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dennis100
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« Reply #690 on: May 11, 2019, 01:15:32 AM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 02/21/2017
Event Type  Malfunction   
Event Description
It was reported by the physician that high impedance was detected on the patient's device. The patient's device was disabled to evaluate the efficacy of the device. Reportedly, the patient's seizures dramatically worsened after disablement and she was referred for surgery. The patient underwent full replacement of her generator and lead due to the high impedance. The suspect product has not been received to date. No further relevant information has been received to date.
 
Event Description
The suspect lead was received. Product analysis has not been completed on the suspect lead, to date. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the generator. The generator was placed in simulated body temperature and monitored for 24 hours. The generator provided the expected current during the entirety of the monitoring period. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The generator performed according to functional specifications with no anomalies found. Product analysis was completed on the suspect lead. The lead was returned in four portions. Pa verified the existence of lead discontinuities. Five fractures were identified. The majority of the coil fractures causes could not be determine due to electro etching, coil thinning, residual material or mechanical damage. One coil break was believed to be caused by stress. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. There were also inner and outer abraded openings of the tubing that provided a leakage pathway for fluids into the tubing. Setscrew marks were found on the lead connector pin which indicates that, at one point in time, a good mechanical and electrical connection was present between the generator and lead. No further anomalies were found no further relevant information has been received, to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6499196
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dennis100
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« Reply #691 on: May 11, 2019, 01:16:16 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's device was showing high impedance and limited output current delivered. It was stated that the physician could not see any lead breakage on the x-ray. The patient reported occasional pain around the generator site and an increase in seizures. From follow-up on the patient's seizures, it was stated that the patient's seizures were controlled, but suddenly began increasing again. The pain was reportedly random and infrequent. Lead revision surgery occurred, and it was stated that the surgeon had cut the lead and placed the new lead electrodes above the old electrodes which were left in place. Images of the explanted lead showed abraded openings and what appeared to be bodily fluid along multiple portions of the outer tubing. It was unclear based on the quality of the images if the inner tubing was compromised. It was reported that the explanted lead was not available to be returned to the manufacturer for analysis. No device was returned to date. No additional, relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8516917
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dennis100
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« Reply #692 on: May 14, 2019, 12:43:00 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 03/08/2017
Event Type  Malfunction   
Event Description
It was initially reported the patient was referred for vns generator replacement surgery due to normal battery depletion. During the generator replacement surgery, the lead was found to have a broken sheath, leaving the wire open and high impedance was observed. Due to the broken sheath and high impedance, the lead was replaced, and the generator was replaced due to the normal end of battery life. It was noted that full lead extraction was unsuccessful; therefore, the new lead was placed beside the old lead. There were no consequences post-surgery. The lead and the generator are expected to be returned to the manufacturer for analysis; however, they have not been received to date.
 
Event Description
Product analysis was completed on the returned lead portion. Note that the electrodes were not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. An abraded opening on the outer silicone tubing and abraded openings in the same location on both of the inner silicone tubes most likely provided the leakage path for what appeared to have once been body fluids in the outer and both outer silicone tubes. Due to the appearance of these findings, the cause may be related to patient manipulation, as the lead was also twisted in several areas. Although set screw marks were observed near the end of the connector pin and indentations were observed on the rear end of the small front o-ring ¿ which indicate the lead had not been fully inserted into the generator at one point in time ¿ there are additional set screw marks found on the lead connector pin in a typical location. Furthermore, programming data showed that lead impedance was within normal limits for at least three years after the previous implant surgery. Besides these observations, the condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed, and no discontinuities were identified. There is no evidence to suggest the presence of discontinuities in the returned portion of the device which may have contributed to the high impedance, although the entire lead was not returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6471823
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dennis100
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« Reply #693 on: May 14, 2019, 12:43:46 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/08/2016
Event Type  Injury   
Event Description
The nurse practioner is referring patient for full revision due to migration. Replacement was stated to be necessary because patient's current vns has migrated to the edge of the chest wall, rendering access very difficult. No known surgical interventions have occurred to date. Additional relevant information has not been received to date.
 
Event Description
Additional information was received that the device migration occurred between visits in (b)(6) 2016 and (b)(6) 2017. There are no known causes for the migration such as trauma or manipulation. Surgical intervention is planned to preclude a serious injury. The previous implant surgeon confirmed that a non absorbable suture was used to secure the generator to fascia during the implant. No known surgery has occurred to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead were received. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There are no performances or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway but has not been completed to date.
 
Event Description
Analysis of the received lead was completed. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the unmarked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6455535
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dennis100
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« Reply #694 on: May 14, 2019, 12:44:36 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/29/2017
Event Type  Malfunction   
Event Description
Clinic notes were received from a visit on (b)(6) 2017. The notes provide that the patient¿s vns showed high lead impedance. It was reported the patient¿s seizures were doing fairly well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explanted devices have not been received by the manufacturer to-date.
 
Event Description
The explanted devices were received 06/21/2017. Analysis is underway, but has not been completed to-date for the lead. Analysis was completed for the returned generator 07/06/2017. The generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. The measured battery voltage did not show a low battery condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was completed on the returned lead portion. A large portion of the lead assembly was not returned and therefore a complete evaluation could not be performed. The lead coils were broken in several locations. Scanning electron microscopy was performed, and the area had evidence of a fatigue stress fracture, fine pitting and rotational stress fracture which likely completed the fracture. Pitting and residual material were observed on the coil surface. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, likely provided the path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the inner tubing fluid, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process. No other anomalies were noted except the set of set screw marks observed near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator, at one point in time. An additional pair of set screw marks provide evidence that, at one point in time, a good mechanical and electrical connection was present.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6481653
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dennis100
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« Reply #695 on: May 18, 2019, 12:31:08 AM »

Model Number 302-30
Device Problems Fracture; High impedance
Event Date 02/09/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was found on the patient's device when interrogated. The patient had an x-ray performed where it was stated no break could be seen. The x-rays have not been reviewed by the manufacturer to date. The patient was referred for a lead replacement 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
It was reported that the patient underwent surgery where the vns generator was replaced and the high impedance resolved. No fractures were observed at the time of the surgery so the lead was not initially replaced. The explanted generator was tested on its own and found to be functioning properly. After the surgery the device was programmed on and intermittent high impedance was observed. This indicated that there might be an intermittent microfracture. The patient was returned to the operating room and the lead was replaced. Impedance was then within normal limits with the new lead and generator. The explanted lead and generator was discarded following the surgery.
 
Event Description
The manufacturer received two user facility medwatch reports related to the events previously captured in this report, (b)(4).
 
Event Description
It was reported that the explanted products were actually not discarded and were available for return. The products have not been received to date.
 
Manufacturer Narrative
Corrected data: describe event or problem; "the explanted lead and generator were received" this information was inadvertently left off on mfg. Report #3. Corrected data: device available for evaluation?; this information was inadvertently left off on mfg. Report #3.
 
Event Description
The explanted lead and generator were received and underwent product analysis. The generator performed to functional specification during analysis. No anomalies were observed during a series of diagnostic tests and interrogations. It was noted only a portion of the lead was received and the segment did not contain the electrodes. Upon visual analysis it was found that the lead¿s pin had two full sets of set screw marks, indicating proper contact between the generator and lead had existed at one point in time. However there was a single set screw mark near the end of the lead pin which indicated that proper contact was not occurring at one point in time. It was unclear when this partial connection occurred. The lead's connector boot was partially detached and there were abrasions near the connector boot. The reason for the partial detachment and abrasions was unknown. Abrasions were noted in the outer tubing in multiple locations and there was fluid inside the inner and outer tubing. The only obvious point of entry was the end of the lead that had been cut during the explant and the abrasions in the outer tubing. Continuity testing was performed on the lead and no discontinuities were identified within the returned lead portion. Other than the abraded outer insulation, no other anomalies were identified in the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6603299
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dennis100
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« Reply #696 on: May 20, 2019, 09:09:33 PM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 04/18/2017
Event Type  Malfunction   
Event Description
A report was received claiming that a patient's generator replacement procedure due to neos became a full revision surgery after discovery of a lead fracture. No pre-op interrogation or diagnostics were performed by the surgeon. After the new generator was implanted, diagnostics were run and revealed high impedance. The old generator was then interrogated, and system diagnostics confirmed the high impedance. After inspecting the lead, the circulating nurse identified the fracture in an area near the shoulder bone. The lead was then replaced.
 
Event Description
The explanted lead and generator were both returned to the manufacturer for analysis which has not been completed to date.
 
Event Description
The generator had analysis completed where it was confirmed that the generator performed according to all functional and electrical specifications. The device confirmed in its ability to properly measure impedance values. No anomalies were identified with the returned generator.
 
Event Description
Analysis was completed on the returned lead portions, but a portion of the lead assembly including the electrodes was not returned, so an evaluation could not be performed on the non-returned portions. A visual analysis was performed and found a lead break in the connector pin and connector ring quadfilar coils. Scanning electron microscopy (sem) was performed on the connector end of the connector pin coil break and identified an area on three of the broken coil strands which had evidence of a stress induced fracture. Sem of the electrode end of the connector ring coil break identified the area as having evidence of a stress induced fracture as well. Abraded openings were found on the inner and outer silicone tubes, which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids. The set screw marks on the connector pin provided evidence that, at one point in time, a good mechanical and electrical connection existed between the generator and the lead pin. No other anomalies were identified with the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6555722
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dennis100
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« Reply #697 on: May 23, 2019, 10:55:13 PM »

Model Number 304-20
Device Problems Fluid Leak; Fracture; Mechanical Problem
Event Date 04/18/2017
Event Type  Malfunction   
Event Description
A system diagnostic test was performed and showed high impedance. It was also reported that patient had been manipulating the device by rotating the generator in the surgical pocket. X-ray images were reviewed by the physician and reportedly confirmed a lead fracture had occurred. The patient had a full revision surgery to replace the fractured lead and generator, and the post-op impedance values were within normal limits. While in surgery, it was reported that the lead was extremely twisted and coiled up. The explanted lead and generator have not been received by the manufacturer to date.
 
Event Description
The explanted generator and lead were both returned for product analysis. Analysis was completed on the returned generator which confirmed that the generator had performed according to all functional specifications. All diagnostic tests resulted in impedance values within expected limits for the applied loads. Data from the generator revealed that high impedance was present prior to the generator being replaced. The analysis on the lead has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed on the returned lead portions, which did not include the electrodes. During the visual analysis, the outer silicone tubing had a twist and compressed appearance. Additionally, several abraded openings were identified on the lead tubing and the quadfilar coil was found to be broken approximately 3 mm from the electrode bifurcation. Scanning electron microscopy (sem) was performed on the broken coil and was unable to identify the coil fracture type. The abraded openings on the outer silicone tubing provided a leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The set screw marks found on the lead connector pin provided evidence that at one point in time, there was a good mechanical and electrical connection between the lead and generator. Other than the abraded insulation and the lead fractures identified in the lab, the condition of the returned lead was consistent with those typically seen following explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6547477
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dennis100
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« Reply #698 on: May 27, 2019, 10:47:40 PM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 05/18/2017
Event Type  Malfunction   
Event Description
It was reported that the patient had a full vns replacement surgery due to high lead impedance. Before the surgery, device diagnostics were performed which resulted in high impedance. When the surgeon implanted the new generator and attached it to the existing lead, device diagnostics also resulted in high impedance. The lead was then replaced. Once the new lead was connected to the new generator, diagnostics were performed and the impedance was within normal limits. The explanted generator and lead were received by the manufacturer and are undergoing product analysis. No additional pertinent information has been received to date.
 
Event Description
The returned generator and lead both had analysis completed. Visual examinations of the generator showed only observations consistent with the explant process; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs in a simulated body temperature environment. The pulse generator showed expected level of output currents and no signs of variation. 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 automated electrical evaluation showed that the pulse generator performed according to functional specifications. The generator data showed that high impedance was present prior to explant. The lead was returned in 3 pieces (281mm, 111mm, and 63mm), but the white electrode was not returned for analysis so a complete evaluation could not be performed on the entire lead product. Multiple abraded openings were identified on the 281mm portion of the lea. Additionally, a coil break was identified on this section of the lead, but scanning electron microscopy (sem) was unable to identify the coil fracture type due to extensive pitting. Low magnification sem analysis of the quadfilar coil showed characteristics typically associated with a lead break. Abraded openings were identified on multiple portions of the lead and provided the leakage path for dried remnants of what appeared to have once been body fluid inside the outer and inner silicone tubes. The set screw marks found on the connector pin showed evidence that, at one point in time, a good mechanical and electrical connection was present between the lead and the generator. Continuity checks of the remaining lead portions did not identify any further lead breaks. Other than the abraded openings and the identified lead break, no other anomalies were identified with the returned lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6649430
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« Reply #699 on: May 27, 2019, 10:48:42 PM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture; Appropriate Term/Code Not Available
Event Date 04/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a vns lead and generator replacement due to high impedance being observed. It was also noted that the patient was experiencing an increase in seizures. The physician reviewed x-rays of the patient and did not observe any obvious fractures however the patient¿s mother reported that the patient ¿messes with it all the time¿. X-rays were reviewed by the manufacturer and no obvious fractures were observed. Based on the ap view there appeared to potentially be a sharp angle in the region of the lead near the strain relief, however due to the quality of the image this could not be confirmed in the lateral view. Also due to the quality of the image provided the integrity of the lead near the lead pin could not be assessed. The connector pin did appear to be fully inserted into the generator and the generator¿s feed thru wires appeared intact. Based on the images provided no obvious source of the high impedance could be identified. It should be noted that the presence of a microfracture cannot be ruled out. It was later reported that the patient's family decided to disable the device before going forward with surgery. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was further clarified that the increase in seizures began approximately a month prior to the high impedance warning being observed. At a later follow-up visit it was reported the patient continued to be experiencing an elevated seizure frequency and the patient's parents decided to change the patient's prescription medications rather than replacing the vns device.
 
Event Description
Patient plans to undergo full revision surgery. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The surgeon took out the old generator but in the process he bent the header too much to where it broke the seal on one side. The new generator was connected to the lead and system diagnostics was performed again resulting in high impedance and >10,000 ohms. The lead was thus taken out. The surgeon noted that the lead wire was completely separated from the silicone cover in the middle portion. The surgeon was able to remove one of the electrodes but the other two helices were left on the nerve. The new lead electrodes were placed above the old electrodes. The explanted devices have not been received to date.
 
Event Description
The explanted generator and lead were received. 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 in the pa lab. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 011 volts , shows an ifi=no condition. The data in the generator memory locations revealed that 13. 112% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway and has not been completed to date. In addition, the header was partially detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was separated from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during the explant process. This will not be coded as it is due to explant process.
 
Event Description
Break was identified in the positive coil at two locations. Also, abraded openings were identified in the positive and the negative lead coils. Scanning electron microscopy of the positive coil show that pitting or electro etching conditions occurred at the 1st break location. Also, scanning electron microscopy images of the positive coil breaks (break-1 mate end, and break-2 ends) showed what appears to be wear (flat surfaces) on the coil strands, resulting in a reduction of the diameter of the quadfilar coil strands up to the break point. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6646622
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dennis100
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« Reply #700 on: May 27, 2019, 10:49:24 PM »

Model Number 304-20
Device Problem Fluid Leak
Event Date 05/23/2017
Event Type  Malfunction   
Event Description
It was reported that during a patient's generator replacement surgery, fluid was identified inside the lead body. The physician indicated that because the impedance values were still within normal limits, he would not remove the lead and would leave it in place. Follow-up was performed with the physician but there were no notes on how severe the fluid leaks were. No further relevant information has been received to date.
 
Event Description
The explanted generator had analysis completed which showed that the device worked as intended throughout the known history. The data from the generator history showed that the impedance prior to explant was within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6647820
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« Reply #701 on: May 30, 2019, 05:44:37 AM »

Model Number 302-20
Device Problem Fracture
Event Date 05/10/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's device had high impedance, which caused low output current, on (b)(6) 2017. The patient was seen about two months prior, and there were no issues. However, the patient did have a fall between the office visits, which the physician believed was the cause of the high impedance. The patient was referred for lead revision surgery, but no surgery has occurred to date.
 
Event Description
The patient had full revision surgery. The generator and lead were received, but analysis has not been approved to date.
 
Event Description
Analysis on the generator was approved. The device performed according to functional specifications and was at an ifi=no battery condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis on the lead was also approved. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The connector ring quadfilar coil appeared to be broken near the end of the connector boot. Scanning electron microscopy was performed on the connector end of the connector ring quadfilar coil break and identified the area as being mechanically damaged with fine pitting which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the connector ring quadfilar coil break and identified the area as having evidence of being worn to the point of fracture with mechanical damaged. Pitting and flat spots were observed on the coil surface. The connector ring quadfilar coil appeared to be broken past the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the outer and inner silicone tubes and slice mark on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities and abraded openings, 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 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 portion were performed, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6610159
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« Reply #702 on: May 30, 2019, 05:45:56 AM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 04/12/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient was referred for a full revision. Clinic notes were received from visits on (b)(6) 2017 regarding a full revision for high impedance. On (b)(6) 2017 it was provided that the patient's seizure control is worse since the last visit. The physician stated that the vns had high lead impedance. On the visit on (b)(6) 2017 x-rays were reviewed and it was provided that the lead has fractured upon review of the x-rays. Surgery occurred and 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. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The battery measured 2. 947 volts during the electrical test, and shows the battery was not at an end-of-service condition. The data showed that 80. 131% of the battery had been consumed. An 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 attributed to clinical use of the device. Analysis was completed for the returned lead portions. The coil appeared to have dissolved in some areas with a greenish tint observed inside the inner silicone tubing. The connector pin coil appeared to be broken scanning electron microscopy was performed coil break and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type. The remaining broken coil strand appeared to be mechanically damaged. 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. What appeared to be white deposits were observed in various locations. No other 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6614319
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« Reply #703 on: May 30, 2019, 05:46:47 AM »

Model Number 302-20
Device Problem Fluid Leak
Event Date 05/30/2017
Event Type  Malfunction   
Event Description
It was reported that during prophylactic generator replacement surgery, the surgeon noted some cream-colored discoloration in the lead near the lead pin. Follow up with the company representative revealed that the surgeon was unsure, but speculated that there was a cream-colored fluid inside the insulation. There were no infections noted or observed. The surgeon inspected all of the visible lead for damage and none was observed. Multiple diagnostic tests were ran and all were within normal limits. The surgeon determined that the lead could be left in. No additional relevant information has been received to date.

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« Reply #704 on: June 01, 2019, 03:17:03 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 07/02/2016
Event Type  Malfunction   
Event Description
It was reported that the patient's device had high impedance. The physician programmed the output current off and ordered x-rays. The patient was referred for full revision surgery. No surgical intervention has occurred to date.
 
Event Description
Further information was received that the patient received a full revision surgery. High impedance and device disablement were confirmed prior to replacement. During the replacement surgery, it was reported that the electrodes were torqued and pulled on the vagus nerve, but the electrodes remained attached to the nerve. One tie-down was found. The surgeon reportedly did not see any gross lead fractures. The generator and lead were replaced which resolved the high impedance. The products were received, but analysis has not been approved to date. No further relevant information has been received to date.
 
Event Description
Product analysis was completed on the generator. The generator was able to be interrogated and system diagnostics were performed using different load resistors. Results were normal. The data from the generator was also reviewed. The measured battery voltage was slightly lower than expected based on the expected charge consumed because of the excess battery drain from high impedance. The data also showed when the 599. 2% change in measured lead impedance from normal impedance to high impedance occurred. No other relevant information has been provided to date.
 
Event Description
Product analysis was completed on the lead. The lead was returned in four parts including one loose tie-down. The electrodes were not returned and could not be evaluated. During the visual analysis of one of the returned portions, the coil appeared to be broken near the electrode bifurcation. Scanning electron microscopy was performed 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 these broken coil strands. The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture with mechanical damage and pitting. Pitting was observed on the coil surface. Abraded openings were also seen on the outer tubing and allowed fluid entry into the outer tubing. No other visual anomalies were seen besides the typical wear normal found after an explant procedure. 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 and other discontinuities were found. No relevant information has been obtained to date.

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« Reply #705 on: June 02, 2019, 12:52:28 AM »

Model Number 304-20
Device Problems Corroded ; High impedance; Mechanical Problem; Low impedance
Event Date 06/09/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was seen on the patient's device. The physician considered programming the patient's device off but was not sure if she should because the patient still had good seizure control. The device history records of the generator and lead were reviewed, and both devices performed to specification prior to release. The physician decided to only decrease the patient's settings since the patient wasn't having any issues associated with the high impedance and was still seizure free. There was also no known cause of the high impedance, such as trauma. No surgical intervention has occurred to date.
 
Event Description
The patient was seen again, and low impedance was present on the patient's device. The patient's device was programmed off. No surgery has occurred to date.
 
Event Description
Lead revision surgery occurred. The explanted device has not been received by the manufacturer to-date.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided on follow-up report#2 that the device had been received by the manufacturer. Device available for evaluation, corrected data: the date the device was received was inadvertently not provided on follow-up report#2.
 
Event Description
The explanted device was received by the manufacturer. Analysis was completed on the returned lead portions. Visual analysis identified broken coils approximately 1. 5 mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged with fine pitting on one of the broken coil strands. The area on the remaining broken coil strands was identified as having evidence of a fatigue stress induced fracture with mechanical damage, no pitting and evidence of a rotational stress induced fracture which most likely completed the fracture. A flat spot was observed on the coil surface. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. 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 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.

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« Reply #706 on: June 02, 2019, 12:53:23 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 06/01/2017
Event Type  Malfunction   
Event Description
It was reported that high lead impedance was discovered on the patient's vns system. Surgery to replace the vns lead was completed. The explanted lead has not been received by the manufacturer to date. No additional pertinent information has been received to date.
 
Event Description
The explanted lead was received by the manufacturer, but analysis has not been approved to date. No additional relevant information has been received to date.
 
Event Description
Analysis was approved for the explanted lead on (b)(6) 2017. The coil of the connector ring appeared to be broken in several locations along the lead. Microscopy identified the break to show evidence of a stress induced fracture with mechanical damage due to fatigue, pitting, and a stress induced fracture due to rotational forces. Mechanical damage in some places prevented the fracture type from being identified. Abraded openings were observed on the outer and inner silicone tubes in several locations that likely contributed to the dried fluid remnants found inside the lead insulation. 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. No additional relevant information has been received to date.

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« Reply #707 on: June 03, 2019, 04:35:14 AM »

Model Number 302-20
Device Problems Fluid Leak; Adverse Event Without Identified Device or Use Problem
Event Date 07/25/2017
Event Type  Malfunction   
Manufacturer Narrative
Device evaluated by mfr? na. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient was going for a vns explant due to the device being uncomfortable for patient and not working. Per a battery life calculation, the device would have reached eos prior to 2010. Therefore the device not working is likely due to battery depletion. The nurse mentioned that the patient had the surgery due to discomfort. Information regarding location of the discomfort and the onset of pain is unknown. The nurse mentioned that the surgery was done because patient requested it. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Further information was received that the lead was also explanted when the generator was explanted. No further relevant information has been received to date.
 
Manufacturer Narrative
The initial mdr indicated that device evaluation was not necessary as reported event(s) were not related to the functionality or delivery of therapy of the device. After the lead was returned and analyzed, a malfunction was found. This lead malfunction may have contributed the reported event as the cause of the reported event was not determined. Therefore, adverse event or product problem, corrected data: follow-up report #1 inadvertently did not include product problem suspect medical device, corrected data: follow-up report #1 inadvertently did not change the suspect device to the lead from the generator. Device code-event problem codes , corrected data: follow-up report #1 inadvertently did not include 1250, fluid leaks as a code. Type of reportable event, corrected data: follow-up report #1 inadvertently did not select 'malfunction' if follow-up what type?, corrected data: follow-up report #1 inadvertently did not select "device evaluation" device evaluated by mfr?, corrected data: follow-up report #1 inadvertently did not select "yes".
 
Event Description
Further information was received that product analysis was completed on the generator. Other than typical explant procedure related observations, no surface abnormalities were noted on the generator. An open can measurement of the battery voltage determined that the battery was depleted. The generator was unable to be interrogated due to this depleted battery condition. The generator performed according to functional specifications. Product analysis was also completed on the returned lead. A section of the lead assembly was returned for analysis in one piece, but the lead's electrodes were not returned for evaluation. 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. Abrasions were noted on the connector boot. Abrasions were noted on the outer silicone tubing at multiple locations. The outer silicone tubing had a compressed appearance at multiple locations. The outer silicone tubing had what appeared to be internal abrasions at multiple locations. Abrasions most likely caused by the presence of a tie-down were noted. The inner silicone tubing of the lead coils is abraded open. The lead assembly had 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. No anomalies or discontinuities were found. An evaluation could not be made on the portion that was not returned. No further relevant information has been received to date.

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« Reply #708 on: June 03, 2019, 04:36:01 AM »

Model Number 302-UNK
Device Problems Fluid Leak; Fracture; High impedance
Event Date 08/02/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's impedance was high on normal mode diagnostics. The physician indicated that per the x-ray, there were no obvious fractures found.
 
Event Description
It was reported that the patient underwent generator and lead replacement surgery due to high impedance. Prior to the surgery, high impedance was again detected on the generator. The surgeon noted a fracture in the lead with fluid in the body of the lead. There were no signs of trauma around break and the patient's mother didn't report any trauma at the lead break site. Product return of the lead is not expected. No further relevant information has been received to date.

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« Reply #709 on: June 05, 2019, 12:31:24 AM »

Model Number 302-20
Device Problems Fluid Leak; Mechanical Problem
Event Date 07/18/2017
Event Type  Malfunction   
Event Description
Report was received that a patient's lead was seen extruding from his chest. A system diagnostic test was performed at this time and resulted within normal limits. Surgery was taken to correct the extrusion. While the patient was in the or, it was visually found that the outside of the lead was stripped and inner metal exposed. This led to the explant of the generator and part of the lead. The surgeon denied performing any actions that caused the abraded insulation while performing the surgery for extrusion. The surgeon also indicated he did not know the cause of the extrusion. Antibiotics were reportedly prescribed by the patient's neurologist as a precautionary measure to prevent infection. No active infection was reported. A review of the lead device history record showed it had been properly sterilized prior to release for distribution. No other relevant information has been provided.
 
Event Description
Further information was received that the explanted lead and generator were received by the manufacturer. Product analysis has not been completed and approved to date. No further relevant information has been obtained to date.
 
Event Description
Product analysis was completed on the lead. The lead was returned in one piece connected to the generator. A continuity check showed there was proper contact between the set screw and lead pin. Multiple cut openings were found on the outer silicone tubing. Parts of the inner silicone tubing of the lead coils also showed some cut openings in the lead coils. These may have been caused by the cut openings from the outer tubing likely from explant. Kinks in the lead coils were found along parts of the lead assembly. There were also abraded openings found along parts of the outer tubing. Remnants of bodily fluid was found in the inner and outer tubing. The bodily fluids in the inner tubing likely entered through the cuts made during explant. There were no discontinuities found with the returned lead portion. An evaluation could not be completed on the part of the lead not returned. No other anomalies except for the normal wear from explant were found with the lead portion. Product analysis was also completed on the generator. It was found that the generator performed according to all functional specifications. No abnormalities were seen on the generator besides typical wear seen in the implant and explant procedure. A review of the data dump from the generator did not indicate there was a possible break. No further relevant information has been received to date.
 
Event Description
Further information was received that the wound from the extrusion had not completely healed. It was reported that about a month after the explant of the lead and generator, the patient returned for debridement of the wound. It was said that there was "serious drainage" seen. When the patient was later seen, it was said that there was a wound on the chest with exposed wire. This wire was likely the remaining lead that was left implanted after some of it had been previously explanted. Further information was received from the neurologist that she believed the entire wound had not healed. She reportedly wanted the remaining lead removed as it had caused redness on the patient's neck likely from rubbing underneath the skin. It had also possibly begun to extrude from the patient's previous wound. Redness was noted at the generator site. No other further relevant information has been obtained to date.
 
Event Description
Further information was received that the remaining implanted lead was removed from the patient. The two electrodes and the anchor were reportedly left around the vagus nerve, but the rest of the lead was removed. This explanted lead was reportedly discarded. No additional relevant information has been received to date.

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« Reply #710 on: June 06, 2019, 01:55:03 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
Patient underwent explant of vns generator and lead as patient felt that it never helped. The device was reported to have been disabled for years prior to explant. Analysis was performed on the returned lead portions. During the visual analysis, the lead coil appeared to be broken. Scanning electron microscopy was performed on the coil break and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. Two of the broken coil strands appeared to have evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Residual material was observed on the coil surface. The remaining broken coil strands were identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (rotational forces) 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 and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. 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 on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon and phosphorus. With the exception of the observed abraded openings and discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Since a portion of the lead assembly including the electrode array section was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #711 on: June 07, 2019, 04:55:08 AM »

Model Number 302-30
Device Problems Low impedance; Device Contamination with Body Fluid
Event Date 04/12/2019
Event Type  Malfunction   
Event Description
Patient presented for low battery generator replacement. The generator was unable to be interrogated due to the depleted battery. After the generator was replaced low impedance was observed on the replacement generator upon interrogation. The surgeon then proceeded with replacing the lead. It was noted that the generator site was irrigated and that it was ensured that the pin was properly inserted multiple times and the low impedance did not resolve. During lead revision, it was noted that the lead was cracked and that there was fluid inside of the lead. The explanted product has not been received by product analysis. No other relevant information has been received to date.

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« Reply #712 on: June 08, 2019, 04:58:11 AM »

Model Number 302-20
Device Problem Device Contamination with Body Fluid
Event Date 04/16/2019
Event Type  Malfunction   
Event Description
It was reported that during a generator replacement due to battery depletion, the surgeon observed fluid in the lead tubing. For this reason he determined to revise the lead as well. No opening in the tubing was observed. X-rays prior to surgery showed no evidence of a lead break. The suspect product was returned to the manufacturer. The return form indicated that the reason for explant was battery depletion, fluid in lead, and the patient feeling muscle spasms with stimulation. Analysis on the returned product has not been completed to date. No further relevant information has been received to date.

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« Reply #713 on: June 10, 2019, 12:21:13 AM »

Model Number 302-20
Device Problem Fracture
Event Date 08/16/2017
Event Type  Malfunction   
Event Description
Report received that high impedance was found after performing system diagnostics on new generator in the operation room. The patient was scheduled for a generator replacement due to battery depletion, and the generator was unable to be interrogated. When the new generator was implanted and connected to the lead, a system diagnostic was run and showed high impedance. The lead was explanted. Further information was received that during the surgery, the lead pin was confirmed to be inserted into the generator properly. Generator diagnostics were also performed on the new generator and the results showed normal impedance. A review of the programming history did not indicate whether or not high impedance was seen prior to the replacement. Recent system diagnostics prior to surgery could not be provided by the patient's physician. The lead and generator were explanted and received by the manufacturer, but analysis has not been approved to date. No other relevant information has been provided to date.
 
Event Description
Product analysis was completed on the generator. The generator could not be interrogated due it reaching normal battery depletion. A review of the generator data showed a 26. 3% change in impedance. The pre and post change impedance values were both normal. The data did not show the onset of high impedance as the battery became too depleted to perform automeasures for impedance. The measured battery voltage was consistent with the estimated charge consumed. No further relevant information has been received to date.
 
Event Description
Further information was received that product analysis was completed on the lead. The lead was returned in two portions. Visual examination showed one portion had stretched and kinked quadfilar coils. On this portion, set screw marks were present and white deposits were observed in various locations. Abrasions were also noted on the connector boot. Dried remnants of what appeared to be bodily fluids were inside the outer silicone tubing. Other abraded openings were seen along the outer tubing of this portion. On the second portion, white deposit was also seen. Besides typical markings and damage associated with explant, no visual anomalies were noted. No discontinuities were found during the continuity checks for the returned portions. However, there was a portion of the lead which included the electrodes which was not returned for analysis and an assessment on that portion could not be made. No further relevant information has been received to date,.

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« Reply #714 on: June 11, 2019, 12:26:58 AM »

Model Number 302-20
Device Problem Fluid Leak
Event Date 09/22/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for vns generator replacement surgery due to an intensified follow-up indicator, or ifi, condition. During the replacement surgery, it was found that the lead was in a knotted state wrapped around the lead connector pin. It was also reported that the insulation was opened was compromised. Images of the lead condition were reviewed by the manufacturer. There appeared to be an opening in the lead insulation and fluid in the lead. The patient underwent a full vns replacement surgery as a result. Follow up with the company representative revealed that the patient was not a known twiddler and that there was no known trauma or patient manipulation that could have contributed to the condition of the lead. It was reported that the vns was still secured via suture when the patient underwent surgery. The explanted generator and lead have not been received by the manufacturer to date. No additional relevant information has been received to date.

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« Reply #715 on: June 12, 2019, 02:24:45 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 09/18/2017
Event Type  Malfunction   
Event Description
Report received that a patient presented with a bad lead. It was later reported that a system diagnostics test was performed and showed high impedance. No further relevant information has been received and no surgical intervention has occurred to date.
 
Event Description
Further information was received that the patient's lead was replaced. After explant, the manufacturer representative noted that a weak spot was present and fluid was found inside the tubing. The lead was reportedly discarded by the hospital after explant. No further relevant information has been received to date.

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« Reply #716 on: June 15, 2019, 11:06:01 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.

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« Reply #717 on: June 17, 2019, 04:12:24 AM »

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.

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« Reply #718 on: June 17, 2019, 11:11:06 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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« Reply #719 on: June 17, 2019, 11:11:56 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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