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dennis100
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« Reply #90 on: October 06, 2017, 02:31:12 AM »

Event Date 05/29/2001
Event Type  Injury   
Event Description
An article about the histological appearance of a chronically stimulated vagus nerve in a pediatric reporter indicated vns therapy moderated a patient's atonic episodes, but the patient experienced "occasional hospitalizations for status epilepticus. " the patient passed away due to asphyxiation (reported on medwatch 1644487-2008-02703). The vns therapy system was explanted with "1. 5 cm of unstimulated nerve superiorly and inferiorly. " the electrodes were dissected from the nerve "revealing grossly normal nerve above and below the stimulator. " "abundant inflammatory cells were present around the stimulated nerve section. " "severe myelin loss and occasional myelin digestion chambers were seen in the nerve fibers. With modified trichrome and luxo fast blue stains, this loss was estimated to be nearly 90%. " good faith attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Article: histological appearance of chronically stimulated vagus nerve in a pediatric patient. Pediatr neurosurg 2001, 35:99-102 2001 r shane tubbs. Et al.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1241164
« Last Edit: October 01, 2018, 09:53:03 PM by dennis100 » Logged
dennis100
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« Reply #91 on: November 27, 2017, 03:09:07 AM »

Model Number 105
Device Problem No Information
Event Date 07/09/2015
Event Type Injury
Event Description
Additional information was received that the patient is still fighting (b)(6) infection and that the physician recommended explant of the lead, which was not previously removed. The initial infection was reported to have started about a week after implant.

Event Description
Per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires. A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015.

Manufacturer Narrative
Suspect device udi: (b)(4).

Manufacturer Narrative
Describe event or problem, corrected data: per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires. A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015. This information was inadvertently left out of the previously submitted emdrs.

Event Description
It was reported that the patient acquired an infection, which was first observed by the physician on (b)(6) 2015. The infection was reported to have started in the chest incision and followed the lead up to the neck site. Patient underwent explant of vns system on (b)(6) 2015 as planned. No patient involvement was suspected. A culture was taken but the results were not available. Review of manufacturing records confirmed that both the generator and lead were sterilized prior to distribution.

Event Description
An image was received showing flushing and puffiness around the generator pocket incision site. Some puffiness was also visible around the neck incision site. Notes from the surgery were also received stating that the patient developed some redness near the incision and some drainage that appears to be infected. The surgeon found some serosanguineous fluid , which was cultured and then removed the generator from pocket. The surgeon also removed the lead and was able to dissect the lead but noted that there was significant amount of scarring and inflammation in the sternoclaoimastoid muscle.

Event Description
Patient underwent lead removal surgery on (b)(6) 2016 and the surgeon removed the two electrode sets and the anchor tether. During the surgery, the surgeon noted that there was evidence of left vagus nerve injury that resulted in hoarseness and coughing. The surgeon's impression was that someone pulled the lead thinking that the electrodes will unwrap themselves. Per the surgeon, the patient had seen a ent a few weeks ago and received an implant in the left vocal cord to get the vagus nerve to more approximate normal location.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5001435
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dennis100
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« Reply #92 on: December 09, 2017, 12:20:01 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type Injury
Event Description
It was reported that the vns caused the patient's gastroparesis, and their seizures were still not controlled. It was stated that the device didn't work for the patient and was therefore it was turned off. Scar tissue formed in the patient's neck, which was very painful, even to turn their head just a little bit was reported to be torture. Patient reported undergoing surgery to remove device and scar tissue. Patient also reported that there was damage to the vagus nerve. The patient's neurologist who managed the patient's vns did not know about any of the symptoms or issues. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7008994
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dennis100
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« Reply #93 on: December 09, 2017, 02:19:57 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 10/16/2017
Event Type Injury
Event Description
It was reported from the patient that her nerve was nicked during implant surgery causing her to have horner¿s syndrome. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7040657
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dennis100
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« Reply #94 on: December 31, 2017, 03:16:18 AM »

Device Problem Insufficient Information
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Date received by manufacturer, corrected data: 08/31/2017. Initial report inadvertently listed the aware date as 09/01/2017 instead of 08/31/2017.
 
Event Description
It was reported that this patient's vagus nerve was damaged, it never helped her seizures and it made her hiccup constantly. It was also reported that the patient could feel the electrical pulse in her throat. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6891887
« Last Edit: October 01, 2018, 09:54:22 PM by dennis100 » Logged
dennis100
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« Reply #95 on: January 06, 2018, 04:32:34 AM »

Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the physician that he had a pediatric patient who suffered nerve damage which required corrective surgery. The physician believed that high output current and rapid cycling caused heating or fibrosis which led to nerve damage. He believed that lowering output current was not effective settings for vns therapy so the physician stopped the rapid cycling with high output current. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7131494
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dennis100
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« Reply #96 on: January 10, 2018, 02:09:09 AM »

Model Number 302-20
Event Date 01/27/2009
Event Type Injury
Event Description
Reporter indicated that a vns pt developed persistent dysphony after vns implant surgery, along with paralysis of the left vocal cord and a partial lesion of the left laryngal nerve. All attempts for additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1409232
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dennis100
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« Reply #97 on: February 02, 2018, 03:13:56 AM »

Model Number 303-20
Device Problem No Known Device Problem
Event Date 11/02/2016
Event Type Injury
Event Description
It was reported that the patient¿s left vagus nerve was damaged. The patient¿s treating ent physician stated that it appeared to occur during a surgery, but it was not clear if vns surgery or a prior brain surgery was responsible. It was believed the site of the damage was slightly higher than the level of the vns leads, specifically referencing damage at the palate region of the nerve. The ent physician reportedly performed a laryngoscopy and showed the patient had reduced sensation of the larynx, and muscle activations were delayed and less forceful. A modified variance swallow study was performed, and the tongue muscles and general pharyngeal muscles were found to not perform as well as they should. The physician¿s assessment of the issue was that since the left vagus nerve innervates the left palate, and the patient¿s left pallet did not elevate, the results signified damage to that vagus nerve. However, patient¿s vocal cords were reported to be normal. Knowing that left palate is innervated higher up on the vagus nerve, the damage was assessed by the physician to possibly have happened prior to vns. The patient was confirmed to have multiple other brain surgeries, including brain tumor removal, over the course of his life. However, the patient's vns surgery could not be ruled out as a contributing factor.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252761
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dennis100
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« Reply #98 on: March 06, 2018, 06:12:19 AM »

Model Number 300-20
Event Date 09/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received from the patient's gastroenterologist. He indicated that the gastroparesis was a conclusion the mother came to on her own, and he is not sure what it is related to. The patient only recently began experiencing gastroparesis, but the vns generator was explanted in 2007.

Event Description
Additional information was received from the patient's mother indicating that the patient has been experiencing gastroparesis since about (b)(6) 2011, has lost 30 pounds, and cannot eat. The patient has reportedly seen many physicians, but she is willing to see more physicians to get to the root of the issue. The patient was recently evaluated by the pediatrician and surgeon again around (b)(6) 2012, and the mother reported that they think the gastroparesis was caused by the damage to the vagus nerve. Follow up with the pediatrician revealed that he did not have any idea if the gastroparesis is a result of possible nerve damage but is treating it as it may be. The patient has impaired gastric emptying, and they recently placed a tube to provide nutrition directly into the large intestine. He did not like this as it would require a pump and cannot provide bolus feeding. He would like for the patient to have a pyloroplasty, however the surgeons do not agree. He stated that vagotomies and pyloroplasties are not often performed any more. He again confirmed that the cause is unknown, but damage to the nerve is being considered as a possibility. He also reaffirmed that the timing is odd. No additional information was provided. Attempts for additional information from the surgeon have been unsuccessful to date.

Manufacturer Narrative
(b)(4): the initial report did not include the zip code.

Manufacturer Narrative

Manufacturer Narrative
Corrected data: the initial report inadvertently reported the incorrect generator explant date.

Event Description
The patient previously had his generator explanted on (b)(6) 2007, prior to the time that the patient has experienced gastroparesis.

Event Description
The gastroenterologist confirmed that the patient only recently had gastroparesis that began with the feeding tube issue, as noted by mother.

Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #1 inadvertently did not include this information.

Event Description
It was reported by the patient's mother that the patient had recently been diagnosed with gastroparesis by a pediatric gastroenterologist. The patient's feeding tube had begun leaking around (b)(6) 2011 and she did not understand why until she saw the physician. It was not indicated what the physician believed caused the gastroparesis. The patient previously had his vns generator removed on (b)(6) 2008, as the patient had been seizure-free since 2007 and did not require vns or anti-epileptic medication. The mother reportedly did some online research and came to the conclusion on her own that the patient's previous vns surgeries caused damage to the vagus nerve resulting in gastroparesis. A vns surgeon saw the patient for evaluation but declined to provide any information. Attempts for follow-up with the gastroenterologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2560609
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dennis100
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« Reply #99 on: March 16, 2018, 01:50:30 AM »

Model Number 304-20
Event Date 06/22/2012
Event Type Injury
Event Description
Reporter indicated a patient developed dysphagia, hoarseness, and difficulty speaking following vns implant surgery on (b)(6) 2012. The patient was seen by an ent physician and was diagnosed with "paresis of the plica vocalis, left recurrent laryngeal nerve paresis, and gastroesophageal disease". The events are felt to be permanent and due to the vns implant surgery. The patient had no pre-vns history of the events. The vns was turned down to low settings, as the patient requested it not be disabled. The patient also received prednisone medication. The patient describes the events as "bearable". Intraoperative vns diagnostics were reported as "ok".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2739617
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dennis100
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« Reply #100 on: April 03, 2018, 01:17:32 AM »

Model Number 302-20
Event Date 04/01/2012
Event Type  Injury   
Event Description
The explanted vns generator and lead were returned for analysis on (b)(6) 2013. Paperwork returned with the explants indicated the vns was replaced due to "lesion in nerve by mri". The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the lead. Note that since a small portion of the lead assembly (body), including the electrode array section, was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. In the pa lab, the generator 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 septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. All attempts to the reporter for additional information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Reporter indicated a patient had vns lead and generator replacement surgery performed on (b)(6) 2012 due to painful stimulation. The patient had an mri in the past that may have damaged the left vagus nerve per the reporter. The new vns lead was implanted on the right vagus nerve. The reporter and the surgeon were both aware of the manufacturer's labeling regarding not implanting the vns lead on the right vagus nerve. Attempts for further information and return of the explanted devices are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2916436
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dennis100
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« Reply #101 on: April 05, 2018, 01:21:57 AM »

Model Number 304-20
Event Date 12/03/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2012 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2012 indicated that the patient has been having hoarseness and difficulty swallowing since the recent full revision surgery. The patient has clear dysphonia and increased weakness of the left arm. The physician reprogrammed the device at 0. 25ma and 0ma which did not change anything. The physician stated that he thinks this is just a postsurgical disturbance of the vagal nerve. They decided to turn the vns for two weeks and then have the vns turned back on in the hope that there will be some healing going on. The physician reported that the patient has damage to her vagal nerve and is experiencing vocal cord paralysis. Previously it had been reported that the patient was experiencing an increased coughing with stimulation after recent full revision surgery on (b)(6) 2012. Additional information was requested from the physician but the only further information he would provide was that he has still not seen the patient since the (b)(6) 2012 visit and that he did not believe she had seen an ear, nose, and throat (ent) physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2904573

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dennis100
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« Reply #102 on: April 07, 2018, 01:38:07 AM »

Model Number 300-20
Device Problem No Known Device Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received indicating that a patient had experienced recurrent laryngeal nerve injury with vns. Per the notes, the patient also experienced a cough with mild pharyngeal pain or dysphagia. Programming history was reviewed for the patient's device, and diagnostics were within the normal limits on the date of implant and one month after implant surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7335848
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dennis100
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« Reply #103 on: April 19, 2018, 12:59:12 AM »

Model Number 302-20
Event Date 10/03/2011
Event Type  Injury   
Event Description
On (b)(6) 2013 it was reported that the vns patient was experiencing a cough and hoarseness that was found on (b)(6) 2011. It was reported that the patient started feeling it soon after vns implant because of laryngeal recurrent nerve paralysis. It was stated that this was resolved on (b)(6) 2011. No further information was provided. Additional information has been requested from the physician but no further information has been received to date.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the paralysis was first observed soon after implant surgery on (b)(6) 2011. The physician believes the event is due to the vns surgery. The paralysis does not occur with stimulation. It was unknown if the patient had been evaluated by an ent. The patient does not have a medical history of this event prior to vns. The physician reported that the coughing and voice alteration were also soon noticed after the vns implant surgery on (b)(6) 2011. The physician believes they related to both stimulation and surgery. According to the physician, the coughing and voice alteration are associated with stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3028936
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dennis100
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« Reply #104 on: May 03, 2018, 01:51:46 AM »

Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2013 an article titled ¿endoscopic laryngeal patterns in vagus nerve stimulation therapy for drug-resistant epilepsy¿ was reviewed. The article stated that the objective was to evaluate laryngeal patterns in a cohort of patients affected by drug-resistant epilepsy after implantation and activation of a vagus nerve stimulation therapy device. There were 14 consecutive patients that underwent a systematic otolaryngologic examination between 6 months and 5 years after implantation and activation of a vagus nerve stimulation therapy device. The article reported that they observed three different laryngeal patterns; four patients showed left vocal cord palsy at the baseline and during vagus nerve stimulation (captured on mfr. Report # 1644487-2013-02125, this report, 1644487-2013-02126, and 1644487-2013-02127), seven showed left vocal cord palsy at the baseline and left vocal cord adduction during vagus nerve stimulation (captured on mfr. Report # 1644487-2013-02128, 1644487-2013-02129, 1644487-2013-02130, 1644487-2013-02131, 1644487-2013-02132, 1644487-2013-02133, and 1644487-2013-02134), and three patients showed a symmetric pattern at the baseline and constant left vocal cord adduction during vagus nerve stimulation (captured on mfr. Report # 1644487-2013-02135, 1644487-2013-02136, and 1644487-2013-02138). The article stated that the vast majority of patients (12/14) reported mild immediate dysphonia after implantation of the vns device, however only 4/14 patients remained dysphonic at the time of their laryngeal examination that occurred between six months and five years after surgery. One patient reported dysphonia at more than one year after surgery. All four patients showed left vocal cord palsy at the time of the examination. It was stated in the article that for the group of patients that showed left vocal cord palsy both at rest and during phonation with the vns both armed and disarmed (4/14 patients), only one of these patients reported dysphonia at the time of examination. It was stated that this laryngeal pattern seems related to iatrogenic damage to the vagus nerve, which is unable to conduct physiological or supraphysiological stimuli. The second group (7/14 patients) that showed left vocal cord palsy at the baseline both at rest and during phonation and persistent left vocal cord adduction during the whole vns stimulation period; only three reported dysphonia persisting at the time of examination, showing good right vocal compensation. The third group of patients (3/14 patients) that showed a symmetrical laryngeal pattern at rest and during phonation at baseline and left vocal cord adduction during the entire vns stimulation period had no patients that reported dysphonia at the time of examination. It was stated that the nerve is not completely damaged in these patients.
 
Event Description
On (b)(6) 2013 the physicians (authors of the paper) stated that they solved their patient¿s side effects some months after implant. They said they have no time to give any further information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3229051
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dennis100
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« Reply #105 on: May 04, 2018, 01:43:47 AM »

Model Number 302-20
Device Problem Detachment of device component
Event Date 08/21/2010
Event Type  Malfunction   
Event Description
It was reported that the patient was undergoing generator replacement surgery when the surgeon identified abraded openings in the lead tubing (reported in mfr. Report #1644487-2018-00663), so a lead revision was then performed. It was then identified that there was no strain relief, and the electrodes were detached from the nerve. The surgeon and ear, nose, and throat specialist stated that the nerve was bubbled and severely scarred from the electrodes rubbing on it. The impedance was within normal limits prior to the surgery, which indicated that the electrodes were in contact with patient tissue while implanted. It was believed that the electrodes rubbed against the nerve after becoming detached, which caused the damage to the nerve. The lead was received by the manufacturer, and analysis was performed (reported in mfr. Report #1644487-2018-00663). However, the electrode portion of the lead was not returned, so no analysis could be performed on the portion of the lead relevant to this report. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7467612
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dennis100
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« Reply #106 on: May 05, 2018, 01:01:47 AM »

Model Number (11)150331
Event Date 08/19/2016
Event Type  Injury   
Event Description
Cyberonics vns magnet model 220 implant on (b)(6) 2016. (b)(6) 2016 device short circuited causing potential damage to vagal nerve. Patient felt extreme heat and could not move for 24 hours. Device then shut off, had to be surgically removed and replaced on (b)(6) 2016. Picture of malfunction device shows bubble that formed to interfere with wires. Device sent back to cyberonics. Lot number 1464006.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7424951
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« Reply #107 on: May 08, 2018, 02:42:30 AM »

Model Number 302-20
Device Problems Corrosion; Fracture; Mechanical issue
Event Date 12/22/2016
Event Type  Malfunction   
Event Description
Analysis of the generator and lead were completed. As a part of testing the generator's output signal was monitored for a 24 hour period while it was placed in a simulated body temperature environment. During this period there were no observed variations in the output current of the generator. Analysis confirmed that the generator performed to functional specifications. It was noted that the lead was received as one portion which did not contain the electrodes or tie downs. Setscrew marks were observed on the lead's connector pin which indicated that at one time there had been proper mechanical contact between the generator and lead. Abrasions were observed in the outer tubing and it appeared that the cause of these abrasions were related to wear. A continuity check was performed on the returned lead portion and no discontinuities were identified. The analysis was unable to confirm the presence of a fracture in the portion of the lead that had been received.
 
Event Description
It was reported that during the replacement surgery the lead's electrode appeared to be corroded. After the lead and generator were replaced the new system was programmed on and the patient began coughing. The physician believed that the coughing was caused by the nerve damage sustained from the explanted lead and generator. The explanted lead and generator were received and are currently pending analysis.
 
Manufacturer Narrative

Event Description
It was reported that the patient was referred for a lead and generator replacement due to high impedance being observed. During the replacement surgery it was noted that the patient's vagus nerve appeared to be damaged. The surgeon reported that the nerve appeared atrophic and discolored immediately around and under the positive and negative electrodes. The surgeon could not determine the cause of the nerve's appearance but noted that the electrodes seemed to be more degenerated than usual. The explanted lead and generator were discarded following the surgery. Therefore product analysis cannot be completed. No additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: describe event or problem; "it was reported that during the replacement surgery the lead's electrode appeared to be corroded. After the lead and generator were replaced the new system was programmed on and the patient began coughing. The physician believed that the coughing was caused by the nerve damage sustained from the explanted lead and generator. " this information was inadvertently left off on mfg. Report #0. Corrected data: (b)(4). This information was inadvertently left off on mfg. Report #0.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6300905
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« Reply #108 on: May 21, 2018, 01:52:00 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 12/22/2016
Event Type  Injury   
Event Description
Follow-up from the physician on (b)(6) 2017 provided that the patient claims ¿being back to normal¿ and does have a vns now. The patient¿s mother claims that replacement of vns fixed the problem. Diagnostics were reported to be ok.
 
Event Description
It was reported by a patient¿s provider that the patient had recently fell and was having some discomfort so he went to the er. Device settings were checked and found to the same. Since the fall, the generator had migrated significantly downward. A call was received from the patient¿s caregiver also reporting that the generator had migrated to the sternum. He reported that the lead is now visible through the skin. He stated that his son has always had voice alteration with the device, but it now seems worse. He has since seen a surgeon about performing a revision surgery. It was also stated he was going to have his vocal cords checked to evaluate for any potential damage that may have occurred with the shifting of the generator and lead. Clinic notes were received from a visit to the surgeon on (b)(6) 2017 for replacement referral. The notes provide that the patient was seen at the ed for pain surrounding his vns battery. X-rays were done and labs did not reveal any sign of infection, so he was discharged home. He returned again to the ed. He did not feel his vns activate for several hours. His vns was found to be working appropriately. The battery was in an uncomfortable position for him, and was at the very superior aspect of the sternum. The skin overlying the battery and nearby lead is thin. He feels significant discomfort when lying down or on his side. He is concerned that the battery moves, but it was reported the battery has always been in this approximate position. He said it may have even been a little higher in the neck right after surgery. He has hoarseness to his voice constantly, and the patient denies any hoarseness prior to surgery. The battery is slightly mobile, but not more than expected. The skin overlying this area is thin but intact. Palpation and manipulation of the battery causes some pain. X-rays reviewed showed the vns generator overlying the superior aspect of the sternum. The lead is in an expected location. There is no evidence of fracture. It was provided the vns is in an unusual position. It was stated that the vns is functioning properly in the current location, but that it is not in the most common site for generator placement and is causing the pain. It was stated they are concerned the patient may have vocal cord paralysis from injury to the recurrent laryngeal nerve. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Generator replacement surgery occurred. The explant facility does not return devices to the manufacturer and the explanted device has not been received by the manufacturer to-date.
 
Manufacturer Narrative
Suspect medical device lot#, corrected data: the lot# was inadvertently not provided in the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309855
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dennis100
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« Reply #109 on: May 27, 2018, 12:22:24 AM »

Device Problem Electrical issue
Event Date 02/25/2015
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
It was inadvertently not provided in follow-up report#6 that the surgery had occurred on (b)(6) 2016. The explant date of the device was inadvertently not provided.
 
Event Description
Additional data was received and review of the programming/diagnostic history shows that the device is still functioning within normal limits. Additional information was received that the patient underwent the cardioversion procedure on (b)(6) 2015. There were no precautions taken during the procedure. A magnet was not used to disable it during the procedure as the operators thought the device was end of life.
 
Event Description
An abstract written by the patient's physician was received on 12/10/2015. The abstract stated that the patient was admitted to the hospital for new-onset atrial fibrillation. Chemical cardioversion was attempted, but was unsuccessful. After being cleared with a tee for an intracardiac thrombus, the patient underwent dc cardioversion to sinus rhythm. Shortly after the dc cardioversion, the patient experienced persistent dysphagia and periodic (in synch with stimulation) throat irritation, dry hacking cough, and symptomatic bradycardia with heart rate dropping to the 20s. The periodic symptoms resolved after the device was deactivated with the magnet, but the patient remained dysphagic. On fluoroscopy for swallow evaluation, the vns leads could be seen exposed in the soft tissue of the neck. The physician believed that the patient's nerve was burned, which caused the persistent dysphagia, and that the vns lead was "naked" and was shocking the patient's neck soft tissue and causing the periodic issues. There were still no plans to replace the generator, as this would aggravate the patient's condition.
 
Manufacturer Narrative
Date received by manufacturer: 12/20/2017. (b)(4).
 
Event Description
The patient was referred for full revision surgery. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explant facility does not return devices to the manufacturer per policy, and it was reported the product may have been discarded.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient sustained damage to his vocal cords following a cardioversion procedure.
 
Event Description
It was reported that the patient experienced sharp painful stimulation every 90 seconds after undergoing an electrical cardioversion for atrial fibrillation with rapid ventricular rate. Prior to the cardioversion, patient had a transesophageal echocardiogram but was reported to be able to swallow without issues following this procedure. After the cardioversion, the patient was having significant and periodic bradycardic events with a heart rate drop from the high 90's into the 30's. Patient would simultaneously moan, bear down, and complain of severe neck pain. Once the vns was turned off, the events ceased. When a system diagnostic test was attempted, the patient again had bradycardia and the programming wand was quickly removed. I didn't think it wise to try that again. With the device off, the patient was tested with modified barium swallow and found to have a complete dysphagia. This test will likely be repeated within a few days to assess any improvement. It is unknown if the device was programmed off when the patient had the cardioversion procedure. X-rays were taken of the neck and there were no obvious anomalies identified in the images received. The physician believes there may be a micro fracture in the lead and stimulating the neck near the vagus nerve causing the pain that triggered a vagal response in a physiologic manner as opposed to via direct vagal stimulation. The physician is concerned that the patient now has a vagus neurapraxia due to electrical injury. It was also reported that there is no definitive way to test for this to be sure. Additional relevant information have not been received to date.
 
Event Description
It was reported that the patient still experienced pain in neck area due to the cardioversion procedure. It was also mentioned that the vns therapy was working well for the patient until the cardioversion incident. The patient also underwent surgery on the throat and reported to have probably burnt his vocal cords. The physician mentioned the theory that the lead passed the energy to the nerve during the cardioversion procedure, which resulted in the patient's adverse events. Review of the programming and diagnostic data for this patient indicates that the impedance value was 2107 ohms on (b)(6) 2015 and has been consistently between 2100 and 2400 prior to cardioversion procedure. On (b)(6) 2015, the impedance value was 1350 ohms. The impedance value on (b)(6) 2015 is 1379 ohms.
 
Event Description
Additional information was received that the patient still has pain despite vns being off. A report on the cardioversion procedure was also received stating that the procedure occurred on (b)(6) 2015 at 15:02. Synchronized bi-phasic cardioversion was performed with a medtronic lifespak 12 cardioversion device. Adhesive patches were used and 200j of energy was used to shock. The patient has a history of hypertension, a vns for seizure disorder, restless leg syndrome, and a new onset of atrial fibrillation. Echo findings showed no laa thrombus. The ejection fraction from the echo was 65%. During the procedure, the patient was brought to the electrophysiology lab in a fasting state after informed consent was obtained. Hemodynamic monitoring was established, and anesthesia was administered. Synchronized biphasic cardioversion was performed, the patient was reassessed, and the patient left the lab in a stable condition. Results showed that pre-rhythm was atrial defibrillation, and the post-rhythm was sinus. 200j of energy was delivered externally. There were no noted complications, and the dc cardioversion was deemed successful. Clinical course was to be observed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4618197

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dennis100
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« Reply #110 on: June 08, 2018, 03:31:29 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 07/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient that her last vns generator replacement surgery was a disaster. The patient reported that she was left with acute nerve damage and a hemorrhage. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544211
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« Reply #111 on: June 23, 2018, 12:29:12 AM »

Model Number 304-20
Event Date 09/24/2014
Event Type  Injury   
Event Description
On 5/17/16 the physician reported that the patient did have a portion of their vagus nerve removed and then stitched back together again on (b)(6) 2014 during the full revision surgery that day.
 
Event Description
On (b)(6) 2016 the physician indicated that the patient's chocking sensation is from misfiring of the vns. He said that the memory issues are not applicable. All diagnostics were reported to be within normal limits with the last one performed on (b)(6) 2016. The physician turned off the patient's vns and the patient is considering having it removed and probably not replaced. The patient does not have a medical history of these events prior to vns. The only event preceding the onset of the chocking/painful stimulation is replacement of the vns. It was previously reported that the patient underwent a full revision on (b)(6) 2014 due to issue following a mammogram. The patient is still having discomfort in the neck with stimulation, so the physician indicated that he would like contact information for a vns surgeon for another opinion as the previous surgeon stated he would not do another revision for the patient. It was reported that a system diagnostics test had not been performed after the recent complaint of painful stimulation. Additional information was requested from the physician but no further information was received regarding whether diagnostics were performed since the replacement. On (b)(6) 2016 the patient's mother reported that the patient has been experiencing painful stimulation as well as profound breathing issues since the generator revision. The breathing issues are described as a strong choking sensation leading to gasping and can last up to 30 seconds at a time. The patient then reported that this issue typically presents when she turns her head to the left or the right and that it has happened "thousands of times" so she is used to the effects. She also is experiencing memory issues. The patient stated that she is now having an increase in seizures since her device was turned off on (b)(6) 2016. She said that at this time, she wants her system replaced because of the shocking and not wanting to have the stimulation turned back on. The patient noted that the magnet is still programmed on. She then indicated that she never had a problem with the previous system and when it was turned on following replacement, she started to feel shocking that was more over the generator site in the shoulder. The issues were also indicated as not occurring with stimulation on-times but always happened and resolved when the generator was programmed off. The patient said that her phrenic nerve is being stimulated per her neurologist, but it wasn't clear how he determined this. She indicated that when the magnet was swiped the day after it was painful, which is why she doesn't want to turn it back on. The patient stated that there is no room on the nerve because the surgeon removed part of her vagus nerve and stitched it back together, which she was insistent that this occurred as the surgeon told her this. The patient said that the old system was completely removed according to the x-rays. On (b)(6) 2016, a physician reported that the patient was hospitalized due to the increased in seizures. He said the primary reason for disablement was painful stimulation, shocking in her neck that occurred when she turned her head.
 
Manufacturer Narrative

Manufacturer Narrative
Inadvertently reported incorrect age on initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5498371
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« Reply #112 on: June 26, 2018, 03:02:11 AM »

Model Number 304-20
Event Date 10/12/2012
Event Type  Injury   
Event Description
It was reported that the patient's treating medical professional did not think the vocal cord paralysis was related to the vns as the vns surgery had occurred some time ago. No additional relevant information has been received, to date. No known surgical intervention has occurred to date.
 
Event Description
It was initially reported that the patient had severe hoarseness since date of implant, and there was consideration at that time to refer the patient to ent for botox injection in the vocal cord area due to possible laryngeal nerve damage. Upon follow-up, it was reported that the patient saw the ent on (b)(6) 2016. The ent noted that the patient had an underlying sleep breathing disorder. The ent discussed that the patient had left vocal paresis that was likely due to the vagal nerve stimulator implant. The ent assessed that given that he is not having significant problems with his voice or airway, the ent recommended observation. Per the reported diagnostics, the device is functioning properly. It was also noted that the patient recently had a tonsillectomy and adenoidectomy, in which the left vocal cord paralysis was initially noted. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6064969
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« Reply #113 on: July 13, 2018, 02:53:51 AM »

Model Number 103
Event Date 08/28/2013
Event Type  Injury   
Manufacturer Narrative
Describe event or problem, corrected data: supplemental manufacturer report #01 inadvertently did not include the additional information received from the neurologist.
 
Event Description
On (b)(6), 2013, the patient's father reported that the patient has been experiencing several adverse events after having his most recent vns replacement on (b)(6), 2013. The adverse events included losing his voice, coughing and choking while he eats, aspiration pneumonia, and a hole in an unspecified location. Attempts for additional information have been made; however, they were unsuccessful. No additional information has been provided.
 
Event Description
The patient was seen for follow-up with the surgeon. The device interrogation was within normal limits. The surgeon indicated that he initially thought the patient's issues were due to the patient being intubated for implant surgery. The surgeon indicated that the patient likely has recurrent left laryngeal polyps which he feels will continue to heal over the next six months. The surgeon offered the patient a follow-up appointment in three months. The surgeon reported that it is reasonable that scar tissue could have been dissected and such outcomes would be reasonable to occur.
 
Manufacturer Narrative

Event Description
Additional information was received from the neurologist stating that following replacement surgery, the vns patient had severe difficulty swallowing, nerve damage, laryngeal issues, and aspiration. The patient¿s symptoms were reported to be somewhat better.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528864
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dennis100
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« Reply #114 on: September 08, 2018, 01:06:53 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient that she wanted the vns lead removed due to high blood pressure. The vns generator was previously explanted to lack of efficacy, but the lead had remained implanted. The patient stated that she was experiencing baroreflex nerve damage and believed it to be due to the presence of the lead. The patient reported following up with physicians and all of the physicians believed that it was not related to the vns lead. The patient stated that this was only a recent issue and that she did not believe it was related to the surgery. No relevant surgery is 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=7819434
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« Reply #115 on: October 01, 2018, 02:43:04 AM »

Model Number 302-20
Event Date 12/15/2005
Event Type  Injury   
Event Description
Initially, it was reported that during a vns system replacement surgery, it was observed that the patient's left vagus nerve was cut and that it presented with signs of having been cut for a long period of time. A neuroma was observed at the level of the cut which was at the lower end of the vagus nerve. No relationship of the cut to vns was noted at the time of initial report. It was later reported during a neurosurgeon expert meeting, that the diagnosis of a complete cut left nervus vagus with a neuroma was made during the replacement surgery. It was noted that the lesion was probably due to direct surgical trauma during the first implant procedure. It was noted that the patient had experienced partial improvement of epilepsy with vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3774040
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« Reply #116 on: October 05, 2018, 01:09:31 PM »

Event Date 12/19/2005
Event Type  Injury   
Event Description
In (b)(6) 2005, i had a vagus nerve stimulator implanted for treatment resistant depression by a dr (b)(6) at (b)(6) medical center in (b)(6). (dr (b)(6) subsequently worked at (b)(6) medical center). Afterwards, i felt as if i were fighting off an infection. I informed the surgeon, but blood work revealed no infection. About three weeks later, however, my chest began puffing out like a balloon, and i was rushed to the hosp. According to my medical records, i was treated for an (b)(6) infection. I did not find that out until i requested the medical records some time later. The device was removed, and i was kept at (b)(6) med ctr for several days on iv antibiotics. Then i took iv antibiotics at home for a few more weeks, with a nurse coming over to replace the iv syringe in my hand every few days. Two months later, another vagus nerve stimulator was implanted by the same surgeon, who damaged my recurrent laryngeal nerve, leaving me unable to speak for a year. I will report that incident separately. (i assumed these adverse events were reported by the healthcare providers, and i was too severely depressed for years to even attempt to report these incidents myself. But now, years later, i want to be sure you know about these incidents). And i will file another report concerning severe sleep apnea caused by the second vagus nerve stimulator (which i cured in (b)(6) 2013 by having to demand that the neurologist adjusting the settings on the device turn it off, after suffering significant sleep apnea even on a bipap machine. At that point, i had found the studies revealing higher settings on these devices cause severe sleep apnea, severe depression, and cardiac arrest during sleep. But again, i will file separate reports for each of these incidents that contributed to the destruction of my health, disability, and having to live off ssdi since 2011. Of course, i do not have the first vagus stimulator that was removed in (b)(6) 2005. At the time the device was implanted, i was suffering from severe, unremitting depression because a psychiatrist misdiagnosed me with bipolar disorder merely because i experienced mild hypomania as a side-effect of sertraline, but not otherwise. Vns had no effect on my depression at the time, but the second vagus nerve stimulator nearly caused me to commit suicide because it was causing sleep apnea with an apnea hypoxia index of 47. On (b)(6) 2006, i had a second vagus nerve stimulator implanted for treatment-resistant depression after the first one had to be removed in (b)(6) 2006, because the surgeon infected me with (b)(6) while the first stimulator was implanted (i have submitted a report concerning that adverse event already). I have also submitted a report concerning damage to my recurrent laryngeal nerve when the second device was implanted, leaving me unable to speak for a year. Over the years, my psychiatrist, and then a neurologist, increased the output of the device. I had no risk factor for sleep apnea. I had been running literally 49 miles per week before i began to experience severe depression, in part as a result of settings for the device. I had a cpap sleep study on (b)(6) 2011, which revealed that i was not breathing between 10 and 30 seconds every minute of the night. My apnea hypoxia index (api) was 47. 4. The doctor who diagnosed me with sleep apnea told me that on a scale of 1 to 10 in severity, with 10 as most severe, he rated my sleep apnea as a 9. The settings on the vagus nerve stimulator as of (b)(6) 2011 were: parameters output current (ma): 1. 5, signal frequency (hz): 2. 0, pulse width (usec): 250, signal on time (sec): 30, signal off time (min): 5, magnet output current (ma): 1. 75, magnet on time (sec): 60, magnet pulse width (usec): 250, lead test/normal mode test output status (ok or limit): ok, lead impedance (ok or high): ok, dc-dc converter code (0-7): 3 eri flag (yes or no): no. Even using a bipap machine, my api fluctuated at scores from 8 to 40 until (b)(6) 2013. On that date, i brought several studies to my neurologist's office that proved indisputably that vagus nerve stimulation causes severe sleep apnea, severe exacerbation of depression and cardiac arrest during sleep. I was waking up for years feeling as though somebody had beaten my body with a baseball bat. The neurologist reluctantly turned the device off. That evening, and every subsequent evening since then, i have experienced no sleep apnea. I still have the product, but it is still implanted, and turned off. I do have the product packaging. Because i have the packaging, i will answer below that i do have the product. I weighed approximately (b)(6) pounds in (b)(6) 2011, as opposed to my weight listed in two other reports related to implantation of this device and a prior implantation of a vagus nerve stimulator. Lyme neuroborreliosis since 1980. Babesia microti infection since 1980, severe, unremitting treatment-resistant major depression from late 2003 to late 2006 because psychiatrist took me off medications i was taking for depression and put me on lamictal, zyprexa, etc. Merely because i experienced mild hypomania five days per month as a side-effect of sertraline; severe-to-extreme treatment-resistant depression from (b)(6) 2008 to present because a doctor caused extreme excitotoxicity by provoking a severe inflammatory immune response for an entire year while treating me far too aggressively for lyme disease, and also caused by vagus nerve stimulation. I was not able to reduce the depression to the moderate range until i discovered that buprenorphine acts synergistically with ketamine to reduce depression, and prevents tolerance to ketamine; i took the same dose of both medications for six years. I was able to get off 300mg intramuscular ketamine daily in six weeks, with no withdrawal symptoms, and with better results treating depression 1. 5 years ago when i began treating the cerebral cortex with a 30 watt, 810 nanometer (near infrared) laser that emits a collimated beam, in continuous wave mode for 50 minutes each evening. My nightly readings on my bipap machine, which i have saved, prove that when the vagus nerve stimulator was turned off, i no longer experienced sleep apnea that severely exacerbated my depression, and which caused extreme physical pain. After a vagus nerve stimulator had been implanted in (b)(6) 2015 and removed on (b)(6) 2015, a second vagus nerve stimulator was implanted by a dr. (b)(6) at (b)(6) medical center in (b)(6), on (b)(6) 2006. During the surgery, my left recurrent laryngeal nerve was damaged. I was unable to speak for an entire year. The surgeon casually told me that he did not know whether i would ever be able to speak again. For an entire year, i had to use as much energy as it takes to scream at the top of one's voice merely to make a rasping sound that was barely intelligible. I have a videotape with audio made about six months after the device was implanted, demonstrating the extent of impairment. I still have that video in digital format. The product itself is still implanted but turned off. Since the surgical procedure, not the product itself, caused the damage, and since the product is still implanted but turned off, i will answer below that i do not have the product so that you can evaluate it. I assumed at the time that the manufacturer or surgeon reported this, and then became too severely depressed as a result of sleep apnea caused by the vagus nerve stimulator (and also as a result of medical incompetence of a doctor treating lyme disease and babesia microti) that i was incapable of reporting it. A psychiatrist misdiagnosed me with bipolar disorder merely because i experienced mild hypomania five days per month as a side-effect of sertraline, but not otherwise. He took me off of sertraline and adderall, and put me on medications such as lamictal and zyprexa. In (b)(6) 2006, i finally felt capable of going to another doctor and asking to be put back on the medications i had been taking before i began seeing the psychiatrist who caused the three-year episode of severe depression. Within a week of being put back on those medications, i was not suffering from depression or mild hypomania. But the vagus nerve stimulator was implanted while the psychiatrist was causing me to suffer a three-year episode of severe, unremitting depression that was not responsive to ect.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7910123
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dennis100
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« Reply #117 on: October 06, 2018, 06:09:31 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/21/2000
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received indicating that during the vns placement the nerve on the right was nicked. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7877120
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« Reply #118 on: November 10, 2018, 04:05:51 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/14/2016
Event Type  Injury   
Event Description
The patient reported that she wants the device removed and has had side effects of nerve damage from vns. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7984823
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