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dennis100
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« Reply #390 on: October 04, 2018, 04:01:44 AM »

Model Number 302-20
Device Problem Mechanical Problem
Event Date 04/19/2018
Event Type  Malfunction   
Event Description
Notes from surgery were received. Per notes, during the surgery, the surgeon noticed that the connecting lead housing was frayed in 4 areas. There was several small openings in the connecting lead housing but no exposure of the wires. Despite this, the lead impedance values were not obstructed. No wires were exposed completely. The surgeon dissected the generator free from significant scar tissue. The surgery was extended by at least 45 minutes due to the difficult nature removing the generator from the entire connecting lead. Surgeon tested the device one more time after connecting existing lead to new generator, which showed the lead impedance value was satisfactory. The explanted generator was received. Analysis is underway but has not been completed to date.
 
Event Description
During the patient's prophylactic generator replacement surgery, the surgeon reported that the lead's outer "sheath" was gone in several places. Multiple system diagnostics were performed and the impedance was within normal limits. The generator was replaced but the lead was left implanted. A review of device history records for the lead shows that no unresolved non-conformances were found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7513206
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dennis100
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« Reply #391 on: October 05, 2018, 12:17:27 PM »

Model Number 302-30
Device Problem Fracture
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
Patient underwent surgery and the devices were explanted. Patient could not be re-implanted because of scarring around the nerve and due to patient's abnormal anatomy. The surgeon decided not to do the revision because of the risk of nerve damage.
 
Event Description
A patient, who had not seen his neurologist for a while, was seen in the clinic. His device was showing high lead impedance with dcdc 7. X-rays were ordered by the neurologist. There are no adverse events experienced by the patient. Clinic notes were received reporting that the patient's mother has concern with the device working properly. Vns interrogation revealed high lead impedance. Per x-ray review by physician, the leads are intact. The battery is a single pin and no abnormality of the batter is noted. There is only one set of electrodes wrapped around the nerve - despite his prior lead revision surgery. Patient was reported to have done well with implanted vns. As patient has an old battery that is likely nearing end of service, patient was referred for full revision. No known surgical intervention has occurred to date.

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dennis100
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« Reply #392 on: October 18, 2018, 01:51:10 AM »

Model Number 302-20
Event Date 08/23/2012
Event Type  Malfunction   
Event Description
An implant card was received by the manufacturer on (b)(4) 2012 which revealed that the patient had lead replacement surgery on (b)(6) 2012 due to "lead discontinuity. " the explanted lead was received by the manufacturer on (b)(4) 2012. However, product analysis has not been completed to date.
 
Event Description
Additional information was received indicating that the physician performed both normal mode and system diagnostics which resulted in okay results. They were perplexed because the diagnostics are okay but the x-rays show a partial lead break (which the physician and company representative also observed). A/p and lateral x-ray images of the chest and neck dated (b)(6) 2012 were also received by the manufacturer. The generator placement appears lower than normal in the left chest. Without images from immediately following implant surgery in (b)(6) 2010, it is difficult to assess whether the generator has migrated. The connector pin appears to be fully inserted inside the connector block, and the lead wires appear to be intact at the connector pin. The filter feed-through wires also appear intact. No portion of the lead appears to be located behind the generator. The electrodes were visualized in the neck and appear to be in the proper orientation. Unlike the previous images dated (b)(6) 2012, there do not appear to be any lead fractures in the chest area above the generator. No gross discontinuities or sharp angles are visualized in the images provided. However, a micro-fracture or unpronounced lead discontinuity cannot be ruled. It appears that there was likely an artifact in the images dated (b)(6) 2012 that made it appear as though there were two partial lead fractures in the chest area. Based on the x-ray images provided, no anomalies can be observed to account for the reported pain and potential generator migration. It can be noted that these are adverse events and not device malfunctions, and therefore, they are not expected to be observed on an x-ray. No gross lead discontinuities or sharp angles could be visualized, however an unpronounced lead discontinuity cannot be ruled out. No anomalies were identified that could account for the adverse event. The physician believes inadequate strain relief in the neck may be contributing to the patient's pain in the neck. She only gets the painful stimulation when she turns her head to the right. They believe the generator has migrated which may be pulling on the leads from the two tie-downs due to poor strain relief. The patient has received good efficacy from vns therapy. The physician believes the way to resolve this is to fix the strain relief, however, no interventions have been planned to date. Although surgery is likely, it has not occurred to date.
 
Event Description
The return product form indicates that the reason for lead replacement on (b)(6) 2012 was due to lead discontiuity. Product analysis on the explant lead has not been completed to date. The generator was not replaced.
 
Manufacturer Narrative
Device available for evaluation, corrected data:the supplemental report #2 inadvertently did not include the date in which the lead suspect device was received by the manufacturer.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
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 on the returned lead assembly was completed. The lead was returned in three portions. The connector pin, connector ring, and lead's electrodes were not returned for evaluation. The reported high impedance and lead discontinuity allegations were not verified within the returned lead portions. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portions.
 
Event Description
Patient reported on (b)(6) 2012 that she is doing well.
 
Manufacturer Narrative
Conclusion, corrected data: the supplemental report #4 inadvertently reported the incorrect conclusion code. No device failure is suspected. No device malfunction is suspected, and the (b)(6) 2012 x-rays did not show a lead fracture, so the event is coded as confirmed invalid. In addition, normal mode and system diagnostics were reportedly within normal limits.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
X-rays were received on (b)(6) 2012, by the manufacturer, and the radiology report indicated that the patient was experiencing neck pain. Review of the ap and lateral chest and neck x-rays, dated (b)(6) 2012 revealed that the generator can be visualized in the left chest and it appears to be in a normal orientation. The lead pin appears fully inserted into the connector block. The filter feedthru wires appear intact and the lead wires appear intact at the connector pin. The lead wire does not appear to be located behind the generator. The electrodes were visualized in the neck and appear in the proper orientation. There appears to be two partial lead fractures in the chest area above the generator. No additional gross discontinuities or sharp angles in the images provided are visualized. Based on the x-rays received, there are two partial lead fractures present in the chest area which may be contributing to the pain. Follow up with the company representative revealed that the patient's pain was thought to be the same pain the patient experienced before in the neck and shoulder area in 2011 due to generator migration and patient trauma from a car accident (before the physician was aware that there appears to be two partial lead breaks). The physician believed the pain may be related to the generator migration or potentially scar tissue at the electrode site which may be making the strain relief less prominent during neck movement. However now, the pain occurs during stimulation and when she turns her head ot the right or left. The plan is to discuss this with her on the next visit and evaluate if surgery may be needed. The physician suspects that the strain relief may or may not be present anymore due to scar tissue or it may be pulling the lead wire back into the neck area. The physician reported that all diagnostics are within normal limits, and he does not think there is a lead break but only associated with the strain relief. It could have had more of a strain relief and then when the generator migrated, caused a less prominent strain relief. If the pain is still present and it is decided to pursue surgery, the physician and company representative indicated that he would suggest to open up the pocket and neck, move the generator higher in the pocket, capture the lead wire and make a proper loop/strain relief. The physician did not know when the patient will be seen next and does not know how much dysfunction the pain is causing her. The pain does not occur every time during stimulation and is not constant, but only when she turns her neck. The device had not been turned off to date as of (b)(4) 2012. Attempts for additional information have been unsuccessful to date thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2754445
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dennis100
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« Reply #393 on: October 26, 2018, 01:02:28 AM »

Model Number 304-20
Event Date 09/24/2012
Event Type  Malfunction   
Event Description
Follow up was performed on (b)(6) 2013, with the nurse at the treating neurologist's office which revealed that the patient is doing well. The nurse spoke to the patient's mother on (b)(6) 2013. After revision on (b)(6) /2012, the patient has only had one seizure. In the cliinic notes dated (b)(6) 2012, it was indicated that the patient had good improvement with vns; however, abnormally high impedance was detected due to "faulty wire. " the device was turned off on this date due to "mechanical failure" per the notes. Mother saw good improvement with vns so she decided to move forward with surgery. The nurse indicated that the patient is a very active boy, but no specific trauma/manipulation was noted. The increased frequency and severity of seizures was believed to be related to high impedance. No external factors were noted to be contributing factors to the reported event. No additional information was provided.
 
Event Description
Product analysis was completed on the explanted generator and lead. 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. Analysis of the lead revealed that the reported high impedance allegation was verified. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil end and the strands show that pitting or electro-etching conditions have occurred at the break location. However, due to mechanical distortion (smoothed surfaces) and surface contamination the fracture mechanism cannot be determined. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observation, no other anomalies were identified in the returned lead portions. Four sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and lead pin existed at least once.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received from the treating nurse that the patient was scheduled to have generator and lead replacement, as the neurologist recommended the surgery. The mother was reportedly happy with the decision as she reported that when the 'patient's device stopped working,' the patient experienced an increase in frequency and severity of seizures. Attempts for additional information regarding the seizures have been unsuccessful from the nurse to date. The full revision surgery occurred on (b)(6) 2012. The explanted generator and lead were received by the manufacturer for product analysis on (b)(6)2013. However, product analysis has not been completed to date. The return product form indicated the reason for replacement on (b)(6)2012 was due to 'lead discontinuity. '.
 
Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient's mother is now ready to move forward with the patient's revision surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received from the nurse practitioner at neurologist's office reporting that during revision surgery, a problem was found due to excessive keloid scar tissue on the vagus nerve. The patient was doing fine after replacement surgery and was continuing titration. No additional information was known at the time of the report by the nurse. Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported that the patient's vns is now indicating high lead impedance. Clinic notes were received indicating the patient has had definite improvement from vns. The patient's vns was disabled upon discovery of the high impedance as recommended in manufacturer labeling. No adverse events have reported. Last known good diagnostics were taken on (b)(6) 2012 per the physician. The physician indicated that no trauma or manipulation had been reported however the patient was noted as 'restless and mentally retarded. ' no x-rays have been taken. The physician referred the patient for lead revision however additional information was later received indicating the patient's family does not wish to pursue replacement at this time.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2803564
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dennis100
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« Reply #394 on: October 30, 2018, 12:35:05 AM »

Event Date 01/01/2008
Event Type  Injury   
Event Description
On (b)(6) 2012, an article was received indicating that a (b)(6) man was implanted with a vns device in 1998. He had pharmacoresistant epileptic encephalopathy and did not qualify for elective epilepsy surgery. He was submitted to two replacements of the pulse generator in 2002 and finally in 2008. A few months after the second pulse generator replacement, the patient developed a serious problem in the healing of surgical scar that caused a breakage of the leads of the electrode. Because of the optimal seizure control resulted from vns treatment, with more than 50% decrease in frequency and number of seizures, the physician decided to replace vns with a new system. Therefore, he was submitted to complete removal of the vns system (pulse generator, leads and electrodes) and to an ex novo implant procedure. The removal of the helical electrode was performed with the aid of an operating microscope; dense scar and fibrosis that linked electrodes to left vagal nerve were peeled out by microscissor and the electrodes and the silicone spiral tether were cut and piecemeal removed. The physician stated that the lack of gross changes of the vagus nerve observed after electrode removal was impressive. When new vns electrodes were placed cranial to the site of the removed electrodes, an excellent nerve-electrode interface was achieved, with impedances comparable to those achieved during implantation in naive subjects. Attempts were made for further information from the physicians who wrote the article but they stated that they were unable to find any information due to a recent total relocation of the department where they work.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2771504
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dennis100
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« Reply #395 on: November 06, 2018, 07:20:00 AM »

Event Date 11/01/2012
Event Type  Injury   
Manufacturer Narrative
Describe event or problem, corrected data: investigation will be housed in file. 1644487-2011-00877.
 
Event Description
Information was received from our consultant in the (b)(6). A patient's mother had reported that their child had fibrosis noted with their previous device and had their lead replaced. The patient's mother doesn't feel it is as effective now. Currently on 2. 75ma. Magnet 3. 25. Good faith attempts are underway. It is unknown when the event occurred or the surgery took place (lead replacement) at this time. Event date (b)(6) 2012 used until further information is attained.
 
Event Description
It was discovered through investigation that this report was a duplicate of medwatch report number: 1644487-2011-00877. Investigation will continue in that file.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854969
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dennis100
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« Reply #396 on: November 07, 2018, 02:05:58 AM »

Model Number 304-20
Event Date 10/03/2013
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient¿s device was tested during an office visit on (b)(6) 2013 and normal mode diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s device was not disabled following the high impedance observation. The patient¿s physician stated that the patient¿s lead likely cracked from the patient¿s seizures. A mass was noted on the patient¿s neck during an office visit on (b)(6) 2013. The patient¿s radiology exam stated that the sonographic findings were most consistent with a hematoma at the patient¿s left neck. An abscess was not expected based on the absence of fever, wbc count, and the overlying redness and swelling.
 
Manufacturer Narrative
Date of event; corrected data: additional information indicates that high impedance was observed on (b)(6) 2013.
 
Event Description
On (b)(6) 2013 it was reported that the patient has high lead impedance. The patient had a fall with seizures approximately 3 weeks ago striking her neck area and developed a hematoma in the neck. When her vns was checked, she was found to have high impedance. It was stated that the surgeon was treating the hematoma with cold and warm compresses but the hematoma did not go down. No x-rays were taken due to patient¿s ¿mr¿ (possibly mental retardation). Patient went to surgery on (b)(6) 2013 to have a full revision but when the surgeon opened the left neck he saw a huge hematoma that entwined the nerve including the part where the helices were. The surgeon said he would not implant another lead/generator on the left side because of the extensive hematoma. The surgeon then elected to place the lead and the generator on the right side due to the severe hematoma and resulting scar tissue on the left side. The explanted lead and generator have not been returned to the manufacturer for product analysis to date.

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dennis100
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« Reply #397 on: November 09, 2018, 02:24:29 AM »

Device Problem High impedance
Event Date 09/24/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient was hospitalized due to increased seizures, and increased seizure duration and intensity. A company representative then checked the patient's generator and found high impedance and that the current was not being delivered. A new lead and generator were implanted on the right side of the patient. The generator was explanted, but the old lead was left in the patient in its entirety. Per the surgeon, no fluid or visible defects were seen on the lead. The physician believes the high impedance to have been due to scar tissue on the left vagal nerve. Attempts have been made for lead product information, but no relevant information has been received to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7975863
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« Reply #398 on: November 10, 2018, 02:42:23 AM »

Model Number 304-20
Device Problem Mechanical Problem
Event Date 09/01/2018
Event Type  Malfunction   
Event Description
During attempts at product return, it was revealed that the explanting facility, historically, discards all explanted devices.
 
Event Description
It was reported that the patient underwent vns lead replacement surgery due to severe neck pain and side effects. The surgeon noted fluid in the lead tubing, but no visible breaks were observed. Follow up with the company representative revealed that the vns had been programmed off a few weeks prior to the surgery due to pain. Diagnostics were reported as within normal limits. It was stated that the patient had been fine and then suddenly presented with bruising on the neck and pain with stimulation. The patient's mother reported that could not identify a single event that could have lead to the observed issues, but that the patient did have violent type seizures, where she falls to the ground, etc. The surgeon reported a lot of scare tissue around the lead in the neck that usually comes from bleeding. The diagnostics prior to surgery were within normal limits. The explanted lead has not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8008797
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« Reply #399 on: November 12, 2018, 07:37:36 AM »

Model Number 300-20
Event Date 01/16/2013
Event Type  Malfunction   
Event Description
The patient was referred for prophylactic generator replacement on (b)(6) 2013. On (b)(6) 2013, it was reported that the patient had generator and lead replacement on (b)(6) 2013 due to the surgeon finding the lead appearing 'frayed' after disconnecting the generator from the lead. It was confirmed that all diagnostics in the office setting were within normal limits prior to surgery. No diagnostics were performed prior to surgery since diagnostics were performed by the neurologist's office the week prior. During surgery, the surgeon noticed scar tissue wrapped around the lead. Surgeon said he was going to clean up scar tissue around the lead. After the surgeon mentioned it looked like scar tissue, he disconnected the lead, and then said 'lead looks broken;' then, the surgeon reported that he actually cut the lead. It was clarified that he said the lead looked broken even more he actually cut the lead. It is unclear why the patient had 'bad scarring' around the lead. The device was turned on after surgery, and the patient is recovering well. No x-rays were taken since no lead issue was suspected prior to surgery. The replacement generator was also explanted due to compatibility with the new lead. The two explanted generators and lead were received by the manufacturer on (b)(4) 2013 for product analysis. However, analysis has not been completed to date. Previously, it was reported from the neurologist's office that the patient was evaluated for the first time on (b)(6) 2012, and per the patient's mother, the patient had good seizure control at one point, but was now experiencing seizures every day (below pre-vns seizure frequency). The mother believed that the increased seizures must have been due to the vns battery, since the patient was doing fine before. There were no other contributing factors, and no medication changes that could have contributed to this increase. The patient was referred for prophylactic generator replacement since the mother was insistent that the seizures were due to the battery. The neurologist reportedly did not know the cause of the increased seizures.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in teh lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The two explanted generators and lead were received for pa. Analysis of the explanted generator and generator not used revealed no anomalies found with the pulse generator. An analysis was also performed on the returned lead portions and the reported lead fracture was not confirmed. The report indicated that during revision surgery the surgeon noticed scar tissue wrapped around the lead. While removing the scar tissue, the surgeon reported that he actually cut the lead. The returned lead assembly was received in two portions, which appeared to have been cut in half. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. 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 of lead fracture with the exception of the accidental cut made by the surgeon. It was reportedly unclear why the patient had 'bad scarring' around the lead. The company representative present at surgery confirmed that the lead appeared to have a full break.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2962475
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« Reply #400 on: November 14, 2018, 09:08:41 AM »

Model Number 302-20
Event Date 01/21/2013
Event Type  Malfunction   
Event Description
On (b)(4) 2013 it was reported that the vns patient underwent a lead revision surgery that day due to high impedance. Pre-operative interrogation showed the patient was at settings of output=0ma/frequency=20hz/pulse width=500usec/on time=60sec/off time=1. 1min/magnet output=2. 5ma/magnet on time=60sec/magnet pulse width=250usec. Pre-operative system diagnostics showed high impedance (>10,000 ohms). The surgeon then explanted the generator and stated the lead pin looked secure and appeared to be fully inserted in the header and there were no obvious issues in the visible portion of the lead. The screwdriver was used to loosen the set screw and the lead pin was examined and there were no obstructions visible in the header. The lead pin was then re-inserted and the set screw was tightened. Proper pin insertion was verified. System diagnostics still indicated high impedance. The lead pin was removed and the test resistor was inserted and tightened. Diagnostics with the test resistor indicated output=ok/lead impedance=ok/impedance value=3957ohms/eri=no. The surgeon then decided the lead needed to be replaced. The incision in the neck was made and all three helical coils were completely removed. The surgeon noted that the anchor coil was not wrapped around the nerve and stated this likely occurred at the time of the original implant because it was scarred in place off of the nerve. There were no obvious discontinuities observed in the old lead. The surgeon then implanted the new lead and connected it to the existing generator. Two in-pocket system diagnostics indicated output=ok/lead impedance=ok/impedance value=1500ohms/eri=no and output=ok/lead impedance=ok/impedance value=1471ohms/eri=no. The surgeon decided to leave the device at the current settings. Final interrogation confirmed settings of output=0ma/frequency=20hz/pulse width=500usec/on time=60sec/off time=1. 1min/magnet output=2. 5ma/magnet on time=60sec/magnet pulse width=250usec c. The circulating nurse stated they do not return explanted items and that the old lead would be discarded. Good faith attempts for further information from the physician were unsuccessful. Review of manufacturing records confirmed the device met specifications prior to distribution.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met specifications prior to distribution.

Event Description
On (b)(6) 2013, additional information was received regarding the patient¿s high impedance when it was reported that when the physician¿s assistant had tried to interrogate the patient¿s vns, they got high impedance (date not provided). The patient¿s settings were noted to be output=2. 25ma/frequency=20hz/pulse width=500usec/on tome=60sec/off time=1. 1min. The system diagnostics test and normal mode diagnostics test showed the impedance value was greater than 10,000ohms and ifi=no. Ap and lateral x-rays were performed which were stated to be negative. The assistant reported that there were clearly seizures that had occurred but no clear cut trauma or no known cause for the high impedance/fracture.

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« Reply #401 on: November 14, 2018, 09:10:58 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
The vns treating physician reported that high lead impedance was found during an office visit on (b)(6) 2013. The patient was last seen on (b)(6) 2012 at which time the lead impedance was within normal limits. The physician reported that an x-rays confirmed a distal fracture. The patient was for replacement surgery as soon as possible to prevent more seizures. Clinic notes from the patient's visit on (b)(6) 2013 were received which indicated the patient continued to do well. However, the patient had a breakthrough seizure earlier in (b)(6), followed by brief myoclonic jerks involving his upper limbs. Since then, he has not had any further seizures. He is seizure free on the ketogenic diet. Also on the last office visit, his seizure medications were being weaned off and had been over of seizure medications for about 8 months. The patient had breakthrough seizures that seem to be related to vns lead fracture. Given the good seizure control, the plan was to continue to wean the patient off of seizure medications. Attempts for additional information from the physician's office have been unsuccessful to date, including to obtain a copy of the x-rays. Although generator and lead replacement surgery is likely, it has not occurred to date.

Manufacturer Narrative
Device failure occurred, and it was believed to have contributed to the patient's increased seizures.

Event Description
Additional information was received from the hospital reporting that the patient had generator and lead replacement surgery on (b)(6) 2013 and the explanted products were available for return. The explanted products were received by the manufacturer on (b)(6) 2013 for analysis. The return product form indicated the reason for replacement as prophylactic generator replacement and due to lead discontinuity. The implant card was also received and confirmed the date of surgery and indicated the reason for generator replacement as battery depletion with near end of service marked. Product analysis has not been completed to date.

Event Description
Operative notes from the patient's revision surgery on (b)(6) 2013 were received which indicated the diagnosis as placement of new lead due to fracture and generator secondary to end-of-life due to length of implant. The patient was doing well but began to lose efficacy with vns. Imaging was obtained which showed a fracture of the lead, explaining the device's 'failure to work. ' during the procedure, an incision was made over the old scar in the neck and dissection was carried down to remove the lead and the anchors. There was significant scar tissue surrounding the sternocleidomastoid, which was carefully dissected free by the surgeon. The lead dove directly posterior at this point, and the surgeon worked through the scar tissue to identify the connecting portion of the electrode. However, the nerve was scarred-in quite heavily, and the surgeon was unable to locate and free up all three of the components that held the nerve. The nerve was traced superiorly into the cicatrix and he tried to free up enough to again identify the previous electrodes, but the scar tissue was so heavy so the surgeon did not feel that he could 'safely dissect the nerve free without some type of injury to it. ' at this point, the surgeon felt that 'removal of the old electrode component was probably not worth the risk of injury to the nerve, and again try to free up as much nerve as possible, although the amount of exposure was very limited. ' the new set of electrodes were then successfully wrapped around the nerve. The surgeon felt that he had adequate contact of the two superior components of the lead, and the third electrode was able to be adequately wrapped around the nerve by laying it down inferiorly. Upon disconnecting the previous lead from the generator, a fracture was observed in the lead. The replacement lead was connected to the replacement generator which resulted in normal impedance upon diagnostics. He noted in the notes that the two electrodes appeared to have good relationships with the nerve. Attempts for additional information from the surgeon have been unsuccessful to date.

Event Description
The surgeon's office reported that there was noted to be scarring around the electrode and vagus nerve. However, the believed cause/relationship to vns was not provided. It may be reasonably assumed that it was related to presence of the electrode on the nerve.

Event Description
Product analysis of the generator showed no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was also completed. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis an abraded opening was observed on the outer silicone tubing and both of the inner silicones were found to be abraded open in half; therefore determination could not be made between the (-) connector pin and (+) connector ring quadfilar coils past this point. These coils were identified as quadfilar coil 1 and quadfilar coil 2. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 239mm, 242mm and 245mm from the end of the connector boot. The (+) connector ring quadfilar coil appeared to be broken approximately 240mm from the end of the connector boot. Scanning electron microscopy was performed and identified the coil break areas as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis quadfilar coil 1 appeared to be broken approximately 247mm from the end of the connector boot and quadfilar coil 2 appeared to be broken approximately 253mm from the end of the connector boot. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting on the quadfilar coil 1 coil break. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Review of the lead manufacturer history records confirmed all quality tests were passed prior to distribution.

Manufacturer Narrative

Manufacturer Narrative
Device failure is suspected and is suspected to have contributed to the patient's increased.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950000
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« Reply #402 on: November 15, 2018, 08:38:26 AM »

Model Number 302-20
Event Date 01/03/2013
Event Type  Malfunction   
Event Description
Clinic notes from the surgery were received. The pre-operative diagnosis listed was seizures, end of service vns lead with high lead impedance status post generator change. It was noted that there was scarring in the neck, minimal blood loss, and no complications. The surgery procedure was detailed, and it was noted that the third electrode was tightly adherent to the nerve so the electrode was left in place as it was encased in the nerve with dense scar tissue. Diagnostics were performed after the lead replacement which showed good lead impedance and indicated the system was functioning perfectly at this point. Follow up with the surgeon's office found that the scarring was related to the vns surgery. Attempts were made to find out if any interventions were taken or planned; however, this information was not provided. No additional information has been provided.

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

Event Description
Clinic notes dated (b)(6) 2013 were received which indicated that the patient had an increased seizures frequency and wanted new magnets as it was believed their magnet was not working. It was stated that the patient's last seizure was approximately six months prior and the patient has a history of petit and grand mal seizures as well as nocturnal seizures. Clinic notes also state that the vns was non-responsive and it is likely the vns battery died off. The patient had a battery replacement on (b)(6) 2013 and a lead replacement on (b)(6) 2013. The lead replacement was performed because it was found during surgery that the patient had high impedance. After the initial generator was replaced on (b)(6) 2013, the new generator was connected to the original lead and diagnostics indicated high impedance. The lead pin was re-inserted and tightened into the generator multiple times to ensure that it was placed correctly. In addition, the generator was checked for debris and buildup, but none could be found. No pre-diagnostics had been performed to check lead integrity as the generator battery was depleted. Attempts will be made for additional information. No additional information has been provided.

Event Description
The patient underwent lead revision surgery on (b)(6) 2013.

Event Description
The explanted generator was returned on (b)(6) 2013 and product analysis was performed. It was found during product analysis that the generator was at end of service due to normal expected battery depletion. 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. Visual examination performed at the test bench, showed tool marks on the pulse generator case and header. These tool marks are most likely associated with manipulation of the device during the explant procedure, as the observed markings are consistent with devices typically used in a surgical procedure (forceps, etc. ). Burn marks were also observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electrocautery tool. Product return attempts were made for the explanted lead; however, the lead was not returned. Attempts for additional information were made; however, they were unsuccessful. No additional information was provided.

Manufacturer Narrative
(b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2939797
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« Reply #403 on: November 20, 2018, 07:34:41 AM »

Model Number 302-20
Event Date 03/15/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 during the patient's generator replacement surgery due to battery depletion (neos=yes), it was observed that one wire of the lead was past the insulation and was visible. However, when testing the lead impedance, everything was "ok". The surgeon decided to change the lead. The lead impedance with the new lead was also noted to be "ok". Further information was later received when it was reported that the damage near the end of the leads is what the surgeon noticed during surgery, although the lead impedance was "ok". The bigger damage on the further end of the lead might have occurred when he was pulling out the lead, but the regional manager was not certain of this. The lead was cut, and the electrodes were left on the vagus nerve because of scarring. No patient manipulation or trauma occurred that is believed to have caused or contributed to the lead break found. It was stated that the explanted generator was discarded but that the explanted lead would be returned to the manufacturer for product analysis. The lead has not been received by the manufacturer yet for product analysis.

Event Description
On (b)(4) 2013 product analysis was completed on the explanted lead. A break was identified in both the positive and the negative lead coils. Scanning electron microscopy images of both the positive and negative coils showed 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. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Abraded openings in both the outer and inner tubing near the break area were also observed. 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 portion. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. It was reported that the patient has not experienced any feeling or symptoms concerning the low impedance. The generator was replaced due to battery replacement. During the replacement procedure, the surgeon noticed that the lead looked broken. They performed diagnostics and the lead impedance was ¿ok¿. No x-rays had been taken.

Event Description
Additional information was received on (b)(4) 2013 when the explanted lead was returned for product analysis. Product analysis is still underway and has not yet been completed. The patient¿s programming history was reviewed and a system diagnostics from (b)(6) 2011 showed output=ok/lead impedance=ok/dcdc=0. The dcdc has been 0 since (b)(6) 2009. A battery life calculation was performed which showed 1. 84 years remaining until eri=yes.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3049388
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« Reply #404 on: November 25, 2018, 06:11:12 AM »

Model Number 300-20
Event Date 04/10/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent surgery on (b)(6) 2013. It was reported that during the surgery the physician dissected down to the nerve and found that normal fibrosis had formed; however, the physician explained to the patient's family that if there was too much fibrosis he would not feel comfortable completing the revision. The physician indicated that due to the patient's anatomy there was not enough room above or below the electrodes to place another lead on the patient's nerve. The physician decided that he will refer the patient to a surgeon who is comfortable removing the electrodes from the patient's nerve since there isn't enough room to place a new lead at this point. The generator analysis was completed on (b)(4) 2013. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that not abnormal performance or any other type of adverse condition was found.

Event Description
It was reported that the patient's family has decided to hold off on surgery at this time. The surgeon considered the fibrosis to be a normal amount.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
During prophylactic generator replacement, device diagnostic testing with the new generator attached to the existing lead resulted in low impedance (less than 600 ohms). The surgeon indicated that the lead pin was reinserted multiple times with the same diagnostic results. The new generator was disconnected from the existing lead and generator diagnostics were performed on the new generator which were within normal limits. The surgeon indicated that he would not replace the lead at this time. The patient was closed with the intent for a later surgery. Clinic notes dated (b)(6) 2013 noted that the device was tested on that day and was reportedly "still functioning", but the exact diagnostic results were not provided in the notes. An implant card was received which confirmed the generator was replaced on (b)(6) 2013 for prophylactic reasons. The lead impedance was not marked. Further follow-up revealed that the patient is scheduled for full vns system replacement. A new generator will be placed to accommodate the new single pin lead that will be implanted. Surgery is scheduled; however, has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3102642
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« Reply #405 on: November 29, 2018, 02:59:00 AM »

Model Number 302-20
Event Date 08/09/2012
Event Type  Malfunction   
Event Description
Additional information was received that the x-rays were received. Based on the x-ray received there was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Product analysis was completed on the generator. The depletion was an expected event as determined by battery life calculation and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

Event Description
It was initially reported that the patient had high impedance. The patient had a generator replacement due to end of service and once the new generator was connected high impedance was received (10,000 ohms). It was noted that there as a lot of fibrosis around the generator site. X-rays were ordered but they have not been provided to the manufacturer for review. The patient did not have the lead replaced that day and the generator was left off. There was no manipulation or trauma. Review of programming history indicated that the high impedance was received prior to surgery and was present since (b)(6) 2012. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed to date. Review of manufacturing records confirmed there were no unresolved non conformances found with the lead prior to distribution.

Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. 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=3168327
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« Reply #406 on: December 07, 2018, 09:08:31 AM »

Model Number 300-20
Device Problem Fracture
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
The patient was found to have high impedance, first seen about three years ago. The patient's leads were not replaced, as the patient and surgeon were not ready or the revision. Follow up to the physician's office found that the patient had high impedance found during a system diagnostic test, and that when the device was temporarily disabled. The notes indicated that the patient would only have a generator replacement due to scarring. No revision surgery has occurred to date for the lead fracture. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8066814
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« Reply #407 on: December 12, 2018, 01:52:50 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient would have a full vns revision surgery due to high lead impedance. The device was replaced due to "malfunction of vns device and high lead impedance" on (b)(6) 2013, per the hospital. Device manufacturing records were reviewed and no unresolved non conformances were found. Attempts have been made for additional information; however, they have been unsuccessful.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received that the high impedance was seen (b)(6) 2013 and the patient was turned off that day. The last good diagnostics was (b)(6) 2013 however results were not provided. X-ray were taken but will not be sent in to manufacturer for review. During surgery there was a lot of scar tissue that was seen and there were no lead breaks or other issue visualized. It was unknown if this was the cause of the high impedance but it was felt that it may have contributed. The cause of the fibrosis/scar tissue was unknown. Product analysis was completed on the generator and lead. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery is 2. 889 volts (not at ifi). The data in the diagaccumconsumed memory locations revealed that 65. 153% 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. Review of internal memory shows that the high impedance occurred (b)(6) 2013. During the visual analysis of the returned 390mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 331mm from the end of the connector boot. Scanning electron microscopy was performed and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, zirconium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3357554
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« Reply #408 on: December 14, 2018, 06:33:29 AM »

Model Number 300-30
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
The generator and lead were returned on (b)(6) 2013 and are pending product analysis.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

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

Event Description
It was reported that during generator replacement for eos = yes system diagnostics were run with the new generator and existing lead which resulted in high impedance reading. It was reported that the generator was completely dead in pre-op therefore diagnostics could not be run before the new generator was implanted. The surgeon then replaced the lead. A new generator and lead were implanted. It was reported that the explanted devices will not be returned to manufacturer for analysis per hospital policy. The surgeon reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The neurologist indicated that the patient had scar tissue on the vagus nerve and that there was partial erosion into a small area of the medial aspect of the left internal jugular vein which is believed to have caused or contributed to the high impedance.

Event Description
The lead assembly was returned in one portion. A portion of the lead assembly (body) including the electrodes and tie downs was not returned. Setscrew marks were observed on the marked and unmarked connector pins. The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead. White deposits were observed on the outer silicone tubing. The generator was returned as it was not implanted in the patient. Visual examination showed no visual anomalies. The septa were not cored. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional 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 battery, 2. 995 volts as measured during completion of the final electrical test, shows a non-ifi condition. 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=3325040
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« Reply #409 on: January 03, 2019, 08:49:52 AM »

Model Number 304-20
Event Date 12/16/2013
Event Type  Malfunction   
Event Description
It was reported that the device was not programmed off after observing the high impedance. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Analysis of the lead was completed on (b)(4) 2014. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil broken ends show that pitting or electro-etching conditions have occurred at the break location. Due to metal dissolution the fracture mechanism cannot be determined. Also, images performed at the vicinity of the discolored region show that pitting or electro-etching conditions have occurred at the discolored area. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that during implant surgery in (b)(6) 2012 a lot of scar tissue was noted. The patient underwent lead replacement. During the surgery the device was interrogated and high impedance was obtained. The lead pin was removed from the generator and then reinserted. System diagnostics again resulted in high impedance. It was reported that the lead was replaced. It was found that the lead was fractured at the bifurcation. The generator was left programmed off after the surgery. The lead was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3643548
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« Reply #410 on: January 04, 2019, 09:14:03 AM »

Model Number 300-20
Device Problem Mechanical Problem
Event Date 11/29/2018
Event Type  Malfunction   
Event Description
During the generator repositioning surgery for lead extrusion reported in mfg report #1644487-2018-02130, it was noted during the surgery that just below one of the lead pins, scar tissue had formed in the shape of a tube around the pin's wire. It was stated that within the tube, the lead wire had a portion that was exposed with the insulation pulled back. Diagnostics were performed outside the pocket noting impedance within normal limits. The generator was then positioned and secured into the pocket. Another diagnostic was performed with ok impedance and the pocket was closed. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8188205
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« Reply #411 on: January 04, 2019, 09:14:47 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/19/2018
Event Type  Injury   
Manufacturer Narrative
Adverse events caused by the surgical procedure are not related to functionality of the vns.
 
Event Description
It was reported that a lead revision due to high impedance had to be aborted due to complications. The high impedance event is captured in mdr #1644487-2018-01964. The surgeon reported that the patient's electrode coils had formed scar tissue due to the initial lead implant that had attached to the jugular vein. It was reported that when the surgeon would attempt to manipulate the vagus nerve the jugular vein would suffer "small cracks" and bleed. After a long time trying to form open space on the nerve to implant another lead, the surgeon became concerned for the patient's health due to the bleeding. As a result he made the decision not to proceed with the lead or generator replacement. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8166999
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« Reply #412 on: January 05, 2019, 02:35:23 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/03/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the infection, extrusion and tissue damage, is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that this patient recently had a generator replacement, and then explanted due to infection. It was stated that the patient wears a vest for circulation over his chest area the vest was most likely rubbing on the patient's chest, rubbed the incision open, and caused the infection as well as the generator to come out of the patient's skin. Operation notes were received that stated that the leads were removed, but the portion of the leads that encircled the vagus nerve were left in place as it was too densely scarred and taking them out would probably injure the nerve. There was no infection in this area at all. Once the leads were taken out, the wound was irrigated vigorously and closed. The generator pocket was opened and cultures were taken. Gross purulence was found and the generator was removed. There was some brownish tissue and some necrotic tissue that was debrided from the chest wall with a knife. No other abscess pockets or tunneling was found anywhere else. This pocket was irrigated thoroughly and a dressing was applied. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. No other relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8162357
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« Reply #413 on: January 06, 2019, 04:13:37 AM »

Model Number 302-20
Device Problem High impedance
Event Date 06/19/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a prophylactic generator replacement initially, but the generator battery was found to be depleted to the point of being unable to be interrogated during pre-op. During surgery, after the new generator was connected to the lead, high impedance was observed. Pin insertion troubleshooting was performed three times and the high impedance was not resolved. The surgeon observed that the electrodes were encapsulated by scar tissue around the lead and indicated that he believed the high impedance was caused by the fibrosis. No lead fractures were observed. Impedance was found to be within normal limits with the new lead. The lead was not explanted and left fully intact in the patient. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6724696
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« Reply #414 on: January 08, 2019, 07:50:43 AM »

Model Number 300-20
Event Date 03/03/2014
Event Type  Malfunction   
Manufacturer Narrative
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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 197mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 25mm and 29mm from the end of the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 25mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 29mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting on two of the broken coil strands. Pitting was observed on the coil surface. The abraded openings and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The abraded openings found on the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sulphur and calcium. 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 setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 8620 ohms) during an office visit on (b)(6) 2014. The patient recently had some slips and falls. The patient underwent generator and lead replacement surgery due to high impedance on (b)(6) 2014. The generator was also replaced as diagnostic results revealed near end of service. The surgeon noted that there was a lot of scar tissue present. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3709847
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