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dennis100
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« Reply #30 on: February 24, 2016, 02:40:24 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
Initial reporter indicated that after their second implant in 2008 that they had to have another one done. This surgery has not been confirmed to have occurred. The pt reported that their incision failed to heal and they had to go to the emergency department and the doctor healed it. The pt also reported that he got scar tissue built up around the electrodes and a lump at the incision site that was "pinching" the nerve because he had numbness of his left arm. Good faith attempts are being made for additional information about the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1440164
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dennis100
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« Reply #31 on: March 03, 2016, 04:25:03 AM »

Model Number 304-20
Event Date 10/05/2015
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received that indicated on a recent visit on (b)(6) 2015 the patient complained that she was feeling tingling in her left neck, left elbow, and left little finger. She had her vns turned off because of these symptoms. The patient requested removal of the vns. Additional clinic notes were received which indicate that the patient feels the vns is not working for her. The patient reported numbness to the arm and feels like it is on fire. Good faith attempts for further information from the physician have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5239410
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dennis100
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« Reply #32 on: March 06, 2016, 04:00:08 AM »

Event Date 07/07/2011
Event Type Malfunction
Event Description
It was reported through a company representative that a physician had contacted him as he could not interrogate a pt's generator. The pt reported still being able to feel a tingle in her throat. The pt was implanted in 2005 and last settings were programmed to 1 ma. At the moment good faith attempts to obtain additional information from the reporting physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2211865
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dennis100
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« Reply #33 on: March 08, 2016, 01:42:10 AM »

Event Date 05/01/2011
Event Type Malfunction
Event Description
It was reported by the pt's father that the pt had been elbowed at the generator site. The pt's generator had been turned off at a previous visit as part of a trial period. After being hit in the chest, the pt claimed that she felt warmth at the generator site and the generator was buzzing and causing tingling up her neck. The mother reportedly held the magnet over the generator site and the pt reported that the buzzing stopped and the heat disappeared as well. They are concerned that the generator may be malfunctioning. Attempts for further info from the site are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2177765
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dennis100
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« Reply #34 on: March 09, 2016, 03:03:04 AM »

Model Number 102
Event Date 04/26/2011
Event Type Injury
Event Description
It was reported that the patient was complaining of a constant tingling/burning sensation around the vns generator. The patient's settings had not been changed since around (b)(6) 2010. The patient would not let the physician disable the device as he was having good efficacy with vns. During a later office visit, the physician disabled the device and the patient reported that the burning/tingling began to dissipate and resolved completely after a few minutes. When the device was turned back on, the sensations began again. No redness or swelling was present around generator. X-rays sent to the manufacturer for review and no anomalies were noted. The patient underwent generator replacement due to the tingling/burning sensation. During surgery, the lead was inspected and no anomalies were seen by surgeon. Further information from physician reveals that the patient had a grand mal seizure prior to report where he banged up his face, which may have contributed to event, but the timeline was unclear. Explanted product was returned to the manufacturer, but analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2155935
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dennis100
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« Reply #35 on: March 10, 2016, 05:17:12 AM »

Model Number 103
Event Date 01/24/2011
Event Type Injury
Event Description
It was reported by the pt's parent that the pt was experiencing breathing problems and numbness of her lips. The pt was seen by her family physician, who said her lungs sounded clear. A x-ray was performed and nothing abnormal was seen at this time. Even use of a rescue inhaler was not beneficial. Diagnostic testing on (b)(6) 2010 revealed normal device function, and the device had just been recently implanted. F/u with the pt's physician indicated that neither the dyspnea nor the numbness was related to vns. The numbness was stated to have first occurred on (b)(6) 2011. Last known settings from (b)(6) 2011 were 0. 75ma, 20 hz, 250microsec, 60 sec, 1. 8 min, 1. 00 ma, 60 sec, 500 micro sec. Later info showed that the pt had undergone more testing by an ent doctor, who saw that the pt's tonsils and adenoids were abnormally large and her left vocal cord was partially paralyzed. He also suggested removal of the adenoids and tonsils. The pt's vns physician, though, did not feel that the adenoid and tonsil issues were related to vns whatsoever, though it was causing the breathing and other issues previously reported. It was not known how the vns affected the paralysis event, though. Attempts for further info have been unsuccessful to date.

Event Description
Additional information was received stating that the vns patient¿s device caused the vocal cord paralysis in the patient. The onset of vocal cord paralysis is unknown. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133424
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dennis100
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« Reply #36 on: March 10, 2016, 05:17:47 AM »

Model Number 102
Event Date 03/01/2011
Event Type Injury
Event Description
The pt reported that his lead had slipped and is now in a knot. The pt reported that he is able to see the knot in his neck. Also, the pt reported being shocked with stimulation in the neck and ear. The pt saw his physician regarding the issue, and the was told the device "works. " the pt's settings were reportedly decreased on (b)(6) 2011 due to the shocking sensation, which has helped the issue. He had also been sent for x-rays and a surgery consult. Furthermore, the pt stated that prior to the setting decrease, the left side of his head had been numb; he had also been having an increase in seizure activity. The mfr's programming history was searched and the pt's last known settings were on (b)(6) 2010. Diagnostic testing on this date showed normal device function. Later info was rec'd indicating no trauma or manipulation had occurred. Recent diagnostics were stated as being "ok", and the pt was still having less seizures than before vns. No medication changes had been made prior to the increase in seizures. The site also said that there were no medication changes prior to the painful stimulation, but the pt's pulse width and frequency were decreased, and the pt then could tolerate stimulation. The physician indicated that the numbness that the pt had experienced was not related to vns. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133423
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dennis100
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« Reply #37 on: March 10, 2016, 01:07:26 PM »

Model Number 302-20
Event Date 05/03/2011
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 by a physician that a pt experienced prickling and tingling sensation in the neck. The treating physician ran diagnostics, which revealed high impedance: 7/limit/high. The neurologist has disabled the device and x-rays were taken. The neurologist suspects that the lead is intact. Additional information from the treating physician indicated that the pt had an increase in seizures that started with the symptoms of the prickling. The last known diagnostics for this pt were of dc dc 3 during the last appointment. No pt trauma or manipulation was reported to have contributed to the event. X-rays were received and analyzed by the manufacturer. Review of x-rays indicated that the generator placement appeared to be normal in the left chest. The filter feedthru wires were intact and the lead pin was fully inserted past the connector blocks. There is a small portion of the lead behind the generator and continuity in that portion of the lead could not be assessed. The electrodes appeared to be properly aligned and placed on the nerve. A strain relief bend and was present and appeared to be per labeling. There are no lead discontinuities or sharp angles observed in the visible portion of the lead body, however, a fracture or microfracture cannot be ruled out. Further information was received from the pt's treating neurologist indicating that the last known good diagnostics were from (b)(6) 2011 and at the moment no surgical interventions are being planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2117888
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dennis100
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« Reply #38 on: March 11, 2016, 02:18:24 AM »

Model Number 102
Event Date 05/02/2011
Event Type Injury
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns pt wants to have her device explanted because she is experiencing a "voice tick", heart fluttering, coughing, and numbness on one side of cheek and throat. The pt had been implanted (b)(6) 2011. She was scheduled to see her nurse practitioner on (b)(6) 2011. On (b)(6) 2011 clinic notes dated (b)(6) 2011 from the vns treating nurse practitioner were received. The clinic notes report that the pt is experiencing an uncontrolled cough and clearing of the throat (worse with stress), pain at the vns generator site, numbness and tingling to chin through her left ear/facial, and was very nervous describing the increasing discomfort the vns has caused. The pt went for f/u with the surgeon and after the pt told him about the numbness and tingling he suggested immediate removal of the vns. The pt's medical history lists migraine headaches, esophageal reflux, and tia; it is unk the relationship of the events to vns. The pt's neurological exam showed headaches associated with dizziness and seizures and the pt feels like her device moves around from the chest area to under her armpit at times. The physician is referring the pt for vns removal and educated the pt about how some of her symptoms may be related to stress and not completely due to vns implant, since they were ongoing after the device was disabled that day. Good faith attempts for additional info from the pt's nurse practitioner have been to no avail thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2103698
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dennis100
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« Reply #39 on: March 11, 2016, 05:52:08 AM »

Model Number 102
Event Date 04/25/2011
Event Type Injury
Event Description
It was reported that a patient had an episode of intermittent esophageal pain that lasted several hours. The generator's normal mode output was disabled, although the magnet output was left programmed. The patient did complain of pain when using the magnet. Diagnostic testing on (b)(6) 2009 showed the device to be properly functioning. Furthermore, the patient's generator was reported to be able to move around in her chest. Follow-up from the patient's physician at the time revealed that the site would not provide any more information on the subjects. However, at a later date it was indicated that the patient had her generator removed due to "pain" in her axilla region, though a migration event could not be confirmed. Additional information from the patient's surgeon's office stated the patient "complained of pain in the axilla and numbness in the left arm from the generator when lying on her left side". Clinic notes from the neurologist indicated that he did not believe the vns was causing left arm numbness. Analysis on the returned generator showed that the septum was not returned, but no evidence of body fluids were observed in the header septum cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098578
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dennis100
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« Reply #40 on: March 19, 2016, 01:28:19 AM »

Event Date 12/17/2010
Event Type Injury
Event Description
It was reported by a surgeon that a vns pt's mother indicated the pt experienced cough and could not talk. The surgeon indicated that the pt had been implanted approximately 1-2 weeks prior to the report. The surgeon further stated that the pt was programmed on to received therapy the following day after surgery. The manufacturer told the surgeon that per the manufacturer's labeling, it's recommended not programming the device on for 2 weeks after surgery to allow pt to recover from surgery. The surgeon agreed to contact the treating neurologist on the manufacturer's labeling as he programmed the pt on. Additional information was received from a company representative indicating the pt was experiencing extreme coughing and her voice was gone/having a hard time talking (voice alteration) since her implant on (b)(6) 2010. Additionally, the company representative reported that the treating neurologist had programmed the pt's device off due to the voice issues. In addition, the nurse at the neurologist's office indicated the pt had some numbness under chin above incision. Further information was received from the implanting surgeon indicating the pt was diagnosed with left vocal cord paralysis by an ent who was not familiar with vns therapy. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1963278
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dennis100
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« Reply #41 on: March 19, 2016, 01:28:48 AM »

Model Number 304-20
Event Date 12/08/2010
Event Type Injury
Event Description
It was initially reported by a pt that she was experiencing extreme numbness in face & throat two weeks after surgery. It was suspected that pt had nerve damage or nerve swelling and the surgeon believed it most likely would heal on its own. The treating neurologist decided to leave the generator off for additional two weeks to allow the nerve to heal. Further f/u with the neurosurgeon revealed that he saw the pt post-op on (b)(6) 2010 but declined any nerve damage or any adverse events. According to the neurosurgeon, no intervention occurred and he was unaware of any pt manipulation or trauma. The treating neurologist confirmed that pt's numbness in face occurred after vns surgery and no mri was performed. The md believes, the numbness is not related to an organic cause. No diagnostic results were provided by the neurosurgeon or the neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956356
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dennis100
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« Reply #42 on: March 26, 2016, 09:21:37 AM »

Model Number 103
Event Date 07/06/2010
Event Type Injury
Manufacturer Narrative
Eval results: review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that right after surgery, the pt started having jerking and jumping at the left neck area. Her face would also pull to the left as these were painful. Our consultant met the pt and the surgeon in the office the day of surgery and checked the device. It was confirmed that the settings were indeed off. Several system diagnostics were performed which all resulted in normal ok results with impedance around 1700 ohms. You could see the muscle twitching. The pt's surgeon felt it was not related to surgery. The patient went home. Later that day, it was reported that the pt started to feel numb and quickly became numb all over her body including her arms and legs. She also lost her ability to speak which did resolved. The pt's husband was not sure if it may have been a seizure, but she was coherent and understood what he said. She just couldn't respond to him. He called the ambulance and the pt was admitted to hospital. It was felt at the time all the pt events were related to pt stress and not taking her prescribed postoperative pain medications. While in hospital it was reported that the pt's generator area became red, swollen, and painful. The pt had an infection at the generator site and was being treated with antibiotics. Their infection did not resolve. During explant surgery a large amount of pus was noted around the lead and generator. They had their lead and generator explanted related to their infection. Their infection was related to their implant surgery. Good faith attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774911
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dennis100
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« Reply #43 on: March 28, 2016, 01:23:11 PM »

Model Number 102
Event Date 12/29/2006
Event Type Injury
Event Description
It was initially reported that the pt was experiencing mild voice alteration with stimulation. It was not believed that a device malfunction was occurring. The painful stimulation that the pt was experiencing was said to "may be due to a massive shoulder operation that the pt had in the near past. " later, it was described that "immediately after the implantation, the pt described a tingling sensation with stimulation. The tingling spread in his left arm and was described as pain with increasing stimulation intensities. The location of stimulation was checked with a plain x-rays, which were not provided to the mfr for review. Subjective and noticeable hoarseness with stimulation was very suggestive of a proper location of the stimulation. The pt did not tolerate the stimulation well and in (b) (6) 2007, experienced pain in the arm with stimulation when 1. 0ma was reached. There was only a quantitative change after reduction of the amplitude or the pulse width during 2008. In the middle of 2009, he noticed involuntary movements of the left arm with each vns-pulse. Therefore, the vns-generator was switched off. On (b) (6) 2010, the vns-stimulator was explanted due to the pain events. At this stage the pt, had clearly visible contractions of the biceps brachii and the deltoid muscle with each stimulation (short test period only). After the operation, he is feeling well again. " the pt was not reimplanted and the device was discarded by the hospital so it would not be returned for product analysis. It is unk if the pt was experiencing a serious injury due to the events or if the device was removed for pt comfort. Review of the programming history available in the mfr's database, showed the last known diagnostics performed were at the time of implant on (b) (6) 2006, which were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1662336
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dennis100
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« Reply #44 on: April 01, 2016, 02:40:40 AM »

Model Number 103
Device Problem No Information
Event Date 10/01/2009
Event Type Malfunction
Event Description
Summary: it was reported that a vns pt was experiencing pain and burning sensation on the generator area along with a tingling feeling in the left neck and ear area. Further info from the treating neurologist indicated that the events were occurring during stimulation and the pt had to go to the er because the pain was so bad. No mentioned interventions were taken at the er other than x-rays and ct scan. Further info from the pt indicated that turning the device off using the magnet ameliorated the reported events. Current system diagnostics provided by the neurologist were ok/ok/3400/ 10 years and both normal and magnet diagnostics were ok. Furthermore, the pt reported a choking sensation when doing a magnet swipe which due to the magnet settings running at higher output and also the fact that the on time is 60 seconds rather than 30 seconds. Furthermore, it was also noticed that the pt had voice alteration issues as current settings were 2/15/130/30/3. At the moment, no pt manipulation or trauma has been reported that could have had contributed to the reported events and no device anomalies are noted as the device is functioning as intended. Further recommendations were made from a company representative to have the device turned off and allow rest to the pt and then program the pt back to intended settings. The recommendation was taken by the neurologist and the pt was programmed off. A week later, the pt was reprogrammed to low setting of. 25 ma but the pt could not tolerate the settings. Interventions were to have the generator and lead replaced due to a suspected malfunction with the devices from the neurologist. Additional info was received in the form of clinic notes from the treating neurologist. A review of the received notes revealed the pt was experiencing the following adverse events prior to having vns explanted. Furthermore, a note was made indicating the pt felt discomfort once the device was re-activated by the neurologist in less than 5 minutes and was recommended vns re-implant due current vns device "not right. " info was received from the treating nurse indicating the reported events of burning sensation, pain in the neck, jaw, left ear, and tingling sensations were related to vns stimulation and the neurologist believe something was wrong with the vns device. The pt's generator was explanted due to painful stimulation and at the moment, good faith attempts to obtain product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1553673
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dennis100
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« Reply #45 on: April 02, 2016, 03:59:37 AM »

Model Number 302-20
Device Problem High impedance
Event Date 09/01/2009
Event Type Malfunction
Event Description
It was reported to manufacturer that the vns patient's device revealed high lead impedance on both systems and normal mode diagnostic tests that were (b) (6) 2009, which revealed normal device function. There was no patient trauma or manipulation reported to have occurred between (b) (6) and (b) (6) 2009. Clinical notes were received which documented the patient's clinical presentation on the date that the diagnostic test revealed high lead impedance. The physician noted that the patient "has been averaging 3. 6 seizures per month over the past three months. This actually is double and almost triple his seizure frequency over the past nine months. " the physician also noted that the patient "will occasionally get some pain as he has in the past but usually he does not. He usually just notices hoarseness in his voice and perhaps a little tingling in his neck. " the device was programmed off on (b) (6) 2009. Good faith attempts to obtain additional information from the treating physician have been made, but have been unsuccessful to date. Revision surgery is likely.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1511693
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dennis100
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« Reply #46 on: April 08, 2016, 01:30:09 AM »

Model Number 105
Event Date 02/24/2016
Event Type Injury
Event Description
The patient was seen at the hospital with a need for a mri scan on (b)(6) 2016. At that time the patient was directed to their physician in order to proceed with device disablement prior to the mri. But it is unknown if the device was disabled prior to mri or if the mri was performed. On (b)(6) 2016, the patient was at the hospital due to experiencing chest pain. The patient also experienced discomfort in both neck and chest during stimulation, tingling sensations, voice alteration, nausea and issues with chewing. A nurse at the treating hospital requested that a company representative visit to turn the device off. A therapeutic consultant, who was present at the hospital at that time, disabled the device (both normal and magnet mode). Diagnostics were performed and reported to be within normal limits. It was unclear if the patient experienced a hear attack. Patient was asked to follow up with the neurologist once discharged. Additional relevant information has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5508303
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dennis100
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« Reply #47 on: April 08, 2016, 03:12:03 AM »

Model Number 304-20
Event Date 02/18/2016
Event Type Malfunction
Event Description
The surgeon reported that the patient was experiencing pain at the electrode site and numbness on her face. During follow up the neurologist confirmed that the pain and numbness experienced were occurring with stimulation. The patient later went to the emergency room where the on call physician disabled her device. The pain and numbness events resolved when the device was disabled however the patient was still experiencing some discomfort. The neurologist attributed the leftover discomfort to the original pain and numbness event. The patient also reported experiencing an increase in seizures that was reflective of pre-vns levels. This event was related to the lose in therapy that occurred when the device was disabled. The surgeon evaluated the patient after the device was disabled. During this visit he noted high impedance and then referred the patient for lead revision surgery. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. No surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5498810
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« Reply #48 on: April 19, 2016, 04:16:55 AM »

Model Number 102
Event Date 04/01/2006
Event Type Injury
Event Description
Reporter indicated that they were experiencing numbness and pain in the neck. Later information was received that the pt underwent surgery to have the device removed, but the surgeon's office is unsure of why the device was to be removed. All attempts for more information have been unsuccessful, and thus the relationship between events and vns therapy cannot be determined. Attempts to have the products returned to the manufacturer for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1368996
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dennis100
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« Reply #49 on: April 20, 2016, 04:03:21 AM »

Model Number 302-20
Event Date 12/01/2007
Event Type Malfunction
Event Description
Rptr indicated that pt was experiencing painful stimulation in his jaw, described as "throbbing" and "tingling". Stimulation of the device was stopped with the use of the magnet. Diagnostic testing resulted in high lead impedance. Rptr also indicated that pt had a fall prior to the onset of symptoms. The device was programmed off, and pain resolved. Radiology report noted the presence of a medical device, without definite lead discontinuity observed. Chest x-rays were sent to mfr for review. No obvious lead discontinuities were observed. Lead revision surgery is likely.

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=988682
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« Reply #50 on: April 28, 2016, 02:09:57 AM »

Model Number 104
Event Date 01/01/2008
Event Type Injury
Event Description
Rptr indicated that the pt had device explanted due to excessive nausea and vomiting as well as intolerable tingling in throat. Prod has been requested, but has not been returned to mfr to date. All attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1209862
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« Reply #51 on: May 01, 2016, 03:42:40 AM »

Model Number 302-20
Event Date 01/01/2005
Event Type Injury
Event Description
It was reported that after a pt's first vns implantation surgery, she experienced numbness, tingling, and burning sensation, probably representing an infection at her neck site. Followup with the treating surgeon revealed that a mild post op infection had been present. No cultures were taken at the time to confirm the infection. The pt was treated with antibiotics, and the infection disappeared. A review of the device history records showed the device to be sterile prior to distribution.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1040263
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« Reply #52 on: May 02, 2016, 01:13:32 AM »

Model Number 102
Event Date 02/18/2008
Event Type Injury
Event Description
Reporter indicated that a vns patient's generator had migrated, and the patient was experiencing a "tingling sensation" under her left arm. No trauma or patient manipulation was reported. The patient had lost a lot of weight. Generator pocket revision surgery is planned. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1031591
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« Reply #53 on: May 03, 2016, 01:17:50 AM »

Model Number 102
Event Date 11/01/2006
Event Type No Answer Provided
Event Description
Reporter indicated that she was experiencing "shocks" and an increase in migraines. Patient's device was turned off, however, the patient "neck still cramp up when she yawns. " it was reported that the patient had to tilt her head back in order to get the cramp out. In addition, the patient has previously experienced tingling sensations in the neck with device stimulation, voice alteration with stimulation, and protrusion of the lead body at the neck site. Patient indicated that she is considering removing the vns system.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1010154
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dennis100
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« Reply #54 on: May 03, 2016, 01:18:29 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
Initial reporter indicated that the vns pt was experiencing "tingling sensations" on the "left axilla. " the device was turned off. Reporter indicated that surgery is planned. Good faith attempts are being made to obtain add'l info.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992143
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dennis100
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« Reply #55 on: May 03, 2016, 01:19:02 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979772
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dennis100
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« Reply #56 on: May 03, 2016, 01:19:43 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
It was reported that the vns patient was experiencing pain at the chest site, and a tingling sensation beginning at the chest site and propagating down the left arm. Additionally, it was reported that the patient was experiencing a "vibration feeling at the generator site. " diagnostic testing following the onset of the reported events revealed normal device function. The treating physician ordered x-rays to assess the device, and it was reported that the implanting surgeon reviewed the x-rays and "did not see anything out of the ordinary. " further information was communicated by the treating physician's office that the belief is that there is an infection present and has recommended removal of the device. Attempts to obtain additional information from the surgeon and treating physician have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=989370
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dennis100
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« Reply #57 on: May 03, 2016, 01:20:36 AM »

Model Number 102
Event Date 11/08/2006
Event Type Injury
Event Description
I am a female who was implanted with a fda approved device called a vagus nerve stimulator for treatment resistant depression. I was implanted in 2006, and stimulation began in the same month. I gave my complete medical history to my cyberonics case manager, cyberonics representatives, as well as my psychiatrist, and implanting surgeon. All were informed i had a traumatic brain injury, and am taking seizure medication for seizure disorder from the brain injury. I recently discovered i was not a candidate for vns because i have a brain injury. It states in the physicians manual there is no proof vns is safe or effective for one with a brain injury. Although the device has worked wonders to treat depression, i am clearly not a candidate for vns because i have a brain injury. My device has now been shut off, and will not be turned back on until there is solid evidence it is safe for me to have the device. It is not clear if any further damage has been done at this point. I will have to undergo further diagnostic testing. It has also ben discovered that vns has contributed to my having horrific headaches. The headaches have decreased in intensity since stimulation has stopped. Dose or amount:. 75 miliamps. Dates of use: 2006- 2007. Diagnosis or reason for use: treatment resistant depression. Event abated after use stopped: yes. Event reappeared after reintroduction: yes.

Event Description
This a follow-up report. My vagus nerve stimulator -vns- for treatment resistant depression -trd- was turned off in 2007 because i discovered a pt with a significant brain injury was excluded from testing for the device. Furthermore, as stated in the physicians manual under section 4 labeled "warnings"/"unapproved uses" history of cns injury. Since further evaluation from my doctors, it is clear the vns exasberated my brain injury condition. While my device was on, i was frequently loosing my balance, falling down, had increased left side numbness and tingling, severe headaches, disorientation, nausea/vomiting on a daily basis which lead to a stomach bleed, increased left eye blurred vision and increased left side weakness. Since my device has been turned off, these symptoms have decreased back to what is known to be normal brain injury condition. My device parameter was set at. 75 milliamps because i could not tolerate 1. 0 milliamps. It is clear i should have never been a candidate for vns because of my brain injury. Dose or amount:. 75 milliamps. Frequency: every 5 mins. Route: intracerebral. Date of use: 2006 - 2007. Diagnosis or reason for use: treatment resistant depression. Event abated after use stopped or dose reduced: yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=970441
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dennis100
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« Reply #58 on: May 03, 2016, 11:54:27 PM »

Model Number 101
Event Date 10/25/2007
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient was experiencing chest pain when the device was on. Additionally, the physician reported that the patient was seen at the "clinic" and the pain was a level 10, and the patient also experienced "numbness tingling in hands". Three days later the patient continued to experience pain and presented at the emergency room believing it was due to vns therapy. At the emergency room, the patient was advised to tape the magnet over the device. The patient then reported that the magnet fell off and it caused sharp pain. Patient experienced breakthrough seizure from the er visit and medications were added. The following day, the treating physician saw the patient and the device was tested. Both normal and system diagnostics test results revealed normal device function. The device was turned off at the office visit. X-rays were sent to manufacturer for review. There were no obvious anomalies observed that could be contributing to the reported events. Attempts to obtain additional information have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=959346
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dennis100
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« Reply #59 on: May 03, 2016, 11:55:18 PM »

Model Number 102
Event Date 09/19/2007
Event Type Injury
Event Description
It was reported that the vns patient began experiencing multiple adverse events which followed an increase in the device settings. The settings were changed from 1. 75m a/30hz/500usec/30sec/1. 8min to 2. 25ma/30hz/500usec/60sec/3min in 7. The patient left the physicians office tolerating the settings. On the way home, the patient began experiencing pain at the generator site during stimulation when the left arm was in a lifted position. Later in the evening, the patient began experiencing muscle twitching under the axilla on the left side with stimulation of the device. The magnet was used to temporarily disable stimulation and the events resolved. The patient was seen by the treating physician the following day and the device was disabled and no diagnostics were performed to assess the functionality of the device. The physician stated that the patients left arm was numb following the events, and the numbness continued while the device was disabled. The physician referred the patient for an mri of the brain to assess for sensory damage. Chest x-rays were taken and sent to manufacturer for review. The connector pin appeared to be fully inserted beyond the connector block and there were no obvious anomalies observed that could have been contributing to the reported events. After further follow up with the physician, it was revealed that the physician believed that "sensory damage" was confirmed after the mri scan but the mri assessment did not indicate any abnormalities. Additionally, the physician attributed all of the events, including the sensory damage, to vns therapy. The patient was scheduled for revision surgery. Prior to surgery, the patient reported to the surgeon that a second opinion was received by a different neurologist, and the patient stated that the physician indicated that "there was spinal damage" and attributed the damage to vns therapy. Attempts to obtain additional information from the second neurologist are underway. During surgery, a system diagnostic test was performed on the device in question and revealed normal function. The chest pocket was opened and the lead pin was verified to be securely connected inside the generator. A second diagnostic test was performed and again revealed normal device function. Per the patients' request prior to surgery, the existing device was removed and a new device was re-implanted. Attempts to obtain the explanted devices are underway, however, the patient has maintained that the "he owns the device". There were no obvious anomalies observed during surgery. The new device was implanted with no complications.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no anomalies were observed that could be contributing to the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=962544
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