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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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dennis100
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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.

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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2061420
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dennis100
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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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dennis100
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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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