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dennis100
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« Reply #360 on: July 31, 2018, 03:34:19 AM »

Model Number 302-20
Event Date 10/15/2013
Event Type  Malfunction   
Event Description
It was reported that the patient would have vns replacement surgery on (b)(6) 2013; however, follow-up information was received which indicated that vns was not implanted on this date. At the time of surgery, it was believed that the electrodes were not on the vagus nerve. The nerve was "disintegrated" and the surgeon had no assessment of what caused the event. No interventions were taken or planned. The generator and lead were explanted and discarded. The patient was not implanted with another vns device. It was unknown if this event was related to vns. No other information was provided.
 
Event Description
On (b)(6) 2013 it was reported that the patient was found to have high lead impedance during an office visit on (b)(6) 2013. The physician requested x-rays and the device was not disabled. The physician sated that the only trauma was that the patient recently had a mammogram which was a little rough but he did not think it would have caused any issues with the device. Clinic notes were received from the (b)(6) 2013 visit which indicated that the diagnostics test showed high lead impedance with a dcdc of 7. The physician indicated that the high impedance may be related to some scar tissue. The patient reported no seizure since her previous appointment in (b)(6) 2013. The patient was referred for surgery. A copy of the patient¿s x-rays were received for review. Due to image angle and quality, complete lead pin insertion cannot be assessed. The lead portion behind the generator cannot be assessed. There are no sharp angles in the lead; however, there is a suspect area of continuity in the lead portion in the chest. The assessment of community in this area is limited by image quality. Based on the images available, the suspect area of continuity in the lead may be a cause for the high impedance. The presence of a microfracture or a discontinuity in the lead portion not visible cannot be ruled out. Although surgery is likely, it has not occurred to date. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
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=3484513
« Last Edit: October 02, 2018, 11:14:36 AM by dennis100 » Logged
dennis100
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« Reply #361 on: August 07, 2018, 01:11:19 PM »

Model Number 304-20
Device Problem Mechanical issue
Event Date 05/07/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during surgery the surgeon was attempting to implant patient, and he was not able to place the positive electrode on the nerve. The surgeon claimed that the electrode was too tight, and he was unable to get it to uncoil in order to place it on the nerve. The surgeon did not believe there was anything abnormal about the patient's anatomy that caused the difficulty, and when a new lead was opened, the surgeon was able to quickly implant the patient with no issues. A review of device history records showed that the implanted lead passed all other quality prior to distribution. The suspect lead was received for analysis; however, analysis has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7562990
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dennis100
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« Reply #362 on: August 10, 2018, 03:33:54 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7714030
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dennis100
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« Reply #363 on: August 16, 2018, 02:22:35 AM »

Model Number 304-20
Device Problem Mechanical Problem
Event Date 12/21/2016
Event Type  Malfunction   
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.
 
Manufacturer Narrative

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252939
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dennis100
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« Reply #364 on: September 06, 2018, 01:35:39 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
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
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
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.
 
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 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
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2229120
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dennis100
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« Reply #365 on: October 06, 2018, 04:49:19 AM »

Model Number 300-20
Device Problem Detachment of Device or device Component
Event Date 08/24/2018
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was feeling irritation in her neck and that the physician had taken x-rays of the neck. It was stated that the physician believed that the electrodes had migrated. The physician wanted to disable the vns to reduce the irritation. The x-rays have not been reviewed 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=7887044
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dennis100
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« Reply #366 on: October 20, 2018, 12:27:20 PM »

Model Number 300-20
Event Date 08/08/2012
Event Type  Malfunction   
Event Description
It was reported that a vns patient was going to be scheduled for a battery replacement for eos. An x-ray was taken, but not sent to the manufacture for review. It was reported that "radiology report came back and stated that there is a fracture of one of the electrodes". At this time no surgery is planned but may be scheduled at a later date. No further information has been attained at this time.
 
Event Description
Additional information was received that there was no surgery date set at this time. The patient does have a history of falls, but it was unknown if they had a fall prior to their lead break. X-rays will not be provided to the manufacturer for review. No previous diagnostics are available for review.
 
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 was completed on the returned lead and generator. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis was completed on their explanted generator. During the analysis, there was no indication from the device that an end of service condition existed. A battery life estimation resulted in 4. 17 years remaining before the eri flag would be set. However, an incomplete programming history (last 6 years are missing) indicates the estimation does not use all the data required to make an accurate estimation. The device performed according to functional specifications of the current automated final test. Analysis of the generator in the lab concluded that no abnormal performance or any other type of adverse condition was found.
 
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient had full revision surgery. No lead break was observed in the surgery. The patient's old electrodes were not removed. A portion of the lead body and explanted generator is being returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2736900
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dennis100
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« Reply #367 on: October 25, 2018, 01:42:30 AM »

Model Number 102
Event Date 06/18/2010
Event Type  Injury   
Event Description
Although vns explant surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
A nurse practitioner at a neurologist's reported on (b)(6) 2012, that a patient was experiencing bradycardia with vns stimulation, and the patient will likely have his device removed as a result. The patient is also being monitored by a cardiologist who has noted that the patient has second- and third-degree heart block during stimulations. She also indicated that he was having a drop in blood pressure during these bradycardia events causing syncope. Due to the adverse events, she expects the device to be explanted, but they are waiting for the cardiologist evaluation to be completed. They first confirmed the bradycardia and syncope on (b)(6) 2012, but she suspects that this has been an on-going issue since the patient was turned on ((b)(6) 2010). The patient is noted as being a poor historian due to issues with alcohol abuse and appointment compliance, and she feels that he cannot tell the difference between a seizure and a syncopal event, which is why she feels that this has been an issue since after implant. She does not feel that the device is malfunctioning, but the placement of the electrodes is the likely cause. She mentioned that they were able to induce an event with the magnet activation, which is how they confirmed the events occurring with stimulation. When asked if the events are occurring with normal mode stimulation, she said that she believed so, which is why there is question about the previous seizures possibly being syncopal events. The events were not occurring with every normal mode activation. The patient's device is now disabled and is wearing a holter monitor to further determine if this event is occurring without stimulation. An ecg/cardiology monitor report was received indicating the patient's average heart rate is 64 bpm. The minimum heart rate was measured as 27 bpm, and the maximum heart rate was 101 bpm. The study concluded that the patient has complete heart block on (b)(6) 2012, at one point. A cardiology consult was placed for the electrophysiologist. The arrhythmia questionnaire was received from the neurologist's office reporting that the patient does not have a prior history of cardiac events nor does his family. The patient does have pre-existing medical conditions of tuberous sclerosis, sleep apnea, and major depression which are unrelated to vns. The patient has experienced 2nd degree type 1 and type 2, in addition to 3rd degree heart block. The patient's normal heart rate is about 64 bpm, but during the bradycardia it dropped to 27 bpm. This did not occur intraoperatively. No traumatic events, medication changes, or vns settings changes were experienced prior to the arrhythmia. The bradycardia occurs with the on time of vns stimulation but not during diagnostics. The neurologist's office believes the arrhythmia is related to vns stimulation. The patient has not been hospitalized for this event. Since the device was disabled, the patient reports that the bradycardia has not occurred again, but they are awaiting the holter monitor results.
 
Manufacturer Narrative
Article citation: american journal of therapy; 2013 jun 21. [epub ahead of print]; late-onset advanced heart block due to vagal nerve stimulation. Schevchuck a, west mb. Department of internal medicine, division of cardiology. (b)(6).
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial report inadvertently did not include this information.
 
Event Description
On (b)(4) 2013 information was received from the reporter that a case study was being published on this patient and event and that an abstract for the article had been received for the article. The article is ¿late-onset advanced heart block due to vagal nerve stimulation¿ by a. Schevchuck and m. B. West, published in the american journal of therapy on june 21, 2013. Figures #1 and #2, which display ekgs of the patient¿s normal sinus rhythm and sinus rhythm during vns stimulation showing advanced atrioventricular block, respectively, are figures not received in the past.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2728697
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dennis100
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« Reply #368 on: October 27, 2018, 12:44:41 AM »

Model Number 102
Event Date 09/19/2012
Event Type  Injury   
Manufacturer Narrative
 
Event Description
On (b)(6) 2012, it was reported that this vns patient experienced an arrhythmia during initial implant surgery that day. The patient was successfully implanted. An in-pocket system diagnostic was normal, and a final interrogation confirmed that the normal mode and magnet mode output currents were 0. 00 ma. During the first system diagnostic test, the surgeon noticed a heart arrhythmia during the vns stimulation period. He stated it was not bradycardia, just an abnormal arrhythmia. The system diagnostic test was repeated multiple times, all tests were within normal limits, and the arrhythmia was still present. Following each test, the surgeon attempted to re-position the coils on the nerve to maximize the distance between the coils and the cervical branch of the vagus nerve. He stated the arrhythmia was minimized but was still present after the repositioning of the coils. He stated this was likely due to the very small size of the patient and the short length of nerve he had to work. Attempts for additional information have been unsuccessful.
 
Event Description
A fax was received on (b)(6) 2012, from the patient's physician. The fax indicated that additional interventions included "cardiology consult and simultaneous". The patient did not have a previous history or family history of cardiac events. The patient's pre-existing conditions included neonatal cerebral abscesses, infantile spasms, intractable epilepsy, and global developmental delay. The patient experienced bradycardia. Prior to the event, the patient's heart rate was 109 bpm. During the event, the patient's heart rate was 104 bpm.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2792641
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dennis100
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« Reply #369 on: November 06, 2018, 07:07:45 AM »

Model Number 304-20
Device Problem Device Dislodged or Dislocated
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 #370 on: November 13, 2018, 07:02:41 AM »

Model Number 304-20
Event Date 12/20/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by a vns implanting surgeon that during implantation of this patient's lead the green sutures came off of the anchor tethers and that the electrodes were coming off the nerve. Ultimately the electrodes stayed on the nerve and diagnostics performed were within normal limits. The surgeon asked if the leads had been made differently because of this and that he said that the electrodes looked like they were 'slightly tilted. ' this surgeon has been using the 304 leads for quite some time and has only used 2mm coils, except for in rare instances when the 3mm was needed. Review of manufacturing device history records for the helical lot used was performed to ensure that all assembly steps were signed off and there were no anomalies or unresolved defects/ncr's. It appears that the lead in this patient has met all specifications prior to shipment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2959687
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« Reply #371 on: November 15, 2018, 08:29:19 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 #372 on: November 15, 2018, 08:30:06 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 #373 on: November 15, 2018, 08:31:24 AM »

Model Number 304-20
Event Date 01/10/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient went back into surgery following implant. The surgeon believed that he placed the electrode on the nerve upside down and took the patient back in to surgery to correct the placement. Diagnostics were within normal limits at implant surgery and were within normal limits following the electrode placement correction. There were no adverse events, the surgeon simply recalled that he placed them upside down and schedule the patient for surgery to correct them. There were no x-rays taken to confirm the event prior to the surgery.

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« Reply #374 on: December 01, 2018, 01:44:43 AM »

Model Number 302-20
Event Date 06/21/2013
Event Type  Malfunction   
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 vns patient¿s vns lead was referred for replacement due to high lead impedance. Battery life calculations revealed that the vns generator had 0. 0 years left til end of service. Good faith attempts have been performed and it was later reported that the high impedance issue was first observed on (b)(6) 2013. The patient did not experience pain or any other adverse events. The office reported that their patient¿s vns devices are not turned off unless they are in pain. Thus, the patient¿s device was not changed to 0 ma. No x-rays were taken. No patient manipulation or trauma is believed to have caused or contributed to the high impedance. However, the physician was not able to provide a reason as to why the high impedance issue occurred.

Event Description
On (b)(6) 2013, it was reported that the patient had the vns generator and lead replaced on (b)(6) 2013. Diagnostics were performed which were all ok and the patient was interrogated prior to leaving the operating room to ensure the device was programmed off. However, when the patient came back into the office for a follow up visit, it was found that the device was turned on (reported in mfr #: 1644487-2013-02883). No other information was provided. The explanted device has not been returned.

Event Description
The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. The lead analysis was completed on (b)(4) 2013. During the visual analysis the white (+) and green (-) ribbons appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the electrode ribbons from coming in contact with the vagus nerve; therefore contributing to the reported allegations. With the exception of the observed tissue-covered (+) white and (-) green electrode ribbons 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 slice marks found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, 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 on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur, chlorine and calcium. 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 which may have contributed to the high impedance. However the "as-received" condition of the helicals suggest they were not mounted on the vagus nerve during some portion of the implant life. The generator analysis was completed on (b)(4) 2013. 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. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3242310
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« Reply #375 on: December 12, 2018, 01:49:00 AM »

Model Number 302-20
Event Date 08/16/2013
Event Type  Malfunction   
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. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient was seen on (b)(6) 2013 and high lead impedance was observed. The physician programmed the patient's device off to 0ma output current. The patient was referred to the surgeon for evaluation and x-rays were ordered, but will likely not be sent to the manufacturer. The physician does not believe that trauma or manipulation contributed to the event. Revision surgery was completed on (b)(6) 2013. Review of the lead device history records confirmed all quality tests were passed prior to distribution. It was noted that the patient previously experienced high impedance after implant in (b)(6) 2010 due to the electrode not being adequately seated on the nerve (reported in mfr #: 1644487-2010-02723). The explanted generator and lead were returned on (b)(6) 2013 and are pending product analysis.

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« Reply #376 on: December 22, 2018, 09:43:58 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
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« Reply #377 on: December 23, 2018, 10:33:35 AM »

Model Number 302-30
Event Date 10/05/2013
Event Type  Malfunction   
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. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Initial mfr. Report inadvertently listed the incorrected suspect device.

Event Description
It was reported that the patient underwent generator and lead replacement. Preoperative diagnostics were within normal limits. The physician's assistant reported that diagnostics in the physician's office were also within normal limits. During the surgery, the lead (including electrodes) and generator were removed. The surgeon indicated that the electrodes were wrapped tight around the vagus nerve and a "branch" and that there was a lot of scar tissue. The surgeon was certain that it was not the cardiac branches or the laryngeal branches. A new lead was placed on the vagus nerve and new generator was attached to the new lead. Diagnostic tests were within normal limits with the new system. The explanted devices were sent to the hospital pathology and the operating room nurse indicated that the hospital does not usually send back explanted devices. A returned product kit was given and a request to have the explanted devices was provided. It was reported that a company representative went to the site to assess diagnostics on the device prior to surgery being scheduled. It was reported that device diagnostics were unable to be performed due to the patient's complaints of pain and swelling in the neck area. It was reported that the patient was told by the physician that he recommended system replacement based on the patient';s pain and swelling and not based on "bad" diagnostics. The physician left the patient to decide on replacement. The patient reportedly decided on having the device replaced because it was felt that the device was of benefit to the patient. The generator and lead were received for analysis. Analysis of the generator was completed on 04/01/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 04/01/2014. The puncture mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, chlorine and calcium. 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 portion 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 portion of the device which may have contributed to the stated complaints.

Event Description
On (b)(4) 2013, it was reported that the patient had the vns device disabled by an unknown doctor in (b)(6) due to chest and neck pain. This was found out by the physician when the patient was hospitalized and admitted to the epilepsy monitoring unit (emu) for an increase in seizures. The physician turned the device back on and performed diagnostics on (b)(6) 2013 (emu admit date) and the results showed low impedance. The patient continued to have chest and neck pain with stimulation. The neurologist turned off the device and it has been off since (b)(6) 2013. Follow up indicates that although the device was implanted since 2004, it was only turned on for the last year or so (per the patient). The patient may be proceeding with device replacement, but no surgery has taken place to date. Attempts for additional information have been unsuccessful. No additional information has been provided.

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« Reply #378 on: December 29, 2018, 04:26:34 AM »

Model Number 102R
Event Date 05/02/2013
Event Type  Death   
Event Description
Additional information was received stating that the vns patient was born on (b)(6) 1946, not (b)(6) 1949 as initially reported. The patient¿s death certificate was obtained. The death certificate listed the immediate cause of death as cardiopulmonary arrest with probable acute coronary syndrome and probable coronary artery disease as sequential conditions that contributed to the death. The patient had other significant health conditions may have contributed to the patient¿s condition. Nurse¿s notes regarding the patient¿s death were received. The notes indicate that the patient was being closely monitored due to treatment with continuous positive airway pressure (cpap). It was noted that the patient¿s cpap mask had be adjusted frequently. No issues were noted with the patient when he was evaluated at 11:00 pm on (b)(6) 2013. At 11:45 pm, the notes indicate that nurse required assistance adjusting the patient¿s cpap mask because the patient kept removing it. At midnight, nurse reported that the patient was pale, warm to touch, breathless, non-responsive, and pulseless. Cpr was immediately initiated and the paramedics that arrived approximately ten minutes later continued cpr until the patient was pronounced dead at 12:33 am on (b)(6) 2013. Follow-up with the nurse revealed that the patient was not having a seizure at the time of death the patient¿s seizure record indicated that the patient experienced several seizures from (b)(6) 2013 which consisted of stiffening, jerking, some forward head drops, flinging of the arms. The patient¿s postictal periods were uneventful with good recovery. With the available information, an internal classification determined that the death was unlikely sudep. The patient¿s body was donated to science and the patient¿s devices were explanted. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The device was confirmed to be at end of service as result of normal battery depletion. The depletion was an expected event as determined by the blc and battery voltage measurement. The module performed according to functional specifications. There is no evidence to suggest an anomaly with the returned portions of the lead. During the visual analysis, the (+) white and (-) green electrodes appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the ribbons from coming in contact with the vagus nerve. With the exception of the tissue-covered (+) white and (-) green electrodes, 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. Note that since a large portion of the lead assembly (body) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Additional information was received stating that the vns patient¿s device was at end of service on (b)(4) 2010.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient passed away on (b)(6) 2013. The patient was found dead on his bed in a supine position. The patient device¿s was disabled at the time of death and was not explanted. It was reported that the patient¿s death was not related to vns. An internal review of the available information determined that the patient¿s death was possible sudep.
 
Manufacturer Narrative
Additional information indicates that the patient¿s dob was (b)(6) 1946.
 
Event Description
It was reported that the patient passed away approximately 3-4 months ago. The cause of death is not know at this time. It was reported that the patient had a pacemaker and known cardiac issues which was previously reported in mfr. Report # 1644487-2013-00834. Attempts to obtain additional information will be made, but no information has been obtained to date.

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« Reply #379 on: January 08, 2019, 07:47:16 AM »

Model Number 300-20
Event Date 02/28/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was not programmed off. Clinic notes were received stating that the high impedance was first observed during an office visit on (b)(6) 2014. The patient has not experienced any changes in her seizure control. The notes also indicate that the battery appeared to be depleting too quickly even with the high duty cycle. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
The patient underwent generator and lead replacement on (b)(6) 2014. The lead and generator were received on (b)(4) 2014. Analysis is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient did not have any trauma, changes in device settings, or changes in medications that may have contributed to the high impedance. The patient's device was disabled on (b)(6) 2014. The patient was doing well following replacement surgery. Analysis of the returned generator and lead was completed. Monitoring of the generator's device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator. During the visual analysis of the returned 385mm lead portion, the (-) green electrode quadfilar coil appeared to be broken approximately 3mm from the electrode bifurcation. Scanning electron microscopy was performed identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. During the visual analysis of the returned 385mm portion the (+) white electrode and ribbon appeared to be embedded in remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the tissue-covered (+) white electrode and ribbon the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Abrasions were observed in various locations, possibly caused by wear. Coils appeared slightly stretched, kinked and wavy in some areas which most likely occurred due to manipulation of the lead during the explant process. 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 other discontinuities identified. Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. However, the positive electrode condition may have contributed to the reported high impedance.
 
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 or serious injury.

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« Reply #380 on: January 08, 2019, 07:48:47 AM »

Model Number 105
Event Date 02/25/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s neurosurgery consultation on (b)(6) 2014. The notes indicate that the patient was experiencing a recent increase in seizures along with a shocking sensation at the generator site; therefore, the patient was admitted to the hospital through the emergency room on (b)(6) 2014. The patient stated that his seizure frequency had increased from five seizures a day to a seizure every hour. The baseline seizures appeared to last approximately 15 seconds and were tonic-clonic or absence seizures. Radiology reported that neck x-rays showed that lead wires were ¿off. ¿ chest x-rays were reported to be unremarkable. Operative notes were received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. The notes indicate that the patient was experiencing a shocking sensation in his neck with stimulation. Imaging revealed abnormal placement of the lead electrodes. The generator was replaced during the procedure as it was nearing end of service. An implant card was received stating that the lead was replaced due to lead discontinuity. Diagnostic results with the replacement generator and lead revealed lead impedance within normal limits (impedance value ¿ 1906 ohms). Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts for additional relevant information were made, but have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. 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. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed high impedance never occurred. Analysis of the returned lead portion found abraded openings on the outer silicone tubing which 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 condition of the returned lead portion 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 portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: additional information indicates that a device malfunction did not occur. Brand name; corrected data: additional information indicates that the suspect device is the generator. Type of device, name; corrected data: additional information indicates that the suspect device is the generator. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator. Date of implant; corrected data: additional information indicates that the suspect device is the generator. Type of reportable event; corrected data: additional information indicates that a device malfunction did not occur. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.

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« Reply #381 on: January 12, 2019, 03:55:22 AM »

Model Number 302-20
Event Date 03/06/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on 09/05/2014 due to lead discontinuity. The explanted lead has been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history 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 or serious injury.
 
Event Description
Additional information was received indicating that the patient underwent surgery. During the surgery, a new generator was attached to the existing lead and device diagnostics were within normal limits (3767 ohms). It was reported that the patient's head and neck were placed in different positions and subsequent diagnostics were within normal limits. The surgery was finalized with only generator replacement. It was later reported that device diagnostics again resulted in high impedance (>10,000 ohms). The generator was programmed off and the patient was referred for lead replacement. No known surgical intervention have been performed to date. The generator was received for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the generator was completed on 08/07/2014. Results of the analysis will be reported on the quarterly remedial actions exemption report.
 
Event Description
Analysis of the returned lead was completed. During the visual analysis, connector pin and connector ring quadfilar coils appeared to be broken. Pitting was observed on the coil surfaces. Remnants of dried body tissue were observed wrapped around a portion of helical and green electrode ribbon. This condition may have prevented the green electrode ribbon from coming in contact with the vagus nerve. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities and the tissue-covered green electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results showed high lead impedance (impedance value - 6709 ohms) during an office visit on 03/06/2014. X-rays were taken but have not yet been provided to manufacturer for evaluation. The device was not disabled. The patient is often injured because she has drop attack seizures, which may have caused or contributed to the reported high impedance. However, no definitive conclusions can be made with the available information. Review of the available programming and diagnostic history showed normal diagnostic results through 08/01/2013. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

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« Reply #382 on: January 14, 2019, 03:55:03 AM »

Model Number 304-20
Event Date 03/24/2014
Event Type  Injury   
Event Description
Analysis of the returned generator was completed. Results of diagnostic testing indicated the device 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 manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the recently implanted vns patient¿s incision sites were red and swollen about 2-4 weeks after implant surgery so the patient was given an antibiotic regiment. The patient¿s lead was reported to be extruding from her neck. It was noted that the patient may have been picking at her neck incision site following implant surgery. Clinic notes were received indicating that the patient had a grand mal seizure that lasted several minutes and subsequently caused her lead the extrude from the left side of her neck. The patient went to the emergency room on (b)(6) 2014 and was admitted to the hospital due to lead extrusion. The patient did not have a fever or any neck swelling. There was no change in the patient¿s seizure frequency. The lead was observed to be extruding from the neck incision site with minimal erythema. The patient¿s chest had a puffy area that was fluctuant but not especially erythematous with no surrounding induration. The surgeon stated that it was most consistent with a seroma with a possible foreign body reaction. The patient underwent surgery on (b)(6) 2014 to explant her generator and revise the lead. Operative notes indicate that there was a mass of inflammatory tissue in the chest wall upon opening the epithelium. An exuberant amount of inflammatory tissue was observed around the patient¿s generator. No abscess was encountered. Other than granulation tissue in the left neck, the lead incision site looked normal and without any sign of infection. A portion of an electrode and a tie-down were observed to be extruding from the neck. The tie-down was removed from the lead. The patient¿s device was tested and diagnostic results revealed lead impedance within normal limits. The inflammatory tissue in the chest wall was removed and the patient¿s generator was explanted. The surgeon explanted the generator because he felt it was too big to be sterilized in the contaminated generator site. The generator pocket was debrided and rinsed with an antibiotic solution. The neck incision was then reopened and the granulation tissue was removed. The surgeon pulled down the disconnected lead in the chest wall and was able to reposition the lead into the deep intramuscular tissues in the neck. The neck incision site was irrigated and then closed. Antibiotic ointment was applied to the neck incision site. The lead was secured in the chest wall with sutures and the chest incision was closed. The patient was given a postoperative antibiotic regiment. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported that the patient had another surgery about three months after the generator explant to have her leads explanted due to foreign body reaction in the left neck and upper left chest. The surgeon removed an inflammatory mass of in the left chest cavity (4cm). No further relevant information has been received to date.

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« Reply #383 on: January 17, 2019, 02:31:40 AM »

Model Number 103
Event Date 01/14/2014
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the recently implanted vns patient underwent surgery to explant her device on (b)(6) 2014. High levels of serous secretion and signs of infection were observed at the generator site with 50% wound dehiscence. There were no signs of trauma at the generator site. The generator site had not improved since implant so the patient¿s device was explanted. The generator pocket was washed out with antibiotics following generator explant. One of the electrodes could not be explanted due to fibrosis which the physician attributed to vns. The remaining portion of the lead was explanted and the wound was washed out with antibiotics. Cultures were (b)(6) and the patient was given an antibiotic regiment. Further follow-up revealed that the infection developed at the generator site approximately three month following implant surgery. The patient is not expected to be re-implanted. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
The lead and generator were returned for analysis on 02/27/2015. Product analysis for the lead was completed on 03/18/2015. 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. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis for the generator was completed and approved on 03/24/2015. Potential contributing factors to the infection have been considered / evaluated and none were found to exist in this situation. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 023 volts as measured during completion of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
The patient was discharged in (b)(6) 2014 because the infection was resolved.

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« Reply #384 on: January 22, 2019, 04:43:53 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.

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« Reply #385 on: January 28, 2019, 05:51:42 AM »

Model Number 304-20
Event Date 08/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the lead being placed on the nerve upside down was confirmed during lead replacement surgery. Further follow-up revealed that the patient requested that the vns be explanted due to ear pain. The patient's device was programmed off, but the patient requested explant. It was reported that despite the lead replacement. The patient claims to still have a buzzing noise along with severe constant ear pain. It was reported that device diagnostics have been within normal limits and there is no belief of device malfunction. There is no relationship of the vns to the patient't buzzing noise and ear pain. The patient underwent vns explant on 12/12/2014.
 
Event Description
Additional information was received stating that the vns patient was referred for surgery to explant her generator. The patient reportedly was hearing a buzzing noise from her device. The patient¿s generator has not been explanted to date.
 
Event Description
It was reported that the vns patient¿s lead was implanted upside-down on the patient¿s nerve. It is unclear how the physician made this determination. An implant card was received stating that patient underwent lead replacement surgery on (b)(6) 2014 due to lead failure. The explanted lead has not been returned to date.

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« Reply #386 on: January 28, 2019, 05:52:28 AM »

Model Number 304-20
Event Date 09/03/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity, the vns patient¿s replacement lead was opened but not used. The surgeon stated that the opened lead was defective and could not be used as the middle helical could not be wrapped around the patient¿s nerve. Another lead was used to complete the procedure. The unused lead has not been returned to date. The lead discontinuity was reported in manufacturer report #1644487-2014-01204.
 
Event Description
The unused lead was received for analysis. Analysis was completed on 02/10/2015. During the visual analysis the (+) white electrode ribbon appeared to be stretched and twisted and the helical appeared to be misshaped. What appeared to be remnants of dried body fluids were observed. The (-) green electrode ribbon appeared to be stretched and the helical appeared to be misshaped. What appeared to be remnants of dried body fluids were observed. The anchor tether helical appeared to be misshaped. What appeared to be specs of dried body fluids were observed. This most likely occurred due to manipulation of the lead during the attempted implant procedure while attempting to place the electrodes on the vagus nerve. Setscrew marks were not observed on the connector pin. The condition of the lead assembly returned is consistent with conditions that typically exist following an attempted implant procedure; therefore the absence of setscrew marks on the connector pin and abrasions on the connector boot and outer silicone tubing is evidence that the lead assembly was not fully implanted. No other obvious anomalies were noted. Continuity checks of the returned lead assembly were performed with no discontinuities identified. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4110329
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dennis100
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« Reply #387 on: February 07, 2019, 02:11:34 AM »

Event Date 01/01/1998
Event Type  Injury   
Event Description
A case study titled ¿optimizing outcomes in refractory childhood epilepsy with vns therapy¿ was presented which included a vns patient who was experiencing painful stimulation and choking sensations months following vns implant surgery. The patient¿s device settings were very low and not high enough to perform system diagnostics. In (b)(6) 2013, an evoked potential test was performed but no abnormalities were observed. The patient underwent generator and lead replacement surgery on (b)(6) 2014. During the procedure, the surgeon noted that the vagus nerve was located more anteromedial to the common carotid arteries than expected possibly due to the large amount of fibrosis. The surgeon did not observe any issues with the patient¿s lead but noted that the electrodes were implanted more proximal to the nerve. The patient¿s physicians determined that the patient¿s issues were due to the electrodes being implanted too high and the nerve being superficial to the larynx. It was noted that the patient had been doing well with vns following the procedure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4461163
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dennis100
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« Reply #388 on: February 07, 2019, 02:12:23 AM »

Model Number 302-20
Event Date 04/16/2004
Event Type  Injury   
Event Description
Initially, it was reported that the patient experienced blurry vision and eyes spasms so the device was programmed off which reportedly resolved the issue. The neurologist and surgeon did not believe this was related to vns therapy. The patient later reported that the vns electrodes were placed too close to the optic nerve and that she went blind for 9 months. The patient had the device explanted. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4459777
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dennis100
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« Reply #389 on: February 12, 2019, 03:11:48 AM »

Model Number 304-20
Event Date 06/11/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
It was reported that a patient had undergone surgical lead revision on (b)(6) 2015 due to high impedance and that stimulation pulses were not perceived. The impedance following the lead replacement was reported to be correct. It was reported that high impedance had been observed on (b)(6) 2014. Review of programming history found that the pulse generator was enabled on (b)(6) 2014. No diagnostics were performed on that date. System diagnostics on (b)(6) 2014 resulted in high impedance, dcdc 7, neos no. It was reported that the suspected cause of high impedance was a wrong implant site of the lead electrodes. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted lead has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4549105
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