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dennis100
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« Reply #60 on: April 28, 2016, 01:50:28 AM »

Model Number 300-20
Event Date 03/12/2007
Event Type Malfunction
Event Description
Reporter indicated a vns patient was experiencing painful stimulation in the neck and generator site and felt that the generator was pulling on the leads. Diagnostics were within normal limits. The device was programmed off at the request of the patient. X-rays were reviewed and no anomies were noted. The patient underwent generator replacement surgery. The lead was not replaced because the surgeon did not believe a problem existed with the generator. The patient's painful stimulation persists. The patient is planning on vns lead replacement surgery. The lead will be implanted on the right vagus nerve. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1297765
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dennis100
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« Reply #61 on: June 05, 2016, 06:59:30 AM »

Model Number 106
Event Date 01/26/2016
Event Type Malfunction
Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
A provider reported that a patient who had previously received a right-sided vns system had been in the hospital for gastrointestinal bleeding and esophagus erosion testing. It was reported that the gi bleed and esophagus erosion developed after right sided placement. The patient's seizures have increased over the past month as the vns titration process is evolving. It is unknown if any of the reported conditions are due to vns. Diagnostic testing of the device revealed all measured values were within normal limits. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5597943
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dennis100
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« Reply #62 on: June 08, 2016, 01:46:29 AM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 09/24/2015
Event Type Malfunction
Event Description
The patient still has not seen the ent to evaluate the vocal cord paralysis, therefore at this time there is no confirmation of the reported vocal cord paralysis. The physician wants the ent to evaluate the right side for vocal cord paralysis since he wants to put the electrodes on the right side.

Event Description
It was reported that the surgeon never opened the patient's neck to visualize the lead. He stated that there was too much scarring and he didn¿t have time to revise the lead. It was assumed that the lead would be scarred in during the next replacement. The surgeon decided that he wants to do a right sided implant a next times a result of the incision scarring. It was reported on 01/19/2016 that the patient¿s neurosurgeon is referring her to an ent to assess right and left side paralysis of the vocal cords. The neurosurgeon¿s plan is to re-implant the vns on the right side. The relationship of the vocal cord paralysis and high impedance is unknown.

Manufacturer Narrative
(b)(4).

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 from the patient's mother that the patient was seen on (b)(6) 2015 and the physician indicated that the device wires are either disconnected or broken. The sales representative was able to see the patient on (b)(6) 2015 right after the report and interrogated the device and found that she did have high impedance >10,000 ohms. Upon examination of the x-rays it appeared that the pin was not past the connector block. She noted that the x-rays were very large and the only copy and she was not allowed to obtain a copy. The physician plans to revise as soon as possible. Although surgery is likely it has not occurred to date.

Event Description
It was reported in (b)(6) 2015 that the patient was in surgery and the lead pin was reinserted but this did not resolve the high impedance issue. The patient is scheduled for lead replacement although this has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5162668
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dennis100
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« Reply #63 on: September 09, 2016, 04:21:47 AM »

Model Number 106
Event Date 07/27/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4). Serial #, corrected data: (b)(4). Initial mdr inadvertently did not list the product serial #. Lot #, corrected data: 203490. Initial mdr inadvertently did not list the product lot #. Expiration date (mo/day/yr), corrected data: 02/18/2017. Initial mdr inadvertently did not list the product expiration date. Device manufacture date (mo/day/yr), corrected data: 05/26/2016. Initial mdr inadvertently did not list the device manufacture date. (b)(4).
Manufacturer Narrative

Event Description
It was reported that the surgeon had to implant the m 106 generator on the right chest of the patient on (b)(6) 2016 and that the heartbeat verification was unsuccessful. It is unknown if a pre-surgical evaluation was performed and if all the troubleshooting steps were completed. Attempts for additional relevant information were made but no additional relevant information was received.

Event Description
Product information was received on 08/08/2016. A review of device history records for the generator shows that no unresolved non-conformances were found. The r-wave verification step was successful per the device history records. The generator is not a laser routed device. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5890558
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dennis100
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« Reply #64 on: December 14, 2016, 10:15:34 AM »

Event Date 12/01/2005
Event Type Injury
Manufacturer Narrative
Khurana, divya s. Et al (2005) vagus nerve stimulation in children with refractory epilepsy: unusual complications and relationship to sleep-disordered breathing. American epilepsy society meetings in washington dc, 2-6.

Event Description
It was reported that a vns patient was explanted for a second time due to staphylococcal infection that did not resolve with antibiotic therapy. The patient was reimplanted several months later on the right vagus nerve. "there were no specific risk factors for staphylococcal infection, such as immune compromise, noted in this case. " good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1007400
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dennis100
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« Reply #65 on: January 23, 2017, 08:13:17 AM »

Event Date 02/15/2011
Event Type Injury
Event Description
I developed brain cancer in my right frontal lobe, found in (b)(6) 2011. The doctor was inserting screws to my skull bone. He tightened one of the screw and it broke so the surgery went longer. I developed an infection with radiation on the area of my previous surgery and the dehisced extending my radiation treatments, these 36 radiation treatments made me very sick. I had to have an emergency surgery to see what was going on in my brain. This surgery revealed that my skull bone was infected and they removed 1/4 or more of my skull and used more screws than they anticipated. I had some kind of infection prior to this and had drains in my head to get excess fluid out of my swollen brain. After this surgery i developed another infection and another hospital stay. Throughout the whole ordeal of dealing with this situation i had six to eight infections, and at least three to four stays in the hospital, some up to 2 weeks. I am not sure what the name of the plates were or what the company was called for these (i have all my notes from this time, i could look through notebooks and files for a day, to find this out). The last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. I moved to (b)(6) to be near my sister who helped me out. The trip from (b)(6) is 45 minutes as opposed to 3 hours. On one trip from (b)(6) i totalled my (b)(6), i don't remember why. Some of the leftover symptoms are: i have not worked since 2011 in a job i loved as (b)(6); i have really bad balance and numbness on my left side, i go to the hospital at (b)(6) every 4 months to get a contrast mri with the neurosurgeon and with a neurologist to check and adjust my medication if needed. I cannot use a ladder, cannot swim alone, cannot kayak or canoe with my family, i cannot snowboard with my girls anymore, occasionally i lose my driver's license for medical reasons. So that is my story. One thing to add is that along the way someone snagged and paralyzed one of my vocal cords, it will remain that way for the rest of my life. After all this happened, my eyesight changed, i never had to use eyewear until after all this. Thank you, and if you need anything further, please feel free to call me (b)(6). I am not sure my cognitive abilities will ever be the same.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529168
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dennis100
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« Reply #66 on: February 25, 2017, 01:27:25 AM »

Model Number 102
Event Date 11/15/2005
Event Type Injury
Manufacturer Narrative
Article reference: epilepsy research, 2008; 08, 003, right-sided vagus nerve stimulation in humans: an effective therapy? spuck, s. , et al.

Event Description
Reporter indicated via a published journal article that a patient experienced intraoperative self-limiting short-term (10 seconds) asystole and short-term (20 seconds) bradycardia during the systems diagnostics test during implantation of the vns therapy system on the right vagus nerve. The patient's normal heart rate was 70 and the rate dropped to 52 during the bradycardic episode. The patient was under medium anesthesia. Atropine was administered as an intervention. The asystole and bradycardia events did not recur during the surgery or postoperatively. The patient did not have pre-existing history of asystole or bradycardia. The patient's hospitalization was prolonged due to observation and correction of vns settings under cardiac monitoring. No additional post-operative adverse events or cardiac-related events have occured.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1260036
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dennis100
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« Reply #67 on: March 03, 2017, 08:49:22 AM »

Model Number 104
Event Date 12/13/2011
Event Type Malfunction
Event Description
Reporter indicated the increased seizures the patient experienced were due to the high lead impedance. The seizures were not above pre-vns baseline level and the seizure type was not known.

Manufacturer Narrative
Describe event or problem, corrected data: information regarding the increased seizures was inadvertently omitted from follow-up mdr #1.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Per the patient's caregiver, on (b)(6) 2012, the patient's incision sites appeared purple and the patient had debridement and irrigation of the vns generator area, and the generator was moved to a new pocket. The patient then had vns prophylactic generator and lead replacement surgery performed on (b)(6) 2012, due to desiring a newer vns model. The vns may have been placed in the right chest due to the patient's continued wound healing problems and possible infection. An implant card was received indicating the vns generator and lead had been replaced due to "malfunction". The explanted vns generator and lead remnant were received for analysis on (b)(6) 2012 and are pending analysis. The vns generator was interrogated successfully in the product analysis lab and did not display any abnormalities upon interrogation. Attempts for further information regarding the wound healing and possible infection are in progress.

Manufacturer Narrative

Event Description
Reporter indicated the new vns generator was implanted in the right chest due to the previous poor healing issues in the left chest incision area. The new lead was tunneled diagonally across the chest. It was unknown what to attribute the poor wound healing to, as the patient had no trauma and it was not felt there had been any device manipulation by the patient. The patient was last seen on (b)(6) 2012, and has been released back to the care of her neurologist, with instructions to call the surgeon's office if issues arise. There have been no calls about the patient since she was seen on (b)(6) 2012. There was no infection present in the wound, but the lead was extruding through the skin prior to the (b)(6) 2012 surgery. The cause of the poor wound healing is unknown, and there was no known trauma or device manipulation by the patient. Additional manufacturer follow up with the treating neurologist's office revealed, the patient is doing well since the surgery, and there have been no issues with the wound healing. Product analysis of the explanted lead and generator was completed. Note that since the majority 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. Scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the pin surface. However, the generator and lead were received connected together, and the generator was programmed on; the generator was outputting to an open load. Other than the above mentioned observations and the typical wear and explant related observations, no product related anomalies were identified in the returned lead portion. Results of generator diagnostic testing and monitoring indicated the device was operating properly and that the battery was at an "ifi = yes" condition. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
Reporter indicated a patient presented on (b)(6) 2011, with swelling around the vns generator site, increased seizures, and high lead impedance with vns diagnostics testing. The patient recently had vns generator replacement surgery performed on (b)(6) 2011, and all vns diagnostics were normal at the surgery. The patient had vns lead pin reinsertion surgery performed on (b)(6) 2011, which resolved the high lead impedance. It was noted during the surgery that one of the lead pins had "popped out" of the generator header. The lead pins were then secured appropriately into the generator header. Vns diagnostics following the lead pin reinsertion were within normal limits. Attempts for further information are in progress.

Event Description
Reporter indicated the patient's vns generator site incision had opened up (wound dehiscence), and the vns lead was visible within the wound. There was not an infection present, and it is unknown why the wound opened up. There was no trauma, and it is not felt the patient manipulated the vns, though she is developmentally delayed. There does not appear to be any hygiene issues, as it was felt the patient was very well cared for at home by her mother. The patient had exploratory surgery performed on (b)(6) 2012. The patient is on antibiotics because she had an open wound. At the (b)(6) 2012, surgery, the wound was washed out and debrided and closed, but no devices were explanted. The patient was seen on (b)(6) 2012 and is doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2408227
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dennis100
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« Reply #68 on: March 03, 2017, 08:50:16 AM »

Model Number 102
Event Date 12/01/2011
Event Type Injury
Event Description
It was reported that the patient had her generator moved to her right chest from her left chest due to pain at the generator implant site. Per physician, there is no reason to explain the pain and patient was benefiting from vns therapy, so it was decided to move the device. Diagnostics were run during surgery and everything was fine.

Event Description
Information from the treating surgeon indicated the intervention was not taken to preclude a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2406192
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dennis100
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« Reply #69 on: March 10, 2017, 04:24:36 AM »

Device Problems Fluid leak; Fracture; High impedance
Event Date 11/18/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
An article entitled "vagus nerve stimulation removal or replacement involving the lead and the electrode: surgical technique, institutional experience and outcome" was sent to the manufacturer and reviewed. During review of the article, multiple reportable events were identified. The article stated that 6 patients had replacement surgeries due to broken wires (lead fractures), and 5 patients had lead surgery due to degradation of the silicone tubing causing high impedance. Of these events, 3 lead fractures and 2 cases of tubing degradation were unable to be identified as previously reported. The patients who had high impedance and lead fractures also reportedly had an increase in seizures due to the device issue. One of the patients who had a lead replacement surgery due to a lead fracture had the replacement lead implanted on the right vagus nerve. This, caused the patient pain and the device had to be removed as a result. The article also contains references to other reportable events for generators which is captured in mfr report number. Additionally, the article stated that a patient had passed away due to sudep which is captured in mfr. Report 1644487-2017-03151. One unknown generator malfunction is reported in mfr. Report 1644487-2017-03153.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309080
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dennis100
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« Reply #70 on: March 10, 2017, 04:25:27 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/30/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported (b)(6) 2017 that a vns patient was scheduled for a prophylactic replacement. High lead impedance was observed prior to the case. The new generator was connected to the lead and diagnostics were repeated. High lead impedance was still observed. The patient had a full revision, with the placement of the new lead and generator on the right side. A portion of the lead was explanted. It was noted by the patient's neurologist that high lead impedance was also observed in clinic after the patient reported some falls. The explant facility does not return the devices without a patient release per policy. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6356440
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dennis100
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« Reply #71 on: April 21, 2017, 02:53:07 AM »

Model Number 102
Event Date 10/25/2007
Event Type Injury
Event Description
Reporter indicated a vns pt's generator was explanted for infection. The pt was later reimplanted with a new generator in the right chest with the original lead. The explanted generator has been requested for return. Further attempts for info are in progress.

Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=964260
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dennis100
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« Reply #72 on: April 25, 2017, 01:24:02 AM »

Event Date 01/01/2006
Event Type Death
Manufacturer Narrative
Shalaby aa, el-saed a, nemec j, moosy jj, and balzer jr. "exacerbation of electrical storm subsequent to implantation of a right vagal stimulator". Clin auton res. (2007).

Event Description
It was reported via scientific article "exacerbation of electrical storm subsequent to implantation of a right vagal stimulator" by shalaby aa, et al. That a pt with advanced ischemic cardiomyopathy underwent implantation of a vagal stimulator in an attempt to control recurrent drug refractory ventricular tachycardia. Four years prior, the pt had an implantable defibrillator (icd) inserted. Electrical storm was exacerbated after the implant of vns and continued after neurostimulation was discontinued. Stimulation was discontinued 24 hrs following implant of vns. Per article, "all vt events after vagal stimulator implant were noted to follow a peculiar diurnal distribution with a clear morning bias (3-11 am) not noted in previous events". The pt subsequently requested to have his icd turned off following events and he died 2 weeks later in hospice care. The report aims to provide a cautionary note to application of vagal stimulation for control of cardiac arrhythmia. However, per the article, "it is possible that the relapse of electric storm after vagal stimulator implant was unrelated to the implant but rather to progression of underlying disease, fluctuations in drug levels or possibly intracellular electrolyte levels". No conclusion could be drawn based on the article. Attempts for further info are in progress.

 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564916
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dennis100
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« Reply #73 on: April 28, 2017, 12:21:33 AM »

Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported that the vns pt had surgery a "few years back" where the pulse generator was moved from the left to the right chest, due to a burning sensation at the generator site. The pt's current treating physician was not seeing the pt at the time the event occurred, and is attempting to retrieve additional info from the pt, such as the pt's physician at that time, so that attempts for additional info can be made with the appropriate medical professional. In addition, the physician has indicated that the pt is a poor historian and that it is very difficult to get clear description of historical events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1552700
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dennis100
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« Reply #74 on: April 30, 2017, 01:35:10 AM »

Model Number 105
Event Date 07/11/2014
Event Type Injury
Event Description
The patient has decided not to re-implant the vns device for fear of infection recurring.

Manufacturer Narrative
Conclusions, initial report inadvertently omitted. Conclusion code for device discarded.

Event Description
It was reported that the patient was scheduled for surgical exploration of the generator incision site. It was reported that the patient's wound was not healing poorly. The operative notes dated (b)(6) 2014 note that the patient is an avid hunter and shoots his gun from his left shoulder. It was noted that the generator is implanted on the right side of the patient's chest. It was noted that the patient was admitted to the hospital on (b)(6) 2014 with the medial 1-2 cm of his right chest incision broken down and a small piece of the lead and generator exposed. Further follow-up revealed that cultures were negative for infection. The patient was taken back to the hospital on (b)(6) 2014 because the incision opened up again. The patient underwent generator explant. It was reported that the lead was left in place. The patient requested explant of the device. The surgeon plans to wait a couple of months with the generator removed so the incision can heal and then reimplant another generator. There was no known cause for the impaired incision healing. It was reported that the patient has had good healing prior to vns implant. The explanted generator was discarded; therefore, will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4051959
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dennis100
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« Reply #75 on: May 03, 2017, 12:14:10 AM »

Model Number 104
Event Date 11/08/2014
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
The patient under went a full re-implant after healing from infection on (b)(6) 2015. The patient's generator was reimplanted in the right chest with a new lead still present on the left nerve. At this time it appears that at the time of explant in (b)(6) 2014 for the known infection, the lead was likely clipped as there is no indication of the lead being salvaged for future use. Additionally, it would be likely that the lead was partially removed at this time as the report doesn't indicate use of an accessory kit.

Event Description
It was reported that the patient underwent explant due to an infection. It was later reported that the device was extruding. It was reported that there was no adverse event or trauma that may have caused the extrusion of the generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318047
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« Reply #76 on: May 06, 2017, 02:06:31 AM »

Model Number 302-20
Device Problem Mechanical issue
Event Date 01/26/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during generator replacement surgery in (b)(6) 2016, the surgeon observed an abraded opening on the outer silicone tubing. The inner tubing was noted to be still intact initially and pre-operative system diagnostic results showed lead impedance within normal limits. It was noted that the patient¿s lead had been placed on the right vagus nerve at the previous lead replacement surgery due to scarring on the left vagus nerve. The physician elected to replace the lead prophylactically during the procedure and implanted the replacement lead on the right vagus nerve. The explanting facility discarded the explanted device; therefore, no analysis can be performed. Additional information was received from the caregiver that during the past lead revision surgery in (b)(6) 2016, the lining around the wire came off, frayed and was stuck in patient's chest, which required a 6 hour surgery. Per mother, the surgeon stated that he had never seen this happen before with vns. Upon investigation, the operative time was 3. 77 hours with the incision starting on 11:47 and closing 15:33. Operative notes were provided, which indicated that the surgeon found the lead to be degraded. Per notes, finding of degraded leads required replacement of the entire device rather than simple replacement of the left-sided battery. The leads coming from the right side, traversing the clavicle, were found and these plunged through the muscle where they traveled to the implantable pulse generator which was under the muscle in the axilla. When these were found, the exposed leads appeared to be intact. The generator was disconnected from the leads. Surgeon then pulled the disconnected lead toward the medial incision and, at this point, saw that the portion of the lead that had been under the muscle was frayed and bare wires were exposed. Surgeon cut the excess lead out, irrigated the wounds copiously with bacitracin-containing solution, and closed the subcutaneous tissue with. The surgeon was able to see the vagal nerve stimulator leads around the vagal nerve which was encased in abundant scar tissue. A new lead was then implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6495945
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« Reply #77 on: May 11, 2017, 12:16:40 AM »

Model Number 102
Event Date 12/01/2007
Event Type Injury
Event Description
It was reported that a vns patient experienced pain at the generator site and underwent revision surgery to have the device location revised. Further follow up with the surgeon revealed that the patient was "not satisfied with the placement of the device and requested that the surgeon replace it on the right side so that it was more symmetrical. " the surgeon then placed the generator on the right side, in a more subclavicular position. The surgeon believes that the pain reported is due to the implant surgery. Diagnostics were performed during surgery revealed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989665
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« Reply #78 on: May 13, 2017, 03:01:53 AM »

Model Number 102
Event Date 08/25/2008
Event Type Injury
Event Description
It was reported to the manufacturer that the vns patient was experiencing tachycardia. The patient's heart rate was consistently around 99-108. The patient has her pacemaker implanted on the left and her vns generator on the right with more than 7-10 inches away. We were informed that every time the patient's vns device delivered stimulation, the patient's heart rate dropped and the pacemaker attempt to correct this by firing to increase heart rate. The physician suggested the patient turn the vns device off by taping the magnet over the generator. The patient was informed to visit with her neurologist and cardiologist to resolve the issue. Good faith attempts to obtain additional information regarding this event are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1175970
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dennis100
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« Reply #79 on: May 17, 2017, 12:17:35 AM »

Model Number 302-20
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient experienced an increase in seizures in (b)(6) 2008. It was reported that the patient underwent surgery where a new vns system was placed on the right side. The revision surgery was previously reported in mfr. Report # 1644487-2009-00566. It was reported that the right sided vns was not as effective as the left system previous had been so the physician has agreed to explant the left vns system and implant a new system on the left side. Surgery is likely, but has not occurred to date.

Event Description
Further follow-up revealed that the underwent generator and lead replacement on (b)(6) 2013. It was reported that only the lead implanted on the right vagus nerve remains implanted and that the left vagus nerve system was replaced. Only the generator from the left system was returned for analysis on 09/25/2013. Analysis of the generator was completed on 10/15/2013. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulse disable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Reporter indicated that pt received high lead impedance on system diagnostics. Chest and neck x-rays were reviewed by physician. No obvious lead breaks were found. Pt will have revision surgery.

Manufacturer Narrative
Corrected data: the lead and generator were explanted and the generator was returned to manufacturer for analysis. This information was inadvertently left off of supplemental mfr. Report #1. Corrected data: this information was inadvertently left off of supplemental mfr. Report #1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1062981
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« Reply #80 on: July 02, 2017, 06:28:48 AM »

Model Number 104
Event Date 07/27/2010
Event Type Injury
Event Description
Reporter indicated a vns pt had an infection at the generator and electrode sites. The vns generator and lead were removed, and a new generator and lead were placed in the pt's right chest and right vagus nerve. The cause of the infection was unk. Cultures of the generator chest pocket resulted in pseudomonas and (b)(4) bacteria. No trauma or device manipulation occurred. Antibiotics were also given as an intervention for the infection. The pt did not show for his post-operative office appointment, and attempts to contact the pt for further eval by the office have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1842099
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« Reply #81 on: August 05, 2017, 11:14:43 PM »

Model Number 302-30
Event Date 05/24/2011
Event Type  Malfunction   
Event Description
Additional information was received on (b)(4) 2011, indicating that the patient's surgeon was inquiring about right sided re-implants if necessary. It was indicated that the surgeon was concerned about the effects or continued re-implants on the left nerve as the patient has already had two vns implants on the left side. Additional information was received from the neurologist's office indicating that x-rays were ordered, however they were uncertain if they were performed as they did not receive a copy. It was also indicated that the high impedance was first observed on (b)(4) 2011, with a dc/dc code of 7. The neurologist's office believed that the patient may not have been receiving intended therapy. No other information was provided by the neurologist. Revision is likely but has yet to occur to date.
 
Event Description
The patient went for revision surgery on (b)(6) 2012, however the revision was not completed. Pre-op interrogation indicated that the output and magnet currents were both set to 0. 0 ma. Pre-op system diagnostics test on the generator indicated high impedance. X-rays were reviewed by the surgeons and they stated they did not see any obvious discontinuity in the lead. The surgeons then proceeded with the neck incision and planned removal of the old lead. Upon opening the neck incision, the surgeons indicated that there was an obvious break in the lead immediately on top of the sternocleidomastoid muscle. The surgeons did not know what may have caused the break in this location but suggested it may have been due to the neck contractures of the patient. Heavy scarring was identified in the neck and in the process of further dissecting the lead wire for removal, the surgeon encountered a bleeding issue and decided they did not want to proceed any further. The surgeon's also noted that there was previous damage to the left vagus nerve. At the time of the surgery, a portion of the lead was removed however the generator was left in. Both surgeons stated they would speak with the patient's family about further options regarding re-implanting the patient.
 
Manufacturer Narrative
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 nerve damage was likely due to multiple previous vns implants on the left side nerve. The portion of the lead that was explanted was discarded following surgery. Per the patient's family, they are not considering re-implant at this time as the patient's seizures have been stable.
 
Event Description
It was reported by a neurologist that a vns pt had high lead impedance and his seizure pattern had changed (increased duration and intensity). Prior to vns, the pt had seizures which lasted about 45 minutes but after the vns implant, the seizure duration reduced to only seconds. The frequency of seizures however has not changed. Recently, pt started having seizures which lasted 1. 5 minutes indicating a change in his seizure pattern. It was also noticed that pt had high lead impedance. There was no known trauma or contributory factor which may have led to pt's high impedance. Pt was referred for x-ray but manufacturer hasn't received the images. Pt will likely have a full revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2255846
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dennis100
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« Reply #82 on: September 03, 2017, 12:37:25 AM »

Model Number 103
Event Date 05/18/2011
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
Additional information was received that patient's vns generator was explanted on (b)(6) 2011, on (b)(6) 2012 the leads were explanted. The patient was not re-implanted with another generator or leads. Currently they are investigating possibly performing a right-sided vns implantation for this patient. No surgery is planned at this time.
 
Event Description
It has been decided not to reimplant the patient's vns. No right sided surgery planned.
 
Manufacturer Narrative

Event Description
A vns treating physician reported that they had a patient whose device lead and generator was explanted for a wound infection in the chest wall pocket. The patient had (b)(6) confirmed by cultures. No patient manipulation or trauma preceded the event. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2471136
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« Reply #83 on: September 05, 2017, 01:10:05 AM »

Model Number 102R
Event Date 09/15/2011
Event Type  Injury   
Event Description
It was reported that the vns patient would be having surgery to move the patient's generator to the right side of the chest as the patient initially had an infection due to a spine surgery unrelated to vns that spread to the left chest. It was initially unknown if the generator had been infected. Additional information was later received confirming that surgery had occurred. On (b)(6) 2011, the patient had presented with an exposed device and infected wound post the spine surgery. The patient's parents indicated that the device site became inflamed one week following the spine surgery. During the surgery to replace the generator, the generator was removed from the pocket and treated with betadine. It was then re-implanted in the right chest. Cultures taken during surgery indicated antibiotic resistant staphylococcus. The patient was last seen on (b)(6) 2012 during which it was observed that the left wound was still open and the right site was intact. No further interventions have been indicated at this time.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2445195
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« Reply #84 on: September 13, 2017, 01:02:42 AM »

Model Number 302-20
Event Date 03/06/2012
Event Type  Malfunction   
Event Description
Additional information was received as an implant card indicating that surgery to replace the patient's vns generator occurred on (b)(6) 2012. The lead was not replaced at that time. Additional information was later received indicating that the surgeon plans to implant a second lead on the right side instead of replacing the previous lead. The previous lead implanted on the left side likely has a fracture since the high impedance did not resolve following generator replacement. The generator implanted for the replacement on (b)(6) 2012 will be placed on the new lead. Surgery for lead revision and generator repositioning is likely.
 
Event Description
It was reported that the patient's vns was now indicating high impedance on system and normal mode diagnostic tests. Source code from the generator from the last available date to the manufacturer on (b)(6) 2011, shows normal device function. Attempts for additional information have been unsuccessful to date. No adverse events have been reported. Surgery to replace the patient's lead and generator is likely.
 
Event Description
Additional information was received as an implant card indicating the lead and generator had been replaced. The explanted products will not be returned per hospital policy. Follow-up with the site found that it is believed that the previous system was explanted and the patient only has one vns system in place contrary to the previous indication by the site.
 
Event Description
Additional information was received as clinic notes including the most recent note dated (b)(6) 2012, that indicated that the patient has not had any seizures. The note on this date also details the high impedance being found and the patient indicating that she does not feel the device working likely as a result of the high impedance. A note dated (b)(6) 2012, indicates the physician checked the device on (b)(6) 2012 and it was noted that it "seems to be working well. " the vns was later checked and adjusted on (b)(6) 2012, however, no diagnostics or observations on the device performance were noted. The notes indicate the patient had an mri of her shoulder on (b)(6) 2012, which manufacturer labeling does not recommend.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Initial report inadvertently did not indicate 30-day.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2518527
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« Reply #85 on: September 16, 2017, 12:07:08 AM »

Model Number 102R
Event Date 04/04/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2012 revealed that the patient was experiencing breakthrough seizures at the patient's previous visit. On (b)(6) 2012 the patient's generator was reported to have physically slipped about 1 inch downward and was causing the patient significant pain at the generator site. The patient was referred to a surgeon for evaluation and possible re-implant to fix the migration. Additional information has been requested from the physician but no further information has been received to date.
 
Event Description
Additional information was received on (b)(4) 2012 when it was discovered that the vns patient had prophylactic generator replacement that day. Pre-op normal mode diagnostics showed a dcdc code of 4 and lead impedance=ok. The patient's old settings were output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=2ma/magnet pulse width=500usec/magnet on time=60sec. The generator was relocated to the right side of chest per patient request. System diagnostic performed in or with new generator showed results within normal limits of dcdc=2/lead impedance=ok. The patient's device was turned on in the o. R. And programmed to output=1. 5ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5min/magnet output=1. 75ma/magnet pulse width=500usec/magnet on time=60sec. The explanted generator was returned to the manufacturer on (b)(4) 2012 for product analysis that is still underway and has not yet been completed.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2561466
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dennis100
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« Reply #86 on: September 23, 2017, 03:19:38 AM »

Model Number 102R
Event Date 06/20/2012
Event Type  Injury   
Event Description
On (b)(6) 2012 a vns implanting surgeon's scheduler reported that the vns patient had an infection and is having surgery to move the generator from the left to the right side. The patient had recently undergone battery replacement on (b)(6) 2012 due to end of service. Surgery took place on (b)(6) 2012 and the generator was repositioned to the right side only; no replacement of the generator occurred. The patient's lead product information was requested from the implanting hospital but they stated they do not retain records over 10 years and since the leads were implanted in 2001 they do not have the records. Attempts for the patient's generator product information were also unsuccessful as the implanting hospital stated they would not give out this information without patient consent. Since patient consent is not available, the information cannot be obtained. (b)(4) attempts for further information from the surgeon were made but were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2680579
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« Reply #87 on: November 14, 2017, 01:39:20 AM »

Model Number 106
Event Date 12/17/2014
Event Type Injury
Manufacturer Narrative
(b)(4). Additional manufacturer narrative; corrected data: the previously submitted mdr inadvertently did not provide the udi number of the suspect device.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Additional information was received that patient underwent lead and generator re implant on (b)(6) 2016. The implantation was on the right vagus nerve. Lead impedance of the new vns system was normal.

Event Description
It was reported that the vns patient developed an infection and would undergo device explant. It was reported that the infection was a post-operative infection and pus was seen at the generator site and superficially at the neck incision. The generator and majority of the lead were explanted on (b)(6) 2015. The surgeon plans to re-implant the device in 4-6 months.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532835
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« Reply #88 on: November 23, 2017, 01:35:10 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 05/11/2015
Event Type Injury
Event Description
It was reported that the recently implanted vns patient was referred for surgery to clean the generator surgical wound site due to infection. No known surgical interventions have occurred to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

Manufacturer Narrative
Suspect device udi: (b)(4). Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Information was received from a physician's office that the patient will be re-implanted with a full system. The office believed that the generator and lead were previously explanted. A company representative confirmed that on (b)(6) 2015 the generator was moved to the right side and the lead was left in place. The patient had a very good response to vns and his parents did not want the system removed. He was unable to confirm that the patient was explanted.

Event Description
The patient was re-implanted on (b)(6) 2015. The vns system was explanted previously due to infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4909155
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dennis100
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« Reply #89 on: November 23, 2017, 01:35:58 AM »

Model Number 103
Event Date 12/15/2014
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 vns patient presented an infection that required surgical full vns system replacement. It was reported that the new vns system was implanted on the right side. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Further information was received indicating that the generator and the lead were explanted in two separate interventions. The health care professional waited 3 months for the infection to resolve and a new vns system was implanted on the right side. The explanted devices have not been returned to the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4921001
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