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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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« 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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« 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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« 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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« Reply #30 on: October 16, 2018, 01:22:43 PM »

Model Number 303-20
Event Date 07/11/2012
Event Type  Malfunction   
Event Description
A portion of the positive helical was missing (appeared to be torn) leaving only the electrode ribbon without the helical support. The suture was also missing. A cause could not be identified, although it does appear to be related to manipulation associated with the attempted implantation. With the exception of the positive helical, the condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure. No other obvious anomalies were noted except for the void / indentation mark that was observed on the inside of the remaining portion of white (+) electrode helical. Setscrew marks were not observed on the connector pin. Continuity checks of the returned lead assembly were performed with no discontinuities identified. No coil breaks were found. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion. However, the positive helical was received with a portion torn and the suture missing. A cause for this observed condition is not known, but may be related to manipulation from the attempted implant procedure.
 
Event Description
It was initially reported by a company representative that a vns implanting md reported to them that the electrode off a vns lead had detached from the lead body during initial implant. The lead was removed and replaced with a new one during the same implant operation. The lead reported as broken was returned to the manufacturer and is currently undergoing product analysis.
 
Manufacturer Narrative
A portion of the positive helical was missing (appeared to be torn) leaving only the electrode ribbon without the helical support. Manufacturing records were reviewed and confirmed the electrode was in place prior to distribution of the lead. A cause for this observed condition is not known, but may be related to manipulation from the attempted implant procedure.

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« Reply #31 on: October 18, 2018, 01:18:02 AM »

Model Number 302-20
Event Date 01/10/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a serious injury or death.
 
Event Description
On (b)(6) 2013, it was reported that the patient had both her generator and lead replaced on (b)(6) 2013 due to end of service and high impedance respectively. Per the implant card, the replacement surgery was due to a lead discontinuity with lead impedance marked as high. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided. The explanted devices have not been returned for product analysis.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.
 
Event Description
Product analysis of the explanted generator found that the battery was not at an ifi condition. The battery voltage measured 2. 881 volts as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 11. 989% of the battery had been consumed. With the exception of parameters related to the reed switch, results of the final electrical test were successful. Functional bench testing, and internal downloaded data from the generator, both demonstrate that consistent magnet activations are attainable. With the exception of the noted test-related issue, there were no adverse functional, mechanical, or visual issues identified with the returned generator. Review of the device history records for the lead confirmed the lead met all final testing specifications prior to distribution. Attempts were made for additional information; however, they were unsuccessful. No additional information has been provided.
 
Event Description
Product analysis of the lead was completed and approved on (b)(6) 2013. 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. A reddish-brown substance was noted on the connector pin in the vicinity of the end tip. The connector pin has what appears to be pitting at this location. 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. Abrasions were identified on the connector boot and on the outer silicone tubing at multiple locations. The lead coils have a spiral appearance along the lead body. The lead coils are stretched along the lead body. The inner silicone tubing appears to have been cut/torn at approximately 38. 5cm from boot. The inner silicone tubing of the lead coils has what appear cut openings in the vicinity of the tubing ends. The cut ends of the lead coils are located at approximately 38cm from boot. The outer silicone tubing has internal abrasions at approximately 33. 5-36. 9cm from boot. The end of the outer silicone tubing appears to have been cut/torn at approximately 38. 3cm from boot. The lead assembly has remnants of what appears to be dry body fluids inside the inner silicone tubing of the lead coils. No obvious point of entrance was identified other that cut end of the returned lead portion. Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils. Scanning electron microscopy images of the connector pin showed that pitting or electro-etching conditions have occurred on the pin. The exact reason for this condition is unknown. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no 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.

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« Reply #32 on: October 19, 2018, 11:15:54 AM »

Model Number 302-20
Event Date 08/14/2012
Event Type  Malfunction   
Event Description
Additional information was received indicating that x-rays were taken; however, the device was not visible. Attempts to obtain new images were unsuccessful. The patient's increase in seizures was attributed to the high impedance. The patient underwent revision on (b)(6) 2012. The new device was successfully implant and verified to be working properly. The generator was replaced prophylactically. After re-implant, the patient responded to treatment. The lead and generator were received on (b)(6) 2012. Product analysis for the explanted lead showed that 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. Four sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. 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. White deposits were identified on the connector boot in the vicinity of the ring/backfill interface. Abrasions were identified on the connector boot. The outer silicone tubing has what appear to be abrasions/imprints. The outer silicone tubing appears to have been compressed at three locations. Abrasions most likely caused by the presence of a tie-down were identified; the outer silicone tubing is cut open at approximately 33 cm from boot. No obvious damage to the lead coils or the inner tubing was noted at this location. The outer silicone tubing has what appear to be internal abrasions at multiple locations. Abrasions were identified on the silicone tubing of the lead coils. The lead assembly has remnants of what appears to be body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. No discontinuities were identified within the returned lead portion.
 
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.
 
Event Description
On (b)(6) 2012, it was reported that normal mode and system diagnostics for a vns patient indicated high impedance. Diagnostics were repeated with the same results. The device subsequently programmed off. The physician requested a new generator due to the fact that this generator was implanted in 2008. The event was reported to be continuous, of moderate severity, and possibly related to stimulation. Device parameters were changed as intervention. It was also noted that the patient had an increase in seizures over the previous seizure rate. The patient reportedly has generalized tonic-clonic seizures and atonic seizures. The patient's settings and diagnostics from this date were provided. Additional information was received that x-rays were taken and would be provided for manufacturer review; however, they have not been received to date. The patient had not had any fall, injury or manipulation of her vns lead that could be attributed to the high impedance. The increase in seizures was over thee pre-vns seizure rate at baseline rate two months prior. The physician attributed the loss of therapy to the high impedance. Adjustments to mediation were made to treat seizures and to preclude a serious injury. Surgery is likely, but has not occurred.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Product analysis for the explanted generator was completed on (b)(6) 2012. The pulse generator was explanted/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 battery life calculation on (b)(6) 2012 indicated 6. 49 years remaining.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2744314
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« Reply #33 on: October 25, 2018, 01:40:20 AM »

Model Number 102R
Event Date 10/03/2012
Event Type  Malfunction   
Event Description
On (b)(4) 2012 additional information was received when it was reported that the patient underwent a full revision surgery that day due to high impedance. During the explant of the generator it was noted to be "falling apart". The surgeon just pulled the generator out of the patient's body and the header just detached from the can. The manufacturer's consultant indicated that the surgeon did not put too much force on the generator; he just pulled it out from the body and noticed that it was falling apart. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(4) 2012 which is still underway and has not yet been completed.
 
Event Description
On (b)(6) 2012, clinic notes were received from the physician from the patient's clinical visit that day. The patient was noted to have no seizures in the past year. The patient's vns has had an increase in impedance; system diagnostics showed a dcdc=4 and normal mode diagnostics showed a dcdc=7. The patient was referred or pa and lateral x-rays of the chest and neck to evaluate for fractures. The patient was stated to need a vns replacement. Good faith attempts for further information from the physician were made but were unsuccessful. Although surgery is likely, it has not occurred to date. A battery life calculation was performed which showed 2. 46 years remaining until eri=yes.
 
Manufacturer Narrative
Analysis of programming history. 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
Additional information was received on (b)(4) 2012 when it was stated that the generator and lead had been returned due to a lead discontinuity and because the header of the generator had broken off. Product analysis is still underway for both the lead and generator and has not yet been completed.
 
Manufacturer Narrative
Additional information was received which changes the product that was reported on the initial report.
 
Event Description
Additional information was received on (b)(4) 2013 when product analysis was completed on both the explanted lead and generator. Analysis of the header detachment in the product analysis lab suggests that two events occurred; partial detachment of the header during implant, and total detachment of the header during the explant procedure (as evidenced by the tool marks on the can and header). A cause for the initial partial detachment condition is not known. The negative feed thru wire was fractured during implant and the high impedance can be attributed to the pulse generator fractured negative feed thru wire. The electrode array portion of the leads was not returned for analysis, therefore 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. The lead assembly has remnants of what appears to be dry body fluids inside 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2807525
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« Reply #34 on: November 02, 2018, 08:26:46 AM »

Model Number 304-20
Event Date 10/09/2012
Event Type  Malfunction   
Event Description
Additional information was received that product analysis was completed on the lead and generator. A break was identified in the positive coil and the large o-ring connector boot has detachment at the connector ring assembly. The exact reason for this condition and when it occurred is unknown. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. Scanning electron microscopy images of the positive coil at the suspected mating end shows what appears to be wear (flat surfaces) on the coil strands resulting in reduction of the diameter of the quadfilar coil strands up to the point of break in at least one strand of the quadfilar coil. One strand of the broken coil mating end shows appearance suggesting that the coil was torn. However, due to metal dissolution or mechanical distortion (smoothed surfaces) the initial fracture mechanism of the broken strands cannot be determined. Results of diagnostic testing indicated the generator was operated 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.
 
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient had high impedance (9744 ohms) at a recent appointment. The patient was at output current 2. 25 ma, signal frequency 30 hz, pulse width 500 usec, on time 20 seconds and off time 3 minutes with the high impedance was observed and had their settings adjusted to 1 ma, signal frequency 20 hz, pulse width 250 usec, on time 30 seconds and off time 5 minutes. The patient was not disabled as the physician felt it was too risky to turn the patient off and the family requested that the patient be left on. There was not reported manipulation or trauma that contributed to the high impedance. X-rays were taken but will not be provided to the manufacturer for review. Surgery if likely but has not occurred to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2821664
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« Reply #35 on: November 03, 2018, 12:15:31 AM »

Event Date 01/01/1994
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.
 
Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A longitudinal (b)(4) study of (b)(4) patients". Was received on (b)(6) 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994 - (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the first of four lead disconnection events listed in the poster. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2814620
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« Reply #36 on: November 04, 2018, 01:47:31 AM »

Event Date 01/01/1994
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.
 
Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A (b)(4) study of (b)(4) patients". Was received on (b)(6) 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994 - (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the second of four lead disconnection events listed in the poster. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2814653
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« Reply #37 on: November 05, 2018, 09:18:18 AM »

Event Date 01/01/1994
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A (b)(4) study of (b)(4) patients". Was received on october 3, 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994 - (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the third of four lead disconnection events listed in the poster. No further information has been received to date.
 
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2814660
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« Reply #38 on: November 06, 2018, 07:09:12 AM »

Event Date 01/01/1994
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.
 
Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A longitudinal single centre study of 143 patients. " was received on october 3, 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994-december 31, 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the fourth of four lead disconnection events listed in the poster. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2814635
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« Reply #39 on: November 06, 2018, 07:09:50 AM »

Event Date 03/09/2015
Event Type  Malfunction   
Event Description
It was later reported through clinic notes the patient experienced widespread muscle spasms in the neck and face prior replacing the lead.
 
Manufacturer Narrative
 
Event Description
It was reported that the patient is feeling a bulging sensation with stimulation. The vns device was tested and no high impedance was found so the neurologist chose to keep the vns device programmed on. X-rays were taken and it was reported that the electrodes appear dislodged from the nerve. The neurologist believes the electrodes were dislodged because the patient began golfing too soon after surgery. It was also reported that the bulge was not visible from the outside; no protrusion. The patient had lead revision surgery on (b)(6) 2015, the generator was not replaced. After the new lead was implanted and connected to the vns generator, diagnostics were performed and were within acceptable levels. Attempts to obtain additional relevant information have been unsuccessful to date. The explanted generator has not been received to date. It was reported that it was likely discarded by the explanting facility.
 
Event Description
It was verified that the lead was detached from the nerve. It was also reported that the lead revision surgery resolved the bulging sensation that the patient was feeling previous to the revision.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953543
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« Reply #40 on: November 07, 2018, 01:46:31 AM »

Model Number 302-20
Event Date 11/05/2012
Event Type  Malfunction   
Event Description
Reporter indicated that device diagnostic testing on (b)(6) 2012, resulted in high impedance and the vns patient's device was subsequently programmed off. X-rays were taken and reportedly showed "the more proximal lead appears disconnected from the generator. " further follow-up revealed that the patient is not going to pursue device revision surgery at this time likely due to insurance reasons. It is unknown if any patient manipulation or trauma occurred that could have cause or contributed to the high impedance reading. It was requested that x-rays be sent to device manufacturer for review; however, it is unknown if they will be sent. Although surgery is recommended and is likely at a later date, surgery is not planned at this time. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2907394
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« Reply #41 on: November 10, 2018, 01:10:18 AM »

Model Number 304-20
Device Problems Fracture; Device Contamination with Body Fluid
Event Date 07/19/2018
Event Type  Malfunction   
Event Description
It was reported that during vns generator replacement surgery, high impedance was observed on the patient's vns. Multiple lead pin insertion troubleshooting attempts were performed and the high impedance did not resolve. The tc stated that they would perform a generator diagnostics when a test resistor was obtained. Follow up revealed that the medical professional believed that the lead was nicked during surgery which was the cause of the high impedance. This was further supported as the pre-op diagnostics and the generator diagnostics were within normal limits. The explanted products were received by the manufacturer. Generator product analysis was completed. The reported near end of service, or neos, condition was duplicated in the product analysis, or pa, lab. An end of service, or eos, message was observed and found to be associated with pulse disablement by the generator. The pulse disabled byte was able to be reset. With the case removed and the battery attached to the printed circuit board assembly, or pcba, the battery voltage measured 2. 30 v, confirming the neos condition. The generator performed according to functional specifications. The electrical performance of the generator in the pa lab was used to conclude that no anomalies existed and the neos/eos conditions were expected events. Other than the pulse disabled event, there were no performance or other adverse conditions found with the generator. Lead product analysis was completed. An abraded opening in the tubing was observed past the electrode bifurcation. The reported fracture of leads was not verified. A portion of the lead containing the electrode array was not returned and, therefore, evaluation could not be made as to that portion. The large o-ring connector boot had partial detachment from the connector ring assembly. The tubing of the negative coil was abraded open at approximately 1 cm past the end of the electrode bifurcation. The negative coil has smoother surfaces indicating wear at this location. The lead assembly has dried remnants of body fluids inside the inner tubing. No obvious point of entrance was noted other than the identified large o-ring boot detachment, abraded opening, and cut end of the returned lead portion. Other than the above mentioned observations and typical wear/explant related observations, no other anomalies were identified in the returned lead portion. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7944430
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« Reply #42 on: November 10, 2018, 01:11:03 AM »

Model Number 102R
Device Problem Detachment of Device or device Component
Event Date 09/17/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A patient's generator was replaced due to battery depletion as the previous device was unable to be interrogated and was believed to be completely depleted. It was also reported that the header was found disconnected form the generator can upon explant from the patient. The disconnection was noted to have occurred prior to the explant procedure, and the caregiver stated that the patient may have influenced the condition of the generator with his hands. There were no previous report of high impedance or any other malfunction found. The generator was to be returned for analysis. No generator was received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7960329
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« Reply #43 on: November 15, 2018, 08:22:27 AM »

Model Number 302-20
Event Date 08/25/2006
Event Type  Injury   
Event Description
Reporter indicated that during a patient's vns generator replacement surgery due to end of service on (b)(6) 2006, it was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. The patient was also reported as experiencing neck pain at the time along with the lead migration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023975
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« Reply #44 on: November 15, 2018, 08:24:00 AM »

Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2013 due to painful stimulation and the patient felt as if the device was flipping. The explanted products were received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date.

Event Description
An analysis was performed on the returned lead portions which identified observed abraded openings on the outer and inner tubing sections have the potential for contributing to the painful stimulation allegation. The abraded opening found on the outer and one inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and one of the inner silicone tubes. For the observed inner tubing fluid remnants found inside the second inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Other than the abraded openings of the outer and inner tubing, no additional 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. One set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is evidence of an abraded opening in the inner tubing, which may have contributed to the stated painful stimulation complaints. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

Manufacturer Narrative
Suspect medical device, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device manufacture date, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device failure occurred, and may have contributed to the patient's pain. Review of lead manufacturing records confirmed that all quality tests were passed prior to distribution.

Manufacturer Narrative

Event Description
It was initially reported that the patient was referred for surgery due to the device slipping. Diagnostics are fine but the patient feels pain. Clinic notes dated (b)(6) 2013 were received due to the patient being referred for surgery. The generator was disabled due to currently experiencing "pain in her neck over the scm muscle as it did once prior in 2006 when revision was needed, because the device had slipped out of place". The events in 2006 were previously reported in mfg report number: 1644487-2013-00840. It was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. It was further indicated in the notes that the patient had noted pain with vns stimulation on times for the past month described as focal pain at the electrode site. The patient's seizures are under good control, but the vns device was turned off due to "lead impedance problems and elevated dc code and pain". However, diagnostics were within normal limits. System diagnostics showed dcdc=2, and normal mode diagnostics showed dcdc=3. Additionally, the lead impedance was indicated as "ok". The physician also stated the generator is not at eos, "but we believe it is disconnected. " x-rays were ordered, and the patient was referred for vns replacement surgery due to painful stimulation which the physician indicated the pain could preclude injury. Upon follow-up with the treating physician, it was reported that they are unable to establish communication with the device currently but then it was later indicated that the device could be interrogated to show the impedance. Current x-rays do not show any obvious discontinuities, but they have not been provided to the manufacturer for review to date. The x-ray report indicates the x-rays were compared to those dated (b)(6) 2006 and there were no evidence of lead disruption or significant displacement identified. Additionally, there was no gross discontinuity involving the stimulator although evaluation was reported to be quite limited. No patient or manipulation is believed to have contributed to the events. The physician does not believe the leads are disconnected and does not believe that there is lead migration at this time. There were no causal or contributory programming or medication changes that preceded the onset of the events. After the device was turned off due to pain in the generator and lead area, the pain stopped. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027440
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« Reply #45 on: November 15, 2018, 08:24:59 AM »

Model Number 300.20
Event Date 07/01/2009
Event Type  Malfunction   
Manufacturer Narrative
"electrode detach from nerve is beyond the scope of activities performed in the product analysis lab". The portion of the lead that was returned for analysis did not reveal any anomalies. However, a device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by the surgeon that the patient underwent a full revision surgery due to lead disconnected from nerve. X-rays were taken which clearly showed top lead disconnected from the nerve. X-rays were not available for further manufacturer review. No patient manipulation or trauma was reported. Explanted products were returned to manufacturer for further review. Analysis was completed on the lead and reported allegation of high lead impedance was not confirmed. Condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1497730
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« Reply #46 on: November 21, 2018, 07:56:53 AM »

Event Date 01/01/2013
Event Type  Malfunction   
Event Description
I was initially reported on a call the physician office needed a company representative to come to their site and they needed their contact information. I was inquired as to if there was a problem or issue that they needed assistance with but it was repeatedly said there was no issue they just wanted the company representative to come to the site as they had not seen him in a while. Shortly before getting off the phone the caller did mention there was a patient whose lead came off the nerve. Attempts were made to determine the identity of the patient but it was unknown. The caller what made them think the electrodes were off the nerve and if there was high impedance seen and the response was ¿i guess so. ¿. All attempts to get any additional information about the patient and the high impedance have been unsuccessful to date. The call was ended before the name of the physician or the facility was able to be attained. The company representative whose contact information was given to the call has not heard from the office.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3129442
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« Reply #47 on: November 24, 2018, 04:41:23 AM »

Model Number 102
Event Date 01/01/2007
Event Type  Injury   
Event Description
It was reported by pt that while she was driving, she jerked her neck and the leads were protruding from her neck. She had to undergo an exploratory surgery to identify the cause of protruding. Pt also stated that during the surgery, the surgeon told her that the leads had migrated and they were off the nerve. Good faith attempts to obtain additional info have been made, but no response has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1889149
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« Reply #48 on: December 03, 2018, 04:14:28 AM »

Model Number 302-20
Event Date 02/20/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that the explanted lead could not be returned for product analysis as it was taken off in pieces and discarded by the hospital.

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

Event Description
On (b)(6) 2013 it was reported that the vns patient underwent a lead revision surgery on (b)(6) 2013 due to a ¿lead discontinuity¿. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. It was later reported that the patient was seen on (b)(6) 2013 with increased seizures. The patient reported trauma to her neck from her boyfriend trying to choke her. The lead impedance was high and x-rays were done. It was stated that the x-rays appeared to show that one of the electrodes was off the nerve and possibly broken. The explanted lead has not been returned to the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3201678
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« Reply #49 on: December 15, 2018, 01:38:32 AM »

Model Number 302-20
Event Date 07/03/2013
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: the initial report indicated the high impedance occurred in (b)(6) 2013 however, additional information received revealed that the date of the high impedance is (b)(6) 2013. The information has been corrected in this report.

Event Description
A review of the data contained within the explanted generators memory revealed that a >25% change in system impedance was estimated to have occurred on (b)(6) 2013 (2442 ohms to 10199 ohms) signifying the start of the high impedance event.

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

Event Description
On (b)(6) 2013, it was reported that the patient was showing high lead impedance on diagnostics performed that day. The patient's settings were disabled during the visit after the high impedance was observed. The patient was referred for x-rays and the surgeon for replacement. Replacement surgery occurred on (b)(6) 2013. Clinic notes dated (b)(6) 2013 confirm that high impedance was seen. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Manufacturer Narrative
(b)(4).

Event Description
The explanted generator and lead were returned on 09/12/2013. Visual examination performed at the bench revealed scratches on the generator can and header most likely associated with manipulation of the device during the explant procedure. Burn marks were also observed on the pulse generator can and header indicating that the pulse generator may have been exposed to an electro-cautery tool. No other surface abnormalities were noted on this device. The generator was subjected to and successfully completed a final electrical test. The generator is operating within specification. Results of diagnostic testing indicated that the battery status indicated ifi=no. The data in the diagaccum consumed memory locations revealed that 36. 384% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The lead was returned for analysis due to allegation of high impedance/lead break. A section of the lead assembly was returned for analysis in one piece. The lead's electrodes were not returned for evaluation. Four sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. The outer silicone tubing has what appear to be internal abrasions at multiple locations. The outer silicone tubing appears to have been compressed at multiple locations. The negative coil is covered with what appears to be organic matter in the vicinity of the anchor tether location. The organic matter was removed to perform proper inspection of the lead. White deposits were noted on the silicone tubing of the negative coil at approximately 0. 6cm past the anchor tether. A break was noted on the negative coil at approximately 0. 2cm past the electrode bifurcation. The negative coil has an opaque appearance at approximately 0. 1cm prior to the broken end. The lead assembly has remnants of what appears to be dry body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portion. The reported high impedance/lead breaking allegations were verified. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil broken ends (including portion with an opaque appearance) and strand segments show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be determined. Note that since the closest and furthest electrode to the bifurcation were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3322939
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« Reply #50 on: December 15, 2018, 01:39:30 AM »

Model Number 103
Event Date 09/25/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the hospital had a generator to return because it was "defective". Review of the generator device history records confirmed all quality tests were passed prior to distribution. Follow up with the site found that the packaging of the generator was opened and the surgeon noticed that the "silicone o-ring that fits where the screw fits was not seated. " (the septum plug was out of the septum. ) this was observed after the packaging was opened, without any manipulation/trauma to the generator. The surgeon did not try to reseat the part on the device and the generator was never implanted in a patient. The generator was returned to the manufacturer and product analysis was performed. Although (in its "as-received" condition) the negative septum was observed to be dislodged from the header cavity, its dimensions and that of the generator septum cavities met design specifications; a reason for observed condition is unknown; septum and setscrew appear to have been manipulated. While signs of manipulation of the setscrew and septum are present, a root cause for the condition could not be determined. All dimensions related to the generator septum cavity and septum are within specifications. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 2. 213% of the battery had been consumed. Other than the visual observations, there were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Although device failure occurred, it did not lead to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3428350
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« Reply #51 on: December 21, 2018, 09:08:25 AM »

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3453435
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« Reply #52 on: December 22, 2018, 09:36:46 AM »

Type of Device:                      Stimulator
Device Brand Name:               VNS Demipluse
Device Manufacturer's Name:  Cyberonics
Date of this Report:                04/07/2011
(mm/dd/yyyy)
Describe the Event                  Left vagal stimulator lead/generator explanted. Stimulator lead "broke,
or Problem:                            and not attached to nerve".
the device(s) may
have                                      Potential for patient harm
caused or contributed to:         

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=24452

« Last Edit: December 22, 2018, 09:45:14 AM by dennis100 » Logged
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« Reply #53 on: January 05, 2019, 01:26:08 AM »

Model Number 105
Device Problems Crack; Detachment of Device or device Component
Event Date 12/05/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported during the investigation for high impedance on the patient's vns, which is reported in mfg. Report #1644487-2018-02288, that during the vns replacement surgery, the vns generator's header was found to be cracked and detaching from the generator can. Follow up revealed that the surgeon stated that it may have been the result of the vns surgery, but was not 100% sure. Therefore, it is unknown the role, if any, the damaged and detaching header played in the high impedance. It was stated that the surgeon had planned to replace the generator during the surgery anyways. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The return of the explanted product is not expected. No additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8162504
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« Reply #54 on: January 07, 2019, 02:50:33 AM »

Model Number 304-20
Event Date 01/14/2014
Event Type  Malfunction   
Event Description
It was reported that a vns lead was being implanted into the patient in the initial implant surgery, but upon opening the lead from the packaging, it was noted that the electrode helical was entangled. The surgeon attempted to attach the helical to the nerve; however, "it did not fit". The helical was described as mis-shaped. Another lead was implanted into the patient and this lead was returned to the manufacturer. The returned product is pending product analysis. No other information has been provided.
 
Event Description
Analysis of the returned lead was completed. Review of the as-received photograph showed one end of the anchor tether silicone helix in the vicinity of the center portion of the helix. Also, the closest electrode to the bifurcation was damaged showing bends on the electrode ribbon and partial detachment of the electrode ribbon and suture from the silicone helix. The furthest electrode to the bifurcation had creases/bends on the electrode ribbon partially losing its helical shape. The lead electrodes including the anchor tether were installed in a training fixture and it was verified that placement of the electrodes and anchor tether was possible. Based on the inspection results it can be concluded that the most likely cause for the observed damage to the closest and furthest electrode to the bifurcation was manipulation of the lead not consistent with our labeling. However, a conclusive determination of whether one of the lead electrodes was tangled prior manipulation of the lead cannot be made.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3627271
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« Reply #55 on: January 15, 2019, 01:42:25 AM »

Model Number 104
Event Date 04/28/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the septum plug from the vns patient¿s replacement generator had detached from the generator. The surgeon was able to reinsert the septum plug, tighten the septum screw, and successfully implant the replacement generator. No complications were occurred during surgery that may have caused or contributed to the detachment of the septum plug. The patient¿s replacement generator was tested with the existing lead outside and inside the generator pocket, and diagnostic results showed lead impedance within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3824759
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« Reply #56 on: January 16, 2019, 01:11:21 AM »

Model Number 302-20
Event Date 04/14/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that prior to prophylactic generator replacement surgery, the vns patient¿s device showed high lead impedance. High impedance was not previously observed so no x-rays were taken and the device was not programmed off. The patient¿s generator and lead were replaced during the procedure. The surgeon noted that the electrodes were detached from the nerve. When replacing the generator, the surgeon was able to explant the generator and lead prior to opening the neck incision site. The explanted lead was fully intact and no other issues were noted. No patient manipulation or trauma was reported. The explanting facility discarded the explanted products; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3802074
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« Reply #57 on: January 18, 2019, 02:37:33 AM »

Model Number MODEL 250
Event Date 04/01/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's programming system was experiencing communication issues. It was reported that the end of the cord on the wand was detaching. The handheld and wand were received for analysis. Analysis of the wand was completed. The event was not confirmed although the strain relief grommet was dislodged from the handle. Continuity testing of the serial data cable and the battery cable passed. After a known good bench battery was installed, the programming wand performed according to functional specifications. Analysis of the handheld was completed. During the analysis no functional anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. The handheld serial cable was not received for analysis. The serial cable is suspected to be the cause of the communication issues. It was reported that the serial cable was discarded and will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3878602
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« Reply #58 on: January 19, 2019, 03:26:50 AM »

Model Number 302-20
Event Date 05/14/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results showed high lead impedance (dc dc ¿ 7). The patient¿s device settings were increased during the office visit. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in an abnormal arrangement. The second electrode appears to either be placed upside down or possibly has come off the nerve. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance may be due to detachment of the second electrode but no definitive conclusions can be made. Further follow-up revealed that the patient¿s device had been disabled and the patient still had good seizure control. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3857029
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« Reply #59 on: January 21, 2019, 11:19:03 AM »

Event Date 03/30/2016
Event Type  Malfunction   
Event Description
Additional information received that patient underwent surgery. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Xrays images were sent to the manufacturer by medical professional for review. Review of the images showed that the generator appears to be low in the chest, just above the diaphragm, in an abnormal placement. The filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared not to be placed in normal arrangement. The anchor tether seemed not to be fixed on the vagus nerve and the anode seemed to be partially dislocated from the nerve. No strain-relief loop and no strain-relief bend were found for the implant of the lead. Two tie-downs were used but their placement is not as recommended in the labeling. It could not be assessed from the images if a part of the lead is behind the generator. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Further information was received from the physician that the reason xrays were taken is they could not communicate with the generator. It was reported that the generator was not implanted auxilliary. It was reported that the vns patient felt following a strong seizure. The generator has dropped from its original location, and is in a lower location in the patient's body which is the suspected cause of the inability to interrogate the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6036347
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« Reply #60 on: January 22, 2019, 04:45:45 AM »

Model Number 304-20
Event Date 12/18/2014
Event Type  Injury   
Event Description
Additional information was received from the neurologist that the patient required a revision of her vns in (b)(6) 2015 secondary to a possible allergic reaction to silicone sheathing. She subsequently had slow wound healing. Patient was seen on (b)(6) 2015 after apparently expressing a ruptured suture. It was not felt by the neurosurgeons to be infected at that time. Patient likely developed a uri in (b)(6) 2016 and then developed a left breast cellulitis necessitating removal of the device.
 
Event Description
Additional information was received that the patient completed her iv antibiotics on (b)(6) 2016 & her picc line was removed. Patient was told that vns could not be re-implanted as she has too much scar tissues. Due to patient's severe allergic reaction to the device & her body rejecting it, the surgeon will not be implant vns again for patient.
 
Event Description
On (b)(6) 2016 an email was received that the patient developed a cellulitis that needs to be removed. Additional information was received that the patient had her battery and lead wires removed on (b)(6) 2016 due to an infection. Patient is not sure if the coils are still intact on the vagus nerve as one of the coils came through the small open wound on patient's neck incision that never healed after she was implanted on (b)(6) 2014. Patient could not remember the month or year this happened. The opening was big enough to insert tip of qtip. Patient stated that the open wound happened approximately about a month after sutures were removed by the surgeon. Patient was instructed to use neosporin on the open wound, keep it dry and let air get to it. No oral antibiotics were given. Patient did not go to primary care provider at this time either. When one of the tie-downs was pushed through the wound opening in patient's neck, patient consulted the surgeon, who discussed that it was patient's body rejecting the device and that patient should be ok since there were two other tie downs in place. In 2015, patient had a mammogram. Patient thinks that the compression from the mammogram machine pulled the wires and made the generator move. Patient had to have surgery on the leads after that because the leads were displaced. Patient underwent repositioning surgery on (b)(6) 2015 for patient comfort. After the leads were repositioned and tied down, patient stated she was ok but still had the small wound on her neck and that it would open and close up on its own and at times leak some fluid. Patient was referred to wound care center for treatment for a couple of months. Patient later got a very bad sore throat, ear ache and was coughing up mucus in (b)(6) 2016. A throat culture was performed but no antibiotics were given. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5867152
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« Reply #61 on: January 24, 2019, 03:48:46 AM »

Model Number 105
Event Date 07/30/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.
 
Event Description
It was reported that during generator implant, the rubber septum plug over the set screw popped out when the surgeon was tightening the set screw. It was reported that the plug fell out of the sterile field. The plug was unable to be located within the or and a new generator was implanted. It was reported that the physician did not use any excessive force that may have caused the plug to come off. It was reported that the plug popped out easily as if it was not attached. The generator was returned for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned generator was completed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. No signs of manipulation of the returned setscrew were present and the septum was not returned for evaluation. The header septum cavity meets specification. Therefore, a root cause for the condition could not be determined. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4042354
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« Reply #62 on: January 24, 2019, 03:49:41 AM »

Model Number 103
Event Date 06/05/2014
Event Type  Malfunction   
Event Description
It was reported that during prophylactic generator replacement surgery, the septum of the vns patient¿s replacement generator had detached from the generator. The surgeon reinserted the septum and implanted the generator.
 
Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3906744
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« Reply #63 on: January 24, 2019, 03:50:22 AM »

Model Number MODEL 250
Event Date 07/31/2014
Event Type  Malfunction   
Event Description
It was reported that the neurosurgeon¿s tablet device was not responding to the tablet stylus but responded to touch from his finger. The stylus battery was replaced; however, the issue did not resolve. The tablet and stylus have not been returned to date.
 
Event Description
Analysis of the returned tablet device was completed. A visual analysis of the digitizer pen identified that the button cover was detached. The button is the equivalent of a right-click. Although the button cover was detached, the pen was able to be used to navigate through the vns software with no anomalies. During the analysis, no anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge. The tablet performed according to functional specifications.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the tablet device passed all functional tests prior to distribution.
 
Event Description
The tablet was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4037136
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« Reply #64 on: January 25, 2019, 09:15:39 AM »

Model Number 300-20
Event Date 07/24/2014
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Corrected data: the initial mfr. Report inadvertently reported the event as both serious injury and malfunction; however, this should only have been reported as a serious injury.
 
Event Description
Additional information was received which stated the patient experienced neck pain prior to the revision surgery, even though the diagnostics were within limits. It was noted that when the lead was explanted fluid was found inside. After the revision surgery, the patient's neck pain didn't go away for the first few days after the surgery, but then it did resolve.
 
Event Description
It was reported that the vns patient was experiencing intense pain in her neck. The patient¿s device was subsequently disabled; however, the patient continued to experience stabbing pains but less frequently than before disablement. X-rays were taken and the lead reportedly appeared to be ¿unwrapped from the nerve. ¿ the patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility discarded the explanted lead; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027949&pc=LYJ
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« Reply #65 on: January 27, 2019, 09:38:14 AM »

Model Number 300-20
Event Date 06/10/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the patient would be referred for generator replacement. Clinic notes dated (b)(6) 2014 note that the patient has not reported any adverse effects with continuing device stimulation and that the patient's seizures remain in good control. It was noted that continuing device stimulation is important as long as the patient does not experience any adverse effects and that generator replacement will be expedited. No known surgical intervention has been performed to date.
 
Event Description
It was reported by the physician that the vns electrodes appeared to have been attached to the sympathetic nerve instead of the vagus nerve. He believes that the electrode had been on the nerve at some point in time and that it may have become detached. The patient has developed horner¿s syndrome, which was due to the surgery. The syndrome was reported to be permanent, but mild, no additional interventions were taken.
 
Event Description
It was reported that the patient underwent generator and lead replacement. The surgeon indicated that the lead appeared to be on a similar nerve close by the vagus nerve. It was later reported that the surgeon believes he may have damaged a nerve during electrode removal that may be causing the patient's eye to droop. It was reported that the explanting facility does not return explanted devices without patient consent. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient has noticed an increase in micro-seizures since using a bone stimulator to help with bone fusion following neck surgery. The neurologist advised the patient to discontinue use of the bone stimulator to see if the seizures decrease. Clinic notes dated (b)(6) 2014 note that when the patient discontinued use of the bone stimulator, the patient's seizures abruptly stopped about 7-10 days later. It was noted that device diagnostics resulted in low impedance (<600 ohms). No surgical intervention has been performed to date.

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« Reply #66 on: January 28, 2019, 05:37:28 AM »

Model Number 300-20
Event Date 08/28/2014
Event Type  Malfunction   
Event Description
Product analysis for the generator that was completed on 04/16/2015 concluded that the generator detachment of components was most likely attributed to explant related events. Therefore the possibility of a lead break cannot be ruled out. The patient's lead has not been explanted to date.
 
Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2015. It was stated that the generator was in two pieces as the header was detached from the generator. The lead was not replaced. When the new generator was attached to the old lead impedance values were good at 2825 ohms. The generator was returned for analysis on 03/19/2015. Analysis is currently underway but has not been completed to date.
 
Event Description
Product analysis for the generator was completed and approved on (b)(4) 2015. 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. The output exhibited output variations on chart. This condition was due to an intermittent connection on the alligator clip, used to establish an electrical connection to the generator. The pulse generator was monitored again for more than 24-hrs and results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The reported ¿detachment of components(s)/header¿ allegation, most likely occurred 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 as received photo shows no evidence of bodily fluid remnants in the case/header area. 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. The generator performed according to functional specifications. Other than the intermittent connection issue that is not related to the generator and the header anomaly (visual analysis), there were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Corrected data: changed suspect device to lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 6). X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

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« Reply #67 on: January 29, 2019, 07:20:46 AM »

Model Number 302-20
Event Date 08/08/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was having issues with pain and with device migration. Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months. She later reported having a strange tremor in her head that occurred several times per day. It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla. Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck. The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside. An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity. The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

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« Reply #68 on: January 29, 2019, 07:21:24 AM »

Event Date 08/19/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the patient¿s lead electrodes were observed to be not in contact with the patient¿s vagus nerve. As result, diagnostic results showed high impedance. It was noted that the patient¿s vagus nerve was very thin. No known surgical interventions for the reported high impedance and electrode placement have occurred to date.

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« Reply #69 on: February 04, 2019, 02:52:49 AM »

Model Number 102
Event Date 10/16/2014
Event Type  Malfunction   
Event Description
It was reported that during vns implant surgery, the septum plug of the generator popped out when the surgeon was withdrawing the hex screwdriver after tightening the setscrew. The septum plug could not be reinserted, so a new generator was used to complete the procedure. The unused generator has been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator was completed. There were no anomalies found with the pulse generator. The septum cavity and septum met the specification measurements. The septum and setscrew was placed in the header septum cavity and was successfully secured by a bench torque wrench. The generator performed according to functional specifications.

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« Reply #70 on: February 07, 2019, 01:23:04 AM »

Model Number 105
Event Date 01/05/2015
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The generator with the detached septum plug was returned to the manufacturer for analysis. No signs of manipulation of the returned setscrew were present. The septa meet specification requirements. The header septum cavity meets specification requirements. Therefore, a root cause for the event could not be determined.
 
Manufacturer Narrative
(b)(4). Additional manufacturer narrative and/or corrected data; corrected data: the initial mdr inadvertently did not include the suspect device udi. This report is being submitted to correct this data.
 
Event Description
It was reported that during generator and lead replacement surgery on (b)(6) 2015 due to high impedance, the septum plug from the vns patient¿s replacement device popped out while removing the hex screw driver after tightening the setscrew. It was noted that the surgeon is very experienced and careful. Another generator was used to complete the procedure. The explanting facility will not return the device to the manufacturer for analysis; therefore, no analysis can be performed. The high impedance event was reported in manufacturer report # 1644487-2014-03035.

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« Reply #71 on: February 07, 2019, 01:24:10 AM »

Model Number 103
Event Date 11/05/2014
Event Type  Malfunction   
Event Description
Review of device manufacturing records confirmed that the suspect device passed all functional tests prior to distribution. The screwdriver used during the surgery was discarded.
 
Manufacturer Narrative

Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the surgeon tightened the setscrew and stated that the septum plug ¿popped out¿ while removing the hex screwdriver. No anomalies were observed with the hex screwdriver. The surgeon elected to reinsert the septum plug back into place and closed the patient. System diagnostic results showed normal device function. Attempts for additional relevant information will be made.
 
Manufacturer Narrative
Corrected data: previously submitted mdrs inadvertently omitted the unique device identifier (udi) for the suspect medical device. (b)(4). This report is being submitted to correct this information.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

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« Reply #72 on: February 07, 2019, 01:24:53 AM »

Model Number 302-20
Event Date 05/10/2012
Event Type  Malfunction   
Event Description
It was reported by a physician that high impedance was read at a follow-up appointment upon performing system diagnostics. The patient was referred for x-rays and the generator was programmed off. The last known good system diagnostics were noted to be from (b)(6) 2011. X-rays were received and evaluated by the manufacturer. The generator was placed in the lower left chest, in the left side of it, a few centimeters below the axilla. The filter feed-through wires appeared to be intact. The lead connector pins appeared to be fully inserted into the generator connector block. The lead wires at the connector pin appeared to be intact. The negative and positive electrode appeared not be aligned, and the negative electrode seems to be detached from the vagal nerve. Portions of the lead appeared to be behind the generator and could not be fully assessed. An acute angle appears to be present right below the positive electrode. At the moment, good faith attempts to obtain further information have been unsuccessful to date.
 
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate type of report. Report should have read 30-day.
 
Event Description
Additional information was received that the patient did not have any trauma or manipulation of their device reported prior to the event. At this time no surgery is scheduled. The patient may in the future have either replacement or explant of their lead. The patient is reported to be doing well and a decision will be made in (b)(6) when they see a surgeon.
 
Event Description
Additional information was received from the area representative indicating there was no manipulation or trauma involved that could have had contributed to the report of high lead impedance. At the moment no interventions have been planned for the patient.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #73 on: February 09, 2019, 01:22:31 AM »

Model Number 304-20
Device Problem Detachment of Device or device Component
Event Date 12/10/2018
Event Type  Malfunction   
Event Description
It was reported that during replacement surgery, new devices were tested outside of the pocket, impedance was normal and then the surgeon was unable to get the set screw driver to disengage the lead terminal pin from the generator. Ultimately a new lead and generator had to be implanted. The new lead's electrodes were successfully implanted onto the vagus nerve and the terminal pin was connected to new device 106 (while still out of the pocket). After successful system diagnostic testing, the neurosurgeon tried to remove the lead from the header of the device and could not do so. The neurosurgeon said the he ¿could not back out the setscrew. ¿ a new system was successfully implanted in the patient. The lead tubing was seen disconnected near the area where the led pins are inserted into the generator. The device have not received to date. No additional or relevant information has been received to date.

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« Reply #74 on: February 09, 2019, 01:23:10 AM »

Model Number 106
Device Problems High impedance; Detachment of Device or device Component
Event Date 08/14/2018
Event Type  Malfunction   
Event Description
It was reported that the diagnostics at the time of implant were normal. The patient's device was interrogated a month after implant and impedance came back has high. X-rays were conducted an no fractures were visible. The pin was possibly not fully in place however it was difficult to visualize through the x-ray. The patient underwent surgery for a possible revision due to the high impedance upon opening the chest incision it was seen that the lead pin had come out slightly as a consequence of the screw coming undone and the silicone cover was detached. It was reported that the lead pin was inserted properly and secured by tightening the setscrew at the time of initial implant. The surgeon removed the generator and replaced the silicone cover and placed the generator back in. The device was tested and normal impedances were seen. After the surgery, while the patient was recovering, 3 diagnostics tests showed high impedance. And low output current delivered. The patient was taken back in to surgery and it was seen that the lead was again not fully inserted. A new generator was implanted and high impedance was still seen, therefore the lead was revised. The set screw being undone and the detachment of the septum plug is reported. The high impedance suspected to be due to the lead is reported in mfr. Report # 1644487-2018-02262. The explanted generator has not been received to date.

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« Reply #75 on: February 11, 2019, 01:15:55 AM »

Model Number 300-20
Event Date 01/15/2015
Event Type  Malfunction   
Event Description
Analysis of the explanted generator was completed. Visual examination confirmed 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. Other than the observed generator header detachment, there were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Event Description
Additional information was received that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high impedance. The explanted generator and lead were received for analysis. When received, the generator's header was detached, but this was stated to have occurred during explant. Analysis of the explanted lead was completed. Note that the majority 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 condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Analysis of the explanted generator has not been completed to date.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results reveal high lead impedance (dcdc ¿ 7). The patient¿s device was subsequently disabled. It was noted that the patient is cognitively impaired and requires ambulatory assistance mainly on the left side which the physician believed, along with the age of the device, was the cause of the high impedance condition. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
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.

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« Reply #76 on: February 14, 2019, 01:15:19 AM »

Model Number 102R
Device Problem Detachment Of Device Component
Event Date 10/23/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was having difficulty with his vns causing pain and some erratic readings. The neurologist notified the surgeon and they wanted him to be seen urgently and possibly have surgery. The patient¿s generator was explanted. Further information was provided that the explanted generator appeared to be ¿split in two. ¿ from images provided it appears that the header on the generator was detached. It was also stated that the patient had felt infrequent stimulation. Impedance prior to surgery was stated to be within normal limits. Regarding the initial report of pain, it was stated that the pain was infrequent, and felt as if he could hardly feel stimulation and all of sudden felt higher stimulation. The pain was felt at the left chest just under the clavicle. The ¿erratic readings¿ report was referring to the patient¿s infrequent stimulation. The 4000-5000 ohms impedance was verified to be from system diagnostics. The physician believes that the detachment of the header occurred prior to surgery, most likely believed to be due to day to day activity as the patient has lived a ¿hard¿ life. The explant generator has not been received for analysis to date. No additional relevant information has been received.
 
Event Description
Product analysis for the generator was completed and approved. The reported ¿detachment of header¿ allegation, was confirmed in the lab. A window was cut into the can and test leads were attached to the output connections for monitoring of the device and for testing purposes. 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 of the current automated final test. Other than the header anomaly, there was no abnormal performance or any other type of adverse condition found with the generator. The cause of the header detachment could not be determined in analysis. Examination did not reveal body fluid remnants on the can, which would indicate partial separation during the implant period.
 
Event Description
The generator was received for analysis. Product analysis is currently underway but has not been completed to date.

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« Reply #77 on: February 16, 2019, 01:43:39 AM »

Model Number 105
Event Date 02/16/2015
Event Type  Malfunction   
Event Description
Analysis of the returned generator was completed. Review of the data indicated that the generator reached end of service condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor for the end of service condition. The pulse generator diagnostics were as expected for the programmed parameters. The battery, 3. 234 volts, shows an ifi=no condition. No signs of manipulation of the returned setscrew were present (socket not stripped) and the septum was not returned for evaluation. The header septum cavity meets the specified requirements. Therefore, a root cause for the condition could not be determined. Additionally, the lead replacement surgery that occurred on (b)(6) 2015 was also reported in manufacturer report # 1644487-2014-01974.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Describe event or problem. Corrected data: the manufacturer report number for the lead replacement surgery was inadvertently left out of the initial report.
 
Event Description
During a lead replacement surgery, the septum plug from the generator came out. The septum plug was reinserted into the generator with no issues. However, after connecting the lead to the generator, diagnostics indicated that the newly implanted generator was near end of service. The use of the hex screwdriver during the placement of the septum plug is suspected to be cause of the premature battery depletion of the generator. The generator was replaced and returned to manufacturer on (b)(6) 2015. Analysis is underway but has not been completed.

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« Reply #78 on: February 19, 2019, 03:08:21 AM »

Model Number 102R
Device Problems Generator; Detachment Of Device Component; Failure to Interrogate
Event Date 09/01/2015
Event Type  Malfunction   
Event Description
It was reported that during removal of the patient's generator the header was observed to be detached from the can of the generator upon opening the pocket. The surgeon used the torque wrench to unscrew the lead from the header. When the lead was connected to the new pulse generator normal diagnostic values were observed. Information received from the provider indicated normal lead impedance was seen on multiple device checks between (b)(6) 2015. The device exhibited it's elective replacement indicator (eri) and on (b)(6) 2015 the device could not be interrogated. There was no reported patient manipulation or trauma noted before the replacement surgery. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution. The explanted generator has not been returned to the manufacturer for evaluation.
 
Event Description
The pulse generator was received for product analysis. Visual examination noted tool marks/dents on the pulse generator case and the header had scratches on it. The marks are most likely associated with manipulation of the device during the explant procedure as the markings are consistent with devices typically used in a surgical procedure (forceps, etc. ). The septum was not cored. Visible adhesive at the generator top matches up with the adhesive on the bottom of the header supporting a secure bond. The anchor tab furthest from the feed-thru capacitors is slightly bent. The anchor tab closest to the feed-thru capacitors is bent on the side furthest from the feed-thru capacitors. Visual assessment of the final manufacturing x-ray showed no abnormalities at the time of manufacture. A scanning electron microscopy (sem) was performed on the anchor welds. The sem images show appearance suggesting that a stress-induced fracture has occurred at one side of one of the anchor welds. However due to mechanical distortion (smoothed surfaces) the fracture mechanism cannot be verified. The device battery was confirmed to be depleted past end of service. The depletion was an expected event as determined battery voltage measurement and battery life calculation. The battery life calculation, based on known programmed settings, indicated 0. 0 years remaining until neos = yes. The module performed according to functional specifications. Other than the header detachment, there were no performance or any other type of adverse conditions found with the pulse generator. Review of the programming history database showed no evidence of high impedance. There is no evidence of device performance being impacted while implanted.

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« Reply #79 on: February 19, 2019, 03:09:33 AM »

Model Number 302-20
Event Date 02/01/2012
Event Type  Malfunction   
Event Description
Product analysis was completed on the generator and lead. 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 generator. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 96mm portion the quadfilar coils appeared to be stretched and kinked approximately 72mm and 92mm past the end of the electrode bifurcation. The end of quadfilar coil 1 appeared to be broken approximately 72mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Manufacturer Narrative
Date of event, corrected data: the initial report inadvertently reported the incorrect date. The clinic notes received on (b)(4) 2012, indicated that the patient blacked out in (b)(6) 2012, fell, and landed on his left shoulder. The patient feels like he pulled the lead at that time which likely contributed to the high impedance.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
The implant card was received and confirmed the generator and lead replacement surgery on (b)(6) 2012. The generator was replaced prophylactically, and the lead was replaced due to the electrode being off the nerve and therefore causing the high impedance. Lead impedance following replacement was okay. Product analysis for the explanted products has not been completed to date.
 
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2012 due to the high impedance. The explanted products were received by the manufacturer for analysis, however it has not occurred to date. The return product form reported that the generator was replaced prophylactically and the lead was replaced due to the electrode being off of the nerve.
 
Event Description
It was reported normal mode and systems diagnostic tests revealed high impedance. The physician's office planned on disabling the device on this day and was referring the patient for x-rays. The patient had a blackout in (b)(6) and feel on his left shoulder. He has had shoulder pain ever since, but has not felt a difference in vns stimulation. This fall may have contributed to the high impedance, per the physician. The last time diagnostics were performed on the patient's device was reportedly a year ago. The patient is likely being referred for generator and lead replacement surgery, but it has not occurred to date. Attempts for additional information have been unsuccessful to date. Film and computer a/p and lateral x-rays images of the neck and chest were reviewed by the manufacturer. It appears that one (or both) electrodes is detached from the nerve, as the positive electrode is angled at approximately a 120 degree angle from the negative electrode. It is unlikely that the patient's nerve curves in such a fashion. It appears that the positive electrode may be detached from the nerve. There were no acute angles or lead discontinuities seen in the visible portion of the lead body. Based on the x-ray images provided, the cause for the reported high impedance is most likely related to the electrode being detached from the nerve. The presence of a microfracture in the lead or a lead discontinuity in the portion of the lead that was behind the generator cannot be ruled out.
 
Event Description
Clinic notes were received dated (b)(6) 2012, which again reported that the patient blacked out in (b)(6) 2012, fell, and landed on his left shoulder. The patient feels like he pulled the lead at that time. It was also noted that the battery is low. The patient felt that the vns was helping him prior to the device being disabled when the high impedance was first observed at (b)(6). The notes also reported that the x-rays revealed that the lead appears to be off the vagal nerve, which was reported by the manufacturer. The physician is referring the patient for generator and lead replacement surgery. Although surgery is likely, it has not occurred to date.

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« Reply #80 on: February 23, 2019, 02:07:41 AM »

Model Number 302-20
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient had been seizure-free following initial implant of the device on (b)(6) 2014 when she experienced two seizures in one day. The patient¿s device settings were subsequently adjusted and the patient was doing well until having a severe seizure on (b)(6) 2015. Prior to implant, the patient had a couple seizure clusters each month. When the patient was seen in (b)(6) 2014, it was noted that there was a slight bulge in the patient¿s skin at the lead incision site. Approximately two months ago, the patient¿s parents noticed that the bulge was more noticeable. The patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). X-rays were taken and were reported by the physician to be unremarkable. The patient underwent lead replacement surgery on (b)(6) 2015. The bulge was found to be the result of protrusion of the lead anchor tether and a tie-down. When opening the lead incision, the surgeon found that the lead anchor tether had detached from the patient¿s nerve and was surrounded by scar tissue. The lead was replaced and system diagnostic results with the replacement lead and generator showed lead impedance within normal limits (dcdc ¿ 2). Patient manipulation is not believed to have caused or contributed to the events; however, it was reported that the patient experienced falls when she had the previously mentioned seizures. The explanted lead has not been returned to date. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

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« Reply #81 on: February 25, 2019, 02:12:49 AM »

Model Number MODEL 250
Event Date 04/17/2015
Event Type  Malfunction   
Event Description
The tablet was returned to the manufacturer. An analysis was performed on the returned tablet and it was noted that the device did not have the power button. No further anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.
 
Manufacturer Narrative
(b)(4). Device manufacturing records were reviewed. Review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the power button of a medical professional¿s tablet had detached from the device and it was lost. The tablet could not be switched on afterwards. Device manufacturing records confirmed that the tablet passed all functional tests prior to distribution. The tablet has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4764437
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« Reply #82 on: March 03, 2019, 04:45:19 AM »

Model Number 302-20
Device Problem High impedance
Event Date 06/25/2015
Event Type  Malfunction   
Event Description
Further information was received indicating that the patient's epilepsy is well controlled without vns and that a surgical revision is not planned. X-rays of the patient dated on were reviewed by the manufacturer. The generator is placed in a normal position in the upper left chest. The filter feed-through wires appeared to be intact. The lead connector pin is fully inserted. The lead wires at the connector pin appeared to be intact. The electrodes at the vagus nerve implant site are not aligned, and the negative one appeared to be detached from the nerve. A strain relief loop was present, but not a bend. One tie-down was visible, securing the loop. Portions of the lead appeared to be behind the generator and could not be fully assessed. No acute angles, no breaks were found in the parts of the lead that could be assessed.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that both the lead and the generator passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient铠vns system was tested on (b)(6) 2015 and system diagnostics returned a high impedance result with >=10000 ohms, current delivered=0. 5ma, ifi=no. The programmed output current was reduced to 1ma and the pulse width was reduced to 250usec. It was reported that the patient was implanted with vns in (b)(6) 2011 and became seizure-free in (b)(6) 2011. It was reported that the cessation of seizures was thought to be a result of natural progression of the disease as opposed to the effect of vns. X-rays were taken and they were reported to be unremarkable by the healthcare professional. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Review of manufacturing records confirmed that the lead and the generator passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4924659
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« Reply #83 on: March 06, 2019, 01:33:19 AM »

Model Number 302-20
Device Problems Detachment Of Device Component; High impedance
Event Date 07/17/2015
Event Type  Malfunction   
Event Description
Additional information was received that the patient's pain had been occurring in the patient's neck prior to the generator and lead replacement surgery. The pain began occurring following a settings increase. Thus, the settings were decreased which helped the pain. The pain was thought to perhaps have been caused by the detached electrode. No additional relevant information has been obtained to date.
 
Event Description
Analysis was completed on the patient's explanted generator. Analysis showed that the generator performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portion. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently failed to report the device evaluation.
 
Manufacturer Narrative

Event Description
Clinic notes were received and indicated that the patient had experienced pain associated with stimulation. There was also a report of a settings adjustment which helped with the pain. The patient then underwent a prophylactic generator replacement surgery on (b)(6) 2015. However, pre-operative system diagnostics resulted in high impedance detected on the patient's vns system. Thus, the lead was replaced as well. It was reported that during the lead replacement, it was seen that the positive electrode and anchor tether of the lead had become detached from the patient's vagus nerve, leaving only the negative helical electrode still attached. No lead fractures were noted. It was unknown how the lead had become partially detached form the nerve. The diagnostics were normal following the generator and lead replacement. The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5002392
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« Reply #84 on: March 07, 2019, 01:40:08 AM »

Model Number 304-20
Device Problem High impedance
Event Date 07/31/2015
Event Type  Malfunction   
Event Description
It was reported the patient's surgery was scheduled for (b)(6) 2015. The replacement surgery was completed on (b)(6) 2015. It was reported the physician believed the anchor tether came off the nerve and he elected to replace the lead. The vns generator was replaced prophylactically. Both the vns generator and the lead received by the manufacturer. Product analysis is expected but has not been completed to date. No additional relevant information has been received to date.
 
Event Description
Product analysis for the returned generator was completed. The end of service warning message was verified and found to be associated with the output being disabled by the vns generator, burn marks were observed on the vns generator which indicated the generator may have been exposed to electro-cautery during explant. The vns generator was reset in order to allow for subsequent testing. It was found using the downloaded data from the generator that the date of the impedance increase was 05/04/2015. Electrical tests were performed on the vns generator and the results demonstrate that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24-hours while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the vns generator current for the entire monitoring period. The electrical evaluation showed that the vns generator performed according to functional specifications. Product analysis for the returned lead was completed. It should be noted the electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Visual analysis showed a portion of the lead assembly appeared to be twisted and knotted together. These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddler). The abraded opening found on the outer silicone tubing and the cut ends that were made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process.
 
Event Description
It was reported by the physician that high impedance was observed on the patient's vns device during an office visit on (b)(6) 2015. It was also reported the patient began experiencing an increase in seizures at the end of (b)(6). It was stated the physician believes the recent increase in seizures is due to the high impedance observed. It was noted the physician will keep the device programmed on for now. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
If explanted, give date; corrected data: this information was inadvertently left off of supplemental #01 mfr. Report. Device available for evaluation; corrected data: this information was inadvertently left off of supplemental #01 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5113453
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« Reply #85 on: March 09, 2019, 01:59:36 AM »

Model Number 1000
Device Problem Detachment of Device or device Component
Event Date 01/18/2019
Event Type  Malfunction   
Event Description
It was reported that a generator could not be implanted during a generator replacement surgery since the setscrew felt loose and would not tighten. It was stated that lead pin was removed and reinserted before attempting to tighten the setscrew again. The silicone cover reportedly came off and the screw was seen to be loose in the socket area. Another generator was implanted with no issues. It was reported that no excessive force was used during the surgery and that the plug fell out while trying to tighten the screw. The surgeon ensured to turn the screwdriver the correct direction (clockwise) when tightening the screw. A review of device history records for the generator was performed and shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. The suspect generator has not been received to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8371550
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« Reply #86 on: March 10, 2019, 02:06:03 AM »

Model Number 300-20
Device Problems High impedance; Material Separation
Event Date 08/25/2015
Event Type  Malfunction   
Event Description
A device check on a patient's device revealed high impedance and a dc dc value of 4. The patient was reported to have an increase in seizures but it could not be determined if they were due to the high impedance, the age of the implanted generator or other factors. The patient was sent for x-rays which were not provided to the manufacturer for review. The physician elected to leave vns stimulation turned on since the patient was not experiencing any pain with stimulation and the patient was scheduled for revision surgery. During the revision surgery it was observed that the generator header had detached from the generator casing. The lead was disconnected from the header and the generator and lead were each explanted and replaced. Lead impedance with the new generator and lead was normal, 1402 ohms. No impedance testing of the explanted lead was performed. It is unknown if patient manipulation or trauma contributed to the header separation from the casing. It was reported that the patient is in a wheelchair and is lifted in and out of it frequently, however, the patient has not been involved in any accident or falls. It is unknown if the pre-surgical x-rays indicated evidence of the header separation. The physician was unable to determine the exact date of the increased seizures or if the seizure frequency was above or below the patient's pre-vns seizure rate. The patient's family stated, "it could have been more. " the explanted generator and lead have not been received by the manufacturer for product analysis to date.
 
Event Description
Based on the observed tool marks on the generator case and the condition of the header and casing in the detachment area, it is very likely that the reported header detachment occurred during the explant procedure. There was no evidence of dried body fluid or corrosion on the header or can in the detachment area. In order to test electrical function of the device a window was cut in the casing to facilitate output connections, however, an internal component was inadvertently damaged during the cutting of the window. After the component was replaced with a known good component, device testing was completed and the device was found to be operating properly according to all functional specifications. The lead assembly was returned in multiple portions, however, the electrodes and tie downs were not returned and therefore a complete evaluation could not be performed on the entire lead product. Abraded openings due to wear and incision marks were identified in multiple locations of the returned lead segments. Dried remnants of what appeared to have once been body fluids were observed inside the outer silicone tubing and likely entered via the cut ends of the lead segments. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector 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. Except for abraded openings in the outer tubing, there were no observed product related issues with the returned lead portions. Based on product analysis of the returned pulse generator and lead it is likely that the reported high lead impedance was due to a lead fracture in a segment of the lead which was not returned to the manufacturer for product analysis.
 
Event Description
The physician stated there were no obvious pulse generator header issues observed on pre-surgical x-rays. The explanted pulse generator and lead have been received by the manufacturer and are currently undergoing product analysis.
 
Manufacturer Narrative
The initial mdr report should have indicated "not returned to mfr. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5097678
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« Reply #87 on: March 10, 2019, 02:06:47 AM »

Model Number 106
Device Problem Detachment of Device or device Component
Event Date 01/20/2019
Event Type  Malfunction   
Event Description
It was reported that the patient underwent a lead replacement surgery, and during the surgery the septum plug came out. Per the report the generator involved was not implanted. The device has not been received by the manufacturer to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8341172
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« Reply #88 on: March 13, 2019, 01:28:10 AM »

Model Number 106
Event Date 10/07/2015
Event Type  Malfunction   
Event Description
During a surgery on (b)(6) 2015, the septum plug and screw detached from the generator during the implant process. While attempting to remove the lead from the generator, the surgeon popped out the septum plug and set screw. Therefore the device was replaced. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The explanted products are expected to be returned but has not been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5193801
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« Reply #89 on: March 18, 2019, 01:38:36 AM »

Model Number 302-30
Device Problems Low impedance; Device Displays Incorrect Message
Event Date 11/06/2015
Event Type  Malfunction   
Event Description
It was reported by the physician that the patient no longer feels stimulation. It was also reported the physician received the low impedance <600 ohms warning when interrogating the device. The patient was referred to a consultation for a full revision and replacement of the vns system. It was also reported the patient is severely mentally retarded and developmentally delayed. The patient is also prone to violent outbursts.
 
Event Description
It was reported the patient is a poor historian and the date of initial onset for the inability of the patient to perceive stimulation is not known. Additionally, it was reported there was no known trauma or incident suspected that could have caused or contributed to the reported event. No additional relevant information has been received to date.
 
Event Description
It was reported the patient underwent lead and generator revision surgery on (b)(6) 2016. Pre-operative testing of the vns verified the low impedance previously observed. The physician put a new generator on the existing lead and found 615 ohms. The decision was made to removed and replace the lead. It was found during surgery the electrodes were not on the nerve and there was no strain relief loop or anchor tethers present. The new lead was placed on the nerve, tethered and connected to the new generator. Diagnostics were performed and showed 2155 ohms. There was no known trauma or manipulation that could have caused the lead to come off of the nerve; however, the patient is autistic and combative. No additional relevant information has been received to date.
 
Event Description
Product analysis for the returned generator was completed. The generator output signal was monitored for more than 24 hours while in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed the generator performed according to functional specifications. The battery voltage measured during analysis showed an ifi = yes (intensified follow-up indicator) condition. There were no performance or any other type of adverse conditions found with the generator.
 
Event Description
Pa for the returned lead portion was approved on (b)(6) 2016. The lead was found to have abraded openings on the outer and inner silicone tubing of the lead coils. Also, the positive and negative lead coils have what appear to be wear (flat surfaces) at the exposed portions located past the electrode bifurcation. The reported ¿low impedance¿ allegation was not verified. Though it was difficult to state conclusively, the identified exposed coil portions at the silicone tubing abraded openings may confirm this to be a contributing factor for the reported low impedance/short circuit condition. However, the exact point in time when the short occurred is unknown. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
It was also observed, during lead product analysis, that the lead connector boot had partial detachment at the ring/backfill interface. The reason for this condition was unknown.
 
Manufacturer Narrative
Describe event or problem; corrected data: this information was inadvertently left off of the supplemental #04 mfr. Report.
 
Event Description
The lead assembly had dried remnant of what appeared to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5257603
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« Reply #90 on: March 19, 2019, 12:43:02 AM »

Model Number 103
Device Problems Screw; Loose or Intermittent Connection
Event Date 09/09/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2015 that a m103 generator was opened but not used due to a loose setscrew and septum plug. It was stated on the questionnaire form that the screw and silicone protection for the screw of the generator disconnected very easily. The physician decided to use another generator to implant because she did not feel safe to implant the generator with the screw loose. Review of the design history record showed that no unresolved defects or non conformances were associated with this device. The device also passed all specifications/inspections prior to distribution. The device is expected to be returned but has not been received to date.
 
Event Description
The generator was received for analysis on (b)(6) 2015 with the reason state as "there was loosening the screw and silicone protection that keeps the fixed electrode in the generator. " product analysis for the generator was completed and approved on (b)(6) 2015. The generator was returned due to detachment of components, septum plug and set screw. Visual examination revealed damage to the bottom of the septum by the setscrew, setscrew marks were observed on the inside of the septum which would indicate that the setscrew was backed out too far. The septum was also cored. The results of the visual examination would indicate that the detachment of the septum was due to user error. Review of the data in the decoder sheet revealed that the impedance value was 4000 ohms and the estimated occurrence was (b)(6) 2015. Which would indicate that the test resistor was inserted into the header and a diagnostic test was performed. Setscrew marks were also noted on the tip of the test resistor. Electrical test results showed that the pulse generator performed according to functional specifications. Other than the septum damaged condition there were no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5154341
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« Reply #91 on: March 24, 2019, 02:44:29 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/23/2015
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2015 that the patient had an appointment that day and system diagnostics were run with results of high impedance. The device was programmed off the day the high impedance was observed. No x-rays are scheduled at this time. They do not suspect that there was any trauma or manipulation. The patient had a full replacement on (b)(6) 2015. It was reported that the negative electrode was detached from the lead. Attempts for product return have been made, but the explanted device has not been received to date.
 
Event Description
Information received on 12/01/2015 indicated that the explanted device was discarded after surgery and is therefore unavailable for analysis.
 
Event Description
Generator and lead were received for analysis on 02/10/2016. Product analysis for the generator was completed and approved on 02/29/2016. From the generator decoder received from the device, the change in impedance from 5058 ohms to 6448 ohms occurred on (b)(6) 2015. In the 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. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis for the lead has not been completed to date.
 
Event Description
Product analysis for the lead was completed and approved on 03/07/2016. Note that portions of the (+) white and (-) green electrode quadfilar coils, the anchor tether and (-) green electrode were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed on one of the inner silicone tubes. 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 connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device.
 
Manufacturer Narrative
 
Event Description
Based on findings from product analysis, no evidence of corrosion was found on the patient's lead. The figures provided show a heavily manipulated lead (suggestive that the patient was a twiddler).
 
Manufacturer Narrative
Describe event, corrected data. Supplemental mdr #5 incorrectly reported information that was inaccurate.
 
Event Description
Re-evaluation of the product analysis results revealed that the manipulation of the lead was attributed to the explant-related events and is not believed to have contributed to the high impedance during implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5263683
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« Reply #92 on: March 26, 2019, 02:13:08 AM »

Model Number 303-20
Device Problem Appropriate Term/Code Not Available
Event Date 12/01/2015
Event Type  Injury   
Event Description
It was reported on (b)(6) 2015 that the patient was experiencing a painful, jolting sensation in her neck. The pain was constant. The device was turned down from 1. 75ma to 1. 25ma, but the patient reported that it was still painful. The date of onset of the pain was unknown. No known trauma had occurred. The physician performed diagnostics, and the impedance was within normal limits at 2800 ohms. It was reported on (b)(6) 2015 that the patient was referred for generator and lead replacement surgery with the device likely programmed to not delivery therapy until surgery. An implant card was later received reporting that the patient had lead replacement on (b)(6) 2015 due to pain at the lead site. The generator was not replaced. No additional relevant information has been received to date. The explanted lead has not been received by the manufacturer for analysis to date.
 
Event Description
Additional information was received from the surgeon reporting that he was observed during lead replacement surgery that one of the helicals was off of the vagus nerve, so he believes this was causing the painful stimulation to the patient's muscles. There was no particular event that was known or believed to have contributed to the helical coming off the nerve, but he notes that she does have tonic-clonic seizures so it may have occurred from a seizure. The helical appeared to be pulled medially and pulled quite a bit. The device was turned off prior to surgery for the pain. He has not heard from the patient since surgery, so takes that as a good sign that her pain has improved/resolved. No further information was provided. The explanted lead was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
Analysis of the lead was also completed. 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, 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. Note that since the (-) green electrode was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #93 on: March 27, 2019, 01:24:25 AM »

Model Number 102
Device Problems Plug; Device Dislodged or Dislocated
Event Date 12/15/2015
Event Type  Malfunction   
Event Description
It was reported that a vns patient underwent lead replacement surgery on (b)(6) 2015. During the connection of the new lead to the existing generator, when the hex wrench was removed after tightening the setscrew, the septum plug pulled out, and remained on the shaft of the hex wrench. The surgeon tried to put the plug back in place into the generator's header. As there is no way to guarantee that the septum plug will remain in place after it has come out, it was decided to replace the generator too. No patient adverse events were reported. The lead was replaced due to high impedance. This event was reported in the medwatch report number 1644487-2015-06742. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. The return of the explanted generator is expected but it has not been received to date.
 
Event Description
The explanted generator was returned to the manufacturer on (b)(6) 2016. Analysis is underway but it has not been completed to date.
 
Event Description
Analysis of the returned generator and septum was completed. Product analysis (pa) indicates that the reported allegation of ¿detachment of component(s)/septum plug¿ cannot be evaluated in the pa laboratory setting. However, measurements obtained in the pa lab of the original generator header septum cavity and septum dimensions meet specification. Septum was returned after the pulse generator had already been received and an analysis completed on it. The septum and setscrew were placed in the header septum cavity of the original generator and the setscrew was successfully secured by a bench torque wrench. In addition, the septum sealed properly in the header septum cavity. The septum was measured and meets specification for the septum measurements. Observed condition of the septum suggests manipulation during the attempted implant procedure contributed to the detachment event. Other than the damage to the septum, there were no other anomalies found. 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 generator performed according to functional. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5346606
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« Reply #94 on: March 29, 2019, 07:43:05 AM »

Model Number MODEL 250
Device Problems Battery; Cover; Break; Failure to Charge; Detachment Of Device Component; Handpiece
Event Date 01/08/2016
Event Type  Malfunction   
Event Description
It was reported that the handheld device would not charge as the handheld battery cover had broken off the device. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis found that the handheld device was returned without a battery cover. As a result, the handheld would not power on. No other anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5405028
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« Reply #95 on: March 31, 2019, 07:13:03 AM »

Model Number MODEL 250
Device Problem Detachment Of Device Component
Event Date 02/17/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the site's tablet was missing its power button, presumed lost after several months in use. The power button has been replaced and the device is able to power on as expected. Review of the tablet computer's device history records confirmed all quality tests were passed prior to distribution. No additional pertinent information has been received to date.
 
Event Description
It was reported that the tablet¿s power button was found to be missing again. The tablet has not been received by the manufacturer to date. No additional pertinent information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The suspect tablet was received by the manufacturer, and product analysis was subsequently completed. The failure for the tablet to power on was confirmed, which was determined to be due to the missing power button. When the push button switch located where the power button was previously attached was pressed, the tablet turned on and completed all functional testing with no observed anomalies. Product analysis concluded that the missing power button appears to be related to retention tabs and/or user error, which allowed accidental removal of the component.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5502341
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« Reply #96 on: April 02, 2019, 12:14:40 AM »

Model Number MODEL 250
Event Date 04/19/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a company representative that the power button on a physician's tablet had come off and was lost. The device turned on when the metal connector in the hole where the power button used to be were pushed with a pen. The programming system has not been received for analysis to date. Additional relevant information has not been received to date.
 
Manufacturer Narrative
Event description, corrected data: the event description inadvertently stated that the device had not been received for analysis. Device evaluation, corrected data: the field was inadvertently provided as not having been received by the manufacturer in the initial report.
 
Event Description
The tablet was received for analysis on 04/29/2016, which is underway but has not been completed to-date.
 
Event Description
Analysis was completed on the returned tablet 06/07/2016. Visual analysis of the tablet was able to verify that the power button was missing. Further analysis also identified that the low profile tactile switch on the power board was damaged. When the power button is pressed, it applies pressure to the tactile switch and powers on the tablet. No further anomalies were identified.

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« Reply #97 on: April 04, 2019, 12:47:56 AM »

Model Number 302-20
Event Date 05/31/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance (>=10000 ohms. ) was observed on vns patient's system. It was reported that the patient had been feeling pain at neck for two weeks. On (b)(6) 2016, the patient's device was programmed at output current 1. 5ma, pulse width 500¿sec, frequency 30hz, on time 30sec and off time 5min. It was reported that the generator was turned off that day. It was reported that x-rays will be performed to see a possible lead discontinuity which could probably be due to a fall. A complete surgical revision will be scheduled but no known surgical interventions have been performed to date. Additional information was received indicating that x-rays have not yet been done, because the parents are quite reluctant about that. It was reported by the physician that in theirs records, there is a notification of the electrode wire-protuberance under the patient¿s skin on the neck; this was on (b)(6) 2014. No coincidental trauma and pain were observed; the device was working normally. It was reported that ultrasound investigation was performed that time, and no structural changes were described: the lead did not look interrupted.
 
Event Description
Further information was received indicating that the patient underwent lead revision surgery on (b)(6) 2016. The lead was replaced due to high impedance. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits with 1480 ohms. Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution. It was reported that the explanted lead will not be returned to the manufacturer for analysis as it was disposed. Additional information from the physician indicated that the patient is now ok with a new e lead in place. It was reported that the patient never had any fall, blow or any other trauma in the neck region or area of vns generator. The lead protuberance appeared suddenly on (b)(6) 2010, under the skin on the lower part of her neck. When this happened, an ultrasound investigation was performed and no other intervention was taken; the patient was doing well, had no pain and very rare seizures and her mother reported that vns works well (hoarseness of patient voice). Later in (b)(6) 2016, the protuberance disappeared; the physician thinks that it was the moment when the electrode finally slipped completely from the vagal nerve. As it turned out during the revision, this protuberance was a part of electrode (a non-active one, the ground) that slipped from the vagal nerve. X-ray performed before the surgical procedure, indicated that one electrode was not in the correct place. It was reported by the physician that the reason must be an inappropriate position-fixation of electrodes when implanted.
 
Event Description
Additional information was received from the physician indicating that the day of the implant, on (b)(6) 2014, the device was tested and system diagnostics returned impedance results within normal limits with 1480 ohms. It was reported that on (b)(6) 2014 (after the lead protuberance appeared on (b)(6) 2014), the vns system was still ok and system diagnostics returned impedance results within normal limits with 2194 ohms.

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« Reply #98 on: April 04, 2019, 12:48:43 AM »

Model Number 102R
Event Date 04/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A patient had generator and replacement surgery due to high impedance, as captured in mfr report # 1644487-2016-00649. During surgery, it was identified that the generator header was completely separated from the can. Product analysis of the generator identified that the battery depletion was an expected event as determined by the battery life calculator and battery voltage measurement. Review of the device history record showed no unresolved non-conformances existed prior to device distribution. During the analysis, it was found that there was sufficient adhesive on the header and can indicating that the separation of the header from the can was not due to any sort of manufacturing error. The presence of foreign matter in the feed-thru area and along the header attach area indicates that this condition was present prior to explant however, the exact time at which the separation occurred is unknown. The cause of the detached header could not be ascertained. However, an area of separation between the generator case and header was noted as evident by the foreign matter in the feed-thru area and along the header attach area.

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« Reply #99 on: April 05, 2019, 01:22:30 AM »

Model Number 304-20
Event Date 05/10/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a company representative that during an initial implant the lead was not used by the surgeon as the metal became detached from the helix on the positive coil. When the surgeon used a new lead, there were no further issues. Review of the device manufacturing records revealed that the device met specifications prior to distribution. The product has been received for analysis which is underway, but has not been completed to-date.
 
Event Description
Analysis was completed on the returned lead portion 06/17/2016. During visual analysis the white electrode ribbon appeared to be stretched and mangled. The helical was misshaped and the suture partially detached. Imprints found on the inside groove of the helical were most likely made by the suture as a result of the manufacturing process. It appeared the ribbon and suture had been pulled out of the helical. The condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure; however the absence of setscrew marks on the connector pin is evidence that the lead assembly was not fully implanted. The stretched ribbons and misshaped helices were most likely caused while attempting to place the electrodes on the vagus nerve. The sutures on the electrode helices appear to be intact. No obvious anomalies were noted. The lead was returned intact. Results of the overall dimensional and resistance measurements show that those parameters are within specification per the manufacturing assembly documentation. The condition of helical electrodes suggest extensive manipulation, leading to a misshaped helical section, and appears to be a user-related issue.

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« Reply #100 on: April 06, 2019, 12:19:42 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/12/2018
Event Type  Injury   
Event Description
Article titled "improved quality of life and cognition after early vagal nerve stimulator implantation in children" was reviewed and three adverse events were identified for the patients studied within the cohort. 3 of the patients developed infections post implant and 1 of those patients required revision surgery due to the infection. 1 patient passed away prior to the study (captured in mfr. Report # 1644487-2019-00452) 1 patient had disconnection of their electrodes from the vagus nerve that required revision surgery(captured in mfr. Report # 1644487-2019-00454). It was reported that there was no permanent morbidity due to these events. No further relevant information has been received to date.

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« Reply #101 on: April 10, 2019, 01:20:35 AM »

Model Number 302-20
Event Date 06/30/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had full revision surgery due to battery depletion. It was later reported that the lead was replaced due to the electrode being detached from the nerve. The explanted generator and lead were received on 07/05/2016. Analysis of the generator identified that the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. The electrical performance of the generator were used to conclude that no anomalies exist and the eos condition is an expected event. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The explanting surgeon confirmed that the lead was not detached from the nerve. High impedance was identified, and there was fluid inside the outer tubing that brought the surgeon to believe that the lead wires had been compromised. Analysis of the lead identified two lead breaks and corrosion at the break locations. Due to wear at one of the break locations, the fracture mechanism could not be determined. The other break appeared to be due to stress/mechanical damage. The electrodes were not returned for analysis, so a complete evaluation could not be performed on the entire product. With the exception of the observed discontinuity the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.

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« Reply #102 on: April 11, 2019, 02:03:14 AM »

Model Number 102R
Event Date 06/17/2016
Event Type  Malfunction   
Event Description
The patient had generator replacement surgery on (b)(6) 2016 due to battery depletion. It was identified as the generator was going to be explanted that the header was completely detached from the generator can. The physician stated that the patient is violent and causes harm to himself. The patient's father also reported that the patient often pounds on his chest, which may have caused the header to be broken. There was not excessive manipulation of the generator during the explant surgery. The device history record of the generator was reviewed, and the device passed all functional specifications prior to release. The explanted generator was received on 07/06/2016. Analysis has not been approved to date.
 
Event Description
Analysis was approved on 07/20/2016. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. There were no tool marks on the can or header, which normally rules out an explant related detachment. There were no dried bodily fluids identified on the can (header area) or header, which normally rules out an implant period related detachment. Therefore, the cause of the header detachment is unknown. The device performed according to functional specifications. Other than the header anomaly, there was no abnormal performance or any other type of adverse condition found with the generator.

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« Reply #103 on: April 11, 2019, 02:04:03 AM »

Model Number 104
Event Date 06/22/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during generator replacement surgery the septum plug on the generator became detached and the surgeon was unable to put it back in place. At that time the generator and septum plug were removed from the field and a different generator was implanted. A review of manufacturing records showed that the generator was sterilized and passed qc inspection prior to distribution. The new generator that the plug came out of was received and is currently pending product analysis.
 
Event Description
Product analysis was completed on the returned generator. It was noted that the positive septum plug was not received. Therefore it could not be analyzed. The negative septum plug was received and it was noted that it was not cored and meet dimensional specifications. The header septa was also evaluated and found to meet dimensional specification. Visual analysis noted tool marks on the generator case and header which appeared to be associated with the manipulation of the device during the attempted implant procedure. Functional analysis found that the generator performed to all functional specifications. The cause of the detachment could not be determined due to the positive septum plug not being received.

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« Reply #104 on: April 13, 2019, 03:32:05 AM »

Model Number 303-20
Device Problem Difficult to Insert
Event Date 08/09/2016
Event Type  Malfunction   
Event Description
It was reported that during a first implant surgery, the surgeon had difficulties to insert the lead into the generator block. It was reported that during the surgery on (b)(6) 2016, the lead got stuck and it wouldn't completely go into the receptor head of the generator. The grub screw was lost out of the head and both lead and generator had to be replaced. It was reported that both products (generator and lead) are still at the hospital for examination to see if there is any defect. No further information was provided to date.
 
Manufacturer Narrative
Udi number: (b)(4).
 
Event Description
Further information was received from a nurse, indicating that the suspected device will be returned to the manufacturer for analysis. It was reported that when the reported issue was found, another device was implanted instead. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.
 
Event Description
The suspected generator and lead were returned to the manufacturer on 09/26/2016. An analysis was completed on the returned lead portions and the reported "insertion difficulties" (lead section) allegation was not confirmed. The connector pin section including the small front o-ring and large o-rings was not returned. A portion of the connector boot was returned. The condition of the returned lead portions is consistent with conditions that typically exist following an attempted implant procedure. No obvious anomalies were noted. Continuity checks of the returned 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 product anomaly with the returned portions of the lead which may have contributed to the stated complaint. An analysis was completed on the returned generator and the reported allegation of "insertion difficulties" was not duplicated in the laboratory. No obstructions were observed in the pulse generator header lead cavity or the connector blocks. The in-line cavity go gauge test passed and a bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions). The pulse generator header lead cavity (critical dimension 1) accepts a pin gauge of 0. 136 inches minus (limits 0. 137 +/- 0. 002). The pulse generator header lead cavity, critical dimension 1, meets specification. In addition, review of the ram/flash data downloaded from the pulse generator shows an impedance test was performed on the date of the attempted implant ((b)(6) 2016). The "time stamp impedance diagleadzhistory" results show: impedance value (ohms): 14240 - time stamp: (b)(6) 2016. This would suggest the lead pin was inserted into the pulse generator header. The reported allegation of "detachment of component(s) set screw" was not duplicated in the laboratory. The septum was cored and damaged on the underneath side. This suggests that the setscrew was extracted up into the septum. This may be the contributing factor for allegation of "detachment of component(s) set screw". The pulse generator performed according to functional specifications. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 0. 767% of the battery had been consumed. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties. First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of. 135 max, it may cause insertion difficulty. Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling. It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed. Review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication. No further relevant information has been received to date.

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« Reply #105 on: April 14, 2019, 01:08:04 AM »

Model Number 106
Event Date 07/22/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the physician was in the process of implanting the patient with a new generator when the septum plug became detached from the generator and was lost. The physician also reported that the set-screw wasn't tightening prior to the septum plug becoming detached. It was confirmed that the septum plug was lost outside of the patient. The generator was received on 07/29/2016. Analysis has not been approved to date.
 
Event Description
Analysis was approved on 08/25/2016. The returned setscrew showed mechanical wear at the socket (suggesting numerous insertion attempts), but the socket was not stripped. The underneath side of the returned setscrew showed indention marks: suggesting a lead pin or test resistor was once secured by the setscrew and; the indention mark on the slanted edge of the setscrew suggests the setscrew caught the edge of the lead pin or test resistor. In addition, the returned setscrew showed mechanical wear on the threads. The mechanical wear on the returned setscrew threads (and based on the scratches / tool marks observed on the negative connector block) suggests re-insertion attempts of the returned setscrew. The negative connector block showed mechanical wear on the flat surface, at the edge before the threads. In addition, scratches and or tool marks (from an unknown source) were observed on the lead pin channel of the negative connector block, which is atypical to what is normally observed in the analysis lab. The septum was not returned for evaluation. The header septum cavity met specification requirements. Therefore, a root cause for the conditions could not be determined. A bench setscrew was inserted into the negative connector block and secured a bench in-line lead, which fully inserted into the generator header past the negative connector block (lab conditions). The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. The battery showed an ifi=no condition. Other than the mechanical wear and scratches/tool marks on the negative connector block, there were no performance or any other type of adverse condition found with the pulse generator.

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« Reply #106 on: April 16, 2019, 12:26:01 AM »

Model Number 304-20
Event Date 09/02/2016
Event Type  Malfunction   
Manufacturer Narrative
Initial reporter phone#: (b)(6).
 
Event Description
High impedance was identified on a system diagnostic test on (b)(6) 2016. The generator was programmed off after the high impedance was identified. The patient underwent full replacement on (b)(6) 2016. X-rays were provided to the manufacturer and reviewed. The generator was shown to be properly placed in the left chest as instructed per labeling, the connector pin appeared fully inserted to the connector block, and the feedthru wires appeared intact. The lead appeared to have adequate strain relief as well as tie-downs present to hold the strain relief as instructed in labeling. No portion of the lead was identified behind the generator, and the lead wires appeared intact at the connector pin. Sharp angles were observed in the portion of the lead near the generator. A gross fracture was identified in the lead. The explanted lead and generator have been returned to the manufacturer, but no analysis has been performed to date.
 
Event Description
The explanted lead and generator were both returned to have product analysis performed. The lead was returned in two portions. During the visual analysis, the outer silicone tubing of both portions appeared twisted and compressed. The connector boot also appeared detached from the connector ring surface. Scanning electron microscopy (sem) was performed on the connector pin quadfilar coil break and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage. The remaining broken coil strands were identified as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil's surface. Scanning electron microscopy was also performed on the connector ring quadfilar coil break, but extensive pitting prevented identification of the coil fracture type. During the analysis of the second returned portion, a coil break was identified and the sem identified the area as having evidence of a stress induced fracture. Identification of the fracture mechanism could not be made on the remaining broken coil strand due to extensive pitting. Abraded openings were identified on multiple portions of the returned lead through both the outer and inner tubing. Dried remnants of what appeared to be body fluids was found within the inner tubing. The setscrew marks found evidence that at one point in time, a good mechanical and electrical connection was present the explanted generator was returned and product analysis was completed on 10/11/2016. Review of the ram/flash data from the generator showed increased impedance occurred on (b)(6) 2016 and resulted in an increase from 9,541 ohms to 12,377 ohms. The battery voltage was found at 2. 956v and approximately 45% of the charge had been consumed. The generator was found as conforming to all functional specifications.
 
Manufacturer Narrative
Supplemental report #1 inadvertently did not update the event date per the new information identified.

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« Reply #107 on: April 16, 2019, 12:26:56 AM »

Model Number 102R
Event Date 07/15/2016
Event Type  Malfunction   
Event Description
Information was received that indicated the header of a patient's generator had become detached. This was discovered during the revision surgery on (b)(6) 2016. The device has not been received to date and no other relevant information has been received to date.
 
Manufacturer Narrative
Correction data: initial mdr inadvertently omitted information known prior to submission of the mdr.
 
Event Description
A device history record review showed that the header was cleaned on 10/02/2012 and secured to the generator can on 10/03/2016. The generator then passed all subsequent quality control tests and was released for shipment. There is no report that the patient experienced any trauma that may have cause the dislodgement of the header from the body of the generator. Diagnostics performed on (b)(6) 2013 show lead impedance within normal limits and battery status not at end of service. The facility where the explant occurred disposed of the device after surgery, thus no product return is expected. The surgeon indicated that the header was partially attached to the generator can when the patient was opened for surgery. Thus the explant surgery did not cause the header to become dislodged.

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« Reply #108 on: April 17, 2019, 06:44:59 AM »

Model Number 106
Device Problem Difficult to Insert
Event Date 09/02/2016
Event Type  Malfunction   
Manufacturer Narrative
Udi number: (b)(4).
 
Event Description
It was reported that during an implant surgery on (b)(6) 2016, the surgeon found a suspected device malfunction. It was reported that when inserting the screw driver into the silicon housing, the silicon became detached from the generator. The surgeon then discarded this generator and used a new device instead. No patient adverse event was reported. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. The return of the suspected device is expected but it has not been received to date.
 
Event Description
The suspected generator was returned to the manufacturer on 09/26/2016. An analysis was completed on the returned generator and the reported allegation of "detachment of component(s) septum plug" was not observed in the product analysis lab. The header septum cavity meets specification. The returned septum meets specification. However, the septum was damaged on the underneath side, suggesting that the setscrew was extracted up into the septum. This may be the contributing factor for allegation of "detachment of component(s) septum plug". The pulse generator performed according to functional specifications. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery showed an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 1. 828% of the battery had been consumed. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
Additional information was provided indicating that the reason the physician had unscrewed the septum to the point of it popping out was due to difficulties he was having inserting the lead pin into the generator header block. The surgeon was reportedly having issues fully inserting the lead, so he kept unscrewing the septum plug until it came out.
 
Event Description
During a preliminary investigation initiated to study field complaints related to insertion difficulties reported during vns implant surgery, it was determined that the dimensions of the lead connector are critical to ease of insertion into the generator header during implant. Any measurement closer to the maximum assembly specification may cause insertion difficulty. It was also determined that the lead assembly document used at a secondary facility allowed for the lubrication of the lead connector with di water or the manufacturer's treated water in cases of excessive insertion force during functional tests, a practice not common to assembly at the main manufacturing facility. No additional relevant information has been received to date.

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« Reply #109 on: April 21, 2019, 03:32:07 AM »

Model Number 102
Device Problem Detachment Of Device Component
Event Date 10/20/2016
Event Type  Malfunction   
Event Description
It was reported by a company representative that a patient¿s vns device had high impedance and was referred for revision surgery. Revision surgery occurred (b)(6) 2016. Follow-up from the company representative who attended the case provided that the patient had high impedance after he had a fall during a seizure. Prior to surgery diagnostics were performed and showed high impedance, and a second set of diagnostics which also showed high impedance. In surgery, the chest pocket was opened and it was discovered that the old generator was implanted under the muscle. When the surgeon was taking the generator out, he said the header was broken and the filter feed-thru wires were already pulled out. After he took the generator out, the header fell completely off. Since the generator was under the muscle, the surgeon thinks the fall may have caused the generator to be pushed up against the bone and broke the header. The new generator was put on the old leads, above the muscle and the diagnostics were within normal limits. The lead was not revised. The explanted device has not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Event Description
The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the returned generator. The reported detachment of header was confirmed. The reported high impedance was confirmed as well, as the output wires from the header were completely broken. After test wires were connected to the device¿s output, the device met functional specifications. With the exception of the header detachment, analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.

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« Reply #110 on: April 22, 2019, 12:53:58 AM »

Model Number 106
Event Date 10/11/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
During a lead replacement surgery on (b)(6) 2016 for the patient, the surgeon was unscrewing the septum plug with a screw driver to perform a generator test, but in doing so, the rubber seal on the implanted generator came off. The generator then had to be replaced. Attempts to retrieve the generator have been made, but the generator has not been received to date.
 
Manufacturer Narrative
The initial report inadvertently did not report: "the lead replacement is captured in mfg report # 1644487-2016-02568. ".
 
Event Description
The generator was received by the manufacturer for analysis. However, analysis has not been completed to date. The lead replacement is captured in mfg report # 1644487-2016-02568.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was performed on the returned generator. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage was measured at 3. 047 volts and shows an ifi=no condition. The data revealed that 18. 459% of the battery had been consumed. The septum was not returned, therefore no measurements could be taken. However, the header septum cavity does not met specification requirements; the header septum cavity measured 0. 127+ (plus pin gauge set) inches (limits 0. 125 inches +/-0. 002). Although the header septum cavity is slightly out of specification, a septum from inventory stock inserted and secured appropriately into the pulse generator header septum cavity. The explant process may have been the contributing factor for the detachment of the septum plug. There were no additional performance or any other type of adverse conditions found with the pulse generator. Review of device history records showed no unresolved non conformances on the generator prior to distribution.

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« Reply #111 on: April 22, 2019, 12:54:57 AM »

Model Number 106
Event Date 11/03/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2016, patient underwent generator replacement. When the new generator was connected to existing lead, high impedance was observed. The surgeon attempted to reinsert the pin, but the high impedance did not resolve. The surgeon backed the set screw all the way out and was unable to put it back in. The surgeon then used a new generator. Diagnostics with the new generator still observed high impedance. As a result, the lead was replaced. Further clarification was received from the operating room specialist. The generator was replaced and the lead pin was inserted into the lead pin and the set screw was tightened. During system diagnostics, high impedance was observed. The operating room specialist instructed the surgeon to remove the lead pin and reinsert it. The surgeon unscrewed the setscrew too far and the septum plug came out while trying to remove the lead pin to re-insert it. The septum plug came out during the unscrewing process. The surgeon wanted to implant a new generator as a result. The high impedance persisted with the new generator and so the lead was revised. After lead and generator revision, the high impedance resolved. Per the hospital policy, the products may not be returned. The suspect generator has not been received to date. The high impedance issue is reported in mfr. Report# 1644487-2007-01886.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6130288
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« Reply #112 on: April 22, 2019, 12:55:52 AM »

Model Number 304-20
Device Problem Mechanical Problem
Event Date 11/07/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
During implant surgery for the patient¿s lead, it was noticed that after the lead had been tunneled a deformity on the electrode was observed. The surgeon was able to connect the anchor and positive electrode with no issues, but when connecting the negative electrode he stated it appeared bent, and he didn¿t think it would attach to the nerve properly. There was no abnormality observed with the lead prior to the lead being removed from the packaging. It is unclear how the deformity occurred. The deformed lead was returned for product analysis which has not been completed to date. The design history record for the lead was reviewed and showed that the lead passed all quality control checks prior to being released for distribution.
 
Event Description
Product analysis for the lead was completed and found that the negative electrode ribbon did appear to be detached from the silicone helix, which has lost its helical shape. There were also creases present on the positive and negative electrodes along with remnants of dried body fluid. These finding are consistent with damage incurred during implant/explant surgeries.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6138374
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« Reply #113 on: April 26, 2019, 06:10:36 AM »

Model Number 103
Device Problem Detachment Of Device Component
Event Date 12/28/2016
Event Type  Malfunction   
Event Description
A generator was being ready to be implanted when the septum plug was found detached from the generator header block. The physician stated that before tightening the set screw, the septum plug came out. A photo of the generator with the septum plug removed was provided and reviewed. The generator was not implanted in a patient and another generator had to be used. The device history record for the generator was reviewed and verified that the generator had passed all quality inspections prior to release for distribution. The generator has not been received to the manufacturer to date.
 
Event Description
The generator that was not implanted was received by the manufacturer for product analysis. The product analysis has not been completed to date.
 
Event Description
Analysis was completed on the returned generator due to the reported septum plug being detached. The returned septum and the septum cavity were both verified to meet all specifications required for their respective components. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The returned setscrew showed mechanical wear at the socket, indicating multiple insertion attempts were made, but the socket was not stripped and the returned torque wrench fully inserted with no issues. Additionally, the underneath side of the returned setscrew showed indentions, suggesting a lead pin or test resistor was once secured by the setscrew.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6272529
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« Reply #114 on: April 26, 2019, 06:11:23 AM »

Model Number 103
Device Problem Detachment Of Device Component
Event Date 01/06/2017
Event Type  Malfunction   
Event Description
During a revision surgery a septum plug of the m103 generator became dislodged during the troubleshooting. The generator was not implanted in the patient. Another generator was implanted successfully. The generator was received for product analysis on 01/24/2017. A review of the design history record found no anomalies. No other relevant information has been received to date. Manufacturing number 1644487-2017-03104 will discuss the issue identified with the lead during troubleshooting.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned generator. Tool marks were present on the can of the generator and header. The set screw plug was not cored. Microscopic assessment of the returned set screw showed mechanical wear suggesting that numerous insertion attempts may have occurred. The set screw appears to have been extracted up into the set screw plug. The first thread on the set screw was bare suggesting that the set screw was bottomed out on the negative connector. The set screw socket was not stripped as a bench torque wrench could fit within the socket. No other anomalies were observed that affected functionality.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6291469
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« Reply #115 on: May 06, 2019, 03:26:47 AM »

Model Number 104
Device Problem Detachment Of Device Component
Event Date 02/16/2017
Event Type  Malfunction   
Event Description
It was reported that the septum plug for the negative lead pin fell out of a generator during replacement surgery. The physician was screwing in the positive lead pin when the negative pin's septum plug fell out. Reportedly, the septum plug fell out without having been touched. The surgeon was able to pop the septum plug back into place, and a backup generator was not available. The surgeon then decided to use the generator with the septum plug popped back into place and implanted it in the patient. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6401681
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« Reply #116 on: May 07, 2019, 07:11:13 AM »

Model Number 303-20
Device Problem Detachment Of Device Component
Event Date 02/01/2017
Event Type  Malfunction   
Event Description
It was reported via clinic notes that a patient was experiencing an increase in seizure frequency and duration. The patient had recently begun experiencing daily seizures for several weeks. One of the patient's medications was increased at a clinic visit two months prior. The physician noted that the patient's battery was at one-quarter remaining as of the current clinic visit and believed that the patient's vns was not as helpful as it used to be. The patient was referred for generator replacement surgery. It was later reported that during generator replacement surgery, the lead was found detached from the nerve and was coiled up in the generator pocket. The surgeon planned to proceed with a full revision. A photograph of the lead was provided, which showed that the patient¿s lead was wrapped around itself inside the generator pocket. When the patient¿s generator pocket was opened during the surgery, the surgeon found the electrodes detached from the vagus nerve and the lead wrapped around itself several times in a large knot. The electrodes were also detached from the lead. The patient¿s generator suture was still intact, and there was scar tissue in the generator pocket that most likely provided contact between the lead and the tissue. It was reported that there was very little scarring on the patient¿s vagus nerve. The patient¿s neurologist did not notify the surgeon or company representatives of any diagnostic issues, consistent with the diagnostic test results reported via clinic notes. Diagnostics performed in the operating room prior to surgery were also within normal limits. The surgeon believed that the patient manipulated the lead and caused it to coil up inside the generator pocket. The patient¿s parents denied any occurrences of their daughter manipulating the lead, adding that the patient¿s disability caused low finger dexterity. The existing lead and generator were discarded after explant and thus were not returned for analysis.
 
Event Description
It was reported that the patient's nurse did not believe that the patient's seizure increase was related to changes in the patient's medication. The nurse believed that a low battery was the cause of the increased seizures, and she stated that the patient's seizure increase was above the patient's pre-vns baseline. As the patient's lead and electrodes were found detached from the vagus nerve during replacement surgery, the report that the patient's seizures were due to low battery is incorrect. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6382903
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« Reply #117 on: May 08, 2019, 10:17:48 AM »

Model Number 303-20
Device Problem Mechanical Problem
Event Date 04/07/2017
Event Type  Malfunction   
Event Description
It was reported that a lead was identified with a misshaped helix out of the box. The helix was reportedly not lined up. The lead was not implanted in the patient and a replacement lead was used in its place. A review of the manufacturing record of the lead confirmed it had passed all quality inspections prior to release for distribution. The lead has been returned to the manufacturer, but analysis has not been completed to date.
 
Event Description
The returned lead assembly was analyzed in the product analysis lab where it was confirmed that the helices were misshapen. Visual analysis identified bends and creases on the positive and negative electrode ribbons. The positive ribbon was partially detached from the helical. No discontinuities were identified with the returned lead, no abrasions were noted, and no setscrew marks were observed, confirming that the lead had never been implanted. The misalignment of the helices as observed in the lab had no adverse effect on the lead's ability to perform as intended.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6529452
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« Reply #118 on: May 09, 2019, 07:13:18 AM »

Model Number 300-20
Device Problem Fracture
Event Date 03/22/2017
Event Type  Malfunction   
Event Description
During a patient's generator replacement surgery, the surgeon unscrewed the two lead pins and attempted to remove them from the patient's device; however, the positive lead pin would not come out of the generator. When the surgeon pulled on the positive lead pin to remove it, the lead wire detached from its silicone casing, breaking the lead. It was later reported that the patient underwent full revision surgery. The patient's explanted devices were discarded and are unavailable for analysis. The device history record of the lead was reviewed, and the lead met all specifications for release. No additional relevant information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6503930
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« Reply #119 on: May 11, 2019, 12:44:29 AM »

Model Number 1000
Device Problem Detachment of Device or device Component
Event Date 03/07/2019
Event Type  Malfunction 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8472063
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« Reply #120 on: May 11, 2019, 12:45:04 AM »

Model Number 106
Device Problem Detachment of Device or device Component
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
Initial report was that the generator's septum plug came out of the generator during lead pin insertion during surgery. The surgeon attempted to replace the septum plug and it was noted that the septum plug would not seat properly in the generator. The lead insertion was noted to be without difficulties. A backup generator was used in place. The device history records for the generator were reviewed and show that no unresolved non-conformance's were found. The device met all specifications for release prior to distribution. The product was received by product analysis. Product analysis has not been completed to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506083
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« Reply #121 on: May 14, 2019, 12:51:36 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/06/2011
Event Type  Injury   
Event Description
It was reported by the patient¿s mother that her son has more seizures when his battery reaches 25%, and that the neurologist increases the keppra dose to counteract the seizures. The patient had generator replacements in 2007, 2011, 2015, and is scheduled for replacement currently. The increase in seizures in 2007 is reported under mfr. Report # 1644487-2007-01077, the increase in seizures in 2015 is reported under mfr. Report # 1644487-2019-00636, and the increase in seizures in 2019 is reported under mfr. Report # 1644487-2019-00652. This report concerns the increase in seizures in 2011 and subsequent generator replacement. The generator replacement was initially reported to be prophylactic. The explanted generator was later received by the manufacturer and an analysis was performed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Additionally, the generator¿s header was found to be detached, but based on the observed tool marks on the pulse generator case it is very likely that this occurred during or after the explant procedure. Other than the header anomaly, there were no performance or any other type of adverse conditions found with the pulse generator. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8491278
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« Reply #122 on: May 14, 2019, 12:52:27 AM »

Model Number 302-20
Device Problems Detachment Of Device Component; Fluid Leak; High impedance
Event Date 01/12/2015
Event Type  Malfunction   
Event Description
It was reported by the physician's office that the patient was referred for a vns consult for an unknown reason and the plan was for vns generator replacement, but a lead replacement may also be needed. No information was initially provided. An implant card was later received showing the patient underwent a full vns revision. The diagnostics for the old device showed high impedance. It was also explained that the lead had visible "holes" and fluid within the silicone tubing. Diagnostics with a new generator and the old lead still showed high impedance. Adequate insertion of the lead pin into the generator was confirmed, but the high impedance did not resolve. The new generator was tested using the resistor pin and confirmed good diagnostics. Upon exposing the electrodes within the neck, it could be seen that one of the electrodes was no longer wrapped around the vagus nerve. Per the anesthesiologist, the patient had been known to have severe falls due to seizure activity and the compromises in the lead may have occurred during one of the falling evens. Once both the lead and the generator were replaced, diagnostics were within normal limits. The explanted generator and lead were reported to be discarded after the surgery.
 
Manufacturer Narrative
This information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
The programming history database was reviewed and no anomalies related to the high impedance was noted. Additional information was received from the patient's following physician stating the reason for the vns replacement referral was due to battery depletion and high impedance. Additionally, the physician did not know the cause of the holes, fluid leaks, or electrode detachment from the nerve.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6461922
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« Reply #123 on: May 18, 2019, 12:38:59 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 05/05/2017
Event Type  Malfunction   
Event Description
It was reported that a generator's septum plug became detached during implant surgery. The septum plug was reportedly stuck to the hex screwdriver. The septum plug was then reattached to the generator header. System diagnostics were performed and returned normal values. No other abnormal instances occurred during the surgery. The physician opted to leave the generator implanted in the patient. A review of the manufacturing record for the generator confirmed it had passed all quality inspections prior to release for distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6598123
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« Reply #124 on: May 18, 2019, 12:39:44 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 02/11/2017
Event Type  Malfunction   
Event Description
It was reported the patient underwent repositioning surgery for patient comfort. During the surgery, the surgeon had unscrewed the setscrew so that the vns generator could be removed from the lead for repositioning. It was noted the septum was no longer lying flat and it was explained that it could be pushed back down flush as it likely dislodged while unscrewing the setscrew. It was later explained the vns generator had to be replaced as the septum popped out when the surgeon attempted to push it back down flush. The device history record was reviewed and confirmed the vns generator passed all tests prior to distribution. The vns generator was received by the manufacturer. While analysis is expected, it has not been completed to date.
 
Event Description
Analysis was completed on the received generator however it was noted that the septum was not received. During analysis the generator performed to functional specification. During dimensional assessment, the header septum cavity was measured and found to be outside of specification (higher than the maximum upper limit). The header lead cavity was measured and found to meet specification. Receiving inspection documentation was reviewed for the lot of septum cavities used to manufacture the generator. No anomalies were observed with the sampled septum cavities. A company representative reported that the following explant the generator left the or and underwent a process prior to being returned to the manufacturer. It was unclear what type of sterilization process the generator may have been exposed to that could have potentially affected the dimensions of the septum cavity. Further follow-up with the explanting facility found that there was no record of the generator undergoing additional sterilization after explant and prior to return to the manufacturer. The cause of the out of specification septum cavity could not be determined as it was unclear if the generator was exposed to additional sterilization after explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6600771
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« Reply #125 on: May 18, 2019, 12:40:39 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6603299
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« Reply #126 on: May 18, 2019, 12:41:27 AM »

Model Number 303-20
Device Problems High impedance; Difficult to Insert
Event Date 05/09/2017
Event Type  Malfunction   
Event Description
It was reported that a lead could not be fully inserted into a generator, causing high impedance to occur during implant surgery. The surgeon tried removing and reinserting the lead multiple times, but the high impedance continued to occur. The lead could not be implanted due to the high impedance/insertion difficulties. The generator was tested with a test resistor and confirmed that it was accurately measuring impedance values. A different lead was implanted and post-op impedance values were all within normal limits. The lead that was not implanted has not been received by the manufacturer to date.
 
Event Description
The lead that was unable to be inserted was returned to the manufacturer for analysis. The visual analysis of the lead found the small o-ring appeared partially detached from the connector pin. Dimensional analysis was performed on the small o-ring, the large o-ring, the connector pin, and the connector boot and provided results all within normal limits. A half set of screw marks was identified on the lead pin confirming that the lead had not been fully inserted during implant. Continuity checks of the returned lead assembly verified that there were no discontinuities present. The remainder of the lead was within specifications and no other abnormal performance or other adverse conditions were identified.
 
Event Description
An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties. First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of 0. 135 in max, it may cause insertion difficulty. Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling. It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed. This lead had both characteristics. The lead's large o-ring boot diameter was 0. 134 in, which is close to the 0. 135 inches specification max and therefore, may cause pin insertion difficulties. In addition, review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6604102
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« Reply #127 on: May 18, 2019, 12:42:11 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 03/08/2017
Event Type  Malfunction   
Event Description
It was reported that the septum plug fell out when the surgeon when he took it out to insert the lead. The generator was not used and the patient was implanted with a different generator. The suspect device was received and was returned due to "faulty generator/loose screw. " analysis is underway but has not been completed to date. A review of device history records for the generator shows that no unresolved non-conformances were found.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was performed on the returned generator and showed that the pulse generator performed according to functional specifications. Detachment of the septum plug was observed ¿as received¿ prior to decontamination, which may possibly be implant-related damage. The returned setscrew shows mechanical wear on the socket (suggesting numerous insertion attempts) and septum debris is in the socket (verifies the setscrew was extracted up into the septum). In addition, the returned septum shows damage on the underneath side, which indicates the setscrew was extracted up into the septum, which may have been the contributing factor for the detachment of the septum plug. The header septum cavity and returned septum meets specification requirements. Other than the noted septum plug detachment, there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6453706
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« Reply #128 on: May 18, 2019, 12:42:52 AM »

Model Number 304-20
Device Problems Detachment Of Device Component; Fracture
Event Date 04/27/2017
Event Type  Malfunction   
Event Description
It was reported that a neurologist observed high impedance on a patient's device during a clinic visit. The neurologist reported that high impedance was not observed during the previous clinic visit (b)(6) prior. The patient's family also reported that she had fallen during her seizures. The patient was referred for surgery. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The patient's father reported that the patient was experiencing an increase in seizures due to the high impedance. According to the patient's father, the surgeon believed that the lead may have become dislodged from the patient's vagus nerve. The patient underwent full revision surgery. The surgeon and company representative confirmed that the electrode had become dislodged from the nerve, but the surgeon did not know what caused the electrode to come off of the nerve. The explanted lead and generator were discarded and are unavailable for analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6586456
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« Reply #129 on: May 20, 2019, 09:14:57 PM »

Model Number 102
Device Problem Detachment Of Device Component
Event Date 04/19/2017
Event Type  Malfunction   
Event Description
It was reported that during a prophylactic generator replacement surgery, the explanted generator was found to have a detached header. The surgeon stated the generator had been implanted under the muscle so he believes that put more pressure on the generator and caused the header to break off. Review of the manufacturing records for the generator revealed no anomalies during the manufacture of the device. The explanted generator was received 05/05/2017. Analysis is underway, but has not been completed to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided on the initial report that the pre-operative diagnostics were within normal limits. (b)(4).
 
Event Description
Pre-operative diagnostics were within normal limits. Analysis was completed for the returned generator. The reported detachment of the header was confirmed. The detachment of the generator header was most likely the result of inadequate adhesive application during manufacture. A lack of adhesive was found on the can and header.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6566110
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