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dennis100
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« on: September 17, 2018, 11:20:16 AM »

Model Number 106
Device Problems Detachment Of Device Component; Mechanical Problem
Event Date 02/14/2018
Event Type  Malfunction   
Event Description
Analysis on the generator was approved. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the device performed according to functional specifications. Each of the returned torque wrenches secured a bench setscrew (each torque wrench made audible clicks) onto a bench lead and extracted the bench setscrew with no issues (lab conditions). In addition, review of the data downloaded from the pulse generator revealed diagnostics were performed, and an acceptable impedance value was obtained on the date of surgery. The setscrew and septum were not returned for evaluation. The header septum cavity met specification requirements. There were no performance or any other type of adverse conditions found with the pulse generator. No further relevant information has been received to date.
 
Event Description
It was reported that the surgeon was unable to tighten the set screw into the generator during an initial implant surgery. It was unknown if the set screw was stripped or if there was another issue. The surgeon eventually applied so much force that the polyethylene header assembly came off the generator can and fell on the floor. The surgeon and company representative were unable to find the set screw as it came out of the header, but it was confirmed that the screw did not fall into the patient. A different generator was then implanted. The device history record of the generator was reviewed, and the device conformed to all functional specifications prior to release. The generator was received, but analysis has not been approved to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7335839
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dennis100
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« Reply #1 on: September 17, 2018, 11:29:51 AM »

Model Number 104
Device Problem Detachment of Device or device Component
Event Date 07/27/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that during a vns replacement surgery high impedance was occurring with the replacement generator (reported in mfr report# 1644487-2018-01451). During the attempts to re-insert the lead pin, the setscrew of the generator became stripped and the septum plug came out. A different generator was used to complete the surgery. The generator has been received by the manufacturer where analysis is underway, but has not been completed to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7801456
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dennis100
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« Reply #2 on: September 17, 2018, 11:31:08 AM »

Model Number 102R
Event Date 11/27/2011
Event Type  Malfunction   
Event Description
Product analysis of the explanted lead and generator has been completed. Note that a large portion of the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. The septa of the explanted generator were not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation" and "stimulation to unintended site"). A window was cut into the pulse generator case to access the feed-thru output connections on the substrate. Bench test connectors were attached to the negative and positive feed-thru wires, at the substrate, to perform a final electrical test. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. It is very likely that the identified, "detachment of component(s) header", occurred while the generator was implanted, and is related to patient trauma. Other than the header observation, there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported on (b)(6) 2011 that a vns patient walked into a door and the edge of the door hit the patient in the chest close to the generator site. Immediately following the hit, the patient began to feel stimulation more intensely in his neck and continued to feel the stimulation however the intensity lessened over time. Systems diagnostics were performed which resulted in ok/ok/1/no but normal mode diagnostics resulted in 7/limit/high. The device was programmed off and the patient was referred for x-rays. The patient's output current is 2. 75 ma. On (b)(6) 2011, systems and normal mode diagnostics were repeated which resulted in 7/limit/high/no. The patient was scheduled for a surgical consult and x-rays were sent to the manufacturer for review. A review of the x-rays did not show any anomalies however it was noted that in a certain portion of the lead, the lead was twisted onto itself suggesting some sort of patient manipulation or trauma. Clinic notes were received dated (b)(6) 2011 where the device was found to be programmed to 2. 75/30/500/30/3/3/500/30. Systems diagnostics resulted in ok/ok/1/no and normal mode diagnostics resulted in 7/limit/high/no. The device was programmed to 0 ma due to the high lead impedance and the patient's aeds were adjusted to compensate for the patient not receiving vns therapy. The notes indicate that following the trauma to the generator site, the patient felt discomfort in the throat with device stimulation. He also has an increase in his cough reflex. The patient had reportedly tolerated his settings until the trauma to the generator site and using the magnet to temporarily disable the device did not help. The discomfort occurred for 24 to 36 hours but has slightly lessened in intensity. If the patient was setting up and leaning forward, the discomfort was not as bad. The patient weighs (b)(6). Good faith attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Additional information received revealed that during revision surgery, the generator site was opened and the header of the generator had separated from the can. The lead itself appeared to be intact. With the generator header separation, lead impedance could not be assessed so a full revision was performed where the lead and generator were explanted and replaced. The explanted products have been returned to the manufacturer and product analysis is currently being performed. The dhr for the generator was reviewed and no non-conformances or other adverse conditions were noted in the generator's dhr.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no non-conformance or other adverse conditions with the generator prior to shipment. Brand name, corrected data: initial report indicated the lead was the suspect device however new information received indicates the issue was most likely caused by the detachment of the generator header. Type of device, name, corrected data: initial report indicated the lead was the suspect device however new information received indicates the issue was most likely caused by the detachment of the generator header. Model #, serial #, lot#, expiration date, corrected data: initial report indicated the lead was the suspect device therefore the lead model number, serial number, lot number, and expiration date were provided however new information received indicates the issue was most likely caused by the detachment of the generator header. Manufacturer date, corrected data: initial report indicated the lead was the suspect device therefore the lead manufacturer date was provided however new information received indicates the issue was most likely caused by the detachment of the generator header.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2389370
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dennis100
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« Reply #3 on: September 17, 2018, 11:31:58 AM »

Model Number 304-20
Device Problem Mechanical Problem
Event Date 12/21/2016
Event Type  Malfunction   
Event Description
It was reported that in an initial implant case, the second electrode of the lead appeared to be bent and have a metallic "foil-looking substance" wrapped around it. The issue was immediately discovered as the implanting surgeon was attempting to wrap the electrode around the vagus nerve. The implanting and attending surgeons observed that it appeared the lead had ¿extra coiling. ¿ by their account, there was apparently extra material, as if it was thicker than normal. The lead device history record was reviewed and found that all specifications were met prior to distribution. The lead was not implanted and was returned to the manufacturer. Product analysis on the lead is underway.
 
Manufacturer Narrative
 
Event Description
Product analysis for the returned lead was completed. The closest electrode to the bifurcation was damaged, showing bends on the electrode ribbon and partial detachment from the silicone helix. This silicone helix also exhibits what appear to be tool imprints. The most likely reason for the observed damaged to the closest electrode was manipulation of the lead not consistent with vns labeling. The measured dimensions were within the specified tolerances. Resistance values were within tolerances and exhibited no evidence of discontinuities. Other than the above mentioned observations and typical conditions that exist after a surgical procedure, no anomalies were identified in the returned lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252939
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dennis100
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« Reply #4 on: September 17, 2018, 11:32:49 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/25/2018
Event Type  Injury   
Manufacturer Narrative
Describe event, corrected data, initial mdr inadvertently reported that the surgery was due to the migration while in fact the migration was discovered during surgery, while the surgery was already being performed for prophylactic reasons.
 
Event Description
During a prophylactic generator replacement surgery for this patient¿s m102r to a m104, while removing the m102r, it was observed that the header of the device had become detached from the generator. It was unclear exactly when the header had become detached. The patient had a significant amount of breast tissue and the generator was beneath the nipple, so the or specialist believed that the header detachment occurred as a result of the physician trying to get the generator out of the patient's body with the clamp and due to a lot of scar tissue. It was also stated that the battery migrated far away from where it was implanted. He interrogated the m102r after explant and saw that the battery was ok, but that no current was being delivered. The surgeon stated that the battery must have not been sutured down in one of the previous 2 surgeries. There was a lot of tissue and adhesions, so the battery was hard to get to and took time. The explanted generator was received for analysis and analysis is underway but has not been completed to date. No additional or relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
Product analysis for the generator was completed and approved. Diagnostics testing during the implant period did not report a high impedance condition. After a window was cut into the can to attach wires and test leads to make output connections to the final test fixture, the device performed according to functional specifications of the current automated final test 102. Other than the header anomaly, there was no performance or any other type of adverse condition found with the pulse generator. The header detachment was found to be possibly explant related. During the initial report, there was no indication that the surgery was for suspected migration. The surgery was only performed prophylactically and then migration was seen during surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7525800
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dennis100
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« Reply #5 on: September 17, 2018, 11:33:44 AM »

Model Number 302-20
Event Date 10/06/2011
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies causing high impedance. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by the physician that the patient had high impedance on diagnostic testing. There was no known cause for the impedance issue. Further information in the patient's clinic notes stated the last known good diagnostics had been performed (b)(6) 2010. The patient was being referred for a revision surgery. Attempts for further information have been unsuccessful.
 
Event Description
On (b)(6) 2012, it was discovered that after the patient's full revision surgery, the lead impedance was within normal limits. Product analysis on the generator was completed on (b)(6) 2012. The generator performed according to functional specifications and there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Product analysis of the lead was completed on (b)(6) 2012. The electrode array portion of the lead was not returned for analysis, therefore a full evaluation and commentary on the entire lead could not be made. Scanning electron microscopy image of the connector ring shows that pitting or electro-etching conditions have occurred on the ring. The exact reason for this condition is unknown. The lead connector has partial detachment at the ring/backfill interface. No adverse effect was identified on the device performance as a result of this condition. The outer silicone tubing was abraded open in multiple locations. The lead assembly had remnants of what appears to be dry body fluids inside the inner and outer silicone tubing. No obvious points of entrance were noted other than the end of the returned lead portion. Other than the mentioned observations and typical wear and explant related observations, no additional anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(6) 2011, when it was discovered that the vns patient had a full revision surgery that day. The generator was replaced for prophylactic reasons and the leads were replaced due to high impedance. The nurse practitioner later reported that no x-rays had been taken. She also reported that no trauma or patient manipulation occurred that is believed to have caused or contributed to the high impedance. The patients settings are output=1. 5ma/on time=21sec/off time=1. 1min. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(6) 2011, that has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2340410
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dennis100
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« Reply #6 on: September 17, 2018, 11:35:10 AM »

Model Number 102
Event Date 04/01/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(4) 2012 when product analysis was completed on the explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. 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 and there were no performance or any other type of adverse conditions found with the pulse generator. Product analysis of the lead was completed on (b)(4), 2012. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portions. Setscrew marks were seen on the connector pin towards the end tip of the pin, providing evidence that contact between the setscrew and the lead pin existed, however the location of the setscrew marks suggest that the connector pin was not inserted completely at one point in time. The exact point in time of when this occurred is unknown. However, based in the location of the setscrew marks on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator "+" and "-" terminals and the lead connector respective contact points existed at least once. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. The outer silicone tubing was abraded open at approximately 34cm from boot. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.
 
Event Description
It was reported that the pt was to have revision surgery for an unk reason. Further info reveals that the pt was experiencing an increase in seizures in (b)(6) 2011. System and normal mode diagnostics were within normal limits. The pt underwent revision surgery due to clinical symptoms on (b)(6) 2011. Attempts for further info and product return have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(4), 2012 when the explanted products were received by the manufacturer for product analysis. Product analysis is still underway and has not yet been completed. Although the returned product form filled out by the hospital states that the reason for surgery was a lead discontinuity, the neurologist stated that the reason for surgery was actually because the patient was experiencing a worsening of seizures and not a lead discontinuity. A battery life calculation was performed which showed 3. 21 years until the elective replacement indicator showed yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2161855
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dennis100
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« Reply #7 on: September 17, 2018, 11:36:10 AM »

Model Number 302-20
Event Date 07/19/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013, the implant card was received for the patient's replacement surgery on (b)(6) 2013. The card indicates that the patient's lead had high impedance of greater than 10,000 ohms. The return product form received states that the reason for explant was that the lead was disconnected from the vagus nerve. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution. The explanted lead was returned on (b)(6) 2013. Follow up found that the device was programmed off to 0ma at an unknown date. No other details concerning the programming history were provided. No x-rays were taken. No patient manipulation or trauma is suspected. The reason for the detachment of the lead from the explant is unknown. The patient's lead was disconnected from the vagus nerve and replaced. No other information has been provided.
 
Event Description
A break was identified in the positive coil. Scanning electron microscopy images of the positive coil show that pitting or electro¿etching conditions have occurred at the break location. However, due to pitting, surface contamination and mechanical distortion (smoothed surfaces) the fracture mechanism cannot be ascertained. The lead assemble had remnant of dry body fluid inside the 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=3286206
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dennis100
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« Reply #8 on: September 17, 2018, 11:38:04 AM »

Model Number 105
Device Problem Detachment Of Device Component
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient's generator had been replaced due to low impedance. During the replacement, the generator was removed and it was visually found that the header of the generator was broken. The patient's neurosurgeon believed this was caused by the patient manipulating the generator with hands. The low impedance will be reported on mfr. Report #1644487-2018-01065. The generator is not available to be returned for analysis. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7631460
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dennis100
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« Reply #9 on: September 17, 2018, 11:38:48 AM »

Model Number 103
Event Date 11/18/2011
Event Type  Injury   
Event Description
It was reported that a vns patient implanted on (b)(6) 2011 had the generator and lead explanted on (b)(6) 2011 due to an infection at the generator site. The infection first was observed on (b)(6) 2011. Additional information received revealed that the infection was most likely due to wound management during/post surgery. It was unknown if there was any manipulation or trauma and no cultures were taken. The dhr of the generator was reviewed and sterility prior to shipment was confirmed.
 
Event Description
Product analysis was completed on the patient's explanted lead and generator. The generator analysis was completed. Results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The lead body was returned for analysis. It was identified that the small o-ring boot has partial detachment from the pin. The reason for this condition is unknown. Visual analysis of the connector pin show that pitting or electro-etching conditions have occurred on the pin surface. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead assembly has remnants of what appears to be dry body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the end of the returned lead portion. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the coils. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Additional information was received on (b)(6), 2012 it was reported that the vns patient underwent re-implant surgery. The explanted generator and lead were returned for product analysis on (b)(6), 2012. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2362510
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« Reply #10 on: September 17, 2018, 11:39:32 AM »

Model Number 302-20
Event Date 01/20/2010
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that high lead impedance was read in system diagnostics during a follow up visit with the treating neurologist. The patient had reported an assault and trauma to the neck area in (b) (6) 2009. System diagnostics were fine (ok/ok/1/no) in (b) (6) 2009 after the incident and the high lead impedance (7/limit/high/no) was encountered on (b) (6) 2010 after performing both a system and normal mode diagnostic test. The device was programmed off by the neurologist and the patient was recommended for x-rays. X-ray review from the manufacturer revealed the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The lead wires appeared to be intact at the connector pin and the lead connector pin appeared to be fully inserted into the generator connector block. Furthermore, no acute angles or discontinuities were observed in the visualized portion of the device, though a small portion of the lead behind the generator could not be visualized or assessed. The patient's positive electrode appeared to be misaligned with the negative electrode, which may be due to electrode/nerve detachment. A clinic note was received from the office of the treating neurologist at the time of the incident which indicated the patient was grabbed by the throat and after he was released, he felt the lead was moved and was hoarse due to the trauma. Follow up with the treating neurologist revealed the patient was doing well with no adverse events and revision surgery had been scheduled and was likely to occur.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1613594
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dennis100
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« Reply #11 on: September 17, 2018, 11:40:35 AM »

Model Number 102
Event Type  Injury   
Manufacturer Narrative

Event Description
The physician reported that the relationship of the pain to vns is unknown. It was not known if there were any causal or contributory programming changes, medication changes or other external factors which preceded the onset of the pain.
 
Event Description
It was reported that the patient's vns device was explanted on (b)(6) 2013 due to lack of efficacy and discomfort at the generator site. The device was disabled and it was stated that the discomfort did not only occur with stimulation. Attempts have been made for additional information; however, they have been unsuccessful. The explanted lead and generator were returned. Product analysis of the explanted generator was performed and product analysis of the lead is pending. There was no evidence of dried body fluid or corrosion observed in the connector block areas of the generator, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the product analysis lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. No additional information has been provided.
 
Event Description
Product analysis was performed on the returned portions of the explanted lead. A section of the lead assembly was returned, however, the lead¿s electrodes were not returned for evaluation. Setscrew marks were seen on the connector pins, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The lead connector has partial detachment at the ring/backfill interface. No adverse effect was identified on the device performance as a result of this condition. An abrasion was noted on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. The outer silicone tubing appears to have been compressed at multiple locations. The lead assembly has remnants of what appears to be dry body fluids/betadine solution inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the end of the returned lead portion. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion follow up with the physician's office provide no additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3331072
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« Reply #12 on: September 17, 2018, 11:41:40 AM »

Model Number 102
Event Date 08/22/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was experiencing pain in his neck and arms. Diagnostic results showed lead impedance within normal limits (dc dc ¿ 2). Follow-up revealed that the patient had recently experienced a drop seizure which may have affected the patient¿s device. Following the drop seizure, the patient began experiencing an increase in seizures. During stimulation on-times, the patient experienced epiglottis contractions, itching around the neck, spasms of the left arm and pain the left arm. The patient stated that he was able to feel the electrical pulse from his device travel through the lead. X-rays were taken and no lead breaks were found; however, the physician stated that the electrodes appeared misaligned on the patient¿s nerve and suspected a partial detachment or shift of the electrodes. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. It was noted that the electrode alignment on the vagus nerve did not follow a straight line. Based on the images provided, the cause of the reported events cannot be determined. No known interventions have occurred to date.
 
Event Description
It was reported that the patient's surgery was cancelled because device diagnostics were within normal limits. The generator was programmed back on.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4113291
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« Reply #13 on: September 18, 2018, 07:44:55 AM »

Event Date 10/01/2001
Event Type  Malfunction   
Event Description
An article titled ¿vagus nerve stimulation after lead revision¿ was received and reviewed by the manufacturer. The authors reviewed all vns lead revisions performed between october 2001 and august 2011 at the university of hospitals and clinics. Twenty-four patients underwent 25 lead revisions. In all cases, the helical electrodes were removed, and a new lead was placed on the previously used segment of vagus nerve. All inpatient and outpatient records of the 25 lead revisions were retrospectively reviewed. All patients were treated by a single neurosurgeon. Twenty-four patients underwent 25 vns revisions between october 2001 and august 2011. Of these 25 revisions, 4 were second and 21 were first lead revisions. ¿the patients in 18 cases (72%) presented with high impedance at the time of revision, 2 cases (8%) involved a short circuit within the system, 4 cases (16%) demonstrated normal impedance, and 1 case (4%) had no implanted vns system and therefore no impedance reading since the system had been previously removed at another institution because of infection. ¿ ¿sixteen (64%) of the 18 cases with high impedance at the time of revision had no visible damage or fracture within the lead and/or cable, suggesting an intrinsic lesion within the lead and/or cable. Other causes of lead failure included visible fractures of the lead in 3 cases (12%), increasing seizure frequency and an impedance indicating a short circuit in 2 cases (8%), normal impedance but pain and shock-like sensations suspect for device malfunction in 2 cases (8%), electrode coil dislocation from the vagus nerve in 1 case (4%), and a previous hardware infection and vns system removal in 1 case (4%). ¿ symptoms varied depending on the etiology of lead failure. The patients in 18 cases (72%) presented with increased seizure frequency; in 4 cases (16%), with neck and/or chest pain, paresthesias, or shock-like sensations¿ all probably the result of a short circuit within the system; and in 6 cases (24%), with no new symptoms. Additionally, 3 cases (12%) had a history of vns-related infection, and 3 cases (12%) had a recent history of head and/or neck trauma. ¿ during lead revision surgery in all cases, the vagus nerve was found encased in fibrous scar tissue which was surgically dissected. There were no postoperative infections. ¿only 1 patient experienced a complication requiring additional surgery; in this patient the lead cable was taut, creating a pulling sensation on neck turning. " in conclusion, the authors ¿found that lead failure occurs for a variety of reasons and in our series was most commonly observed in cases of high impedance within the vns lead, which was found in 72% of [the] lead revisions. The majority of patients (89%) who presented with high impedance had no visible damage or gross fracture of the lead or cable. The etiology of high impedance and lead failure is not entirely clear in these cases. ¿ it was found that the ¿placement of a new vns lead at the previously used segment of vagus nerve provided a proper contact in all 16 such cases as well as normal impedance, implying that the presence of dense scar tissue was probably not the cause of lead failure. ¿ ¿in addition to an intrinsic increase in lead impedance and device failure, [it was] observed other factors resulting in lead failure. ¿ ¿vns lead failure most commonly resulted in an increased seizure frequency. In some cases, a very dramatic increase in seizure intensity and frequency was observed. However, other symptoms alerted patients to device malfunction and included neck and chest pain, shock-like sensations, and paresthesias. Short circuits within the system may cause these types of symptoms. ¿ the shock-like sensations, pain, and paresthesias resolved after revision. The article also noted that ¿other confounding variables include the changing antiepilepsy drugs patients potentially received over the follow-up period. Furthermore, the clinical absence of dysphonia or aspiration does not preclude the possibility of vagus nerve injury, and therefore underreporting of actual injury may be present. ¿ attempts for additional information, including patient information, have been unsuccessful to date. This report captures a patient's high impedance with no patient adverse events reported. The patient's history of vns infection is captured in mfg report number: 1644487-2013-01457. The events of high impedance accompanied with increased seizures are captured in mfg report numbers: 1644487-2013-01426, 1644487-2013-01428, 1644487-2013-01431, 1644487-2013-01432, 1644487-2013-01434, 1644487-2013-01435, 1644487-2013-01436, 1644487-2013-01443, 1644487-2013-01445, 1644487-2013-01448, and 1644487-2013-01451. The events of lead fracture accompanied with increased seizures are captured in mfg report numbers: 1644487-2013-01427 and 1644487-2013-01438. The other events of high impedance with no reported patient adverse events are captured in mfg report numbers: 1644487-2013-01429, 1644487-2013-01430, and 1644487-2013-01441. The event of high impedance due to electrode detached/dislocated from the vagus nerve is captured in mfg report number: 1644487-2013-01440. The event of high impedance accompanied with increased seizures and shock sensation is captured in mfg report number: 1644487-2013-01433. The event of postoperative ¿bowstring complication requiring surgery 1 month later¿ is captured in mfg report number: 1644487-2013-01465. The event of lead fracture (with normal lead impedance value) with no reported patient adverse events is captured in mfg report number: 1644487-2013-01458. The events of short circuit accompanied with increased seizures are captured in mfg report numbers: 1644487-2013-01442 and 1644487-2013-01455. The other events of infection are captured in mfg report numbers: 1644487-2013-01437 and 1644487-2013-01454. The events of increased seizures with one patient experiencing it with shock sensation and with one patient experiencing it with neck/chest pain are captured in mfg report numbers: 1644487-2013-01446 and 1644487-2013-01452, respectively. The event of an unknown of amount of patients with increase in seizure intensity is captured in mfg report number: 1644487-2013-01466.
 
Manufacturer Narrative
Device failure is suspected, and did not cause or contribute to a death or serious injury.

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« Reply #14 on: September 18, 2018, 07:46:23 AM »

Model Number 105
Event Date 06/12/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2013 information was received from the reporter that the patient had a measurement of high impedance. The physician observed a high impedance message of 6071 ohms while running system diagnostics for the patient during a (b)(6) 2013 visit. The physician did not disable the patient¿s generator after the impedance warning. X-rays were taken of the patient, but will not be sent to the manufacturer due to the format in which they were recorded does not allow for the physician to send them. The physician stated that the patient is very active and the physician does believe that manipulation or trauma could have possibly contributed to the high impedance. The physician also stated that he would be referring the patient to a neurosurgeon for evaluation. Device manufacturing records were reviewed for the patient¿s generator and lead and the manufacturing records confirmed that they both passed all functional tests prior to distribution. A review of the manufacturer¿s programming history was performed, showing that programming history data is available from (b)(6) 2011 to (b)(6) 2013. High impedance was observed as having occurred on (b)(6) 2012 with a reading of 6,202 ohms during a system diagnostics test. High impedance was observed as having occurred on (b)(6) 2013 with a reading of 6,071 ohms during a system diagnostics test. Based on a rough battery life estimation using calculation tables for the model of generator implanted and the last known settings, the generator is not at end of service. Follow-up determined that the patient was seen for consult by a neurosurgeon on (b)(6) 2013 and that he is tentatively planning a full vns system revision, but that surgery has yet to be scheduled. Attempts for additional information will remain in continuation.
 
Event Description
The lead analysis was completed on 09/04/2013. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The following was found during the visual analysis of the returned 132mm portion: the connector pin appeared to be pitted. Scanning electron microscopy was performed and identified evidence of surface irregularities, pitting and electro-etching on the surface of the connector pin. The end of the (-) connector pin quadfilar coil appeared to be broken approximately 78mm from the end of the connector boot. Discoloration was observed on the (-) connector pin quadfilar coil, in some areas and the coil appeared to be dissolved in other areas, throughout. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the identified discontinuities and observed surface irregularities, pitting and electro-etching observed on the connector pin surface, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious issues were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Setscrew marks were observed on the connector pin, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin. The connector pin appeared to be pitted. The (+) connector ring inter-face backfill appeared to be partially detached and the (+) connector ring quadfilar coil appeared to be kinked. White deposits were observed, in several areas. What appeared to be remnants of dried body fluids were observed inside the outer and (-) inner silicone tubing, in some areas. An abraded opening was observed on the outer silicone tubing approximately 43mm-45mm from the end of the connector boot with the inner silicone tubes and quadfilar coils pulled and looped thru. The (-) connector pin quadfilar coil appeared to be discolored, in some areas. The end of the (-) connector pin quadfilar coil was observed at approximately 78mm from the end of the connector boot. Incisions were made to expose the end of the coil and the end appeared to be broken. An abraded opening was observed on the outer silicone tubing approximately 82mm-86mm from the end of the connector boot. The end of the outer silicone tubing appeared to be abraded open / cut. The following was found on the returned 47mm portion: the end of the outer silicone tubing appeared to be abraded open / cut. The (-) connector pin quadfilar coil appeared to have dissolved. A slice mark was observed on the outer silicone tubing. The mark penetrated the outer insulation. Unable to determine if the inner silicone tubes were damaged. A white deposit was observed on the outer silicone tubing. What appeared to be remnants of dried body fluids were observed inside the outer silicone tubing, throughout. The following was found on the returned 220mm portion: white deposits were observed on the outer silicone tubing. Portions of the (-) connector pin quadfilar coil appeared to have dissolved. The (-) connector pin quadfilar coil appeared to be broken approximately 103mm, 134mm and 185mm (with abraded opening on inner silicone tubing) from the end of the cut / torn outer silicone tubing. Discoloration was observed on the (-) connector pin quadfilar coil. Incisions were made to expose the broken coil ends and to allow for sem photos. During the cleaning process a small portion of the coil break found at 103mm became detached. A slice mark was observed on the outer silicone tubing. The mark penetrated the outer insulation. Unable to determine if the inner silicone tubes were damaged. The end of the (-) connector pin quadfilar coil appeared to be broken approximately 220mm from the end of the cut / torn outer silicone tubing. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The generator analysis was completed on 09/04/2013. Visual examination performed revealed scratches on the generator can most likely associated with the explant procedure. The septum was not cored, but body fluid remnants were noted on the connector block. Body fluid remnants were also noted on the canted spring. No other surface abnormalities were noted on this device. The generator is operating within specification. Results of diagnostic testing indicated the device was operating properly. Other than the observed condition of body fluids remnants on the connector block and canted spring, there were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported the patient had an additional surgery unrelated to the event discussed within this mfr. Report. During the surgery, the surgeon removed the remaining electrodes which were not previously removed during the explant of the lead. The explanted electrodes have not been received by the manufacturer to date.
 
Event Description
Review of the investigation showed the lead discontinuity was likely caused by a charge imbalance caused by the m105 generator, once a lead becomes compromised, causing corrosion which can result in lead discontinuity. This information was initially reported correctly in mfr. Report # 1644487-2014-00290. The second mfr. Report (1644487-2014-00290) was inadvertently created but did correctly report the incident.
 
Manufacturer Narrative
The information was inadvertently reported on an additional mfr. Report (1644487-2014-00290). Brand name, model #, serial #, lot #, exp. Date, implant date and mfg date: the information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
On (b)(4) 2013 it was reported that the patient underwent a full revision surgery on (b)(6) 2013. Pre-operative interrogation showed the device at settings of output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 1min/magnet output=2. 75ma/magnet pulse width=500usec/magnet on time=60sec/eri=no. Multiple pre-operative system diagnostics were inconsistent and showed impedance values ranging from 5718 ohms to 7549 ohms. The generator was explanted and the surgeon reported he could visualize the lead pin past the connector block and that the set screw was tight. A new generator was then connected to the existing lead. Proper pin insertion was verified and the set screw was tightened. System diagnostics resulted in high lead impedance (>10,000ohms). The surgeon then explanted the lead. He stated that there were no obvious issues with the visible portion of the lead extending from the generator pocket. However, in the process of removing the lead from the neck incision, he reported that one of the lead segments past the bifurcation was milky white colored and was not connected to any helical coil. The other lead segment appeared normal and was cut as close to the helical coil as possible. He was not sure which wire was which due to heavy scarring. All three helical coils from the old lead were left on the nerve and the surgeon reported he implanted the new lead coils distal to the old helical coils. The new generator was then connected to the new lead. Proper pin insertion was verified with the surgeon and a single click was heard when tightening the set screw. Two system diagnostic tests (one out-of-pocket and one in-pocket) indicated output=ok/lead impedance=ok/impedance value=1164ohms/eri=no and output=ok/lead impedance=ok/impedance value=1124ohms/eri=no respectively. The surgeon ordered the new generator to be programmed to the same settings as the old generator. Final interrogation confirmed settings of output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 1min/magnet output=2. 75ma/magnet pulse width=500usec/magnet on time=60sec. The explanted lead and generator were returned for product analysis on (b)(4) 2013. Product analysis is underway and has not yet been completed.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed both the generator and lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #15 on: September 18, 2018, 07:47:43 AM »

Model Number 102R
Event Date 04/14/2011
Event Type  Injury   
Event Description
Reporter indicated the patient developed seromas in the chest and neck that later developed into abscesses, which is why the patient's vns was explanted. The events are felt to be related to trauma to the arms and neck by the patient's attendants while repeatedly moving the patient. The patient is recovering satisfactorily from the explant surgery. Analysis of the explanted vns generator was completed. Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached 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. In addition, the generator shows no evidence of bodily fluid remnants in the case/header areas. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Event Description
Reporter indicated that a patient presented on (b)(6) 2011 with vns generator migration to the axilla along with generator extrusion through the skin. No infection was present. It was unknown what caused the migration or generator extrusion to occur, or if anything precipitated the events. It is not known if the patient had any trauma or if device manipulation occurred. The patient is developmentally delayed. The generator was surgically repositioned on (b)(6) 2011 in a new pocket under the pectoralis muscle and was secured to the fascia with a silk suture. No devices were explanted. The patient was also given antibiotics and is healing well.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the device manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported on (b)(6) 2012, by a caregiver to the manufacturer that the vns patient had surgery on (b)(6) 2011, due to generator migration, infection and wound dehiscence at the generator site. The patient recovered per the caregiver until (b)(6) 2012, when it was noted there was swelling and redness along the vns lead wire in the neck area. On (b)(6) 2012, the patient had surgery to debride the neck area, and the patient was given antibiotics. The wound was also packed daily with gauze. 8 weeks after the surgery the wound opened up and the patient was again put on antibiotics. It was previously reported by the treating surgeon that no infection was present at the generator site at the time of surgery on (b)(6) 2011, but wound dehiscence and migration at the generator site had occurred. Clinic notes were also received from the treating surgeon documenting the neck abscess/dehiscence reported by the caregiver, and that cultures of the neck wound site noted rare (b)(6) bacteria. The patient had developed a neck abscess that had healed, but subsequently opened up recently and was very superficial. The area was cauterized with silver nitrate. The patient was also on oral antibiotics. The patient also has a chest seroma in the area of the vns generator that may be due to trauma, and is being watched for now. Additional manufacturer follow-up with the treating surgeon revealed the neck abscess/dehiscence was felt to be due to trauma and patient manipulation. No medication changes contributed to the events, and no additional interventions have been performed for the neck abscess/dehiscence or chest seroma. The patient is recovering per the surgeon.
 
Event Description
Reporter indicated the patient may be reimplanted with the vns in the future, but no surgery has been scheduled to date. The vns has been helpful for the patient's seizures in the past per the reporter.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Reporter indicated the patient would have vns lead and generator explant surgery due to infection at the left chest generator site. Prior to the surgery, it was noted on (b)(6) 2012 that the chest wound was opened. The patient had developed seromas of the neck and chest over the last year, which were opened up and packed. The seromas had abscesses. The neck wound had recently healed. The chest wound was packed with nu gauze, and the patient was to continue daily wound packing. The patient later had generator and lead explant surgery performed on (b)(6) 2012. No new devices were implanted. The generator only was returned and is pending analysis. Attempts for further information are in progress.

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« Reply #16 on: September 18, 2018, 07:48:49 AM »

Model Number 102
Event Date 11/11/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was initially reported that during generator replacement surgery when the physician was removing the generator with forceps that the header detached from the can of the generator. System diagnostic that was run prior to removing the generator was output status = ok, impedance = ok, dcdc = 0, eri- yes. The surgeon first visualized the header but reported to continue to excise the generator before removing. The header was grabbed by the forceps for removal. There was no unusual amount of tension and there was no corrosion, visible breakdown or issue with the area. The surgeon was more concerned with the lead which was later confirmed with diagnostics to be fine (impedance = 2045 ohms and 1980 ohms). The patient had no adverse events prior to replacement. The generator has been returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
Additional information was received that indicated that product analysis was complete on the generator. The alleged end of service were determined to be the result of normal battery depletion. The eri=yes screen was observed. The eri=yes was an expected event as determined by blc and current measurements. The battery is partially depleted. The module performed according to functional specifications. As received, the generator's header was separated from the generator can. The event likely occurred during or after device explant. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

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« Reply #17 on: September 18, 2018, 07:50:04 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 05/01/2011
Event Type  Malfunction   
Event Description
Attempts for additional information have been made to both the patient's treating neurologist and surgeon, and no information has been made available by either site.
 
Event Description
Product analysis of the returned generator was completed. Visual analysis showed only observations consistent with the explant procedure; no surface abnormalities were noted on this device. The pulse generator communicated normally and the eri flag was not set. The device performed according to functional specifications. No abnormal performance or any other type of adverse condition was found.
 
Event Description
It was reported that a patient was experiencing pain in his neck and had lost his voice. Diagnostics performed on the patient's generator showed high impedance with a dc/dc of 7. The generator was programmed to 0ma and the patient was sent for x-rays. It is unclear if the x-rays will be sent to the manufacturer for review. The patient has been scheduled to see an ent and has been referred for surgery. Surgery is likely, but has not occurred to date.
 
Event Description
Additional information was received that the patient would have the device explanted and go for a surgical work-up. The nurse indicated that the patient is not likely a surgical candidate, so will have a new vns implanted at a later date. No additional information was provided. Surgery is likely, but has not occurred to date.
 
Event Description
Additional information was received indicating that the patient has declined replacement. His device has since been disabled. Attempts for additional information have been unsuccessful to date.
 
Event Description
The explanted lead and generator were received by the manufacturer for product analysis. Product analysis was completed on the returned portions of the explanted lead. During the visual analysis of a returned 3. 5mm portion of the negative green electrode, it was observed that the coil portion of this segment was not present. What appeared to be a greenish tint was observed inside the inner silicone tubing. This was an indication the coil had most likely dissolved and became detached from the ribbon at one point in time. Stimulation was present for a certain period of time as evidenced by the presence of greenish tint inside the inner silicone tubing. Based on the findings, there was evidence to suggest a discontinuity in the returned portions of the device. With the exception of the discontinuity, the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portion were performed and no other discontinuities were identified. The set screw marks found on the lead connector pin provided evidence that, at one point in time, a good mechanical and electrical connection was present. The returned generator is undergoing product analysis.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery due to lead discontinuity on (b)(6) 2014. Attempts to have the product returned for analysis were made but were unsuccessful.

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« Reply #18 on: September 18, 2018, 07:50:56 AM »

Model Number 302-20
Event Date 12/17/2012
Event Type  Malfunction   
Event Description
A patient's mother called and reported she saw their neurologist back in december and was told her daughter has a lead disconnect. The mother then explained that on (b)(6) 2012, the patient was seen to have her device and the settings checked and the physician informed them that the "wires were detached". She stated that the physician kept referring to the chest area and she confirmed that the physician disabled the device that day by "turning off the output current". The mother also stated that the physician did not order any x-rays and informed the parents that they have to make a decision to have a replacement surgery or have the device entirely removed. The patient's mother reported that her child has cognitive medical issues and that it might be best if the device is explanted since the "wires have been detached" since december. She also stated that the patient has mitochondrial issues which make it difficult to undergo anesthesia. She reported that since (b)(6) 2012, she had noticed that her daughter does not cough when the magnet is swiped on her device whereas before, she was distinctly coughing every time the magnet was swiped over the device. She explained that this may have been the point in time that the device started not functioning but she was unsure. When asked about trauma or patient manipulation, the mother explained that there has not been patient manipulation but that patient had stabbed herself prior to (b)(6) 2012 with an empty catheter hoping to cure her keloid scars. The mother explained that the patient had keloid scarring at both the generator site as well as the lead site that required steroid injections and the patient had attempted to inject herself like the medical professionals used to do to try to cure her scars. Addressed in medwatch report number: 1644487-2013-01220. The mother confirmed that the catheter was empty and that nothing was injected but that the patient has severe cognitive issues and thought she was doing the right thing. The mother stated that this may have been a contributing factor as the device may have been affected by this trauma. The patient's mother reported that she was not sure the device really ever helped so not sure wants to reimplant or just remove. Good faith attempts have been made for further information and no further information has been received.
 
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.

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« Reply #19 on: September 18, 2018, 07:52:03 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/25/2018
Event Type  Injury   
Manufacturer Narrative
Describe event, corrected data, initial mdr inadvertently reported that the surgery was due to the migration while in fact the migration was discovered during surgery, while the surgery was already being performed for prophylactic reasons.
 
Event Description
During a prophylactic generator replacement surgery for this patient¿s m102r to a m104, while removing the m102r, it was observed that the header of the device had become detached from the generator. It was unclear exactly when the header had become detached. The patient had a significant amount of breast tissue and the generator was beneath the nipple, so the or specialist believed that the header detachment occurred as a result of the physician trying to get the generator out of the patient's body with the clamp and due to a lot of scar tissue. It was also stated that the battery migrated far away from where it was implanted. He interrogated the m102r after explant and saw that the battery was ok, but that no current was being delivered. The surgeon stated that the battery must have not been sutured down in one of the previous 2 surgeries. There was a lot of tissue and adhesions, so the battery was hard to get to and took time. The explanted generator was received for analysis and analysis is underway but has not been completed to date. No additional or relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis for the generator was completed and approved. Diagnostics testing during the implant period did not report a high impedance condition. After a window was cut into the can to attach wires and test leads to make output connections to the final test fixture, the device performed according to functional specifications of the current automated final test 102. Other than the header anomaly, there was no performance or any other type of adverse condition found with the pulse generator. The header detachment was found to be possibly explant related. During the initial report, there was no indication that the surgery was for suspected migration. The surgery was only performed prophylactically and then migration was seen during surgery.

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« Reply #20 on: September 18, 2018, 07:52:59 AM »

Model Number 304-20
Device Problem Fracture
Event Date 07/02/2018
Event Type  Malfunction   
Event Description
It was reported that a vns patient¿s device had been programmed off because it was "misfiring", and the lead was not working, and a full revision was scheduled. High lead impedance was observed prior to surgery, and also during the surgery when the new generator was connected to the lead. The lead was reportedly tangled and kinked, and the lower electrode had become detached from the nerve. Full revision surgery occurred. The explanted devices were received. Analysis is underway, but has not been completed to-date.

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« Reply #21 on: September 23, 2018, 02:40:18 AM »

Model Number 102
Event Date 02/12/2008
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The device history record (dhr) for this generator was reviewed. The generator passed all quality inspections, functional, and electrical tests prior to distribution.
 
Event Description
Product analysis on an explanted generator was completed on (b)(6) 2011. During product analysis an out of specification component was identified in the generator. The pulse generator unit failed the feed-thru capacitor tests. The backup capacitors function as emi filtering and do not affect the supply current that would contribute to battery depletion. X-rays and visual assessment on the feed-thru assembly, performed at the pa test bench, showed possible excessive bends in the negative feed-thru wire. In addition, separation of the silver polyimide to the negative feed-thru wire connection was observed. The most probable root cause for the failed backup capacitor tests was identified to be an open capacitor, which manipulation of the feed-thru wires may have been a contributing factor.

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« Reply #22 on: October 01, 2018, 01:59:26 AM »

Model Number 302-20
Event Date 03/06/2012
Event Type  Malfunction   
Event Description
A vns programming physician reported that a patient was seen in clinic and had high lead impedance. The patient has not experienced any trauma to cause a lead break. A lead break was noted on x-ray review by their treating physician. The patient had full revision surgery and their explanted product is at the manufacture pending completion of product analysis.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal and anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis was completed on the returned explanted product. The pulse generator was returned due to prophylactic replacement. 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. A section of the lead assembly was returned for analysis in one piece. The lead's electrodes were not returned for evaluation. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is unknown. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition an abraded opening was identified in the outer silicone tubing at approximately 15. 8-16. 1cm from the end of the connector boot. The reported fracture was not seen on the portion of the lead returned. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

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« Reply #23 on: October 02, 2018, 12:20:46 AM »

Model Number 302-20
Device Problem Detachment Of Device Component
Event Date 08/21/2010
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was undergoing generator replacement surgery when the surgeon identified abraded openings in the lead tubing (reported in mfr. Report #1644487-2018-00663), so a lead revision was then performed. It was then identified that there was no strain relief, and the electrodes were detached from the nerve. The surgeon and ear, nose, and throat specialist stated that the nerve was bubbled and severely scarred from the electrodes rubbing on it. The impedance was within normal limits prior to the surgery, which indicated that the electrodes were in contact with patient tissue while implanted. It was believed that the electrodes rubbed against the nerve after becoming detached, which caused the damage to the nerve. The lead was received by the manufacturer, and analysis was performed (reported in mfr. Report #1644487-2018-00663). However, the electrode portion of the lead was not returned, so no analysis could be performed on the portion of the lead relevant to this report. No further relevant information has been received to date.

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« Reply #24 on: October 03, 2018, 03:25:54 AM »

Model Number 300-20
Event Date 07/17/2011
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2012. The implant card confirmed the date of surgery and indicated the reason for replacement as battery depletion with neos=yes and lead discontinuity. The explanted products were received by the manufacturer on (b)(6) 2012, however product analysis has not been completed to date.
 
Event Description
A physician reported on (b)(6) 2012 that upon interrogation of a patient's model 104 generator, the physician received a warning about low output. The patient's output current was at 1. 0ma, so the company representative instructed the physician to turn the output current up to 1. 5ma. Normal mode diagnostics at 1. 5ma were performed and showed low output current, and then systems diagnostics were performed and showed high lead impedance. On the patient's previous visit on (b)(6) 2012, all diagnostics were reportedly okay. No patient trauma is suspected to have contributed to the high impedance. The patient did pick up a (b)(6) child in (b)(6), and the child wiggled around. The physician was unsure if this may have caused the high impedance. The physician does not suspect that fibrosis would cause the high impedance. The patient has not experienced an increase in seizures. The physician is requesting x-rays be taken of the patient's vns, but it is unclear if the x-rays will actually be taken. Therefore, the x-rays have not been received to date. The physician elected to keep the device programmed on because the patient is doing fine, and he did not want to stop therapy. Although surgery is likely, it has not occurred to date. No additional information was provided.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays received by the manufacturer, no gross lead discontinuities visualized.
 
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect date of the event, so the patient age was reported incorrectly. Date of event, corrected data: the initial report inadvertently reported the incorrect date of the event. With the additional information received, the patient's symptoms began around (b)(6) 2011 and the impedance began to increase as first captured on this day.
 
Event Description
It was reported on (b)(6) 2012, that the patient had x-rays taken in (b)(6). The ap and lateral cervical spine x-rays were later received by the manufacturer on (b)(6) 2012. The radiology report was also received which reported that the leads appeared to be radiographically intact. Due to only neck images being taken, the generator cannot be visualized, and thus, resulting commentary on pin insertion and feed-thru wires being intact cannot be assessed. The electrodes appear to be in alignment. There are no gross lead discontinuities or sharp angles present. However, resulting commentary on the area in the chest that is not visible cannot be assessed. In addition, the presence of an unpronounced lead discontinuity or discontinuity in the portion of the lead not seen in the provided x-rays cannot be ruled out. Therefore, there is no indication from the x-rays that would reveal the cause of the high impedance. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
Additional clinic notes were received for the upcoming surgery which has not occurred to date. The notes dated (b)(6) 2011, does not indicate any vns abnormalities or patient adverse events. The vns settings were changed, and there were plans to titrate the settings higher. On the next visit on (b)(6) 2011, it was reported that the patient was "doing somewhat worse since the last visit. " the husband reported that her seizures were slightly worse. He reported a total of eight bigger seizures in the past two months. Her milder, atypical absence episodes are just as long but less intense. There were no recent other changes in the patient's medical history. The patient's vns settings were still titrated up to prior settings, the output currents were increased on (b)(6) 2012. The patient was doing about the same on the (b)(6) 2011, visit. The notes indicated the patient was now reporting about 15-20 seizures in the last 10 weeks on (b)(6) 2012, and the patient was not satisfied with her seizure control. The vns settings were titrated up again. In the notes dated (b)(6) 2012, the patient reported 3 tonic-clonic seizures and four smaller seizures since the last visit. She reported improvement with the vns increase and no side effects, and she was somewhat satisfied with her seizure control at that point. She was doing better since the last visit. An increase in output current was attempted but the patient experienced coughing, so the pulse width was decreased. However, the device indicated high lead impedance from system diagnostics. The physician planned to leave the output current at 1. 0 ma with increased pulse width to 750usec. Attempts for additional information from the physician have been unsuccessful to date. Review of the diagnostic history revealed that a > 25% impedance occurred on (b)(6) 2011.
 
Event Description
The patient reported that she "does not like the magnet because it hurts. " however, the company representative followed up with the physician's office. The clinic notes were provided to him to review, and there was no mention of the patient experiencing pain with the magnet in the notes. In addition, there did not seem to be a recent change in magnet settings. Attempts for additional information from the physician's office were unsuccessful.
 
Event Description
The clinic notes and cover sheet were received from the patient's physician's office. It reported that the patient has been referred for surgical follow up regarding the "lead issues" and the fact that the leads have been implanted for about 12 years. Although surgery is likely, it has not occurred to date.
 
Event Description
Product analysis of the generator and lead was completed. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. During analysis of the explanted lead, an abraded opening in the outer tubing was observed as well as dried body tissue on the positive electrode ribbon. Note that a portion of the lead assembly (body) was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 87 mm portion pitting was observed on the surface of the marked connector pin. The front portion of the connector boot appeared to be detached from the connector pin. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the marked connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. Of note, suture indentations were observed on the outer silicone tubing. Manufacturer labeling indicates to not use sutures on the lead body. 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. During the visual analysis, the (+) white electrode ribbon appeared to be embedded in remnants of dried body tissue. This condition may have prevented the electrode ribbon from coming in contact with the vagus nerve; therefore, contributing to the reported allegations. Other than observed pitting on the marked connector pin and tissue-covered (+) white electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations.
 
Event Description
Follow up with the physician was performed which revealed that the patient's increased seizures were believed to be due to loss of vns therapy. The patient experienced coughing with attempted increase in vns settings. The increase in the patient's seizures in 2011, were still below pre-vns baseline levels, and there were no clear causal factors for the increased seizures. The patient experienced painful stimulation during vns programming changes on (b)(6) 2012. To prevent morbidity from seizures, the patient's background medication dosing was adjusted while waiting to address the vns issue, per the physician. No additional information was provided.

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« Reply #25 on: October 10, 2018, 02:32:41 AM »

Model Number 300-20
Event Date 09/19/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but is not suspected to have contributed to the patient's death.
 
Event Description
A lead for a patient who passed away was received by the manufacturer on (b)(6) 2012, as previously captured in manufacturer report number: 1644487-2011-02547. The product analysis of the lead was completed on (b)(6) 2012. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the cut end and at the suspected pitted area. A significant portion of the lead (including the electrode array) was not returned for evaluation. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Two sets of setscrew marks were seen on each connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. Both the marked and the unmarked connector boot have partial detachment from the pin at the area where the pin exits the boot. Abrasions were identified at the areas located between the end of the connector boots and connector bifurcation. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion.

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« Reply #26 on: October 11, 2018, 06:15:42 AM »

Model Number 302-20
Event Date 05/25/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012 it was originally reported by a nurse practitioner that the vns patient was scheduled for a full revision surgery as the patient (non-verbal) was experiencing pain near the electrode site. The patient was seen on (b)(6) 2012 and the pain was timed as the patient winces with the pain, and it was found to be associated with stimulation. Normal mode and system diagnostics were run and were within normal limits; system dcdc=2, normal mode dcdc=3. The patient's current settings are: output=1. 5ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 8min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. Based on just the physical symptoms, the doctor has decided to move forward with a full revision for the patient. No x-rays have been done and will not be done. No setting changes, medication changes, or trauma had occurred prior to the patient's pain. The doctor is aware that the diagnostics show that the device is functioning as intended, but wants to move forward with the full revision in hopes that it will resolve the patient's pain. The reason for the replacement is prophylactic based on the age and the patient's settings. On (b)(6) 2012 the patient had a full revision surgery. Diagnostics were within normal limits prior to surgery and in surgery. Although the revision was because of painful stimulation, the surgery was for patient comfort and not a serious injury. Prior to surgery, the surgeon stated that he thought the helices may have slipped off the vagus nerve but during surgery he noticed that they had not. Everything looked fine when he dissected to the vagus nerve. As vns had been a great success for the patient, the parents and surgeon decided to replace the entire system as vns was the only thing that worked for the patient and they didn't want to lose efficacy. X-rays were taken in the operating room and looked normal. After surgery the patient was going to be programmed to output current of output=1ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 8min/magnet output=1. 25ma/magnet on time=60sec/magnet pulse width=250usec. The explanted lead and generator were returned for product analysis on (b)(6) 2012. The returned product form reported that the patient's system was replaced due to "stimulation causing patient pain and drops". The manufacturer's consultant clarified that these drops were actually a reaction to the painful stimulation. Product analysis of the leads was completed on (b)(6) 2012. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. The positive coil appears to be retracted against the connector ring. The positive coil tubing appears to be torn open at the ring/backfill interface. Further inspection of the lead verified that the inner silicone tubing of the positive coil appears to be torn open at the ring/backfill interface. Based on the appearance of the lead it is believed that this condition was most likely caused by forces exerted on the lead during manipulation of the lead. However, the exact point in time of when this occurred is unknown. The outer silicone tubing is cut at approximately 28. 7cm from boot. The inner silicone tubing of the lead coils is cut/torn in the vicinity of the outer tubing end. A portion of the lead coils is exposed at the end of the returned lead portion. The lead assembly has remnants of what appears to be body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Product analysis of the generator was completed on (b)(6) 2012. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. 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 and there were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #27 on: October 11, 2018, 06:16:29 AM »

Model Number 300-20
Event Date 03/30/2012
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Initially a battery life calculation was requested on a vns patient's generator. The patient's settings were 2. 5/30/250/30/3. Their system diagnostic testing was dcdc 3, eri no. The battery life calculation was negative. The patient went to surgery for a prophylactic generator replacement. In preop a system diagnostic test was performed that resulted in the following: high lead impedance with an ok output status, dcdc=6 and eri=yes. The patient was programmed at 2. 75ma. It was noted in the or that the patient's generator had a detached header. There was no specific trauma that was reported preceding the event. The header detachment did not occur during the explant. The explanted generator has been returned for analysis. Addressed in medwatch report number: 1644487-2012-01054 analysis was completed on their explanted lead. An analysis was performed on the returned lead portions. Note that a portion of the lead assembly (body); including the electrodes was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. There were confirmed openings of the inner tubing, exposing conductive quadfilar coils; and outer abraided openings. Fluid was noted inside the inner and outer tubing. The cause was unknown and may be wear related. With the exception of the abraded inner tubing opening, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.

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« Reply #28 on: October 13, 2018, 04:28:58 AM »

Model Number 302-20
Event Date 06/22/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that a patient underwent total revision on this date and that the explanted devices would be returned to the manufacturer. The generator was replaced due to end of service, and the lead was replaced due to high impedance. A manufacturer's consultant also indicated that these physicians may not be willing to provide additional information. On (b)(6) 2012, the explanted generator and lead were returned and are currently undergoing product analysis. A returned product form received on (b)(4) 2012, indicated that the lead came out in pieces and the largest piece was returned. A battery life calculation was performed on (b)(4) 2012. The results indicated negative years to eri = yes. On (b)(6) 2012, it was reported that the physician would not provide any additional information regarding these events.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis for the explanted generator and lead was approved on (b)(6) 2012. The near end of service flag was set (n eos = yes) for the generator. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Only a section of the lead was returned for product analysis. The lead's electrodes were not returned. Two tie-downs were returned with the lead. Two sets of setscrew marks were seen on the connector pin, providing evidence that contact between the setscrew and the lead pin existed at least once. One of the setscrew marks is located toward the end tip of the connector pin. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time when this occurred is unknown. Based on the location of the setscrew marks on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator "+" and "-" terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. White deposits were identified on the outer silicone tubing at various locations. The lead assembly has remnants of what appears to be dry body fluid 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. An energy dispersive spectrometry analysis performed on a sample of the white deposits identified si, p, ca, na, and mg as the composition for the substance. The exact reason for the presence of the substance is unknown. The lead assembly was returned for analysis due to high impedance. The reported high impedance allegation was not verified within the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

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« Reply #29 on: October 15, 2018, 11:26:47 AM »

Model Number 302-30
Event Date 07/16/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that this patient underwent complete revision due to generator battery depletion and lead discontinuity. A battery life calculation on (b)(6) 2012, indicated 1. 26 years to eri = yes the explanted generator and lead were received on (b)(6) 2012 for product analysis. Product analysis for the lead and generator was approved on (b)(6) 2012. Product analysis of the explanted generator showed that during the analysis, there was no indication from the device that an end of service condition existed. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. The lead assembly was returned for analysis due to the allegations of lead fracture. The reported allegations were verified. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. Also, the appearance of one strand at the positive coil mating end indicates a stress-induced fracture has occurred; however, due to metal dissolution, mechanical distortion (smoothed surfaces and/or surface contamination, the fracture mechanism of the coil wires cannot be determined. Scanning electron microscopy of the positive coil exposed portion show that the coil was exposed to some type of electro-cautery tool. This was most likely caused during the explant/implant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. The lead assembly was returned for analysis in two pieces. The lead assembly had what appeared to be internal abrasions at multiple locations. Inspection of the first portion of the returned lead showed two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The lead connector had partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. The lead assembly has remnants of what appears to be body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the ends of the returned lead portions. Inspection of the second portion of the returned lead showed that abrasions most likely caused by the presence of a tie-down were identified. The lead assembly has what appears to be organic matter. A suspected coil break was identified in the positive coil at approximately 0. 2 cm past the anchor tether. The anchor tether was tangled. When untangled, no anomalies were identified on the helix. An opening in the silicone tubing of the positive coil was identified. The appearance of the lead assembly suggests the lead coil was exposed to some type of electro-cautery tool at this location. The positive coil was kinked at various locations. The silicone tubing of the positive coil has what appear to be punctures at various locations. The negative coil is kinked/nicked at various locations. The silicone tubing of the negative coil has what appears to be puncture openings at various locations. The closest electrode to the bifurcation is damaged showing bends in the electrode ribbon and detachment of the electrode ribbon and suture from the silicone helix. The furthest electrode to the bifurcation is damaged showing bends in the electrode ribbon and detachment of the electrode ribbon from the silicone helix. Attempts for additional information have been unsuccessful.
 
Event Description
Information was received indicating that prior to the battery replacement the patient went into status and ended up in the hospital. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Analysis of programming history. Device failure occurred, but did not cause or contribute to a serious injury or death.
 
Event Description
A fax from the physician was received on (b)(6) 2012. The physician stated that the patient had a malfunction of his vns with an increase in lead impedance noted more than five years after implantation. On this basis, the patient's family was advised that there was probably a lead discontinuity or fracture or that excessive scar had formed between the lead and the electrode, and in either case the system would need to be checked intraoperatively. Preoperatively, the surgeon obtained x-rays of the hardware, and no lead discontinuity was noted. At the time of surgery, the physician initially replaced the pulse generator and retested impedance, finding it to be still elevated. He then removed the entire existing hardware and performed neurolysis on the vagus nerve for removal of excessive scar. He placed a new electrode and connected it to the new pulse generator. A lead impedance check then showed "ok". Based up on these findings, the surgeon believed that the device began to malfunction because of excessive scar separating the nerve from the electrode and that the excessive scar had developed over the past five years since initial vns implantation; however, he could not rule out the possibility that there may have been a microscopic fracture of the electrode.

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