electro-etching conditions have occurred at the break location. Due to mechanical distortion and/or metal dissolution, the fracture mechanism of the coil could not be determined. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead. No further relevant information has been obtained to date.

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dennis100
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« Reply #753 on: June 17, 2019, 11:31:05 PM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 09/03/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during an annual clinical appointment, high lead impedance was observed on the patient's vns. The patient reported no pain or change in seizure activity and that, as far as the patient could tell, the device was still working. Clinic notes were later received and indicated that the patient's mother did not feel that the vns was working like it had in the past when using the vns magnet activations. The patient denied any pain or changes in stimulation. The patient's mother still hears the patient occasionally cough when the vns activates. X-ray images were received by the manufacturer and reviewed. The m106 generator was placed normally per labeling. The connector pin of the lead appears to be fully inserted inside the connector block due to the position of the back of the pin. The feed thru wires appear to be intact. The lead visibility varies throughout the length of the lead. The review was unable to assess if all strain relief and tie-downs were present and placed according to labeling. No apparent sharp angles or gross fractures were identified in the visible portions of the lead. However, a segment of the lead is behind the generator and the visibility of the lead is lost at the neck and these could not be fully assessed. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
The patient underwent full vns replacement surgery due to the high impedance. The explanted products have not been received by the manufacturer to date.
 
Event Description
The explanted vns products were received by the manufacturer and are pending product analysis.
 
Event Description
Generator product analysis was completed. The generator performed as expected for the programmed parameters and according to functional specifications. The battery measured 2. 978 v at the completion of the fet, indicating an intensified follow-up indicator, or ifi, = no condition. Diagnostics were as expected and no battery status indicator was observed at the time of testing. Review of the lead impedance history in the internal generator data revealed intermittent high impedance. There were no performance or other adverse conditions identified with the generator. Lead product analysis was completed. The allegations of a fractured lead were verified in the product analysis, or pa, lab. A break was identified in the negative vns lead coil approximately 32. 4-32. 5 cm past the connector boot. Pitting or electro-etching conditions occurring at the observed break and at the exposed positive coil surfaces past the electrode bifurcation were identified with scanning electron microscopy, or sem, images. The appearance of the coil break suggested that a stress-induced fracture occurred in at least one strand of the quadfilar lead coil. The fracture mechanism of the remaining strands could not be ascertained due to metal dissolution and mechanical distortion. The portion of the vns lead past the anchor tether was not return and, therefore, analysis cannot be made as to that portion of the lead. A continuity check between the set-screw and end of the lead portion attached to the generator "as received" verified proper contact was present. The outer tubing was abraded open at approximately 16. 3-16. 7 cm and approximately 32. 3 cm past the connector boot. The inner silicone tubing of the positive coil was abraded open at approximately 0. 4 cm and 1. 7 cm from the connector boot. Remnants of dried body fluids inside the inner and outer tubing were identified with no obvious point of entry beyond the identified openings and ends of the return lead portions. Other than the mentioned observations and typical wear/explant related observations, no additional anomalies were identified in the return lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7003742
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dennis100
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« Reply #754 on: June 17, 2019, 11:31:50 PM »

Model Number 304-20
Device Problems Corroded ; Fracture; Low impedance
Event Date 11/21/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Low impedance was observed on a patient's device during a clinic visit. Three weeks earlier, impedance values near the bottom of the normal range had been observed on the patient's device. The impedance was otherwise normal throughout the remainder of the available programming history. The patient was scheduled for revision surgery due to the low impedance. X-rays images of the patient's lead and generator were reviewed by the manufacturer. The lead appeared wavy in several portions. A portion of the lead was not visible in the x-ray images, indicating the likelihood of a larger lead break. A sharp angle was observed at the center of three tie-downs used to secure the top of the lead, indicating the presence of a lead discontinuity or short circuit condition. The patient underwent lead and generator replacement surgery. The lead had reportedly become disconnected inside the patient. The physician reported that the patient did not manipulate the device or experience any trauma that may have led to the low impedance or broken lead. The explanted devices have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
The distributor and physician believed that low lead impedance was observed on the generator because the lead was short-circuited at the lead break. The explanted lead and generator were received by the manufacturer for analysis, but analysis has not been approved for the explanted devices to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was approved for the lead and generator. When received, the data was downloaded from the pulse generator and reviewed. The last significant change in impedance value registered on the generator was observed the day before explant surgery. And both impedance values were below 1000 ohms. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The lead was returned in two portions. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Set screw marks were observed on the connector pin, providing evidence that proper contact existed between the lead and generator at least once. Microscopy identified a stress-induced fracture at the lead break location, and secondary stress-induced fissures were also noted in two strands of the positive coil. A portion of the positive coil is exposed and stretched at a lead break location. An intermittent contact was identified between the lead coils. Pitting and wear were identified near the break location on the negative and positive coils. Abraded openings were identified along the outer and inner tubing of the lead and were points of entry for dried fluid observed in both layers of tubing. The appearance of the lead suggested patient manipulation of the implanted device. Identification of portions of the lead coils being exposed may confirm this to be a contributing factor for the reported low lead impedance. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

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dennis100
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« Reply #755 on: June 17, 2019, 11:32:36 PM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 11/13/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Report received that high impedance was observed on a patient's vns. When the patient was seen by the physician, she reported that her vns did not seem to be working for the "last two weeks". It was then interrogated where high impedance was found. Further information was received that the patient did not feel the vns stimulation which was why she believed the vns was not working. It was also reported that the patient presented with an increase in seizures due to the high impedance. The lead was later replaced. The surgeon reportedly did not noticed any gross visual lead fractures but did indicate that fluid was in the lead tubing. The explanted products were reportedly returned to the manufacturer but they have not been received to date. No further relevant information has been obtained.
 
Event Description
Further information was received that the explanted lead and generator were received by the manufacturer. Product analysis was later completed on the lead. Product analysis observed abraded openings and torn areas on the outer and inner silicone tubing. These openings provided a leakage path for dried remnants of what appeared to have once been bodily fluid to enter the inner and outer tubing. Additionally, two areas on the quadifilar coils were found to be broken. Scanning electron microscopy was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. With the exception of the abraded open / torn areas and 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 set screw 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. An evaluation was not made on the portion of the lead that was not returned. No further relevant information has been received to date.
 
Event Description
Further information was received from product analysis on the generator. Visual analysis found no anomalies other than marks and discoloration associated with the normal implant and explant procedure. Both interrogation and system diagnostics were performed on the generator. Results showed communication was ok, lead impedance and current delivered were normal for all diagnostic tests performed. The generator output signal was monitored over 24-hours and no signs of variation in output signal were found. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data from the generator was also reviewed the day of the first occurrence of high impedance could not be found from the data. It showed that the remaining voltage was slightly lower than expected based on the estimated charge consumed, but this was likely due to the generator being connected to a lead with high impedance. No other anomalies were seen with the generator. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7137758
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dennis100
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« Reply #756 on: June 17, 2019, 11:33:17 PM »

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

Event Description
It was reported that a patient was getting a prophylactic replacement surgery. Diagnostics that were run before the operation and after the battery replacement indicated high impedance. The patient underwent a full revision surgery. The lead and generator were received and are currently pending analysis.
 
Manufacturer Narrative

Event Description
Product analysis was completed for the explanted lead and generator. Product analysis for the generator was reviewed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 658 volts as measured, showed the battery was not at an end-of-service condition. The data in memory locations revealed that 58. 740% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis for the lead was reviewed. The leads were returned in one piece, without the electrodes. A break was identified in the coil. Scanning electron microscopy images show that pitting or electro-etching conditions have occurred at the break location. Due to mechanical distortion (smoothed surfaces) and/or metal dissolution the fracture mechanism cannot be ascertained. Abrasions were noted on the outer silicone tubing at multiple locations, and were suspected to be caused by the presence of tie-downs used to secure the lead in the body. The silicone tubing was cut and the coils were kinked at various locations of the lead. These were likely caused during the explant procedure and likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The set screw marks seen on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.

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dennis100
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« Reply #757 on: June 17, 2019, 11:34:14 PM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 06/29/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a system diagnostic test was run on this patient's device indicating high impedance. No known surgical intervention has occurred to date. No other relevant information has been received to date.
 
Event Description
It was reported that the patient's generator and lead have been replaced. The vns device has not been received by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
The lead and generator have been received by the manufacturer for product analysis. The generator underwent product analysis where diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway but has not been completed to date. No other relevant information has been received to date.
 
Event Description
The returned portion of the lead underwent product analysis and a lead fracture was observed near the electrode bifurcation of the quadfilar coil. Scanning electron microscopy was performed at the coil break which identified the area as being mechanically damaged with fine pitting and pitting on the coil surface. Scanning electron microscopy was also performed on the electrode side of the coil break which was also identified as being mechanically damaged with fine pitting, residual material and pitting on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification scanning electron microscopy analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. No other obvious anomalies were noted.

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« Reply #758 on: June 17, 2019, 11:35:08 PM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Low impedance
Event Date 12/08/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a low impedance warning message was observed when the patient¿s device was interrogated during a routine office visit. A low impedance warning typically indicates that a short circuit condition may be occurring. The physician ordered x-rays and was considering referring the patient for a lead revision. No additional relevant information has been received to date. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient underwent a lead and generator replacement due to the low impedance. The explanted products have not been received to date.
 
Event Description
The explanted lead and generator were received and are currently pending analysis.
 
Event Description
Analysis was completed on the explanted generator and lead. The generator passed functional testing and performed to specification. No anomalies or impedance issues were observed with the generator. The lead was returned as one segment which included the lead pin which was still inserted into the generator. Abraded openings were observed on the inner and outer tubing and the lead coils appeared to have signs of wear on the exposed portions of the lead. Fluid was observed inside the lead and the point of entry appeared to be the cut end of the lead or the abraded openings. No discontinuities were identified within the returned lead portion. Sem imaging was used to inspect the exposed lead coils and signs of pitting were observed.

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« Reply #759 on: June 17, 2019, 11:36:03 PM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture; Mechanical Problem; Insufficient Information
Event Date 11/21/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported through clinic notes that the patient had high impedance x-rays were taken and the radiologist identified a lead fracture at the base of the patient's neck. The vns was left on. No further relevant information has been received to date. No known surgical intervention has occurred to date.
 
Event Description
It was reported by the hospital that the patient's lead and generator were replaced due to high impedance and battery depletion. A lead fracture was observed. The hospital indicated that a couple of years ago the lead was repaired at a different location than the fracture. The repair is reportedly visible on the lead. No further relevant information has been received to date. The suspect device has not been received to date.
 
Manufacturer Narrative
Device available for evaluation?, corrected data: return of the suspect product was inadvertently excluded from supplemental mdr 1.
 
Event Description
The explanted products were received for product analysis. Product analysis was completed on the returned generator. Product analysis did not replicate battery depletion. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive electrical evaluation showed that the device performed according to functional specifications. No anomalies were identified. Product analysis was completed on the returned lead. The electrode array was not received for product analysis. There were two portions of the lead wrapped with pieces of white tubing that were attached with black sutures. These are presumably the lead repairs previously reported by the surgeon's office this white tubing covered abraded openings in the outer silicone tubing. One additional abraded opening in the outer tubing was identified. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. Four lead fractures were also identified. The connector ring coil was broken in two places close to one of the white tubing repairs. In this location there were also multiple abraded openings in the outer and inner tubing. At one break, scanning electron microscopy (sem) identified extensive pitting which prevented identification of the fracture type. Sem on the second break showed that the area was worn to the point of fracture with flat spots on the coil surface with no putting. At the same place, the connector pin coil was broken and appeared to be melted on both sides of the break. The melted coil is believed to be due to exposure to a high temperature device like an electrocautery tool during the explant of the lead. The connector pin and connector ring coils were found to be broken at the end of the returned portion of the lead at the electrode array end. Sem found evidence of a stress (fatigue appearance) induced fracture at the connector pin fracture. At the connector ring fracture in this location, sem found evidence of fracture due to fatigue and rotational forces with pitting on one of the coil strands. Based on the pitting found on the lead, it is believed that stimulation was present for some time after lead fracture occurred. Product analysis identified no further anomalies in the returned portion of the lead. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No further relevant information has been received to date.

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« Reply #760 on: June 17, 2019, 11:36:54 PM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 08/31/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was observed on a patient's device during a clinic visit. The physician planned to perform revision surgery. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent lead and generator replacement surgery due to the high impedance. The explanted lead was received by the manufacturer for analysis, but analysis has not been approved for the device to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
It was clarified that the patient's generator was replaced prophylactically. Analysis was approved for the lead. The lead was returned in two pieces. Three sets of set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once. A break was identified in the negative coil. Microscopy images of the negative coil show that pitting occurred at the break location. Due to metal dissolution and mechanical distortion, the fracture mechanism could not be determined. The lead had a spiraled or wavy appearance at some locations. No additional relevant information has been received to date.

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« Reply #761 on: June 17, 2019, 11:38:17 PM »

Model Number 302-20
Device Problems High impedance; Appropriate Term/Code Not Available
Event Date 12/08/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient was referred for a prophylactic generator replacement. During the replacement surgery, high impedance was observed with dcdc - 7 on system diagnostic test with the existing device. The surgeon inserted the lead pin into the generator a couple of times to rule out incomplete pin insertion but continued to get high impedance. The lead and generator were therefore replaced. The explanted devices have not been received to date.
 
Event Description
The explanted devices were received. Analysis is underway but has not been completed to date.
 
Event Description
The generator was explanted for prophylactic reasons. The device performed according to functional specifications of the current automated final test. Analysis of the generator in the analysis lab concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portions and the reported allegations of fracture of lead were confirmed. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned portion what appeared to be pitting and rust-like deposits were observed on the connector pin surface. Energy dispersion spectroscopy (eds), which provides chemical or element identity/composition analysis, was performed on the connector pin rust-like deposits and identified the area as consisting of sodium, silicone, phosphorus, nickel, chromium and iron. Another eds procedure was performed on the clean connector pin surface and identified the area as consisting of chromium, silicone, sulphur, iron and nickel. A definite cause for the pitting could not be determined based on the lead portions returned. Several broken coils were observed. Scanning electron microscopy (sem) was performed and identified the some areas as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type with pitting on the broken coil strands. 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. No other obvious anomalies were noted. The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.
 
Event Description
It was noted during a review of a programming data card that high impedance was observed during system diagnostics the patient's generator implant surgery on (b(6) 2016. This is the generator that was explanted with the lead. It is unclear if this is related to pin insertion troubleshooting event or related to the lead fracture. No further relevant information has been received to date.

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« Reply #762 on: June 17, 2019, 11:39:16 PM »

Model Number 304-20
Device Problems Corroded ; Fracture; Mechanical Problem; Under-Sensing ; Low impedance
Event Date 06/05/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the generator was not detecting heart rate. The internal data of the generator was reviewed and it was determined that low impedance had been detected on the device in the past as well as a large drop in impedance. Low impedance may interfere with heartbeat detection. The generator was later able to detect heart rate when the sensitivity was set to its least sensitive detection setting (sda sensitivity - 1). However, approximately four months later, the generator continued to have difficulty detecting heart rate. Low impedance was detected intermittently through system diagnostics. The patient reported that approximately a year ago she had felt a 'movement' in her neck, where the lead connected to the nerve and when she moved her head back, the movement reversed and 'went back. ' the patient said that she still felt normal and magnet mode stimulation. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's lead and generator had been replaced due to low impedance. During explant a kink in the lead was observed that had caused the tubing to rupture. Reportedly there was nothing unusual about the placement of the lead on the nerve. The explanted lead and generator were received, but product analysis on the devices have not been completed to date. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned generator. The generator was able to sense heart-rate normally. No anomalies were identified with the generator. Product analysis was completed on the returned lead. The lead was received in two pieces and the electrodes were not received. Two (2) abraded openings in just outer tubing were identified. One abraded opening in the inner and outer tubing was observed. At this opening, a lead break in the positive coil was found and pitting conditions were observed at the location. Dried body fluids were identified in 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 portion. No other anomalies were identified in the returned lead portions. No further relevant information has been received to date.

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« Reply #763 on: June 18, 2019, 12:23:07 AM »

Model Number 304-20
Device Problems Corroded ; High impedance; Appropriate Term/Code Not Available
Event Date 11/17/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was seen on the patient's device. The lead was replaced but the generator was not replaced. The explanted lead has not been received to date.
 
Event Description
The explanted lead was received. Analysis is underway but has not been completed.
 
Manufacturer Narrative
 
Event Description
Abraded openings were noted on the outer and the inner silicone tubing of the returned lead portions. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. The reported fracture of lead was verified. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. The positive coil shows what appears to be wear (smoothed surfaces) at the mate end in the vicinity of the break location. Also, the appearance of the positive coil mate end suggests a stress-induced fracture occurred in at least one strand of the quadfilar coil. Due to metal dissolution and or mechanical distortions (smoothed surfaces) the fracture mechanism of other strands cannot be ascertained. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
Additional information was received that the high impedance was first observed. The explanted lead was reported to be eroded or corroded into the jugular vein. No additional relevant information was received.
 
Event Description
No known interventions were taken specifically for the corrosion.

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« Reply #764 on: June 19, 2019, 04:02:50 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance
Event Date 09/19/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was observed on the patient's vns. The patient was referred for vns replacement surgery. Clinic notes were later received revealed that at an office visit with the patient's neurologist, the high impedance was observed and the patient's vns was programmed off. The patient was referred for neurosurgery to determine if imaging was needed to assess the vns lead. The physician noted that the vns had likely not been working for some time and the patient did not have any clinical seizures. It was stated that if there were frequent seizures observed with an ambulatory eeg monitoring, the patient would need a vns replacement. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
The explanted vns generator and lead were received by the manufacturer and are pending product analysis.
 
Event Description
It was reported that the patient underwent full vns replacement surgery due to the high impedance. The explanted vns products have not been received by the manufacturer to date.
 
Event Description
Generator product analysis was completed. The pulse generator performed according to functional specifications. The battery measured 2. 965 v at the completion of the fet, indicating an intensified follow-up indicator, or ifi, condition. Diagnostics were as expected and no battery status indicator was observed. There were no performance or other adverse conditions found with the generator. Lead product analysis was completed. The allegation of high impedance was verified in the product analysis, or pa, lab. A lead break was identified in the negative coil. Scanning electron microscopy, or sem, images suggest that a stress-induced fracture occurred in at least two strands of the negative quadfilar coil and secondary stress fissures were noted in one strange of the coil at the break. Sem images showed that pitting or electro-etching conditions occurred at the break location. Due to pitting or mechanical distortion, the fracture mechanism of the other strands could not be ascertained. The portion of the lead containing the electrodes was not returned and analysis could not be made on that portion of the lead. Set-screw marks were observed and indicated that proper contact between the set-screw and the connector pin was present at least twice. The break in the negative coil was identified at approximately 1. 1 cm past the electrode bifurcation and the secondary broken strands were observed in the vicinity of the coil break. Other than the mentioned observations and typical wear/explant related conditions, no additional anomalies were identified in the returned lead portions.

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« Reply #765 on: June 21, 2019, 12:20:48 AM »

Model Number 302-20
Device Problem Fracture
Event Date 11/07/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient underwent prophylactic vns generator replacement surgery. During pre-operative diagnostics, high impedance was observed. The surgeon was not aware of any lead issues prior to the case and connected the vns lead to the new generator. The high impedance did not resolve and the vns lead was replaced as well. The two electrodes from the previous lead were left on the nerve with the new electrodes attached below. The company representative reviewed the patient's notes and it was revealed that high impedance was noted previously by the patient's physician, but the surgeon was not notified. The explanted generator and lead have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
The explanted vns generator and lead were received by the manufacturer and are pending product analysis.
 
Manufacturer Narrative
Relevant tests/laboratory data, including dates, corrected data: initial report inadvertently left out "((b)(6) 2017) systems diagnostics: lead impedance - high".
 
Event Description
Lead product analysis was completed. The reported fractured leads were verified in the product analysis, or pa, lab. A break was identified in both the positive and negative lead coils. Scanning electron microscopy images showed pitting or electro-etching conditions occurred at the lead fractures, but due to the metal dissolution/mechanical distortion, the fracture mechanism could not be identified. The portion of the lead containing the electrodes was not returned and, therefore, analysis of that portion could not be performed. Set-screw marks were identified on the connector pin, indicating that, at one point, a good mechanical and electrical connection was present. Other than the above observations and typical wear and explant related observations, no other anomalies were identified. Generator product analysis was completed. The reported low battery status was duplicated in the product analysis, or pa, lab. Diagnostics were as expected and a neos status was observed at the time of testing with a battery voltage of 2. 50 v. There were no performance or other adverse conditions found with the generator.

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« Reply #766 on: June 21, 2019, 12:22:00 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 11/16/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic notes indicated that high impedance was observed on a patient's device. Although the device was programmed to deliver 2ma, diagnostic testing on the device indicated the device was only providing 1. 5ma of normal mode output current. The generator was programmed off due to the high impedance, and the patient was referred for surgery. The patient underwent lead and generator replacement surgery. The explanted lead and generator have not been received by the manufacturer to date.
 
Event Description
The explanted lead and generator were received by the manufacturer for analysis, but analysis has not been approved to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Analysis was approved for the lead. A portion of the lead, excluding the electrodes, was returned in one piece for analysis. Set screw marks were observed on the connector pin providing evidence that proper contact between the set screw and connector pin existed at least once. A coil break was identified is the positive lead coil. Microscopy identified pitting at the coil break, and flat surfaces were observed at the break locations. Abraded openings were observed along the inner and outer tubing of the lead, and body fluids were observed both layers of tubing. Other than the observed anomalies, no other anomalies were observed with the returned portions of the lead. Analysis was also approved for the generator. When received, the data was downloaded from the generator and reviewed. The last measured significant impedance change was observed on the date of explant. The impedance values prior to and after the point of change were both indicative of high impedance, confirming that high impedance was present for the system prior to explant surgery. No surface abnormalities were noted on this device. Diagnostics for the generator were within the normal limits for the programmed parameters. The generator performed according to functional specifications. There were no adverse issues identified with the returned generator. No additional relevant information has been received to date.

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« Reply #767 on: June 22, 2019, 03:22:25 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 01/10/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was seen on the patient's device, and the battery is not at eos. No known surgical intervention has occurred to date. No other relevant information has been received to date.
 
Event Description
The patient¿s full revision surgery has been completed. The products have not been received by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
The lead and generator were received by the manufacturer for product analysis. The lead underwent product analysis where the negative electrode quadfilar coil appeared to be broken near the electrode bifurcation. Scanning electron microscopy was performed and identified evidence of a stress induced fracture. Extensive pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded opening found on the outer silicone tubing 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 abraded opening and 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. Analysis of the generator is underway but has not been completed to date. No other relevant information has been received to date.
 
Event Description
The generator underwent product analysis and internal investigation showed that the generator battery prematurely depleted and the premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths. This is captured in mfr report # 1644487-2018-00755. The device history record of the generator was reviewed, and the device passed all functional specifications prior to release, it was also confirmed that the device was laser-routed during the manufacturing process. During analysis, interrogation and system diagnostic tests were performed, and resulted in ok communication, lead impedance, and current delivered for the generator. The pulse generator performed according to functional specifications with the exception of the expected low battery voltage. No other relevant information has been received to date.

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« Reply #768 on: June 23, 2019, 03:47:31 AM »

Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 12/18/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was observed on the patient's device. The patient was referred for a full revision surgery because the generator was at 25% battery and the lead replacement is due to the high impedance. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the patient's lead and generator were replaced due to the high impedance. The explanted generator and lead were planned to be sent back to the manufacturer so product return is expected. The lead and generator have not been received by the manufacturer to date.
 
Manufacturer Narrative
 
Event Description
The explanted lead and generator were returned for analysis. Analysis was completed on the lead. The lead was returned in one piece for analysis however the electrodes were not included. There were set screw marks on the connector pin indicating that at one point in time proper contact existed with the device. There were multiple locations of abrasions noted on the exterior of the lead. There were also internal abrasions noted most likely because of the presence of tie downs. A coil break was identified in the positive coil past the electrode bifurcation. A segment of the positive coil was subjected to sem inspection. The sem showed pitting at the lead break location however due to dissolution of the metal the fracture mechanism could not be obtained. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
Generator analysis was completed on the explanted generator. There were no performance or any other type of adverse conditions found with the generator other than a low battery condition that was contributed to by the high impedance noted on the device.

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« Reply #769 on: June 25, 2019, 12:54:05 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 12/22/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was identified on the patient¿s device. The patient had been having more violent behavior, which may have been sub-clinical seizures, for the previous three weeks. Swiping the magnet did seem to help with the violent behavior. No further relevant information has been received to date.
 
Manufacturer Narrative
Corrected data, explant date - the explant date was inadvertently omitted from the initial report.
 
Event Description
The patient had full revision surgery due to high impedance. The generator and lead were received, but analysis has not been approved to date.
 
Event Description
Analysis on the generator was approved. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified. The device output signal was monitored, and 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. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis on the lead was also approved. Abraded openings were noted on the outer and the inner silicone tubing. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil (including strand segments) shows that pitting or electro-etching conditions have occurred at the break location and at the discolored surface. Also, the positive coil show that a stress-induced fracture has occurred in at least two strands of the quadfilar coil. However, due to mechanical distortion (smoothed surfaces), surface contamination and/or metal dissolution the fracture mechanism on others strands cannot be ascertained. Scanning electron microscopy images of the negative coil verified that pitting or electro-etching conditions have occurred at the suspected area. Note that since a portion of the electrode array portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. No other anomalies were identified in the returned lead portions.

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« Reply #770 on: June 25, 2019, 12:54:49 AM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 01/23/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for vns generator replacement due to battery depletion. It was stated that the battery was fully depleted and could not be interrogated prior to the surgery. However, upon connecting the new generator, high impedance was observed with two diagnostics tests. The surgeon removed the dual lead pins, cleaned them, and reinserted them into the generator. The high impedance did not resolve. It was reported that the surgeon visualized a lead fracture. The patient underwent a full vns replacement as a result. The newly implanted generator was replaced as well due to lead incompatibility. The two explanted vns generators and the vns lead were received by the manufacturer and are pending product analysis. No additional relevant information has been received to date.
 
Event Description
The initially implanted generator product analysis was completed. The reported low battery status was duplicated in the product analysis, or pa, lab. The generator would not interrogate during attempts at bench interrogation. Therefore, system diagnostics, vbat calculation, and the fet could not be performed. With the case removed and the battery still attached to the printed circuit board assembly, or pcba, the battery measured 0. 811 v, confirming the end of service, or eos, condition. Postburn electrical tests confirmed that the pcba performed according to functional specifications. The second generator product analysis was completed. The generator performed according to functional specifications. There were no performance or other adverse conditions found with the generator. Lead product analysis was completed. The allegation of fractured leads was verified in the product analysis, or pa, lab. A break was identified in the positive and negative lead coils approximately 0. 2 cm past the end of the electrode bifurcation. Abraded openings were noted on the silicone tubing of the lead coils. Scanning electron microscopy, or sem, images of the positive and negative lead coils identified pitting or electro-etching conditions had occurred at the breaks. Due to metal dissolution and mechanical distortions, the fracture mechanism could not be ascertained. The positive coil showed signs of wear in the vicinity of the break. A portion of the vns lead containing the furthest electrode to the bifurcation was not returned and, therefore, product analysis could not be made on that portion of the lead. The silicone tubing of the lead coils appeared to have been torn and abraded open at the location of the suspected coil break. The silicone tubing of the positive coil was cut open approximately 0. 4 cm prior to the closest electrode. Remnants of what appeared to be body fluids were observed inside the inner and outer silicone tubing. No other obvious points of entry were noted other than the identified openings and the ends of the returned portions.

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« Reply #771 on: June 25, 2019, 12:55:39 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 01/31/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A nurse practitioner reported to a company representative that she observed an impedance value around 7000 ohms on the patient's device, indicative of high impedance. Since the patient was receiving good seizure control with vns, the nurse wanted to keep stimulation enabled, so the vns output current was programmed to 1ma for the patient's device; however, shortly after the settings adjustment, the patient experienced painful stimulation in her neck. Stimulation was reduced to 0. 75ma, and the patient was referred for surgery. X-ray images were provided to the manufacturer for review, but due to the quality of the images, a cause of the high impedance could not be determined. Proper pin insertion or integrity of the lead body could not be evaluated with the provided images. The patient underwent lead and generator replacement surgery due to the high impedance. The surgeon did not visually observe any problems with the lead or with the insertion of the lead pin into the generator. The existing generator was explanted and replaced with a new generator, and high impedance was observed multiple times on the system. The surgeon verified that the lead pin of the existing lead had been fully inserted into the new generator. The existing lead was then replaced with a new lead, and diagnostics were within the normal limits. The explanted lead and generator have not been received by the manufacturer for analysis to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The explanted lead and generator were received by the manufacturer for analysis. Analysis approved for the generator. When received, the data was downloaded from the generator and reviewed. High impedance values were observed in the data. The generator was interrogated, and system diagnostics were performed and returned results within the normal limits. The generator was able to deliver the output current as programmed over a 24-hr monitoring period. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator. Analysis was approved for the lead. The lead was returned in multiple pieces. Note that since the electrode portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Microscopy images of the negative coil show that pitting occurred at the break location. The microscopy images also suggested that a stress-induced fracture occurred in at least three strands of the coil. Abraded openings were noted on the outer and the inner silicone tubing, and dried remnants of body fluid were observed inside the tubing at these opening locations. A lead break was identified in the negative coil. The observed abraded openings on the outer and the inner silicone tubing may possibly have contributed to the painful stimulation the patient experienced. No other anomalies were identified in the returned lead portions. No additional relevant information has been received to date.

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« Reply #772 on: June 25, 2019, 12:56:24 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 12/15/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The patient's neurologist reported that high impedance was found on the patient's vns system. X-rays were reportedly reviewed and no issues were found. The lead has been replaced. The explanted device has not been received for analysis to date. No additional or relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
A portion of the lead was received for analysis. The lead's electrodes were not returned. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. Product analysis of the lead identified a coil break in the positive coil. Scanning electron microscopy images of the suspected positive coil break show that pitting or electro-etching conditions occurred at the break location. However, due to metal dissolution, the fracture mechanism cannot be ascertained. Scanning electron microscopy image on the connector pin surface shows that pitting or electro-etching conditions occurred. Since the lead¿s electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. No additional or relevant information has been received to date.

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« Reply #773 on: June 25, 2019, 12:57:09 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture; Mechanical Problem; Appropriate Term/Code Not Available
Event Date 12/12/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that prior to a generator replacement case, high impedance was detected on the patient's generator. The device was programmed at 2. 75ma and the current delivered was 0. 75ma. There were no visible fractures, but at the end of the lead that inserts into the generator there was a white material on the outside of the lead. The surgeon did try to remove it, but nothing would come off. The lead and generator were replaced. The explanted products were received but product analysis has not been completed on the suspect device has not been received to date. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the returned lead. The lead was returned in 5 portions with the anchor tether and second electrode not returned. A coiled portion of the lead was encased in a large piece of body tissue. There were white deposits along the lead bod, which; energy dispersion spectroscopy found to contain silicon, phosphorus, sodium, magnesium and calcium. Product analysis identified two lead fractures in the lead body. With regards to the first fracture, scanning electron microscopy found that one strand break had evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. The other three strand breaks' fracture mechanism could not be identified due to mechanical damage. Pitting/corrosion was observed in the area of the fracture. With regards to the second fracture, scanning electron microscopy found that three of the coil strands at the fracture had evidence of a stress induced fracture (fatigue appearance. The final strand's fracture mechanism could not be identified due to mechanical damage. Corrosion was observed in the area of the second fracture. The corrosion at the lead fracture sites provides evidence that stimulation was present for some time after the fractures occurred. Finally, an abraded opening in the inner and outer tubing at the location of one of the lead fractures. Two other abraded opening were identified in the outer tubing. These openings provided a leakage path for body fluids into the inner and outer tubing. No further anomalies were identified. Product analysis was completed on the returned generator. As received, the generator was in near end of service condition (neos-yes). A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and was in ifi-yes condition. No further relevant information has been received to date.

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« Reply #774 on: June 25, 2019, 12:57:54 AM »

Device Problems Fluid Leak; Fracture; Appropriate Term/Code Not Available
Event Date 12/18/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A physician assistant reported that (high) lead impedance was identified for a patient's device upon interrogation. The patient was referred for full revision surgery. Diagnostics were reported to be abnormal because (high) impedance was detected. Multiple parameter changes were undertaken to optimize efficacy and tolerability. Clinic notes were later received confirming that high impedance was observed and it was also mentioned the patient has noticed discomfort with the vns around the generator and left portion of her neck as though the setting is higher than normal. Settings were adjusted due to the impedance and pain. Patient is somewhat satisfied with seizure control, but not with vns side effects. During patient's previous appointment, high impedance was not observed and patient was satisfied with seizure control and side effects, indicating that the vns side effects are related to the high impedance. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision of the generator and lead. The reason for the replacement was high lead impedance. The explanted generator and lead were received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative
 
Event Description
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. However, due to mechanical distortion (smoothed surfaces the fracture mechanism cannot be ascertained. Also, a suspected inclusion was noted in one of the broken wires of the quadfilar coil. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #775 on: June 25, 2019, 12:58:39 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance; Mechanical Problem
Event Date 06/17/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the company representative was asked to attend a surgery she thought was only a generator replacement. However upon checking the device prior to surgery high impedance was observed. The lead and generator were then replaced. The explanted products have not been received to date. No additional relevant information has been received to date.
 
Event Description
The explanted lead and generator were received and are pending analysis. The lead's product information was identified following the explant. It indicated that the lead had been implanted for several years. A review of the diagnostic history from the internal database showed that impedance was within acceptable limits in the most recent history.
 
Event Description
Analysis was completed on the returned lead and generator. The generator case had scratches, tool marks and burn marks which are consistent with manipulation and exposure to electrocautery during the explant procedure. Upon interrogation the battery indicator was found to be ifi = yes. A series of interrogations and diagnostics were performed on the generator and the results were normal. During testing the generator performed to functional specification and passed electrical testing. The lead assembly was received in two pieces with the lead¿s pin still connected to the generator. The furthest electrode to the bifurcation was not returned for evaluation. Prior to decontamination a continuity check was performed while the lead pin was still inserted into the lead and the continuity check verified there was proper contact between the set screw and the lead pin was present. Visual analysis of the lead completed for both lead segments. It was found that the lead was tangled and the outer tubing was abraded in the segment which included the lead pin. In both segments the lead coils were kinked and the electrode was noted to be damaged and partially detached, this was potentially related to the explant procedure. A fracture was identified in the lead coil in the lead assembly that was not attached to the lead pin and therefore not part of the continuity check. Pitting was observed at the point of fracture which indicates that the stimulation was being provided while the fracture was present.

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« Reply #776 on: June 25, 2019, 12:59:42 AM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Adverse Event Without Identified Device or Use Problem
Event Date 12/09/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A report was received that the patient was experiencing discomfort at the generator site in their chest on (b)(6) 2018. The patient later provided that she had a fall in summer 2017 and since has complained of occasional burning up her lead. During a clinic visit on (b)(6) 2018 systems diagnostics were ran and it showed a result of high lead impedance. Follow-up from the patients¿ mother on (b)(6) 2018 provided that the patient was having continuous seizures and was taken to the er. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The diagnostics indicated high lead impedance. The surgeon stated he could see corrosion and fluid in the lead but no large visible breaks. The hospital would not return the explants to the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7275202
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dennis100
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« Reply #777 on: June 26, 2019, 05:58:41 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 01/08/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
High impedance was observed on a patient's device during generator replacement surgery due to low battery. System diagnostics indicated high impedance was present with the existing system. The existing generator was replaced, and high impedance was still present when an additional system diagnostic test was performed, indicating a problem with the existing lead. Using a test resistor, a generator diagnostic test was performed for the explanted generator and returned results within the normal limits, confirming proper function of the generator. The lead was then explanted and replaced with a new lead. The explanted lead and generator have not been received by the manufacturer for analysis to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: initial report inadvertently did not include updated device disposition. Device available for evaluation?, corrected data: initial report inadvertently did not include updated device disposition. Device evaluated by mfr?, corrected data: initial report inadvertently did not include updated device disposition.
 
Event Description
The explanted lead and generator were received for analysis. Analysis was approved for the generator. The low battery flag was properly set according to the as-received voltage of the generator. The device performed according to functional specifications. No abnormal performance or any other type of adverse condition was found with the performance of the generator. Analysis has not been approved for the lead to date.
 
Manufacturer Narrative

Event Description
Analysis was approved for the lead. Note that since a portion electrode array of the lead was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Three sets of set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once. Abraded openings were noted on the outer and inner tubing. A tear was identified in the connector boot, partially exposing the manufacturing id tag. A lead break was identified in the positive coil. Microscopy images of the positive coil show pitting and flat surfaces at the break location. No other anomalies were identified in the returned lead portions. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7240526
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dennis100
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« Reply #778 on: June 26, 2019, 05:59:29 AM »

Model Number 300-20
Device Problems Corroded ; Fracture; High impedance
Event Date 02/16/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient's generator would be replaced due to end of service, pulse disabled. Prior to surgery, the patient's impedance was within normal limits. After the generator was replaced, however, high impedance was observed the lead pin was cleaned then reinserted, but system diagnostics again showed high impedance. The lead was not replaced. The physician did not want to do any more testing. No visual anomalies in the lead were observed during this surgery. The explanted generator has been received but product analysis has not been completed on the returned generator to date. No further relevant information has been received to date. No known further relevant surgical intervention has occurred to date.
 
Event Description
The patient's lead and the generator (that replaced the generator in the initial mdr) were replaced due to high impedance. The suspect product was received but product analysis on the device has not been completed to date. Product analysis was completed on the first generator. End of service condition was verified. The generator performed according to functional specifications with no anomalies identified. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the returned generator. 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. Product analysis was completed on the returned lead. The lead was returned in 4 portions. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil break show that a stress induced fracture (due to rotational forces) has occurred on the quadfilar coil. Also, scanning electron microscopy images of the negative coil show that pitting or electro¿etching conditions have occurred in at least two strands of the quadfilar coil at the mating end. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7339638
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dennis100
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« Reply #779 on: June 26, 2019, 06:00:16 AM »

Model Number 302-30
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 02/20/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was seen at a routine post-op appointment. The patient had a recent generator replacement on (b)(6) 2018. The pa stated x-rays were taken to check the leads and they appear fine. The patient had surgery on (b)(6) 2018. Pin insertion was attempted but unsuccessful as high impedance still showed. The test resistor connected with the generator showed normal impedance therefore the lead was replaced which resolved the issue. The explanted lead has not been received for analysis to date. No additional or relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The explanted lead was received for analysis. Product analysis on the lead was completed and approved. An analysis was performed on the returned lead portion and the reported allegations of lead fracture were confirmed. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the end of the connector pin quadfilar coil appeared to be broken approximately 122 mm 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 and pitting on the coil surface. It is unknown if the break 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, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. With the exception of the discontinuity and abraded openings, the condition of the returned lead portion is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7343004
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