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dennis100
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« on: January 01, 2016, 12:29:20 PM »

Model Number 102
Event Date 05/08/2007
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(4) 2013, it was reported that for a while the vns was efficacious for the patient but when the settings were increased, the patient began experiencing abdominal cramping which became so bad the patient wanted the device disabled. After several years, the patient had transferred care and the new physician decided to start the patient back up with vns the past summer to try vns again. He had gradually ramped the patient up, but the patient¿s abdominal issues came back, as well as voice alteration with stimulation. The physician stated that now that they have tried their best with vns for this patient, he is going to turn the patient¿s device off as the side effects are too much for the patient to handle. It was indicated the device is functioning properly. The physician believes that the abdominal issues occur with stimulation and that for the most part, the event had subsided when the patient¿s device had previously been disabled. The patient had not experienced this event pre-vns. The only interventions being planned at this time is device disablement. Previously in 2007 it was reported that the patient experienced constant abdominal cramping, and that this resolved when the output current was decreased to 0. 25ma. The physician reported that the patient has had this symptom "to varying degrees in the past", but the patient "feels the abdominal cramps have been worse since vns. ".

Event Description
On (b)(6) 2013, it was reported that the physician stated the patient¿s device has been disabled again and that it is going to be permanent in nature.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3137212
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dennis100
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« Reply #1 on: January 07, 2016, 09:50:36 PM »

Model Number MODEL 250
Event Date 09/22/2015
Event Type Malfunction
Event Description
It was reported that a vns patient's device had an abnormal change in programming parameters / settings during 19 months after implant. It is not clear if the parameters were changed voluntary. It was reported that the patient experienced several adverse events during that period, that were said to be possibly or probably related to stimulation (abdominal cramps, larynx spasms, coughing and voice alteration with social impact). It was reported that these events may have led to the change in programming settings. The site indicates an off time of 180 minutes on the last recorder parameters with 0ma, on (b)(6) 2015. This was double-checked and confirmed by the physician. The normal mode stimulation parameters were as follows: output current, 0ma / frequency - 20hz / pulse width - 130usec / on time, sec / off time, 80min. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5321978
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dennis100
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« Reply #2 on: February 02, 2016, 12:36:29 PM »

Model Number 300-20
Event Date 03/01/2012
Event Type Injury
Event Description
It was reported on (b)(6) 2012, that a vns patient thought his device was malfunctioning as it was sending electrical impulses to other parts of his body. The patient elaborated by saying he has been experiencing abdominal cramping, chest pain and should pain that was occurring every 5 minutes so he believed it as occurring with stimulation. The patient was also experiencing a shocking pain down his left arm and abdomen. When the patient met with his physician, he described the issues as a sharp pain in the left neck area, and sometimes it affects the left upper extremity, causing it to twitch, almost like a shock. At other times the pain is a funny sensation also in the right upper abdomen going to the right side of the abdomen. This lasts for about 30 seconds and occur every 3-5 days. Overall the pain is not and symptoms are not as severe, but they are still recurring, and strangely they do not occur every rhythmic beat with different time periods in between. The patient has not had any new weakness or numbness. No bowel or bladder changes. No trauma that could explain the symptoms. The patient does not have much of neck pain follow up with the physician revealed that the pain as subsided and the vns settings were lowered. The physician stated that the chest pain, should pain, and abdominal cramping were all related to vns however he did not indicate the relationship. There was no trauma or manipulation prior to the onset of any of the events nor was there any causal or contributory programming or medication changes. The physician will be programming the device off as a result of the reported events. The patient does not have a medical history of chest pain, shoulder pain, or abdominal cramping. When asked if there were any suspected device issues the physician responded "lead break?" however there were no diagnostic results available that indicated a device issue. X-rays were taken and sent to the manufacturer for review however no cause for the patient's adverse events was found. Additionally, no lead break or sharp angles were observed. The patient is going to be referred for revision surgery.

Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient denies having any pain with the device programmed off and there has not been any seizure activity either. The patient feels that the medications he is taking are controlling the seizures and he did not want to have his vns replaced at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2565708
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dennis100
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« Reply #3 on: February 08, 2016, 06:14:41 AM »

Model Number 105
Event Date 12/23/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
The patient reported that she is experiencing an increase in seizures as well as change in seizure pattern. She now states that her seizures appear to have an abdominal component as her stomach is upset with her seizures. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5370584
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dennis100
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« Reply #4 on: February 16, 2016, 03:26:23 AM »

Model Number 102
Event Date 06/15/2010
Event Type Injury
Event Description
Additional information was received that it was unknown when the patient's sleep apnea first occurred. It was not known or documented that it occurred with stimulation. The patient had a sleep evaluation performed on (b)(6) 2010 and is now on a cpap machine.

Manufacturer Narrative

Event Description
Clinic notes were received for review from a vns patient's office visit dated (b)(6) 2010. It was reported that a vns patient's husband had noted snoring, apnea, and prominent abdominal movements with her sleep breathing and she will be referred to a sleep clinic for a sleep apnea evaluation. Good faith attempts thus far have not yielded any further information about the reported event and the relationship to their vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434788
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dennis100
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« Reply #5 on: March 10, 2016, 05:10:05 AM »

Model Number 302-20
Event Date 02/28/2011
Event Type Malfunction
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the vns patient was experiencing painful stimulation in her abdomen. The patient's generator was implanted in the abdomen due to her small size. Diagnostics of the vns were performed at the patient's next visit that indicated high impedance. The physician was advised to disable the patient's vns; however, the physician chose to leave the stimulation enabled. It was noted that the patient has grown 7 inches since her initial vns implant. Surgery to replace the patient's vns lead and generator has occurred. When the lead was explanted, the lead was noted to be fractured. Attempts for the return of the explanted lead and generator have been unsuccessful to date. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2118871
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dennis100
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« Reply #6 on: March 20, 2016, 03:11:02 AM »

Model Number 102
Event Date 11/11/2010
Event Type Injury
Event Description
On (b)(6) 2011, additional information was received when the physician's assistant reported that the lead infection was first noticed on (b)(6) 2010 when the patient's family noticed a knot on the left side of neck and chest. The patient was told to go to the hospital for evaluation and the lead was removed around (b)(6) 2011. The patient was given iv antibiotics. The patient's family reported that the patient had had (b)(6). No patient manipulation or trauma had occurred that was believed to have caused or contributed to the infection. The physician's assistant did not know if it was the same infection as the infection at the generator site. He also was not aware that the patient was having any pain but said that it was probably related to the surgery and infection.

Event Description
Additional information was received on (b)(6) 2011 when the manufactures consultant reported that the patient had a neck exploration surgery that day to determine whether or not the patient would be reimplanted with vns. The surgeon decided not to implant a new vns system as he found that the vagus nerve was adhered with scar tissue to the internal jugular. The surgeon stated that he did not think it was possible to dissect the vagus from the internal jugular without damaging the internal jugular.

Event Description
Additional information was received on (b)(6) 2011 when clinic notes from the patient's physician were received. In the clinic notes dated (b)(6) 2011, the patient reported that not only had the generator become infected, but the lead also became infected and he had to have the lead explanted as well and go on more antibiotics. He reported that the infection was a (b)(6). Since the explant he reported that he has been having some dizziness and is unstable with ringing in his ears and dots in his vision and sometimes feel like he is going to black out. He also reports pain under his left axilla that goes down across his chest and stomach. Clinic notes dated (b)(6) 2011 revealed that the patient wants a vns re-implanted. Although surgery is likely, it has not yet occurred. Good faith attempts for additional information from the physician have been made but no further information has been received to date.

Event Description
Reporter indicated that his vns generator was explanted due to infection at the generator site in the chest, and the vns lead was left intact. The pt is currently on antibiotics for the infection. All attempts to the treating surgeon for further info have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of the 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=1943766
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dennis100
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« Reply #7 on: April 02, 2016, 03:56:28 AM »

Model Number 302-20
Event Date 08/01/2009
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported to mfr that the vns pt began experiencing a recent onset of painful stimulation in the chest and abdominal area, which occurred erratically, not with every stimulation cycle. Additionally, there was report of an increase in seizures activity, below the pre-vns baseline. Both system and normal mode diagnostic tests were preformed following the onset of the reported event and revealed normal device function. The physician believes that there is a device issue, and has referred the pt for surgery to replace the lead and the generator. X-rays were taken and sent to mfr for review where there were no gross lead discontinuities observed, and there were no other obvious anomalies visualized which could be contributing to the events. There was no report of trauma or manipulation of the device prior to the onset of the reported events, however, the mother reports that the pt is a "rowdy kid".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1510635
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dennis100
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« Reply #8 on: April 04, 2016, 02:17:38 AM »

Model Number 103
Event Type  Death   
Manufacturer Narrative
 
Event Description
Additional information was received from the physician stating that the vns patient¿s death was unrelated to vns. The patient achieved seizure reduction with vns and was receiving therapy at the time of death. Diagnostic results showed normal device function at the patient last office visit on (b)(6) 2014. Based on the available information about the patient¿s death, an internal classification has determined that the death was unlikely sudep.
 
Event Description
It was reported that the vns patient passed away. It was reported that the death certificate lists the cause of death as cardiac arrest, sepsis secondary to peritonitis. A significant condition was listed as seizure disorder. The relationship of the vns to the cause of death is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4381874
« Last Edit: October 29, 2018, 10:32:57 AM by dennis100 » Logged
dennis100
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« Reply #9 on: April 05, 2016, 03:03:22 AM »

Model Number 102
Event Date 04/08/2009
Event Type Injury
Event Description
It was reported that a vns patient was experiencing "severe issues with stomach ulcerations" and that the issue resolved with device disablement. Follow up with the patient's treating vns therapy, physician revealed that the patient had complained of an abdominal discomfort eight months prior to this initial report and that a endoscope performed earlier in this year had revealed the presence of several "brown spot and ulcerations". The physician indicated that there had not been any changes to patient therapy settings or medications prior to the onset of the abdominal discomfort and that the event began to improve with a decrease in therapy settings. Recent device diagnostic reportedly confirmed proper device function. The physician opted to disable the patient's device which reportedly resulted in "a cessation of abdominal pain. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1415218
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dennis100
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« Reply #10 on: April 05, 2016, 03:04:05 AM »

Model Number 102
Device Problem Extrusion
Event Date 06/20/2008
Event Type Malfunction
Event Description
A vns patient reported that she began experiencing numerous issues with vns therapy since implantation including weight loss, continuous abdominal pain and painful stimulation. The patient indicated that she had attempted to inhibit vns stimulation by taping her vns therapy magnet to her chest, but this had only resulted in the initiation of magnet stimulation and added that she would be seeking surgical consult for device explantation. Additional information was received from the patient who reported that in addition to developing a new seizure type, her seizures have increased "a thousand fold" since implantation. The patient also indicated that her carotid artery had been cut during implant surgery and added that she has lost around "2/3rd of her body weight" since implantation without any changes in diet or exercise. The patient stated that due to this weight loss, her generator and lead are now visible under the skin. Follow up with the patient's implanting surgeon revealed that the patient's carotid artery had not been cut during her implant surgery and that she has actually only lost around (b) (6), since being implanted with her vns device. The surgeon indicated that he had agreed to remove the device at the patient's request and added that explant surgery would occur within the week. Device diagnostics were performed at the patient's recent surgical consult and reportedly confirmed proper device function. Good faith attempts to the patient's past and present treating vns therapy physicians for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1473053
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dennis100
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« Reply #11 on: April 26, 2016, 03:34:50 AM »

Model Number 302
Event Date 06/01/2007
Event Type Injury
Event Description
Since i was implanted with cyberonics, inc vagus nerve stimulator in 2007, i have suffered a series of adverse reactions. These included: weight loss over a 2 month period- requiring 2 hospitalizations for dehydration -due to anorexia and abdominal pain-; severe left ear pain requiring visits to my ent and subsequent lowering of the strength of stimulation; severe shortness of breath accompanied by airway constriction, and low blood oxygen levels requiring evaluation by a pulmonologist, pulmonary function studies, and a cat scan; sleep hypopnea demonstrated by polysomnogram and a choking sensation. I must use the magnet provided by cyberonics inc at least 75% of the time. The stimulator, which was implanted for trd, never seemed to relieve my depression. Dates of use: 2007 - 2008. Diagnosis or reason for use: trd. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1033973
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dennis100
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« Reply #12 on: April 29, 2016, 03:29:28 AM »

Model Number 102
Event Date 07/17/2008
Event Type Injury
Event Description
It was reported that the pt experienced severe pain in her lower abdomen. The physician indicated that the pain may be related to stimulation. The pt was hospitalized for the pain, and her device settings were changed which resolved the pain.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1180455
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dennis100
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« Reply #13 on: April 29, 2016, 03:30:18 AM »

Model Number 103
Event Date 01/01/2008
Event Type Injury
Event Description
It was reported that pt has several issues with respiratory distress when he sleeps. In the last 2 months off and on, the skin around his collarbone would sink in and he would wheeze. Pt's caregiver attributed this to recent adjustments of the vns and dismissed it as it was infrequent; however, during his nap recently, he had his abdomen sinked under his ribs and had erratic breathing for about one min. It happened again fifteen mins later but much more violently. His heart was reportedly beating rapidly and his breathing was a high pitched wheeze. His entire abdomen was spastic. It took about a min for the pt to get back to normal. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1153329
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dennis100
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« Reply #14 on: May 04, 2016, 06:46:21 AM »

Model Number 302-20
Event Date 08/01/2005
Event Type Injury
Event Description
Initial reporter indicated that since implant of the vns device, the patient reported that they are having electrical shocks in the anterior shoulder region of the left clavicle and proximately into the neck. It was reported the shocking is present when the device is on, and is precipitated with forward flexion and rotation of the head to the right, with an occasional shock that radiates into her upper abdomen in the midline that takes her breath away. Left lateral bending of the head may give a shock in her left ear. Diagnostics ran have been within normal limits. The patient is scheduled to see a surgeon for evaluation and possible surgical revision.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=940334
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dennis100
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« Reply #15 on: May 27, 2016, 09:04:35 AM »

Model Number PULSE MODEL 102
Event Type No Answer Provided
Event Description
Device placed earlier this year and patient has been experiencing chest and abdominal pain since.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=788164
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dennis100
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« Reply #16 on: June 22, 2016, 02:09:36 AM »

Type of Device: Cyberonics VNS Pulse Generator
Device Brand Name: Demipulse
Device Manufacturer's Name: Cyberonics
Date of this Report: 03/08/2011
Describe the Event or Problem: Explantation of Cyberonics VNS Demipulse model 103 from left upper anterior chest due to malfunction. Patient reported shock-like sensation on the site extending up to the neck and down to left arm and left upper abdomen. Patient did not experience permanent harm.

the device(s) may have caused or contributed to: Minor injury to the patient or health care provider

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?id=23991
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dennis100
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« Reply #17 on: August 19, 2016, 04:59:43 AM »

Event Date 07/23/2008
Event Type Injury
Event Description
Vagus nerve stimulator implanted: 2006, turned on: the following month, explanted the following month: coil/electrodes not removed. Er visit: infection at incision site on my neck: a month after the original month. I told the nurse practitioner that something felt wrong with the lead in my neck. It felt like something had moved, it just didn't fell right. The first time i told her was in five months later, i believe. Er visit: nerve stimulator malfunction: the following month, no one there knew what to do, taped my magnet on and went home. Had x-ray, that was sent to cyberonics i had it turned off for at least a month. I was so afraid of turning it back on. Once i had it turned back on, i started having migraines almost everyday. I put up with it for several more months, then i asked for it to be turned off, and i asked about getting it removed. I believe it was turned off in 2007. After it was turned off, i started getting severe cramps in my neck. I had an appointment with dr at medical center in 2008 to discuss removal of my vagus nerve stimulator. He said the surgery was too dangerous, there could be scar tissue entangled around the carotid artery and or jugular vein. Surgery could result in a stroke or even death. He also said surgeons do not like to remove items implanted by other surgeons, because he doesn't know how it was put in. He suggested i do some stretching exercises. He said a muscle relaxer might help, but would not be good for my bi-polar. He said if it were him, he would leave it in until i couldn't bear the pain any longer. He also said, he thought there may be something else going on, the leads may not be causing the spasms. I told him that if i were not able to stretch my neck and get the cramping to stop, i would have to go to the er. I am afraid of that happening more, so now after what he has said about the surgery. I had to go to the er after an adjustment caused severe electrical shocks. The doctor in the er didn't have a clue what to do, and had never heard of the vns. They told me to go to the doctor that implanted it. That doctor is in missouri! the cramps/spasms are becoming more frequent. What happens if i do have to go to the er, are they going to have a doctor-neurosurgeon- there to do emergency surgery! my asthma is worse. I have to use inhaler every night. As soon as i lay down, i start to wheeze and cough. I wake up coughing and have to use the inhaler again. I don't need the inhaler during the day? - my abdomen has sharp pains when i turn over during the night. -the abdomen pain comes and goes - happened during the day only a couple of times - i am having terrible sneezing attacks that last 12-15 hours per day. But, if i sit completely still, i will not sneeze. These attacks are about every other week, or more. They completely wear me out! i have not felt well for a couple of months, fatigue, nausea and lots of bouts of diarrhea. I have pain - comes and goes - in both my breasts, like electrical shocks from the top all the way to my nipples. They are sore to touch, comes and goes. May be: the vagus nerve stimulator has aggravated my vagus nerve - and who knows what else - and is causing some of the problems i listed above. I called the surgeon in missouri - i live in nc now - and the nurse told me the doctor said the leads should not be removed. She said the doctor said surgery would cause more scar tissue. I was never told that the complete device couldn't be removed. Had to remove device approx four months later. Dates of use: 2006 -- 2007. Diagnosis or reason for use: depression.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1100549
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« Reply #18 on: August 25, 2016, 03:44:49 AM »

Model Number 103
Event Date 08/01/2015
Event Type Death
Event Description
Follow-up to the vns physician at the patient's group home revealed that the patient had died from a sudden cardiopulmonary event. Diagnostics performed on (b)(6) 2015 were within normal limits.

Manufacturer Narrative

Event Description
It was reported that a vns patient was deceased. Follow-up to the patient's long-term group care facility revealed that the cause of death was cardiac arrest. It was reported that in the week prior to the patient's passing the patient indicated abdominal discomfort and was evaluated by the staff. A physical examination on (b)(6) 2015 revealed the patient was alert, hydrated, and not in distress. The patient's lungs were noted to be clear of congestion. An ekg was performed and detected no murmur, no arrhythmia, and indicated normal function. Of the heart the patient was then seen by the treating neurologist on (b)(6) 2015 and the vns was checked. The patient experienced the cardiac arrest on (b)(6) 2015 and was taken to the nearest hospital. It was stated attempts to resuscitate were performed, but were unsuccessful and the patient was pronounced dead at arrival to the hospital. The hospital and the long-term group care facility declined to perform an autopsy. It was reported that as there was no clinical evidence of the underlying cause of cardiac arrest, sudep was possible. No additional relevant information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5462820
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« Reply #19 on: March 12, 2017, 01:19:47 AM »

Model Number 101
Event Date 01/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a patient was having his vns therapy pulse generator replaced due to battery end of service, and the new implant repositioned due to the fact that the original was placed in the abdomen region. Generator was subsequently returned to manufacturer for analysis. During analysis the reported end of service was confirmed based on battery voltage measuring 2. 017 volts during interrogation. Additionally, during testing it was noted that there was an out-of-limit measurement for the output back-up cap. This was determined to be due to an electrically "open" negative feed-thru capacitor. However, the "open" capacitor would not impede generator output or stimulation as the capacitor is provided for electro-magnetic interference protection only.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=970731
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« Reply #20 on: April 19, 2017, 12:01:10 AM »

Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
It was reported via clinic notes that a patient had an abdominal infection with a past generator replacement surgery. It is unknown which of the patient's surgeries the infection occurred after. The surgeon reported that the abdominal infection was unrelated to the vns implant site. The patient remained in the hospital after surgery for the infection to be treated. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6415443
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« Reply #21 on: May 02, 2017, 01:54:02 AM »

Model Number 302-30
Device Problem Migration of device or device component
Event Date 01/01/2014
Event Type Injury
Event Description
It was reported by the physician that the patient has had chest pain, in the form of an intermittent shocking pain, for over a year. It was reported this pain radiates to the neck and epigastric regions. It was reported that deactivation of the vns system does not help. The patient's x-rays appeared normal and system diagnostics all appeared normal. The patient has been referred for replacement. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
It was reported that the team of physicians elected to proceed with a generator replacement in an attempt to resolve the complaint of intermittent radiating pain. Surgery was performed on (b)(6) 2015. A diagnostic test was performed which showed the device was working as intended prior to explant. During the surgery, the physician noticed inflammation surrounding the generator site that he thought to be caused by the original placement of the device. Upon closing the patient, the surgeon witnessed a small break in the lead about an inch away from the lead pin. A full revision was performed, having the lead and generator both replaced. A diagnostic test was run with the newly implanted device which still showed normal impedance levels. The explanted lead and generator were sent to the pathology department of the hospital. It was also found by the surgeon during surgery that the explanted lead did not appear to be attached to the correct nerve. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The surgeon later described the inflammation found during surgery. He stated the lead insulation was torn with exposed wires at the generator site. The surgeon also stated the patient's pain has resolved since the vns revision surgery. No additional relevant information was received.

Manufacturer Narrative
Evaluation, corrected data: this information was inadvertently left off of supplemental #02 mfr. Report.

Event Description
It was reported that the patient's generator has migrated and is causing constant pain at the chest site. Device diagnostics were within normal limits. The patient was referred for x-rays. The physician believes that the migration is a result of weight change and growth since implant. It was reported that surgery will be required to reposition the device. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative
Brand name; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report. Type of device; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report. Model#, serial #, lot#, exp. Date; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report. Device manufacture date; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4341541
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« Reply #22 on: May 03, 2017, 12:47:01 AM »

Model Number 103
Event Date 11/10/2014
Event Type Injury
Event Description
It was reported that the vns patient was experiencing shocking sensations in his abdomen that travelled up to his chest. The patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results showed lead impedance within normal limits (impedance value ¿ 4272 ohms). The patient¿s device was disabled on (b)(6) 2014. It was noted that the patient was unable to tolerate stimulation on-times with the output current programmed greater than 0. 25ma. The nurse stated that the patient¿s pain may not be related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4316922
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« Reply #23 on: May 06, 2017, 09:12:51 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 03/06/2017
Event Type Injury
Event Description
It was reported to a company representative by a vns patient¿s mother that the patient was having an increase in seizure frequency and intensity. The mother believes the battery is no longer functioning, possibly since (b)(6), and said the patient has pain in the chest and at the side of her neck and in her abdomen. The patient had 3 grandmal seizures in a 12 hour period about a week or 2 ago and as-of (b)(6) 2017 she was having a grand mal seizure every day or every other day. Generator replacement surgery occurred (b)(6) 2017. The explanted device has not been received by the manufacturer to-date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6491260
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« Reply #24 on: May 07, 2017, 07:54:47 AM »

Model Number 103
Event Date 08/19/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that following vns implant the physician ordered a g-tube to be placed and a one night stay in the hospital. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4095649
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« Reply #25 on: July 07, 2017, 03:14:58 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/26/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was having pain due to upgrading from a 103 to a 106 due to the increase in size of generator. Clinic notes indicated that the patient had had some pain at the generator site since the procedure. She also had felt a continuous electric shock in her chest wall since her replacement that radiated to her left arm and left upper abdomen as well as numbness down her left arm. After she turned her generator off, her symptoms improved. She continued to have daily auras and seizures and had the worst period of seizures that she's had in years. For these reasons the surgeon recommended replacement of her generator with a m103 due to previous good results. The surgeon's office indicated that they believed that the continuous shocking may be caused by autostimulation. The issues resolved when the device was turned off, but the patient's seizure rate increased because of this. The surgery was indicated to be due to medical necessity. The patient was replaced due to painful stimulation. Lead impedance issues were not detected prior to the replacement. Per the surgeon, he did not observe any lead defects on the visible portion of lead during surgery. No further relevant information has been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6668568
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« Reply #26 on: July 14, 2017, 03:45:57 AM »

Model Number 104
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was initially reported by a vns patient's mother that the pt was experiencing "a lot of severe gi issues. " the mother clarified by saying she first sought help for the issues in (b)(6) 2010, but the pt had to have his gall bladder removed in (b)(6) 2010 due to gall stones. The pt had now recently developed "severe esophageal erosion", a hiatal hernia, and severe reflux. According to the mother's report, the esophageal erosion was severe enough that a food bolus was lodged in the eroded cavity in the patient's throat. The mother did report that she was pleased with the seizure control from the vns, but she was worried the vns may be causing the gi events. Follow-up with the patient's gastroenterologist was obtained. However, the pt had only been seen at the site twice. The pt had been referred to the site because of nausea, vomiting, and abdominal pain after his gall bladder surgery. The nausea and vomiting were likely related to the patient's surgery, and notes from the patient's neurologist indicated that the pain could not be caused by vns. The gastroenterologist had performed a ct scan on the pt in (b)(6) 2011, which showed a thickening of the bladder wall, but this was not attributed to vns. The gastroenterologist's office stated that the issues of the patient's reflux, gall bladder, hernia and erosion could not be answered by them, but the patient's family practitioner who had referred the pt to them may be able to provide more info. Good faith attempts made to the patient's family practitioner to date for more info on the patient's reflux, gall stones, hernia, and esophageal erosion have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1972380
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« Reply #27 on: July 27, 2017, 11:23:27 AM »

Event Date 01/05/2011
Event Type  No Answer Provided   
Event Description
Explantation of cyberonics vns demipulse model 103 from left upper anterior chest due to malfunction. Patient reported shock-like sensation on the site extending up to the neck and down to left arm and left upper abdomen. Patient did not experience permanent harm.

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« Reply #28 on: August 20, 2017, 07:52:19 AM »

Model Number 300-20
Event Date 09/22/2011
Event Type  Malfunction   
Event Description
Product analysis of the explanted vns generator and lead was completed. No anomalies were identified with the generator and the generator performed per specifications. Analysis of the lead portion returned identified abraded openings on the outer and inner silicone tubing. Note that since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations typical wear and explant related observations, no additional anomalies were identified in the returned lead portions. No lead discontinuities were identified.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated the patient had vns generator and lead replacement performed on (b)(6) 2011, due to a lead discontinuity, but an actual lead fracture was not visualized during the surgery. Significant scarring of the lead was noted. The lead was removed in pieces, and was noted to be coiled behind the generator. The generator was implanted in the abdomen intentionally when the patient was 2 years old. It is believed the patient's body growth may have contributed to the suspected lead fracture. The explanted vns generator and lead have been returned and are pending product analysis.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal a lead discontinuity. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
All attempts to the reporter for additional information have been unsuccessful to date.
 
Event Description
Reporter indicated a patient had high lead impedance readings with the vns. The vns was disabled and the patient was referred for x-rays and possible surgery. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2302139
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« Reply #29 on: October 04, 2017, 01:08:53 AM »

Model Number 103
Event Date 10/01/2012
Event Type  Malfunction   
Event Description
A vns patient's caregiver reported that the patient was having "a lot of problems" since her last cluster that started (b)(6) 2012, which included one grand mal seizure. The patient and caregiver reportedly talked to the treating vns physician on (b)(4) 2012. The caregiver indicated that he was "pretty sure that the vns device is causing problems and may be malfunctioning somehow". The device was reportedly disabled for periods of time on (b)(6) 2012, and the patient feels much better with the device disabled. The caregiver was leaving the vns magnet taped over the device to keep the device disabled. The caregiver was planning on having the patient evaluated by the treating physician to perform diagnostic tests. Attempts for additional information from the treating physician have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received indicating the patient was seen by the physician again on (b)(6) 2013, and the patient/spouse and physician elected to turn the device on to low settings at 0. 25ma. All is reportedly well with the patient at this time and the patient will continued to be monitored.
 
Manufacturer Narrative
Age at time of event, corrected data: additional information received indicates the event date was around (b)(4) 2012, and therefore, the initial report inadvertently reported the age incorrectly. Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not list that intervention was taken. Date of event, corrected data: additional information received indicates the event date was around (b)(4) 2012, and therefore, the initial report inadvertently reported the date incorrectly.
 
Event Description
The patient had an appointment with the treating vns physician on (b)(6) 2013, and the company representative attended the appointment. The clinic notes for the office visit were received and reviewed. The patient's device was turned off on (b)(6) 2012, but the magnet output current was left at 1. 0ma so she could still swipe the magnet when she feels a seizure coming on. The interval month was met with a lessening in frequency and intensity of partial epilepsy. The patient has utilized this feature, per the clinic notes. The device was turned off because of tachycardia arrhythmia and epigastric pain and pyrosis which was felt potentially to be aggravated by the vns. The patient was wearing an monitor from the cardiologist, and the arrhythmia reportedly stopped after the device was turned off. She did not have any more episodes. The epigastric pain and pyrosis is believed to have begun around the same period of time as the arrhythmia. The physician does not believe the device is malfunctioning, as diagnostics are within normal limits. However, the physician noted that it is of interest that the patient has not had any cardiac sinus tachyarrhythmia or epigastric pain/pyrosis since the device normal output current has been turned off. The physician notes there is a questionable relationship of these events to vns therapy, and the epigastric pain/pyrosis is suspicious for vagotonia. At this time, the plan is to keep the device turned off (except magnet mode) and monitor the patient. Previously on (b)(6) 2012, the physician mentioned that the patient had a high pulse rate at 140 bpm at a previous dosing session (unknown date) but later dropped to 106 bpm. The physician did not think the issue was related to the vns at the time, but did refer the patient to cardiologist for evaluation. The physician noted at that time that nothing was found.
 
Event Description
Additional information was received from the patient indicating that she was taken to emergency room in (b)(6) 2012 due to tachycardia experienced during vns stimulation. She denied any reoccurrence of tachycardia since vns was "turned down. ".

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« Reply #30 on: October 06, 2017, 10:10:17 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 08/16/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient woke up one day and was experiencing severe pain in the chest and neck. There was no known trauma to the vns and the neurologist didn't know what the cause was. The patient's settings were lowered and x-rays were ordered. Clinic notes indicated the patient patient's mother had called and reported that the patient was having severe chest pain and the patient was given fentanyl en route. A chest x-ray was unremarkable. A neurologist disabled her normal mode output current. Post pain medications and device disablement , the pain went away with no recurrence. The pain appeared to be prominently in the left side of the chest but also went into her neck and lower trunk region. The patient's mother indicated that the patient's pain was cyclical. There was no recent trauma to the head, neck and chest, and no patient manipulation. When the vns was turned on to 0. 5 ma the patient began to experience pain again, and her device was re-disabled. It was believed that the patient's pain was related to stimulation. The patient's device was reportedly working properly with good impedances. The physician believed that the patient's generator and leads may need to be replaced. The pain was reported to be serious. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6858790

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« Reply #31 on: October 19, 2017, 01:25:34 AM »

Model Number 103
Event Date 01/01/2013
Event Type Malfunction
Event Description
It was reported that the patient underwent generator and lead replacement surgery. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the returned lead and generator was completed on (b)(4) 2014. Analysis of the returned generator revealed no anomalies, and the device performed according to specifications. The output signal of the generator was monitored for more than 24-hrs and the 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. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. 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. Analysis of the returned lead revealed that, other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

Manufacturer Narrative

Event Description
Follow up with the physician found that the physician tried the magnet on the patient and there were no muscle spasms, and therefore did not believe they were related. On (b)(6) 2013, the patient reported that she had a seizure the night prior and went to the ed. After being released from the ed, they patient was called back and told that the cat scan showed a tumor, cyst, or spot on her brain. Per the patient, the leads were on backwards and she was having a lot of gi problems. Follow up with the physician found that the patient was no longer his patient as of the last six to seven months. However, the patient was under the physician's care as of (b)(6) 2013. The patient's vns was found to be in proper working order and of proper function. Diagnostics on each visit were found to be appropriate as of the last visit on (b)(6) 2013. The patient has had seizures on and off since the initiation of her care in 2011. On her visit of (b)(6) 2013, the patient stated that she had a seizure the day previous on (b)(6) 2013. Over the last several months, the patient's vns has been adjusted. Her output has been increased. Her medications have also been adjusted appropriately. The physician received a fax from the patient on (b)(6) 2013 stating, "the last medication and vns adjustments that you made worked perfectly and i haven't had a seizure since my last appointment. " her last appointment before (b)(6) 2013 was on (b)(6) 2013. The patient alleges that has had increased seizures for six to seven moths; however, her seizures have been somewhat sporadic. The patient's chart also alludes that she has had a complaint of abdominal spasms, possibly not related to her seizures. The physician's inquiry did not reveal any relationship of these spasms to her vns device whatsoever, however, he stated that he is now aware that they patient told the manufacturer that her spasms are related to her magnet use. When the magnet diagnostics were performed in the physician's office on the patient's last visit of (b)(6) 2013, the patient had no evidence for abdominal spasm visually perceived by the physician nor complaint of the spasm at that time, verbally complained by the patient. No cause or contributory programming changes, medication changes, or factors that the physician is aware of seem to increase the patient¿s seizures. In summary, the patient¿s vns device appears to be working properly. There appears to be no connection between the patient¿s vns device and her complaint of increased seizure events. No additional information has been provided.

Event Description
On (b)(6) 2013, the patient reported that she has been having some "bizarre" symptoms lately and that she has been having an increase in seizures over the past six to seven months. She stated that she has about one per day. The patient is also experiencing muscle spasms in her abdomen on the left side that is affecting her bowel movements. On (b)(6) 2013, the patient reported that she is having issues with her magnet not helping her stop her seizures and that she is experiencing muscle spasms in her diaphragm and abdomen. The patient is not sure if the muscle spasms are related to her vns, but has noticed the spasms occur when she uses her magnet. Follow up with the physician found that the patient was seen in her office on (b)(6) 2013. The physician ran diagnostics and everything was ok. The physician stated that she swiped the patient's magnet and the patient was able to feel stimulation. There were no muscle spasms or any issues with the patient when she received the magnet stimulation. Per the physician, the patient appeared anxious, so it was discussed if she should see someone for her anxiety. No additional information has been provided.

Event Description
Clinic notes dated (b)(6) 2013 note that the patient suffered a seizure while driving in (b)(6) 2013 and rear-ended another vehicle at 70 ml/h. It was noted that since then the patient's seizures have significantly worsened. It was noted that the patient's output current was reduced and she was doing somewhat better. It was noted that device diagnostics showed lead impedance "ok". The patient was sent for x-rays of the chest and abdomen. Chest x-ray report indicated that the x-ray did not identify any obvious lead fractures. Abdomen x-ray report indicated that the impression was a negative exam.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3283359
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« Reply #32 on: October 24, 2017, 01:06:11 AM »

Model Number 104
Event Date 04/01/2013
Event Type Injury
Event Description
On (b)(6) 2013, a patient¿s mother reported that her son developed gastroparesis in (b)(6) 2013. The mother stated that the physician had said they have no information on what it could have been caused by. The patient¿s device was last interrogated on (b)(6) 2013, and to the mother¿s knowledge, everything was ok. There were no noted events that preceded the gastroparesis. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Clinic notes were received for the vns patient¿s office visit with his neurologist on (b)(6) 2014. The notes listed epigastric abdominal pain as one of the patient¿s current problems.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3452684
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« Reply #33 on: November 07, 2017, 02:00:36 AM »

Model Number 103
Event Date 08/12/2014
Event Type Injury
Event Description
It was reported that the study patient experienced an increase in seizures, epigastric pain with hospitalization, loss of appetite, vomiting, diarrhea and nausea. An adverse event form was received indicating that the patient experienced vomiting, diarrhea and gastroenteritis. It was reported these events were not related to vns and have been resolved. No additional relevant information has been received to date.

Manufacturer Narrative
Report source; corrected data: the previously submitted mdr inadvertently did not indicate "study" as a report source.

Manufacturer Narrative

Event Description
Further information was received which disregarded vomiting and diarrhea as individual adverse events. The reported gastroenteritis was not associated with congenital anomalies or birth defect, it did not result in a persistent or significant disability or incapacity and it was not associated with other serious or important medical events. The reported gastroenteritis was not a life threatening event and it did not result in death.

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« Reply #34 on: November 10, 2017, 02:14:59 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/05/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 that the patient experienced dizziness just before the device turns on and if she is standing she feels as if she will pass out. The onset of this event was about 3-4 weeks prior to the report ( (b)(6) 2014). The patient was initially implanted on (b)(6) 2014 and the neurologist last increased her normal mode output to 1. 25 ma. The patient also reported burning in the epigastric region during stimulation. Diagnostics were normal. Additional information received indicated that the patient alleged that her device was stimulating more frequently than every 5 minutes as it was set to do. The patient put a magnet in place to disable the device, and went to urgent care for treatment. Further information was received indicating that the pulse generator had been disabled. X-rays were taking with no remarkable findings by the medical professional. No surgical intervention has occurred to date.

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« Reply #35 on: November 12, 2017, 03:28:41 AM »

Model Number 105
Event Date 04/17/2013
Event Type Injury
Event Description
It was reported that the vns patient experienced vomiting, melena, abdominal pain, and other various gi issues since (b)(6) 2013. The physician stated that the patient¿s symptoms were more consistent with colitis per colonoscopy. The physician believed that the events were more likely gi related but was unable to rule out vns as a contributing factor. The patient¿s device settings were subsequently decreased. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was received that the vns patient was seen and it was determined that their events were not related to their vns, but rather to colitis.

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« Reply #36 on: November 20, 2017, 03:26:54 AM »

Model Number 102
Event Date 04/23/2015
Event Type Injury
Event Description
It was reported that the vns patient had presented increased seizures for 6 weeks. It was reported that the patient had benefited from vns therapy when the duty cycle was increased from 16% to 29%. Night seizures had not occurred since (b)(6) 2015 after the increase in the duty cycle. The night seizures occurred again six weeks earlier and the patient also presented complex partial seizures during the day, after waking up, with anxiety, rapid heartbeat, panting, stiffening of the arms and partial loss of conscience, being able to hear but not to respond. It was also reported that the vns generator was interrogated and the output current was found at 1ma while it had been programmed at 2ma in the last follow up visit, with the rest of the settings unchanged: frequency 25 hz, pulse width 500usec, 21sec on time, 1. 1min off-time, magnet output current 2. 25ma. The patient¿s device was tested and system diagnostics returned impedance results within normal limits with dcdc 2 and normal mode diagnostics returned dcdc 5. It was reported that the impedance results were the same as in (b)(6) 2015. It was reported that the output current was set to 2ma and the duty cycle was increased from 29% to 36% with 21sec on-time and 0. 8min off-time. The patient had not noticed when vns stimulation did not alter the voice any longer. The patient is (b)(6) years old and has had epilepsy since her (b)(6) year. During the first year she had several seizures per year over a period of 3-4 weeks with anxiety seizures and milder seizures with rapid onset of abdominal pain with paleness without loss of consciousness and generalized tonic-clonic seizures. From her (b)(6) year she presented mainly 3 night seizures per week w, no longer in clusters. The epilepsy is mri negative, with both temporal as frontal symptoms. Review of the available programming and diagnostic history showed normal diagnostic results and no programming anomalies through (b)(6) 2015. Review of manufacturing records confirmed that the generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that both the generator and the lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4874298
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« Reply #37 on: December 10, 2017, 01:52:59 AM »

Model Number 102
Event Date 06/01/2015
Event Type Death
Manufacturer Narrative

Event Description
Clinic notes were received regarding the patient's reason for admission to the hospital and her death. It was noted the patient was admitted to the hospital on (b)(6) 2015 and discharged on (b)(6) 2015. It was noted that the day before she was admitted, she was on the toilet and fell to her side, injured her left ribs, but the staff did not think too much about it because she did not really complain. But, as time went on, she started complaining more of shoulder pain, breast pain, and lateral chest pain, so they brought her into the e. R. Where 2 fractured ribs on the left anterolateral side were found. It was felt by the physician that the patient should be admitted so that they could observe her. The patient was admitted and had no problems over the weekend. On monday morning, the physician was told the patient had an arrest. He discussed with the physician on call and the nurse and it was explained that around 3 am the patient had some nausea and abdominal pain. They provided the patient with zofran and then when they went to check on her again, she had vomited and it was noticed she has some pudding around her mouth. At that time, she was just staring and then just "went out. " a sternal rub was performed and a code was called, but they were unsuccessful. It was decided the patient most likely aspirated and an autopsy was not performed.

Event Description
It was reported by the company representative that the patient had passed away. An obituary search provided the date of the patient's death, but no cause of death was provided. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5463400
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« Reply #38 on: December 14, 2017, 03:36:31 AM »

Model Number 103
Event Date 01/29/2016
Event Type Death
Event Description
Follow-up information from the physician indicated that the patient's cause of death was abdominal sepsis / renal insufficiency, not related to vns therapy.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2016 that the patient died on (b)(6) 2016. The patient was implanted with vns on (b)(6) 2014. Attempts for additional information have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5499226
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« Reply #39 on: April 23, 2018, 01:12:08 AM »

Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
Garci´a-navarrete e, et al. Long-term results of vagal nerve stimulation for adults with medication-resistant epilepsy who have been on unchanged antiepileptic medication. Seizure: eur j epilepsy (2012), http://dx. Doi. Org/10. 1016/ j. Seizure. 2012. 09. 008.
 
Event Description
An article entitled ¿long-term results of vagal nerve stimulation for adults with medication-resistance epilepsy who have been on unchanged antiepileptic medication¿ was received. Forty-three patients were followed. After implant, patients were evaluated on a monthly basis increasing stimulation 0. 25 ma at each visit, up to 2. 5 ma. Medication was unchanged for at least 18 months since the stimulation was started. Of the 43 operated patients, 63% had a simulation or great than 50% reduction in seizure frequency. Differences in the responder rate according to stimulation intensity, age at onset of epilepsy, duration of epilepsy before surgery, previously epilepsy surgery, and seizure type, did not reach statistical significations. Most side effects were well tolerated. One patient reported an increase in the duration and intensity of his seizures. Twenty-two patients experienced side-effects. The most common were mild, consisting in hoarseness, neck tingling or occasional coughing at the time when the signal was on, all of which were usually well tolerated. Two patients had intermittent dyspnea, and another patient experienced occasional episodes of dysphagia with stimulation. Irritability was reported by two families, in the context of a general improvement in the level of alertness. Five had severe side effects, requiring their vns generators to be inactivated or explanted. Three of the 5 patients that stopped receiving stimulation had been responders. Reasons for explanation were infection in two patients, and odynophagia, in one patient. One patient had an exacerbation of a previous behavior disturbance, with severe aggressiveness, which improved when the stimulator was inactivated. Seizure reduction was maintained after the stimulation was stopped. Another stimulator was removed at family request, owing to a persistent abdominal pain. One explant due to infection is captured in this report: mfr report# 1644487-2013-01450. The other explant due to infection is captured in mfr report #1644487-2013-01453. The explant due to odynophagia is captured in mfr report #1644487-2013-01449. The explant due to abdominal pain is captured in mfr report #1644487-2013-01447. The report of increased seizure duration and intensity is captured in mfr report #1644487-2013-01444.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3120504

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« Reply #40 on: April 28, 2018, 12:53:37 AM »

Model Number 302-30
Event Date 01/16/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 clinic notes were received dated (b)(6) 2013 that indicated the patient has been experiencing an increase in seizures; the patient had about 30 abdominal rushes (averaging about 6 per month) which is an increase since before (4 per month). The patient also complained of ¿pulling of her vns¿ about once a month, lasting for several minutes, especially when she is laying down at night. The patient¿s settings were noted to be output=3. 25ma/frequency=20hz/pulse width=250usec/on time=60sec/off time=1. 1min/magnet output=3. 50ma/magnet on time=60sec/magnet pulse width=250usec. Diagnostics showed results within normal limits of output=ok/lead impedance=ok/impedance value=1673ohms/neos=no. The clinic notes dated (b)(6) 2013 indicate that the patient has had 20 auras but no seizures since the office visit on (b)(6) 2013. Good faith attempts for further information from the physician were unsuccessful.

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« Reply #41 on: May 02, 2018, 01:58:44 AM »

Model Number 302-20
Event Date 03/26/2015
Event Type  Injury   
Event Description
It was reported that the vns patient had presented a sharp pain in the left side of the neck and pulling sensation. The patient did not perceive the stimulation and she could not indicate whether the pain occurred with stimulation or not. The settings were programmed at 1. 5ma, 25hz, 130usec, 30secs on and 5mins off. The patient has dystonia and moves her neck quite a lot. X-rays were recommended but the patient did not wish to undergo any further surgical revision and preferred to have the generator disabled. Additional information was received indicating that the patient was implanted for depression. The pulse generator vns was disabled as the patient was experiencing severe discomfort. The patient wishes to undergo vns explant surgery because she believes that her cervical dystonia/torticollis is being worsened by vns. It was reported that the patient presented a severe pain episode caused by the lead, which seemed to be protruding more than it had done previously. It was reported that the patient also presented breathing difficulties, loss of some vision in one eye, severe pain in the middle of her back and abdominal pain which was relieved by the application of plasters. It was believed that these symptoms were related to the patient¿s depression. Surgical intervention for the explant of the vns system is expected but it has not occurred to date.

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« Reply #42 on: May 04, 2018, 01:26:11 AM »

Event Date 06/18/2013
Event Type  Malfunction   
Manufacturer Narrative
The initial report inadvertently reported the incorrect date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Manufacturer reviewed device history records. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Review of lead device history records confirmed all quality tests were passed prior to distribution. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
A vns treating nurse reported that the patient who recently had generator replacement on (b)(6) 2013 was recently checked by the nurse for the first time after receiving new medical care. The nurse checked the vns system via diagnostics prior to replacement surgery and in recovery after surgery. All was reportedly okay with the lead, according to the diagnostic readings. The patient was later seen in the local emergency room a couple of days later due to some abdominal pain found to be mostly gas and not related to vns. However, a chest x-ray was performed, and the vns lead was found to be fractured as confirmed by the surgeon. The nurse reported a ¿7. 5 cm gap between the ends of the lead in patient's chest. ¿ the patient was seen on (b)(6) 2013 for post-op vns visit, and she again checked the lead with okay results with lead impedance value at 3561 ohms. The nurse turned off the device on (b)(6) 2013, and reported that the patient may or may not have the lead replaced. No manipulation or trauma was reported to the nurse that may have contributed to the lead fracture. The patient has not reported a change in stimulation perception; however, the patient is developmentally delayed so the nurse is not sure that he would know to report it. Attempts for lead product information have been unsuccessful to date. Ap chest and abdominal x-rays were received by the manufacturer for review. Based on the x-rays images received, there is a gross lead fracture in approximately the middle portion of the lead which is most likely a result of the patient twiddling the lead in the chest. Also, the portion of the lead behind the generator could not be assessed, therefore a lead fracture in that portion of the lead cannot be ruled out. The presence of an additional micro-fracture in the lead also cannot be ruled out.

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« Reply #43 on: May 15, 2018, 08:22:19 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death. Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Brand name; corrected data: additional information indicates that the suspect device is the lead. Type of device, name; corrected data: additional information indicates that the suspect device is the lead. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead. Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury. Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity. The patient¿s pain was occurring with stimulation and due to lead discontinuity. The explanted products have not been returned to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr. Report. Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr. Supplement report #3. Additional manufacturer narrative, corrected data: mfr. Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr. Report. ".
 
Event Description
It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea. The patient experienced pain and coughing at the time of device interrogation.
 
Event Description
Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.
 
Event Description
The patient¿s pain was occurring with stimulation and due to lead discontinuity. The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).
 
Event Description
It was reported that the vns patient was experiencing very painful side-effects from vns. Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple. This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches. The patient was most uncomfortable at night and when she was lying down. The patient later reported that the pain was getting worse and that she was feeling sick and panicking. The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression. The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms. The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function. No known interventions have occurred to date.

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« Reply #44 on: June 18, 2018, 01:15:16 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death. Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Brand name; corrected data: additional information indicates that the suspect device is the lead. Type of device, name; corrected data: additional information indicates that the suspect device is the lead. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead. Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury. Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity. The patient¿s pain was occurring with stimulation and due to lead discontinuity. The explanted products have not been returned to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr. Report. Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr. Supplement report #3. Additional manufacturer narrative, corrected data: mfr. Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr. Report. ".
 
Event Description
It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea. The patient experienced pain and coughing at the time of device interrogation.
 
Event Description
Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.
 
Event Description
The patient¿s pain was occurring with stimulation and due to lead discontinuity. The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).
 
Event Description
It was reported that the vns patient was experiencing very painful side-effects from vns. Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple. This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches. The patient was most uncomfortable at night and when she was lying down. The patient later reported that the pain was getting worse and that she was feeling sick and panicking. The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression. The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms. The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function. No known interventions have occurred to date.

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« Reply #45 on: June 21, 2018, 12:33:13 AM »

Model Number 302-20
Event Date 06/01/2010
Event Type  Malfunction   
Event Description
It was initially reported that the pt was scheduled for a head scan (with head coil) mri and was in the scanner for 59 seconds. At the time, the pt's mother had not told scanning technicians about the pt's vns device; consequently, it was not disabled during this brief time period. Once the vns implant was discovered, the scan was stopped. The nurse performed a system diagnostics test, which showed high lead impedance. The pt was known to have her pulse generator placed in the abdominal cavity due to her comorbidities. The pt was disabled and the mri was continued. It was later indicated that the pt had a fall about two weeks prior to the mri, of which the mother was not initially forthcoming about. The pt apparently fell and hit her stomach area, which is the place where the pt has her generator placed due to the many shunts she has in place due to her disease. She indicated that she received a copy of the radiologist's reports and there was a note that there was a lead fracture in the neck area. The x-rays were requested to be sent to the manufacturer for review, but have yet to be received. There was a belief that the fall was the cause of the high impedance and not the mri. A search performed in the manufacturer's programming history database showed that the last known diagnostics were within normal limits. It is unk at this time if the pt will be having the device replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774433
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« Reply #46 on: July 12, 2018, 01:10:34 AM »

Model Number 103
Event Date 08/12/2014
Event Type  Injury   
Event Description
It was reported that the study patient experienced an increase in seizures, epigastric pain with hospitalization, loss of appetite, vomiting, diarrhea and nausea. An adverse event form was received indicating that the patient experienced vomiting, diarrhea and gastroenteritis. It was reported these events were not related to vns and have been resolved. No additional relevant information has been received to date.
 
Event Description
Further information was received which disregarded vomiting and diarrhea as individual adverse events. The reported gastroenteritis was not associated with congenital anomalies or birth defect, it did not result in a persistent or significant disability or incapacity and it was not associated with other serious or important medical events. The reported gastroenteritis was not a life threatening event and it did not result in death.
 
Manufacturer Narrative
Report source; corrected data: the previously submitted mdr inadvertently did not indicate "study" as a report source.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4278678
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« Reply #47 on: October 04, 2018, 04:15:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/30/2014
Event Type  Death   
Event Description
A representative of the following neurologist's facility confirmed that the patient was deceased. The representative did not provide a cause of death for the patient. Clinic notes on file for the patient indicated that the patient was admitted to the hospital for abdominal pain and was pronounced dead two days later. It was unknown whether the patient's abdominal pain was related to the patient's death or to the vns. The representative did not provide an assessment regarding the relationship of the patient's death to vns. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Explanted devices were received from another medical device manufacturer. The reason for explant was not indicated; however, an obituary search indicated that the patient implanted with the devices was deceased on (b)(6) 2014. Product analysis was performed on the explanted lead and generator. Analysis was approved for on the returned generator. An end-of-service message was observed on the generator. Review of the data downloaded from the indicated increased impedance; the pre-change impedance value was 1705 ohms, and the post-change value was 19911 ohms. The time of change detection (b)(6) 2014, indicating likely explant on this date. The pulse generator was tested and performed according to functional specifications, and there were no adverse conditions found with the generator. Analysis was approved for the lead. No discontinuities were identified within the returned lead portion. Setscrew marks were observed on the connector pin, providing evidence that proper contact between the setscrew and the connector pin existed at least once. Microscopy showed that pitting occurred on the surface of the connector ring. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant. Note that since a significant portion of the lead, including the electrode array, was not returned for analysis, an assessment cannot be made on that portion of the lead. No anomalies were identified in the returned lead portion. No additional relevant information has been received to date. The circumstances of the device explant have not been confirmed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7073931
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« Reply #48 on: October 29, 2018, 10:33:49 AM »

Model Number 102
Event Date 05/01/2009
Event Type  Injury   
Event Description
It was reported that the patient was having abdominal cramps, vomiting, nausea and multifactorial abdominal pain. The events were severe in nature. Patient was hospitalized. As per medical professional, patient's abdominal pain was possibly related to implantation, vomiting was possibly related to implantation and stimulation, nausea was possibly related to implantation and stimulation and multifactorial abdominal pain was possibly related to stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1431958
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« Reply #49 on: January 16, 2019, 02:39:28 AM »

Model Number 302-20
Event Date 04/11/2014
Event Type  Malfunction   
Event Description
The generator appears in the left abdominal area in an abnormal placement.
 
Manufacturer Narrative
The initial manufacturer report incorrectly stated that the x-rays showed normal placement of the generator in the upper left chest. The x-rays showed abnormal placement of the generator in the left abdominal area.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested on (b)(6) 2014 and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently programmed off. There was no change in the patient¿s seizure activity. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin was fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the x-rays images, the cause high lead impedance could not be determined. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. During the procedure, it was noted that the electrode had visible damage right beyond the anchor tether. The explanting facility discarded the explanted products; therefore, no analysis can be performed.

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« Reply #50 on: January 20, 2019, 03:26:46 AM »

Model Number 103
Event Date 04/22/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the medical staff believed the vns patient¿s generator was fried due to cautery. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Event Description
Good faith attempts for further, relevant information have been unsuccessful. It was reported that the patient is a complex medical case, and there are a lot of other factors, such as psychiatric issues.
 
Event Description
It was reported by a surgeon that the patient experienced sharp pain with stimulation prior to replacement in the left neck, left shoulder and back of scapula accompanied by stomachache.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. 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 pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. 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. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator. It was reported that the surgeon told the patient that the generator was "fried". It was reported that the surgeon interrogated the generator after removing it from the patient after electrocautery was used. Since diagnostics prior to surgery were within normal limits, it appears that the surgeon caused the premature end of service with the electrocautery. An implant card received confirmed that only the generator was replaced.
 
Event Description
It was reported that after going through airport security, the vns patient was experiencing increased headaches and auras, pain at her generator site, and issues with her magnet. The patient felt five constant jolting sensations at her generator site every few minutes. The patient¿s magnet had to be swiped at least three times to activate magnet mode stimulation. Prior to the event, the patient¿s magnet always activated magnet mode stimulation immediately. At airport security, the patient did not go through the metal detector but was within 10 feet from the airport security wand. The patient taped her magnet over her generator but continued to feel pain and jolting sensations. The patient went to the er on (b)(6) 2014 due to pain at her generator site that radiated through her arm and armpit every three minutes. When the magnet was placed over the patient¿s device, the patient had a burning pain and her generator site turned red. The magnet was removed and the patient¿s device was disabled as of (b)(6) 2014. The pain and redness subsequently resolved. The patient device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 2870 ohms). The patient was admitted to the hospital due to pain, erratic stimulation, increase in seizures and lack of magnet control. The patient stated that she experienced severe pain in her shoulder whenever her device was tested and did not have the same seizure control since her generator was replaced in (b)(6) 2013. Since her device was disabled, the patient experienced six generalized seizures. The patient underwent generator and lead replacement surgery on 05/20/2014. The patient¿s family believed there was an issue with the patient¿s lead and that her generator was fried due to cautery. The explanted devices have not been returned to date.
 
Event Description
Additional information was received that the patient's generator could never get regulated correctly. It is suspected that the regulation of the device refers to titration. Available programming history for the generator was reviewed. The patient's device was disabled the day of explant. Diagnostics at that time were within normal limits. After implant of the device, it was titrated to 0. 25 ma and the output current was increased up to 1. 5 ma a few months later. However, the settings were reduced down and disabled shortly after.
 
Manufacturer Narrative
Only the generator was replaced.

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« Reply #51 on: March 14, 2019, 06:09:11 AM »

Model Number 304-20
Event Date 10/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during a vns repositioning surgery for placement of a gastrostomy tube unrelated to vns, the surgeon pulled on the lead and it appeared to have broken while he tugged on it from its location at the upper incision. An implant card was also received indicating the lead was "fissured" during surgery when the lead was pulled back for repositioning. The generator was previously in the abdomen due to the patient's small size. The physician wanted to salvage the lead and replacement was not intended. They needed to re-tunnel for the lead so both incision sites were opened. The physician tugged the lead back, towards the neck. It was reported that the lead had frayed and broken near the lead pin and occurred while the physician was pulling on it very hard by hand. No surgical instruments were used on the lead. Diagnostics after the break were high. It was noted that the case was very difficult based on the patient铠size and complication due to the gastrostomy tube. It was reported that diagnostics were reportedly within normal limits prior to surgery. The generator was replaced as the battery was reported to be at near-end-of-service. The lead was discarded at the end of the procedure. The explanted generator has not been received to-date. No additional information has been received to-date.

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« Reply #52 on: April 06, 2019, 01:46:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/26/2019
Event Type  Injury   
Event Description
It was reported that the patient had abdominal pain and nausea and the physician questioned if the patient¿s electrodes had been placed correctly. The patient was at 0. 75ma output current, and was asked to practice with the vns magnet providing 1ma stimulation once or twice a week. When the patient practiced with the magnet she experienced massive abdominal pain. The patient was ramped up to normal output current 1ma. Two weeks later, the patient had reduced continuous abdominal pain. The duty cycle was changed. Two weeks after that, the patient stated that the pain was reduced further but still not gone. The frequency was lowered from 30 hz to 20 hz. After a month, the patient still had pain and developed symptoms of diarrhea and no appetite. The patient¿s general practitioner had no assessment of the symptoms. The patient¿s device was disabled at the request of the patient and the pain resolved. X-rays were received and reviewed for the patient. Per the x-rays, the generator placement appeared to be normal in the left axillary chest area. Complete pin insertion was confirmed as the pin can be seen coming through the second connector block. The feed through wires, and the lead wire continuity appeared normal. The lead was observed in the neck and chest. Part of the lead appears to be behind the generator and could not be assessed. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. The electrodes are placed correctly, as there is a single wire present on the top electrode, and double wires present after the second electrode, indicating proper orientation. Note that the presence of a micro fracture and/or a lead discontinuity cannot be ruled out in the portion of the lead that is not visible in the provided images. No additional or relevant information has been received to date.

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« Reply #53 on: June 13, 2019, 03:24:10 AM »

Model Number 304-20
Device Problem Fracture
Event Date 11/01/2017
Event Type  Malfunction   
Event Description
It was reported that during diagnostic testing, high impedance was observed on the patient's vns. It was reported that there was no recent trauma to the area. Clinic notes were later received indicating that the patient strongly declined the disablement of the vns. The patient was referred for vns lead replacement surgery. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was later reported the patient was experiencing severe abdominal pain and was wondering if it was related to the vns leads and the high impedance. The patient presented to the physician's office due to the pain. No additional relevant information has been received to date.
 
Event Description
The patient underwent full vns replacement surgery. During attempts at product return, it was revealed that the facility, historically, does not return explanted devices and had discarded the products.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7046309
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