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dennis100
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« Reply #570 on: January 06, 2017, 07:49:09 AM »

Model Number 304-20
Event Date 07/23/2016
Event Type Injury
Event Description
It was reported that a patient was having dyspnea and voice alteration. The symptoms occurred even between stimulations. Diagnostics were within normal limits. The physician decided to disable the device to see if the symptoms get better. The patient was still experiencing vocal cord problems even with the generator programmed off. The vocal cord issue did not start until later into the titration phase and did not resolve with the disablement, so the physician believed that the nerve was inflamed and wanted to wait and titrate the device up again. The patient later reported that her implant surgery took two times as long as it should have because the surgeon had difficulty implanting the lead. While in recovery, she choked on water and could not swallow. The patient lost a large amount of weight because she could not swallow food. She also reported that she was diagnosed by an ent with left vocal cord paralysis, spasms in the trachea and esophagus, and damage to the swallow and sensory nerves. Due to these issues, she could not talk, breathe, or sleep. The left side of her face was also reportedly paralyzed. The patient was having speech and swallow therapy, but she was told that this would not help. The physician considered disabling the patient's device to allow inflammation at the nerve to go down, but the patient was receiving efficacy from vns therapy. The physician decided program the patient's device to low settings for all modes of stimulation. No further intervention was taken. No additional information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6150194
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dennis100
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« Reply #571 on: January 06, 2017, 07:49:45 AM »

Model Number 106
Event Date 06/24/2016
Event Type Injury
Event Description
It was reported by the nurse practitioner that the patient received a full vns revision a few months ago and now has partial vocal cord paralysis, but is seeing an ent for treatment and improving. The physician decided to leave the vns programmed on. It was also noted when the patient turns her head to one side, her voice goes high and faint. The surgeon had later noted that this most recent surgery had been the third time someone was in the patient's neck accessing the nerve and he was not surprised the patient would have some vocal cord paralysis and voice alteration. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6183257
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dennis100
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« Reply #572 on: January 23, 2017, 08:15:56 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 #573 on: February 10, 2017, 04:51:31 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
The patient had their generator disabled due to unilateral vocal paresis and marked reduction in speech output. Recently the patient elected to have their vns replaced and underwent surgery. This surgery was not for the patient's vocal cord paresis. A programming history review showed that the patient's device had been disabled and the last known diagnostics were with in normal limits. No other relevant information has been received to date. The explanted device have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6267938&pc=LYJ
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dennis100
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« Reply #574 on: February 10, 2017, 04:52:08 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 12/22/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient has vocal cord paralysis per the surgeon. The surgeon decided to see if it would heal on its own. Patient has a follow-up after 2 months to do a vocal cord injection if it hasn't improved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6288742&pc=LYJ
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dennis100
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« Reply #575 on: February 12, 2017, 09:11:44 AM »

Event Date 03/01/2013
Event Type Malfunction
Event Description
On (b)(6) 2013 it was reported that the vns patient recently presented with a persistent voice change, which was confirmed to not be due to puberty, and was not the type of voice change that could be considered hoarseness with stimulation. It was a constant event. The patient's vns was checked and high impedance was observed with an impedance value of about 9000ohms; there appeared to be a lead fracture. The patient was referred to an ent surgeon and it was confirmed that the patient had vocal cord paralysis. The patient's settings were noted to be output=1. 75ma/pulse width=500usec/on time=30sec/off time=1. 8min. The patient's identity was not provided but it was stated that he was a (b)(6) male. Good faith attempts for further information from the nurse practitioner were unsuccessful.

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=3019027
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dennis100
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« Reply #576 on: February 12, 2017, 09:12:14 AM »

Event Date 01/01/2010
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
On (b)(4) 2013 it was reported patient has experienced vocal cord paralysis. She had a change in voice accompanied by high lead impedance that occurred in 2010. The physician stated that she presented with a lead fracture. The patient's settings were noted to be output=1. 75ma/frequency=25hz/pulse width=500usec/on time=30sec/off time=0. 8min. No patient information was provided other than that the patient is a (b)(6). Additional information was requested from the nurse practitioner but no further information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3019674
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dennis100
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« Reply #577 on: February 13, 2017, 04:32:17 AM »

Model Number 304-20
Event Date 08/24/2011
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient had been experiencing voice alteration since having his vns lead replaced on (b)(6) 2011 and an ent physician had diagnosed the patient with left vocal cord paralysis. The patient was referred for surgery to correct the vocal cord issue. The patient's vns had previously been disabled for one month in (b)(6) 2011 to attempt to resolve the issue however this did not improve the hoarseness. Follow-up with the physician's office found that the surgery was completed on (b)(6) 2012. The site described the surgery as a "thyroplasty adenoid adduction for dysphonia. " the vns diagnostics were normal following surgery however specifics were not provided. A letter from the ent physician indicated that the patient was "pleased with the results" of the surgery. The patient does not have a medical history of vocal cord issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2511636
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dennis100
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« Reply #578 on: February 21, 2017, 01:33:44 AM »

Model Number 300-20
Event Date 04/21/2009
Event Type Injury
Event Description
Reporter indicated a patient developed an infection at the vns generator and lead sites after generator replacement surgery and the generator and lead were explanted due to the infection. The cause of the infection is unknown. The patient has a history of trauma with neck-twisting, but it is unknown if this is related to the infection. Cultures taken from the wound sites identified staphylococcus aurous coagulase-positive bacteria. The patient also received intravenous antibiotics and has fully recovered from the infection. After the vns lead and generator were explanted for infection, the patient developed left vocal cord paralysis. The left vocal cord paralysis is attributed to the explant surgery. The patient has no history of vocal cord paralysis. The vns system was functioning properly at the time of explant per the reporter. The patient has had a stent placement as an intervention for the vocal cord paralysis which has significantly improved his speech.

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=1642166
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dennis100
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« Reply #579 on: February 22, 2017, 02:45:53 AM »

Model Number 300-20
Event Date 06/01/2006
Event Type Malfunction
Event Description
While reviewing the handheld data, it was observed that the pt had a high lead impedance on both normal and system diagnostics. It was also noticed that the pt had experienced vocal cord paralysis, hence device was turned off. Voice returned to normal (b) (6) 2007. F/u with the physician revealed that no pt manipulation or trauma had occurred that contributed to the onset of the event. Ct scan was done and no anomaly was found with the lead. No lead fracture was observed on the ct scan. Pt's last good diagnostics were obtained in (b) (6) 2006. Pt's device is currently turned off and there are no plans of revision surgery. Physician also indicated that pt's vocal cord paralysis was possibly related to the high lead impedance. No medication or programming changes contributed to the onset of the event and pt did not have medical history of this event.

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=1362365
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dennis100
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« Reply #580 on: February 23, 2017, 01:45:33 AM »

Event Date 01/01/2001
Event Type Injury
Manufacturer Narrative
Matthew smyth, shane tubbs, martina bebin, paul grabb, and jeffrey blount. "complications of chronic vagus nerve stimulation for epilepsy in children". (2003)500-503.

Event Description
It was reported in a scientific article that a patient experienced possible ipsilateral vocal cord paralysis. This was reportedly discovered following device implantation when the patient was undergoing laryngoscopy for another indication. The author reported that the event was not confirmed because it was not known whether the vocal cords were examined during a stimulation-off or a stimulation-on cycle which could have mimicked vocal cord paralysis. 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=1336524
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dennis100
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« Reply #581 on: February 26, 2017, 01:39:47 AM »

Event Date 01/01/2006
Event Type Injury
Manufacturer Narrative
R. Pratap, a. Farboud, h. Patel, p. Montgomery: 2008: vagal nerve stimulator implantation: the otolaryngologist's perspective: eur arch otorhinolaryngol.

Event Description
It was reported in an article that one pt out of a group of twelve developed partial vocal cord paresis which the pt felt was a tolerable side effect.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1291935
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dennis100
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« Reply #582 on: February 26, 2017, 01:40:42 AM »

Event Date 02/01/2003
Event Type Injury
Event Description
Reporter indicated that a vns patient presented voice alteration immediately after device implantation surgery. Upon medical examination, it was found that the patient's left vocal cord was immobile. The follow up seven months later revealed minimal activity of the left vocal cord which would possibly demonstrate early recovery of the vocal cord paresis. The reporter indicated that the patient's device was programmed on and the vocal cord paresis did not appear to be affected by device stimulation. Good faith attempts to obtain additional information such as patient implant information have been unsuccessful to date.

Manufacturer Narrative
Laryngopharyngeal dysfunction from the implant vagal nerve stimulator. Zalvan, c. Et. Al. The laryngoscope 113. February 2003: pp. 221-225.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1289413
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dennis100
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« Reply #583 on: February 26, 2017, 01:41:48 AM »

Event Date 01/01/2008
Event Type Injury
Event Description
It was reported in an abstract of an unpublished article that a vns pt had developed vocal cord paralysis.

Manufacturer Narrative
Abstract citation: pati, sandipan, r. Zimmerman, a. Thieler, j. Drazkowski, k. Noe, d. Shulman, l. Tapsell, s. Sabesan, and j. Sirven. Eight year-long term outcome of vagus nerve stimulation (vns) in refractory epilepsy. Epilepsia. (abst. 1. 131), 2008.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1283141
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dennis100
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« Reply #584 on: March 10, 2017, 06:11:25 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 10/13/2014
Event Type Injury
Event Description
It was reported that the patient had been breathing poorly since her vns was replaced. The patient described the assessment of her treating ent physician in her own words. Of the portions of the throat that open and close with breathing, only one side opens correctly. The other side only opens about halfway due to being disturbed by the stimulation from the vns, leading to less efficient breathing cycles. Follow up with the patient¿s treating neurologist showed that the patient has vocal cord paralysis and a long history of dyspnea. It was initial stated it was unclear when these events began. However, a subsequent comment indicated that the patient dates the shortness of breath issues to her 2014 generator replacement. Review of programming history showed that device settings and diagnostics were within normal limits before and after the generator replacement. Attempts for additional pertinent information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6300095
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dennis100
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« Reply #585 on: March 10, 2017, 06:12:01 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 01/16/2017
Event Type Injury
Event Description
The patient reported that she was having difficulty breathing and went to her ent physician to be evaluated. There the ent physician diagnosed her with vocal cord paralysis and considered placing a trach to help these issues. It was unclear if these issues were being associated with vns therapy. Attempts for information from the neurologist who manages the patient's vns found that the patient suffers from numerous other health issues. However the neurologist was going to let the ent physician care for the vocal cord paralysis and difficulty breathing. A review of the internal programming history found that the impedance value of the system was within acceptable limits for most of the implant life however the last recorded test occurred approximately 2 years prior to this report. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6324827
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« Reply #586 on: March 10, 2017, 06:12:35 AM »

Model Number 303-30
Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient was experiencing vocal cord paralysis. The date of onset of vocal cord paralysis was not provided. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6357087
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« Reply #587 on: March 10, 2017, 06:13:09 AM »

Model Number 103
Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was to have her vns explanted for vocal cord paralysis and dysphagia. The device was reportedly disabled in an office visit. The patient's settings were being lowered before the disablement. Additionally, the patient's surgeon would also be performing further treatments for the vocal cord paralysis. Device explant has not occurred to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6322174
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« Reply #588 on: April 19, 2017, 12:27:35 AM »

Model Number 303-20
Device Problem No Known Device Problem
Event Date 02/18/2017
Event Type Injury
Event Description
A patient reportedly experienced vocal cord paralysis that was presented two days after the patient's implant surgery. The patient vocal cord paralysis was believed by the patient's surgeon to not be permanent. A review of the manufacturing record for the implanted lead confirmed that it had passed all quality inspections prior to release for distribution.

Manufacturer Narrative
Device evaluated by manufacturer, additional information: an analysis of the lead would not provide supplemental information with respect to the reported event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6381014
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dennis100
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« Reply #589 on: April 19, 2017, 12:28:15 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 05/04/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing neck pain, discomfort, and vocal cord paralysis since the initial implant. The patient is unable to tolerate any increases in parameter settings as per the standard dosing protocol. The patient was being referred for a possible full system revision. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6447366
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dennis100
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« Reply #590 on: April 20, 2017, 01:11:23 AM »

Model Number 103
Event Date 02/13/2008
Event Type Injury
Event Description
Reporter indicated that a pt developed vocal cord paralysis following a revision surgery during which both the vns generator and lead were replaced. It was reported that the pt's output current and magnet current had been set to 0ma in surgery. The reporter indicated that the event was most likely due to the surgery and "possibly swelling of the vagus nerve. " it was reported that the pt's voice has recovered and she no longer experiences hoarseness.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1021160
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« Reply #591 on: April 20, 2017, 01:16:25 AM »

Event Type Injury
Manufacturer Narrative
"the use of repetitive transcranial magnetic stimulation and vagal nerve stimulation in the treatment of depression. ".

Event Description
It was reported a vns therapy patient experienced persistent vocal cord palsies lasting 2 months. 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=1018971
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« Reply #592 on: April 20, 2017, 01:17:00 AM »

Event Type Injury
Event Description
It was reported a vns therapy pt experienced persistent vocal cord palsies lasting 6 months. Good faith attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
Fitzgerald, p. B. & daskalakis, z. J. "the use of repetitive transcranial magnetic stimulation and vagal nerve stimulation in the treatment of depresseion. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1018990
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dennis100
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« Reply #593 on: April 20, 2017, 01:17:30 AM »

Model Number 302-20
Event Date 10/17/2007
Event Type Injury
Event Description
Initial reporter indicated that one of the pt's vocal cords was paralyzed. No further info has been attained after good faith attempts to gather add'l info have been made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1020274
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« Reply #594 on: April 20, 2017, 06:08:02 AM »

Model Number 302-20
Event Date 11/12/2007
Event Type Injury
Event Description
Initial reporter indicated that postoperatively the pt developed hoarseness and numbness near their neck incision. It was additionally reported that the pt was evaluated by an ent surgeon and was diagnosed with left vocal cord paralysis. No interventions have been planned to treat the left vocal cord paralysis. The pt's vns has not been programmed on and they have not had any seizures since their revision surgery. The treating physician is attributing the vocal cord paralysis to the revision surgery. There are no plans to program the vns therapy on at this time. Mdr report number: 1644487-2007-01964 can be referenced for the revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979772
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« Reply #595 on: April 25, 2017, 01:57:28 AM »

Event Date 05/01/2009
Event Type Injury
Event Description
My daughter had her first vns implanted in 2004. She did not have success, had many traumas with her throat, and it ultimately caused paralysis to her vocal cord. We were advised by our doctors to get another - new and improved - vns since we are trying to avoid additional meds and surgery on this pt. When the surgeon opened the area to replace the old with the new, he discovered darkened tissue, corrosion, and a complete failure of the device. He said, he had never seen it in over 300 vns surgeries. Because of the extent of the problem, he had to replace more than the generator, and had to attempt removal of the wire that has long been encased in scar tissue. We were advised by cyberonics that they could fully investigate and contact the fda. After 7-months, cyberonics can only identify's dodge-ball hit 4 years ago as the cause of failure. The device has read "normal" during this entire time on every routine recheck. We would never have known of this failure if we didn't have a second surgery. Cyberonics' investigation states the cause is "blunt force trauma" 4 years ago. Indeed, being cautious parents, we did see her neurologist after that incident to ask if the ball could possibly have caused damage - the neurologist assured us, but performed the standard usual diagnostics and said the device was not damaged - again, 4 years ago. Cyberonics also advised today that her current neurologist - md - did not perform recommended "diagnostics" on her device while under his care - approx. 1 year, but only "interrogations" which would not reveal a "failure" status. Dr surely had no idea that was required or he would have done a diagnostic reading. We thought that he "interrogations" he was doing, were "diagnostic" evaluations. The question looms as to when the device failed, and how would we have known it was in this condition, buried under her skin, showing no signs of distress. Our earlier problem with her paralyzed vocal cord was also met with disinterest as we sought to discover that caused the permanent condition. We could only suspect the vns was ramped up too quickly to higher intensities. If that were true, they would simply have to re-examine their protocol, but they did no investigation into cause. We quietly went away without pressing for an answer. Now, another encounter with the cyberonics product is met with the same response. Why aren't they concerned that their device was indicating "normal" at every office visit? since it never controlled her seizures, there were zero signs it was in this state. Cyberonics advised that their last communication with fda was in august, and they reported "lead failure" as the cause. Now, we have a second vns in her chest - no seizure improvement; in fact, worsening, and we have no idea what went wrong or when. The surgery doctors also remain baffled. Is there any accountability in this investigation process? is it up to me to keep pressing for resolution, or does the fda hold them accountable for such serious incidents? vocal cord paralysis - and an electrical failure resulting in darkened tissue - three years later does not seem to warrant an unbiased investigation that goes beyond proving their own blamelessness. I asked them today for the fda report, hoping to glean something on why, when, or how the device failed. Cyberonics said, they would not provide that info. It feels we are left begging cyberonics for a responsible response to this incident. I have contacted them no less than 12 times in 7 months via phone calls and emails. Cyberonics "deal with us". It was never our intent to be their problem. Only to understand more fully the risks we are exposed to with their device, how we can protect our daughter from further harm, and assist them in identifying product concerns. Advised she would have to contact their legal dept. To provide fda info. Why is that? we are a modest family, and do not have access to a legal department. Do incidents such as this require a legal department to provide people who have trusted them with answers?.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564881
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dennis100
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« Reply #596 on: April 25, 2017, 01:58:20 AM »

Event Date 01/01/2009
Event Type Injury
Event Description
It was reported through the presentation given by the physician on a scientific article that a patient experienced vocal cord paralysis after vns implant. No further information was given. Good faith attempts to obtain additional information has been unsuccessful.

Manufacturer Narrative
Abstract reference: elliott, r; morsi, a; kalhorn, s, et al. "vagus nerve stimulation for refractory epilepsy: single surgeon experience of over 700 consecutive operations". American epilepsy society meeting. 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1565110
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dennis100
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« Reply #597 on: April 28, 2017, 01:37:10 AM »

Event Date 11/17/2009
Event Type Injury
Event Description
It was reported that a recently re-implanted vns pt developed an infection on the neck incision site and was explanted. Info from the treating neurologist revealed the pt started taking antibiotics and was referred to a neurosurgeon for follow up. Additional info was received from a company rep indicating the pt was evaluated by an ent physician who identified the pt's left vocal cord to be paralyzed. At the moment the cause for the pt's left vocal cord paralysis is unk as the neurologist believes the cause for the infection was related to surgery. Good faith attempts to obtain product and additional info from the implanting surgeon and ent have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1552334
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dennis100
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« Reply #598 on: Today at 12:58:38 AM »

Event Date 01/01/2008
Event Type Injury
Event Description
Reporter indicated that she had a vns therapy patient "implanted for several years who presents a paralysis on the left" vocal cord. Additionally, it was stated that she was unsure at this point if it was related to vns therapy. Good faith attempts for further information, including patient information and relationship to vns therapy, are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1035953
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