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dennis100
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« Reply #60 on: July 19, 2016, 11:10:11 AM »

Model Number 102R
Event Date 05/31/2014
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that the patient has experienced different seizures than she's had in the past. It was reported that the patient squinches her eyes closed prior to the spells and her eyes stay closed during. The patient appears to be fighting the spell and then will go into it. Her hands and arms will go forward and if she is laying down they go over her head and she will go limp. It was noted that these last only a few seconds and with in a few minutes she will be back to whatever she was doing. It was noted that the patient is generally incontinent with these spells and they do not occur when she is dancing. It was noted that the patient was seizure free from 01/2013 to 05/30/2014 and that the only change was diazepam was discontinued. Diazepam was resumed and the seizures have continued. The physician reported that the patient has experienced some increase in seizures with a loss of therapy, but that the seizures were not above pre-vns baseline frequency. It was reported that medication changes have helped. The physician does not believe that the discontinuation of diazepam was related to the seizures. The patient has been referred for prophylactic generator replacement. No known surgical intervention has been performed to date.

Event Description
It was reported that the patient underwent prophylactic generator replacement. Pre-operative device diagnostics were within normal limits (neos - no). Device diagnostics with the new generator connected to the existing lead were within normal limits. The explanted generator was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the generator was completed on 10/02/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027967
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dennis100
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« Reply #61 on: July 20, 2016, 02:19:33 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 10/13/2013
Event Type Injury
Manufacturer Narrative

Event Description
Patient underwent prophylactic generator replacement on (b)(6) 2015. The explanted generator was reported to be discarded.

Event Description
Clinic notes were received for reimbursement purposes on (b)(6) 2015. Notes dated (b)(6) 2015 indicate that the patient's generator is 10 years old and that it is nearing end of life. Patient was also reported to be having seizures and was referred for generator replacement. Notes dated (b)(6) 2015 from the generator replacement surgery indicates that the patient had increased seizures.

Event Description
Clinic notes dated (b)(4) 2014 noted that the patient has had increasing episodes where she feels like she is going limp, her head goes ack and her eyes roll back. It was noted that the patient is sleepy the remainder of the day and that this has been occurring for approximately 4-5 months. The device was interrogated and ifi was no. The device output current was increased from 1. 75ma to 2ma. The patient was referred for surgery. No known surgical interventions have occurred to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4329443
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dennis100
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« Reply #62 on: July 29, 2016, 03:51:40 AM »

Model Number 102
Event Date 11/08/2007
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that the vns patient had to have the vns turned off due to severe side effects and he was still depressed. It was previously reported on (b)(6) 2007 that the patient has made suicidal gestures. Further follow up with the physician revealed that the gestures were not related to vns therapy. Additionally, the patient's treating medical professional indicated that patient was experiencing vomiting, nausea, dyspepsia and headache on (b)(6) 2008. The medical professional has stated that all these events can be related to vns. Even though the patient has had medical history of these problems, they appeared to be worsened with vns stimulation. An additional event of cognitive changes where the patient was entering dream states was reported. Follow up with the treating medical professional revealed that the event is believed not to be related to vns therapy, but likely related to the patient's underlying psychiatric condition. The patient is reportedly doing better with emotional freedom exercises and they are considering putting the patient on an anti-psychotic. An additional report was received that this patient is experiencing side effects from vns including difficulty breathing, migraine, photophobia, nausea, indigestion, and reflux. Good faith attempts were made for additional information, but were unsuccessful. Even though a response was not received regarding diagnostics results, investigation of a report of cognitive changes showed the device to be functioning properly on (b)(6) 2008. No additional information was received regarding the dyspnea and visual disturbances events. Additional information from the site indicated that diagnostics on (b)(6) 2008 showed the device to be functioning properly. The physician indicated that all events except migraines were present from the first stimulation. The migraines and photophobia events began after the output current was increased. The dyspnea and dyspepsia events are associated with stimulation on times. It appears the patient had reflux 10 years ago, and the gi symptoms reappeared with vns therapy. It appears that the cognitive changes had disappeared, and then recurred about 2-3 times in one week. An additional contributing factor to the migraines and photophobia is the patient's hypertension. Decreasing the pulsewidth has seemed to help these events. Medication is being administered for the dyspepsia and migraine events. The patient is still undergoing relaxation techniques and therapy. The programming history database was searched. The patient was last programmed to output=1. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=5min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec on (b)(6) 2010. The last system diagnostics test was from (b)(6) 2009 which showed output=ok/lead impedance=ok/dcdc=3/eri=no. On (b)(6) 2012 a nurse stated that the patient's output current was increased from 1. 75 to 2. 25, signal frequency decreased from 30 to 25, and off time was increased on (b)(6) 2011. The patient's side effects then became intolerable. On (b)(6) 2011, they turned the device completely off after the patient had turned it off with his magnet for a trial period from (b)(6) 2011. The patient still has the device turned off at present and the patient has since felt better. Additional information was received on when a form dated (b)(6) 2011 from the physician stated that the patient's reflux/indigestion and migraines resolved after turning off the vns. The physician later reported that the lack of efficacy was first observed on (b)(6) 2007. The patient was noted to have severe refractory depression that has been and continues to be non-responsive to therapy, medications, and vns.

Event Description
On (b)(6) 2013 the physician¿s nurse stated that the vns was not working for this patient, the patient just never got better. The patient had severe side effects and just had a really rough time with vns. The patient¿s depression didn¿t get better. The nurse stated that she thinks it is related to his underlying illness, being treatment resistant. She also mentioned that he has a history of suicidal thoughts ongoing and some suicidal gestures. She mentioned that he started or continued to have suicidal thoughts very shortly after he was implanted and the vns was turned on. She said she thinks it was because he thought the vns was going to work for him and it didn¿t. The nurse stated that she looked over the patient¿s progress reports and she saw where the device was turned on at 5. 5 weeks and the patient didn¿t feel that his mood had changed. The patient was still feeling depressed and having a lot of side effects.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118167
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dennis100
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« Reply #63 on: August 05, 2016, 09:34:49 AM »

Model Number 106
Event Date 05/26/2016
Event Type Injury
Event Description
It was reported that the patient's left eye was drooping following vns implant surgery. The nurse practitioner reported that there was no other anomalies noted during his neurological exam. The nurse practitioner stated that she could not determine a direct cause of the eye drooping. She had ordered a carotid ultrasound to determine if there was a hematoma the could be compressing the carotid artery however it was noted that the neck incision was well healed and there was no evidence of neck edema or swelling. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5784007
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dennis100
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« Reply #64 on: September 09, 2016, 05:45:41 AM »

Model Number 106
Event Date 12/22/2015
Event Type Malfunction
Event Description
It was initially reported by the by the patient that she was having painful stimulation and increase in seizures, dysphagia, and coughing. It was noted by the physician's office that the patient's increase in seizures were not above pre-vns baseline levels and that simple vns setting adjustments resolved the issues and were not considered as serious injuries. However, the patient called again reported painful stimulation, voice alteration, and the inability to turn vns settings up. Additionally, the patient stated she has a feeling of being hungover for 72 hours after every settings change, which is described as a post-ictal state, including symptoms of blurred vision, headaches, very tired and lethargic. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5889627
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dennis100
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« Reply #65 on: April 22, 2017, 01:16:10 AM »

Model Number 101
Event Date 03/28/2000
Event Type Injury
Manufacturer Narrative
Article citation: american journal of ophthalmology, march 2001; pp 383-384, horner syndrome associated with implantation of a vagus nerve stimulator. Kim, w, clancy, rr, and liu, gt. See scanned pages.

Event Description
Reporter indicated via a published article that a vns pt developed horner syndrome as a result of an initial vns implant surgery. The pt had a spontaneous recovery 4 weeks later. The authors concluded that pts implanted with vns should be observed postoperatively for horner syndrome. The authors concluded that the horner syndrome in this pt was likely transient dysfunction of third-order oculosympathetic fibers within the carotid sheath. The pt later underwent prophylactic generator replacement surgery in 2007 for generator near end of service.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1327980
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dennis100
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« Reply #66 on: May 05, 2017, 02:46:22 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/27/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient went to the emergency department due to feeling painful stimulation in her chest and right eye for the past 5 days. The patient was informed how to use the magnet to disable the device, but it was unknown if that was done. Attempts for further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6530315
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dennis100
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« Reply #67 on: July 07, 2017, 11:23:27 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/22/2017
Event Type  Injury   
Event Description
Report was received that a patient had experienced left facial drooping after a lead replacement surgery dye to a lead fracture as reported in mfr. Report #1644487-2017-03897. The patient's left eye also appeared smaller than her right eye. The physician reportedly did not observe these characteristics when the patient returned for a follow-up appointment after the initial report. The system diagnostic test after the patient's lead replacement surgery was within expected limits. A review of the dhr indicated the device was properly sterilized and passed all quality inspections prior to release for distribution. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6664531
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dennis100
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« Reply #68 on: July 27, 2017, 05:17:52 AM »

Model Number 302-20
Event Date 03/24/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2011, a vns treating physician reported that the vns patient was presenting with high lead impedance from a systems diagnostic test that showed limit/high/7/no that day. The physician said that the patient doesn't know of any specific incident that could have resulted in a potential lead fracture. The physician was advised to disable the patient's device, which she did later in the appointment. She was then told that if the patient were to continue therapy, his lead would likely need to be replaced. The physician noted that recent diagnostics performed were within normal limits, but she didn't have the results in front of her. On (b)(6) 2011, the patient's spouse requested information on the coverage for explanting the patient's device due to the need for an mri. The patient's wife said, they have decided not to replace the device due to a device malfunction, which she said was a fracture. She then went on to explain that prior to the high lead impedance, the patient was experiencing pain the neck and some visual issues where he couldn't see very well. The visual issues were later determined to be the result of a stroke so the patient needed to be referred for an mri, but her understanding was that because, he had an implantable device, he could not get one. Just the pain in the neck was thought to be related to vns, not the patient's stroke. The patient had been referred for multiple cat scans, which did not show a stroke so far; now the family wants the vns removed so they can do an mri. She was told that an mri could be performed, but there are specific precautions listed in our labeling. The wife then said that the vns id card said they couldn't do mris, but when asked to verify that the statement is present, she confirmed it was not. She then changed it to it was the physician who also said that an mri could not be performed, so she was informed that an mri is possible with certain limitations, as they are performed regularly by mri facilities. She was also told that the device can remain implanted and is not required to be removed, just disabled. Since the device has not been explanted and x-rays have not been received, a lead fracture has not been confirmed as the cause for the patient's high impedance. The patient's physician reported that the patient had gone to the emergency room for the pain in the neck and that a ct and an angiogram were performed which showed nothing abnormal. The physician does not know where the pain is related to vns or not. It is not known whether, the patient will have the device removed or replaced. The physician said that they will discuss it during the patient's next appointment; the specific date of the patient's next appointment was unknown. The physician said that after the patient returned from the hospital, the patient noticed that he wasn't having any voice alteration with stimulation. The patient was worried that his device wasn't working since he could not perceive any voice alteration. The physician does not think that the pain is associated with stimulation because, the patient could not be receiving stimulation due to the high impedance since the device may not be able to deliver the full current. The patient used to always have voice alteration with stimulation but it was not serious and no interventions were ever taken. The patient denied any trauma or fall that could have caused this. The physician could not provide any more settings or diagnostics. Additional information regarding the next steps the patient and physician were going to take for the patient's high impedance and pain was requested. The physician reported that x-rays were taken on (b)(6) 2011 and that they showed no anomalies. However the x-rays were not sent to the manufacturer for review. If additional information is received, it will be reported.
 
Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2073724
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dennis100
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« Reply #69 on: October 13, 2017, 12:45:41 AM »

Model Number 102
Event Date 09/01/2012
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
The patient reported her experience to the fda in medwatch report mw5061274. The patient reported the following: "the last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. I moved to (b)(6) to be near my sister who helped me out. The trip from (b)(6) is 45 minutes as opposed to 3 hours. On one trip from (b)(6) i totaled my (b)(6), i don't remember why. Some of the leftover symptoms are: i have not worked since 2011 in a job i loved as (b)(6); i have really bad balance and numbness on my left side, i go to the hospital at (b)(6) every 4 months to get a contrast mri with the neurosurgeon and with a neurologist to check and adjust my medication if needed. I cannot use a ladder, cannot swim alone, cannot kayak or canoe with my family, i cannot snowboard with my girls anymore, occasionally i lose my driver's license for medical reasons. So that is my story. One thing to add is that along the way someone snagged and paralyzed one of my vocal cords, it will remain that way for the rest of my life. After all this happened, my eyesight changed, i never had to use eyewear until after all this. Thank you, and if you need anything further, please feel free to call me (b)(6). I am not sure my cognitive abilities will ever be the same. " mfr report #1644487-2016-01151 reports the potential infection from replacement surgery on (b)(6) 2013 per the following portion of the patient's report: "i had yet another surgery and infection".

Event Description
On (b)(6) 2013, it was reported that the vns patient had an infection one month after implant that required explant of the vns. The patient was scheduled for re-implantation of the vns on (b)(6) 2013. The patient underwent re-implant surgery on (b)(6) 2013 and the surgeon placed the leads on her right side due to a previous surgery that caused her right vocal cord to be paralyzed. The surgeon stated that after her previous infection on the left with the original implant, he didn't want to take the chance of damaging her left vocal cord. The previous surgery that caused the right vocal cord paralysis was a cervical fusion done may years ago. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead were sterilized prior to distribution. Good faith attempts for further information from the physician have been unsuccessful.

Manufacturer Narrative
The serial number provided for the generator provided on page 4 of the medwatch received indicated "(b)(4)". This is the generator that was implanted in 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3119822
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dennis100
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« Reply #70 on: November 11, 2017, 03:17:04 AM »

Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a patient¿s sister that the patient was implanted with a vns that did not improve her seizures. She also reported that her sister is still experiencing sharp pain on the side of her neck, her left eye now has a damaged pupil and has become a lazy eye. The patient's seizures seem to now be under control after two brain surgeries. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6983496
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dennis100
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« Reply #71 on: November 20, 2017, 03:47:01 AM »

Model Number 103
Event Date 10/31/2012
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the vpcs were too frequent so the ectopic heartbeat was moderate. The ectopic heartbeat was determined to be not related to vns stimulation.

Event Description
On (b)(6) 2012, it was reported that the vns patient was experiencing an ectopic heartbeat that began on (b)(6) 2012, and resolved that same day. The patient recovered without sequelae. The patient was noted to have premature ventricular contraction and this ectopic heartbeat was moderate in severity. It was reported to not be related to the vns implant but the relationship to stimulation was probable; at the time of stimulation, the ectopic heartbeat was appearing. It was intermittent. The pulse width was reduced to 130usec and the output current was increased to 0. 5ma but the patient had frequent coughing and therefore the patient was kept at an output of 0. 25ma and pulse width of 130usec. It was also reported that the patient was experiencing a burning sensation in their eyes that began on (b)(6) 2012, and resolved on (b)(6) 2012. It was reported that the burning sensation in the patient's eyes was not related to the vns implant but possibly related to vns stimulation. The event was continuous. No actions were taken for the event and the patient recovered without sequelae. The patient had mild severity of burning sensation in both eyes and itching at the time of sensation. There was no decrease in vision at the time of the event and there was no gritty sensation, redness, watering, or discharge either. The patient did not go for consultation for this event but the patient used cineraria maritin schuade eye drops for two times at the time of burning sensation from (b)(6) 2012. It was later reported that patient also experienced giddiness and weakness that began on (b)(6) 2012, and resolved on (b)(6) 2012. These events were not related to vns implantation but were possibly related to vns stimulation and both events were mild. These events were continuous. No action was taken for the events and the patient recovered without sequelae. The patient was not subject to any consultation with doctors regarding the giddiness. No action was taken regarding the events. It was reported that on (b)(6) 2012 the patient had his second titration visit where the patient was increased to 0. 5ma but experienced a cough and the current was decreased back to 0. 25ma; the cough then disappeared. The patient was kept at an output of 0. 25ma. From the next day, (b)(6), 2012, the patient started having burning sensation in the eyes, giddiness, and weakness. No consultation was taken with an ophthalmologist, neurologist, or physician for the adverse events. The patient has a past medical history of dilated cardiomyopathy, mild mr, severe lv dysfunction (lvef-30%), acute decompensated heart failure (nyha class ii). The patient has no history of shortness of breath even on exertion and no history of chest pain, syncope, or giddiness. The patient had a coronary angiography in (b)(6) 2006 which showed normal coronaries. A 2-d echo cardiography dated (b)(6) 2012 showed a dilated lv, global hypokinesia of lv, severe lv dysfunction (lvef-31%), moderate mr/mild tr, mild pah/no clots. A chest x-ray dated (b)(6) 2012 had noted cardiomegaly. Additional information has been requested but no further information has been received to date.

Event Description
Additional information was received on (b)(6) 2013 when the physician reported that diagnostics were within normal limits. The patient's settings were noted to be output=1ma/frequency=10hz/pulse width=250usec/on time=14sec/off time=1. 1min/magnet output=0ma/magnet on time=60sec/magnet pulse width=500usec. The patient was noted to have a history of dilated cardiomyopathy, severe lv dysfunction, no "ccf", and "nyha class ii".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870871
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dennis100
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« Reply #72 on: December 05, 2017, 02:24:57 AM »

Model Number 102R
Event Date 02/01/2015
Event Type Injury
Event Description
It was reported that a vns patient had vagal episodes from (b)(6) 2015 and persisted for 6 months. The device parameters were not changed. It was reported that during that period, the patient was in a clinic study (trial) from (b)(6) 2015. But due to high discomfort, she stopped it in (b)(6) 2015. It was reported that those discomforts included especially dizziness with nausea, sometimes accompanied by blurred vision and pallor, without loss of consciousness. It was reported that when a cardiologist saw the patient in (b)(6) 2015 for a clinic examination / ecg / abpm, the patient showed a sudden hypotension (70-80 systolic) without symptoms reported above. The patient was again seen by the cardiologist in (b)(6) 2015, who indicated that everything was fine. It was reported that the patient was initially implanted with vns in 2002, and then replaced in 2010. No patient adverse events were reported during that period before (b)(6) 2015. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5245961
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« Reply #73 on: December 22, 2017, 03:45:25 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/19/2016
Event Type Injury
Event Description
The patient later reported that she is having an increased sensitivity with clonic jerks, poor large muscle control upon movement, blurred vision, slurred speech, headaches, and a longer recovery time after seizures. She stated she was also having increased light sensitivity. The patient thinks some of the symptoms may be related to medications, but it is not confirmed. She did note that she had a 5 day veeg. She was taken off of 2 of her medications and had a decrease in symptoms of ataxia and stated the majority of her symptoms were medication induced. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The patient later reported that when her neck it flexed forward, or her hands are on her chest, the device seems to stimulate. Attempts for additional relevant information have been unsuccessful to date.

Event Description
It was reported by the patient, it took her 5 hours to come out of anesthesia after vns implant surgery and that she had jerking and ataxia along with an increase in seizures. The increase in seizures and ataxia were later possibly attributed to abruptly stopping xanax. The patient was given gabapentin for the jerking. The patient also noted it took her a week to get strong enough to walk without a walker. The patient also stated she has a drop in her gait, abnormal movements, slurred speech, and flailing extremities while she was in the hospital. She stated she had been admitted due to seizures. The patient was later seen by her physician and was doing better and was able to walk in sunlight without sunglasses and without jerking and headaches. The patient also mentioned having swallowing issues. It was also noted the patient was able to tolerate the magnet swipes after the 3rd swipe, but it was unknown what tolerability issues were noted with the first 2 swipes. Lastly, the patient noted she can see the lead protruding (still under the skin) when she wakes up in the morning for a few hours before it goes back to flush with her skin. Attempts for additional information have been made but have been unsuccessful to date.

Event Description
Additional information was received from the physician stating the patient's symptoms were related to medications. Additionally, the physician did not believe the patient's pinching sensation was related to vns and no interventions have been taken due to the reported pinching sensation.

Manufacturer Narrative
This information was inadvertently left off of supplemental #02 mfr. Report.

Event Description
The patient later reported she has had a lot of pinching around the axilla of the left breast incision, and displacement of the device upon moving around in bed. Attempts for additional information have been unsuccessful to date.

Event Description
Further information was received that the patient was experiencing an exacerbation of symptoms with vns including sleeping disturbances, ambulatory difficulties, and dysphagia. It was also reported that these symptoms started after her device was programmed back on in june 2017, indicating it had been previously turned off. No other relevant information was received from the patient's physician.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698649
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dennis100
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« Reply #74 on: January 04, 2018, 02:10:12 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that on (b)(6) 2016 when the generator was programmed back on the patient slept all day. The patient was reportedly did not have any cardiac events after the generator was programmed on until (b)(6) 2016 when he lost consciousness for approximately 5 minutes. The holter monitor personnel did not notify the patient's caregivers that this event was asystolic. The patient then presented for a follow-up appointment where system diagnostics were found to be within acceptable limits and the vns was left programmed on. However the patient suffered another event on (b)(6) 2016. This time the caregivers were informed by the holter monitor personnel that this event was asystolic. The monitor recorded that the patient was in asystole for 14 seconds during the event. The physician then decided to program the generator off. No additional relevant information has been received to date.

Manufacturer Narrative
This information was inadvertently left off on mfg. Report #1.

Event Description
Further follow-up found that the physician believed that the patient had an unusual heart rhythm pattern not associated with medication. The unusual rhythm ceased after the vns was turned off and it was reported that patient was doing fine after medications were resumed without vns therapy. Based on the information available it appears that the there may be a relationship between the cardiac events and vns therapy. Vns therapy in combination with medications could be contributing to the cardiac events however it is unclear at this time. As previously reported, diagnostic testing has shown that the vns generator is functioning normally and the battery is not depleted. Therefore it does not appear that a malfunction is occurring. Cardiac events are a known potential adverse event associated with vns therapy which is discussed in labeling.

Event Description
It was reported that the patient began experiencing episodes of syncope starting in (b)(6) 2016. The patient was originally implanted with a vns device in 2004 and the most recent generator replacement occurred in (b)(6) 2012. No syncope or cardiac events were reported with previous vns devices. During the syncopal episodes, the patient felt dizzy and light headed. He would see black spots in his vision and complained of heart palpitations. During three of these episodes he lost consciousness and one of these episodes resulted in the patient going to the emergency room. At that time the vns settings were reduced and the daily dose of lamictal was increased. The patient was evaluated by the physician in (b)(6) 2016, however there were no reports of cardiac or syncope events. The patient did report experiencing an increase in seizures due to stress. The physician then increased the vns settings and again increased the daily dose of lamictal. In (b)(6) 2016 it was noted that the patient was suffering from drop attacks where he would have a staring spell then he would quickly fall to the ground. It was noted that the drop attacks decreased after the patient started a low dose of phenobarbital. An extra dose of phenobarbital was added later added. The vns settings were reduced and the lamictal dose was again adjusted. The drop attacks continued and an attack at the end of the (b)(6) 2016 resulted in the patient going to the er where he was admitted. During the admittance a holter monitor was used to confirm that the patient was going into sinus bradycardia followed by asystole that could last up to 14 seconds followed by difficulty with any type of ventricular reentry. The physician decided to disable the vns device on (b)(6) 2016 and kept the medication levels unchanged, though the reason for this change was not provided. It was noted on (b)(6) 2016 that the patient did not experience any syncope episodes during the previous 4 days. This led the physician to be concerned that the syncope events may be related to vns therapy. The vns device was then programmed back on at a lower setting on (b)(6) 2016. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6142575
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« Reply #75 on: March 09, 2018, 03:36:13 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/17/2018
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a patient¿s mother that the patient was sick and ever since then she has started turning her head to the left and is keeping her eye closed. She is worried there might be a nerve issue or something wrong with the vns and maybe the vns is not working properly. It was later reported by the patient¿s mother that she was in the icu. She had severe seizures and in a sedated coma to stop the seizures, and the relationship to vns was unknown. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7297582
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« Reply #76 on: March 29, 2018, 01:33:11 AM »

Model Number 102
Event Date 05/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the surgeon's office that the patient had generator replacement surgery on (b)(6) 2012. However, attempts for product return have been unsuccessful to date.

Event Description
Attempts for product return were unsuccessful as the explanting facility indicated that they could not locate the explanted generator, so it was assumed by the facility that the device was discarded.

Event Description
Clinic notes dated (b)(6) 2012 were received by the manufacturer and reported that the patient had been experiencing lue/lee twitching episodes for the prior six months that last for about three to four minutes with no impairment of consciousness. In the notes dated (b)(6) 2012, it was indicated that the patient usually had mix types of seizure including grand mal, petit mal, partial seizure. After vns placement, he has not had any grand mal seizure in the past five years. Currently, he describes the seizure as arm, eye twitch (early sign). These events were now happening about once a week. Follow-up with the treating physician was performed. He reported that the patient's new seizure type is not believed to be related to any vns problem, and his vns seems to be fully functional. However, the manufacturer battery life calculation determined that as of november he had less than half a year left on his battery. That fact, combined with the fact that since then i have increased his settings to 2. 0ma on (b)(6) 2012, which will most likely lead to an even shorter battery life, led the physician to believe that it is best to replace the generator prophylactically. The physician also reported that he has no way to know if the increased seizures are related to vns. The patient feels the vns stimulation, and the interrogation says that it is not near end of service. Therefore, the physician stated that he has no reason to suspect that the vns is not functioning properly, although perhaps the battery is "just low enough to cause an increase in seizures. " although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2874197
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« Reply #77 on: July 06, 2018, 10:27:14 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 01/18/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that this patient has one pupil that is more dilated than the other which was said to have occurred after the patient¿s vns was implanted. The patient's neurologist believes that this is due to a nerve being nicked during the implant surgery, but believes that it will resolve on its own over time. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7569111
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« Reply #78 on: September 14, 2018, 08:12:52 AM »

Event Date 10/19/2011
Event Type  Injury   
Event Description
Additional follow-up with the treating surgeon revealed the patient's drooping eyelid/horner syndrome was not related to the vns device.
 
Event Description
Reporter indicated a vns patient had a drooping left eyelid. The patient was newly implanted with the vns two days earlier, and the drooping eyelid was not present prior to the surgery per the reporter. Follow up with the vns implanting surgeon revealed the drooping eyelid (horner syndrome) was diagnosed prior to the vns being implanted. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2340907
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« Reply #79 on: October 03, 2018, 07:20:10 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury   
Event Description
The abstract for article "bs17. The 'uncommonly common' horner syndrome following a vns insertion" was received and reviewed. The abstract captured a case report and literature review in which it was stated that a (b)(6)-year old woman was implanted with vns. There were no intraoperative complications, but was diagnosed with horner's syndrome about two weeks after being implanted, described as vision issues in the left eye. This was still not resolved 4 weeks post-operation. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7787116
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« Reply #80 on: October 05, 2018, 12:58:30 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient's heart monitor was showing 69% bradycardia. It was also reported that the patient had dizziness-diminished eye focus, episodes of fainting, and felt like their throat was closing. The device was reported to be disabled and to monitor the patient. No additional relevant information has been received to date.
 
Manufacturer Narrative
Patient problem :(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7903445
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« Reply #81 on: November 10, 2018, 04:03:03 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/31/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Following implant surgery, patient reported experiencing migraines and blurred vision. Per patient, vns was turned on and patient was given a steroid for the migration. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7928300
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dennis100
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« Reply #82 on: January 14, 2019, 04:36:40 AM »

Model Number 102
Event Date 05/02/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was shocking the patient on (b)(6) 2014. The patient¿s device was tested on (b)(4) 2014 and diagnostic results revealed high lead impedance. The patient¿s device was subsequently programmed off. No patient trauma had occurred. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The patient was last seen on (b)(6) 2014 and there was no evidence of a device malfunction at that time; the patient's device settings were reported to be stable. The notes indicate that the patient¿s device was providing stimulation on an irregular basis and was dysfunctional but did not cause any seizures. The shocking from the device caused coughing and pain. The patient went to the emergency room on 05/02/2014. The magnet was taped over the patient¿s device. The patient felt one pulse of stimulation and the device reportedly stopped responding. The patient did not have any seizures while in the er but did have 2-3 auras. During the office visit, the physician noted a little lateral gaze nystagmus and the patient¿s device showed high impedance. With the magnet removed, the patient jumped whenever his device delivered stimulation which caused coughing and pain. The magnet was taped back over the device and the patient¿s medication was increased. X-rays were provided to the manufacturer for review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The complete lead connector pin insertion could not be assessed due to the poor quality of the images provided. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. Incomplete lead pin insertion could be a possible cause of the high impedance. However, no definitive conclusions can be made with the images provided. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator has not been returned to date. Review of the available programming and diagnostic history showed normal diagnostic results through 12/28/2010.
 
Event Description
Further information was received that the physician recalled that the patient also had continuous stimulation during the time the vns had high impedance. No further relevant information has been received to date.
 
Event Description
An implant card was received indicating that diagnostic results with the replacement generator and existing lead showed lead impedance within normal limits (impedance value ¿ 2644 ohms).
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3838963
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« Reply #83 on: January 19, 2019, 03:48:10 AM »

Model Number 103
Event Date 08/05/2011
Event Type  Injury   
Event Description
It was reported by the pt that she had experienced an arrhythmia while in the hosp for her vns initial implant. She did not specify what kind of arrhythmia it was but only stated that it "was not there before. " it was not clarified if it occurred during the surgery or post-implant. F/u with the neurologist's office found that the site had not heard of any adverse events and the pt was doing well at the visits following vns implant. Per the site, the pt's vns is functioning normally however specific vns diagnostics were not provided. A staff member at the surgeon's office said she was not aware of any of the events but would confirm with the surgeon. The pt also reported hotness and swelling at the wound site, nausea, visual disturbance, difficulty swallowing, and choking following surgery as well however none of these events were able to be confirmed with the neurologist or surgeon at this time. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2249204
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« Reply #84 on: March 09, 2019, 03:21:44 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/27/2018
Event Type  Injury   
Event Description
It was reported that the patient presented with dilated pupils, tremulous behavior and showed signs of horner's syndrome after vns implant surgery. It was reported by the that the patient's symptoms appeared to be the same when the device output current was programmed off and therefore the patient's generator was programmed on. The physician indicated that the patient's horner's syndrome was related to the vns surgery. It was reported that the patient's symptoms had not resolved post surgery to date. The reported tremulous behavior was reported to be caused by the patient's seizures per the physician. No known 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=8296503
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« Reply #85 on: April 04, 2019, 02:01:32 AM »

Model Number 102R
Event Date 03/07/2013
Event Type  Death   
Event Description
It was reported that a vns patient passed away on (b)(6) 2013. Their death was not related to their vns device but sudep is suspected to be the cause of their death. The pt weighed (b)(6), the etiology of their seizures: iatrogenic hypoglycemia secondary to insulin in the nursery. The patient had quadriparesis, cortical blindness dysphagia and gerd. The patient had seizure reduction with the vns. They were receiving vns therapy treatment at the time of death. They were set to 2. 00 ma,20 sf ,250 pw ,7 seconds on time,30 seconds off time ,2. 25 ma ,60 seconds on time ,250 pw. No products were explanted at the time of death. No autopsy performed, their death was not witnessed. The patient was found pulseless in the am, cold, lying in bed and no signs of a struggle. The patient did have a history of nocturnal seizures. The patient does have a history of mild aspiration with no recent pneumonia at time of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3035470
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« Reply #86 on: April 06, 2019, 01:56:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient that their vns generator had migrated and that they experienced a burning feeling in their ear, on their arm, and up their neck. The patient indicated that they wanted the replacement generator to be implanted on the right side due to "too much scar tissue. " another report was received by the patient that their eyes were constantly fluttering and that the vns magnet swipe helped the eye fluttering. The patient was referred for an urgent generator and lead replacement and a letter was received by the surgeon indicating that the generator had migrated and caused the patient severe pain, burning sensations, and limited use of their arm. It was reported that the patient's generator was replaced and a company representative indicated that the patient experienced pain at the generator site that may have been caused by the scar tissue due to the number of replacements the patient has had. The patient experienced neck pain and pain when the turning her neck. The surgeon assessed that the cause of that pain was due to the generator migration which caused the strain relief loop to be too small and cause the pulling when the patient's head turned. The surgeon repositioned the tie downs and made a larger relief loop in the leads. The hospital reported that the explanted generator could not be released and therefore, return of the suspect product is not expected to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404293
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« Reply #87 on: June 14, 2019, 06:23:19 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was hospitalized due to nausea, vomiting, double vision, and tremors attributed to the vns surgery. A hospital discharge form for the patient notes that the symptoms were caused by peak dose effect of medication and dehydration and poor oral intake in the immediate aftermath of his surgery. It was stated that there is no relationship to any vns malfunction as the device was not turned on, but there is a clear relationship of the adverse events to the after effects of the surgery and anesthesia. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8658323
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« Reply #88 on: August 10, 2019, 01:38:30 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/19/2019
Event Type  Injury   
Event Description
It was reported that the patient was experiencing discomfort with stimulation and the patient underwent a full revision for the pain. The patient was complaining of electric shocks to the brain and behind the eyeballs and thus the doctor went ahead with the full revision. The physician did not provide an assessment of the reported pain. It was stated, though not explicitly stated by the physician, that the revision was noted to be for the patient's complaints and their intractable seizures and therefore for both patient comfort and to preclude a serious injury and thus reported. Diagnostics were reported to be within normal limits. The patient's replacement surgery facility is known to discard products after surgery and is a no return site and therefore product has not been received. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8781134
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