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dennis100
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« Reply #420 on: June 07, 2019, 05:05:13 AM »

Model Number 302-20
Device Problem High impedance
Event Date 04/15/2019
Event Type  Malfunction   
Event Description
High lead impedance was observed by the surgeon during a generator replacement surgery due to battery depletion. The patient's previous generator was unable to communicate with the programmer due to an end of service condition; and therefore, the diagnostics/settings could not be obtained prior to surgery and lead impedance could not be verified. The generator was then replaced, with previous lead still implanted, and the diagnostics were performed to verify lead impedance. The diagnostic test resulted in high lead impedance, so the lead pin was re-inserted and diagnostics were performed again. Once again high lead impedance registered. The surgeon then proceeded to open the patient's neck and inspect existing lead. Upon visual inspection, he discovered that the there were no lead electrodes on the vagal nerve. The surgeon attempted to find the electrodes, and he could see that they were in neck, but was not sure where they were implanted. He did not want to attempt to remove electrodes due to excessive scar tissue and only cut lead. He left remaining electrodes in neck and still was unsure exactly where the electrodes were implanted. He implanted a new lead on vagal nerve and when connected to the newly implanted generator resulted in ok lead impedance. Both the explanted lead and generator were discarded during surgery; and therefore, the explanted product will not be returned for product analysis. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8595064
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dennis100
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« Reply #421 on: June 18, 2019, 12:35:47 AM »

Model Number 302-20
Device Problem Fracture
Event Date 11/28/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high lead impedance was observed with the patient's device as a result of normal mode and system diagnostic tests. The device was disabled and the patient was referred for surgery. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.

Event Description
It was reported that the patient underwent lead and generator replacement surgery. The surgeon noted he experienced difficulty explanting the electrodes due to scar tissue however the nerve's condition appeared good. Following the surgery the lead was discarded and was not returned to the manufacturer. However the explanted generator was received and is pending analysis.
 
Event Description
Product analysis was completed on the explanted generator. Visual analysis showed that device had scratches on the can and header. These markings are consistent with the manipulation that occurs during the explant procedure. Upon interrogation it was noted that the battery end of service flag was not set and during testing the generator performed to functional specification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7131163
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dennis100
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« Reply #422 on: June 22, 2019, 03:28:13 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/14/2017
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the physician's office that they suspected that the patient's vns electrodes were loose as the patient was not perceiving stimulation. However, the physician reviewed x-rays and lead detachment was not observed. It was noted that at an appointment, the patient did not perceive normal or magnet mode stimulation. It was reported that the output current was increased all the way and the patient felt nothing. It was unclear what the office meant by "all the way. " it was noted that the patient typically experiences slight hoarseness, but did not have any when turning the device up, which lead to the suspicion that there was a lead break or loose leads. The patient's seizures seemed worse at the time that the patient reported not feeling stimulation. The patient's friend noted seeing a bruise at the vns electrode site several days prior to an appointment and the physician noted that there was a bruise at the generator site. The physician's office mentioned that the patient normally experiences severe drop seizures and has multiple in a day. Follow up with the company representative revealed that the representative had seen the patient and diagnostics were within normal limits. The patient's vns settings were low and she could not feel stimulation, even with a magnet swipe. The patient reported that the vns worked for a while, but she experienced a recent increase in seizures. The x-rays have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
Follow up with the physician's office revealed that the reference to increasing the output current "all the way" was to 1. 00 ma per protocol. It was stated that the patient could not feel the stimulation as she had previously and that the patient could not feel the 1. 50 ma magnet stimulation. It was reported that the increase in seizures was just the same as before the vns. The bruising was thought to be the result of a seizure. It was stated that the physician thought that the increase in seizures were due to the electrodes not being connected well. The physician believes that a seizure may have caused electrode detachment and the patient was sent for evaluation, despite the diagnostics showing as within normal limits and detachment not being verified in x-rays.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7176252
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dennis100
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« Reply #423 on: June 23, 2019, 03:52:13 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance; Mechanical Problem
Event Date 06/17/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the company representative was asked to attend a surgery she thought was only a generator replacement. However upon checking the device prior to surgery high impedance was observed. The lead and generator were then replaced. The explanted products have not been received to date. No additional relevant information has been received to date.
 
Event Description
The explanted lead and generator were received and are pending analysis. The lead's product information was identified following the explant. It indicated that the lead had been implanted for several years. A review of the diagnostic history from the internal database showed that impedance was within acceptable limits in the most recent history.
 
Event Description
Analysis was completed on the returned lead and generator. The generator case had scratches, tool marks and burn marks which are consistent with manipulation and exposure to electrocautery during the explant procedure. Upon interrogation the battery indicator was found to be ifi = yes. A series of interrogations and diagnostics were performed on the generator and the results were normal. During testing the generator performed to functional specification and passed electrical testing. The lead assembly was received in two pieces with the lead¿s pin still connected to the generator. The furthest electrode to the bifurcation was not returned for evaluation. Prior to decontamination a continuity check was performed while the lead pin was still inserted into the lead and the continuity check verified there was proper contact between the set screw and the lead pin was present. Visual analysis of the lead completed for both lead segments. It was found that the lead was tangled and the outer tubing was abraded in the segment which included the lead pin. In both segments the lead coils were kinked and the electrode was noted to be damaged and partially detached, this was potentially related to the explant procedure. A fracture was identified in the lead coil in the lead assembly that was not attached to the lead pin and therefore not part of the continuity check. Pitting was observed at the point of fracture which indicates that the stimulation was being provided while the fracture was present.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7167569
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dennis100
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« Reply #424 on: June 25, 2019, 01:11:14 AM »

Model Number 106
Device Problems Detachment Of Device Component; High impedance
Event Date 01/18/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was observed on the patient's vns generator. The patient was referred to the surgeon for evaluation. Follow up with the surgeon's office revealed that it was unknown if there was any trauma or patient manipulation that could have contributed to the high impedance. It was stated that x-rays were performed to assess lead pin insertion. The patient was referred for vns lead replacement surgery. The x-rays have not been reviewed by the manufacturer to date. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent surgery to address the high impedance observed on the vns. It was stated that the surgeon thought it looked like the electrodes were not fully on the nerve. The surgeon removed the electrodes and then placed them back onto the nerve as well as relieved tension in the lead. Multiple diagnostics were performed during surgery and post-op and the impedance values were within normal limits.
 
Event Description
It was reported that high impedance was observed on the patient's vns again. The patient was referred for lead replacement surgery. Follow up with the tc revealed that the during surgery, the surgeon observed that the vns lead pin connector was loose in the generator header and appeared to not be properly secured. Lead pin insertion troubleshooting was performed and the high impedance was resolved. Several additional diagnostics were performed with the patient's neck in various positions to test the impedance values. The results were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7265105
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dennis100
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« Reply #425 on: July 04, 2019, 12:51:25 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the lead had "fused" to the patient's vagus nerve, which indicated that fibrosis had likely occurred at the location of the nerve and lead electrodes. In addition, the patient had surgery that appeared to be related to the fibrosis. The patient reported no complications with the surgery. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7630304
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dennis100
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« Reply #426 on: July 26, 2019, 01:07:36 AM »

Model Number 300-20
Device Problem Fracture
Event Date 01/07/2019
Event Type  Malfunction   
Event Description
X-rays were received of the patient's lead and it was stated that the patient's physician observed frays in the lead near the coil. X-rays were reviewed. Based on the scope of the image, the generator was not visible, so placement could not be determined as well as if the feed thru wires were intact, if the connector pin was fully inserted, if the lead was behind the generator, and if the lead wires were intact at the connector pins. The strain relief bend and loop were present, but were not per labeling as the loop was before the tie downs and appears to be too close to the bifurcation. A tie down could be visualized, but was not placed according to labeling. The lead was assessed and found to be a fracture of the lead. An item was also noted that something appears to have been wrapped around the electrodes which looks to be an unapproved material. Based on the x-rays received, the lead was found to be fractured before the coil. Note that the presence of a gross fracture in the portion of the lead excluded from the images or a micro-fracture along the lead body cannot be assessed. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8264303
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dennis100
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« Reply #427 on: July 30, 2019, 10:24:58 AM »

Model Number 300-20
Device Problem Fracture
Event Date 05/18/2018
Event Type  Malfunction   
Event Description
Initial report was an implant card received indicating that a patient underwent generator replacement due to high impedance. It was noted on the implant card that the lead had an "electrode defect. " further information was received that the generator was replaced due to eos. It was stated that "the battery was so empty that the physicians could not do an interrogation. " after generator replacement high impedance was observed. It was stated that the surgeon spent 5 hours trying to explant the lead and the "gave up and decided to speak with the treated doctor how to proceed. " further information was received that there was "many fibrosis that the physician did not get through the vaugs. " the lead was not replaced. It was also stated that a dual pin lead was not available during the surgery for replacement. The operation was stopped to further consult the patient's treating physician. The explanted generator was reported to be given to the patient's parents. It was stated that due to the surgery circumstances and the lack of x-ray availability during the surgery, the surgeon speculated that the electrode may be broken. Further information was received indicating that patient physiology was the cause of the fibrosis and that no intervention was taken for the fibrosis. The only noted reason that the surgery took several hours was that the surgeon was attempting to clear the fibrosis for several hours before deciding to end the surgery and consult the referring physician. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8298957
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dennis100
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« Reply #428 on: August 09, 2019, 11:12:02 PM »

Model Number 303-20
Device Problem Detachment of Device or device Component
Event Date 09/07/2018
Event Type  Malfunction   
Event Description
It was reported that the patient experienced pain at the neck associated with the stimulation of their vns generator. The patient felt the "great pain" every 5 minutes, and it was reported that the physician assessed this pain was due to the dislocation of the patient's electrodes. It was reported that the patient was referred for a lead revision. The physician suspected lead discontinuity, likely referring to the dislocation. There was no report of high impedance to date. The physician reported that the cause of the suspected dislocation was incorrect initial implant location. The patient was reportedly not receiving effective stimulation due to the dislocation. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8784977
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dennis100
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« Reply #429 on: August 09, 2019, 11:12:39 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/09/2019
Event Type  Injury   
Event Description
Patient admitted to the hospital because he was picking at his neck incision site. The incision site was opened and the patient pulled the electrodes and anchor off of the nerve. It was noted that the patient is severely autistic. The patient underwent generator and lead explant surgery the following day. The explanted products were noted to be discarded. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8375680
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dennis100
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« Reply #430 on: August 09, 2019, 11:13:34 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/24/2019
Event Type  Injury   
Event Description
It was reported by the representative that the patient experienced an asystole drop when stimulation was initiated and that the patient continued to have a drop in asystole in mid 40 bpms after device was on and parameters were set to previous settings. The anesthesiologist suggested to monitor the patient in recovery with atrophene. The generator was programmed off. It was reported that the patient continued to have heart rate drops when the device was programmed back on. Surgeon made the decision to take patient back into surgery and remove old electrodes and reposition new electrodes, which reported resolved the patient's heart rate issues. Multiple attempts have been made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8774235
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dennis100
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« Reply #431 on: September 06, 2019, 10:25:51 PM »

Model Number 302-20
Device Problem Fracture
Event Date 04/10/2019
Event Type  Malfunction   
Event Description
An implant form was received reporting explant and replacement of a patient's generator and lead. The form marked that the lead replacement was due to high impedance "bottom coil not attached". The reason for the generator replacement was not indicated on the form. Further follow up confirmed that the generator replacement was prophylactic. The explanted product has not been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8854840
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dennis100
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« Reply #432 on: September 06, 2019, 10:30:05 PM »

Model Number 302-20
Device Problem Fracture
Event Date 07/22/2019
Event Type  Malfunction   
Event Description
The physician reported a high impedance reading for one of their patients'. It was noted that the patient received an x-ray, where the physician assessed no disconnection of the lead within the generator header. The physician also noticed a possible breakage of the electrode, however it was noted to not be 100% conclusive. It was also mentioned that the patient experienced a recent fall during a seizure (which was not alleged to be related to vns), which may have contributed to the recent high impedance report. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8900970
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dennis100
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« Reply #433 on: September 06, 2019, 10:30:58 PM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/25/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's spouse reports that the physician has not been able to program the vns to therapeutic settings due to the patient experiencing head jerks at higher output current settings. The patient's spouse reports that x-rays were performed and that the neurologist believes the vns electrodes may have been placed on the muscle in the neck, instead of on the vagus nerve. She noted that the vns is not efficacious for the patient as the output current cannot be set to a therapeutic range. It was also mentioned that the patient has a fever, and according to the patient's spouse, the neurologist believes there may be an infection at the electrode site. The patient's wife later reached out to their sales representative reporting that the patient was recently discharged from the hospital due to increased seizures. The patient's wife mentioned that the physician informed them that the vns was not "installed correctly" and that the electrode can be seen protruding underneath the skin in the neck. It was noted that the physician cannot increase patient's settings as this would worsen patient's hoarseness, increases pain at neck , and causes the patient's neck to jerk. The patient has been referred to a surgeon. No known surgical intervention has occurred to date. Multiple attempts have been made to the physician for additional information; however, no other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8878845
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dennis100
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« Reply #434 on: October 12, 2019, 12:22:12 AM »

Model Number 304-20
Device Problem Mechanical Problem
Event Date 08/09/2019
Event Type  Malfunction   
Event Description
During an initial implant surgery the surgeon noted that the electrode helices were stuck together by plastic. The plastic was cut and the lead was implanted. Impedance was reported to be ok after surgery. Design history records were reviewed for the lead. The lead passed all specifications prior to distribution. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8957523
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dennis100
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« Reply #435 on: October 12, 2019, 12:23:10 AM »

Model Number 303-20
Device Problem Detachment of Device or device Component
Event Date 08/20/2019
Event Type  Malfunction   
Event Description
It was reported that the patient had their leads revised due to "vns-linked lead malposition. " it was reported that the electrode had dislocated from the nerve, caused by migration. The patient was reportedly not receiving stimulation due to the detachment and the surgeon had "issues with the anatomy of the subject. " the return of the explanted lead to the manufacturer is not expected to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9137616
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