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dennis100
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« Reply #270 on: May 21, 2018, 01:38:57 AM »

Model Number 302-20
Event Date 01/19/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.
 
Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.
 
Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.
 
Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.

http://www.vnsmessageboard.com/index.php/topic,4682.msg3894142.html#msg3894142
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dennis100
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« Reply #271 on: May 30, 2018, 03:48:18 AM »

Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that x-rays were performed because the patient's device was not working. X-rays were sent to manufacturer for review. Review of the x-rays did not identify any obvious discontinuities with the vns system; however, the presence of a microfracture could not be ruled out. Further follow-up with the physician identified that high impedance (dc dc code - 7) was observed. It was reported that the patient had complained of discomfort and burning at the back of the throat. It was reported that device frequency was reduced from 25hz to 20hz for the discomfort. The patient reported that the discomfort and burning began approximately two months prior and occurs with device stimulation. The patient mentioned that the pain and burning worsens when moving the head from side to side. The patient denied and trauma that may have caused or contributed to the high impedance. The physician reported that the device was programmed off and the patient would be referred for surgical consult. No surgical intervention has been performed to date.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity and battery depletion. It was reported that the explanted devices were sent to pathology and disposed of. No product analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3782517
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dennis100
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« Reply #272 on: June 08, 2018, 03:21:29 AM »

Model Number 1000
Device Problems Mechanical issue; Low impedance
Event Date 01/01/2018
Event Type  Malfunction   
Event Description
It was reported that a patient was having an increase in seizures and cannot feel stimulation. She stated that there an initial improvement in seizure activity after the vns was placed, but that was short lived and the patient has been having 10-12 seizures/day recently. The patient had a follow-up appointment and there was difficulty programming the patient¿s generator. The sales representative was able to interrogate it without any difficulties, but when she tried to switch from scheduled programming to manual mode, it would give her error code 254. When she tried to apply a schedule to scheduled mode, it also gave her the same error. She was not able to program any of the patient's settings without getting error code 254. She used two programming systems with the wand on bluetooth and plugged in for both of them and she got the same error code every time. She confirmed the batteries in the wands were not depleted and that they were not near electrical equipment. The wand was reset as well, but when she tried interrogating after the reset, it showed error code 350 when trying to switch to manual mode. She also confirmed trying multiple positions of both wands, and confirmed that the wand was kept approximately half an inch from the generator. A generator reset was then performed. Upon re-interrogation, she was given a warning message that the device was at low impedance. She also noted that the patient's generator was still programmed to 0. 75ma after the generator reset. She then performed a system diagnostic test and re-interrogate the device, but it continued to show the low impedance. She checked the previous session report from earlier today and it had normal impedance. She was able to change the patient's settings now, but it continued to give a low impedance warning. The representative indicated they were nor near any electrical equipment that would interfere and they moved from one room to another so that the physician could continue seeing patients as we attempted to resolve the issue so there were 2 completely different environments, neither of which contained any equipment that would interfere. During this time, the patient had 2 seizures and lost consciousness. This was not unusual based on her seizure history but speaks to the urgent need for a therapeutic level of vns. After the reset, i was able to change the output settings on the device. The patient stated that when she swiped the magnet she could feel ¿a tickle in her throat¿ at that setting. He also adjusted the duty cycle and decreased the off time from 5 minutes to 3 minutes, increasing the duty cycle to 16%. Further review of tablet data received after this visit suspected that there may be a hardware malfunction with the generator's magnet detection circuitry, and that in this state, the device does not deliver any therapy despite diagnostic results indicating that current was delivered. At a later follow up clinic visit, diagnostics were performed again and still indicated low impedance. A review of the device history records for the generator indicated that the device met all specifications and passed all quality inspections prior to distribution. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7539165
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dennis100
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« Reply #273 on: June 08, 2018, 03:22:02 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 04/30/2018
Event Type  Injury   
Event Description
It was reported that the patient's vns was firing non-stop and causing intense chest and neck pain. The patient also felt sick and faint. Symptoms resolved after the output current was decreased from 2. 00 ma to 1. 50 ma. The patient's family reported that there was no trauma or manipulation to the vns. System diagnostics were within normal limits. The patient had previously been set to an output current of 2 ma for over 6 months. It was reported that the patient was admitted to the cardiac unit due to the chest pain; however, the full cardiac workup turned out to be negative. The patient's family indicated that they had been swiping the magnet more often which they believed could have led to the overstimulation. On the day of the event, he had an otherwise normal day until the evening when he suddenly "grasped his left chest" and stated that he was having sharp pain and discomfort. He also reported that he was having difficulty swallowing. This episode lasted "several minutes but seemed better" by the time they arrived at the hospital. While in the hospital, however, he again experienced "about 5 minutes" of grasping his chest, and experienced a sharp pain, throat pain, and difficulty swallowing. He continued to have repetitive episodes of chest pain, throat discomfort nausea, and feeling "sick" until the vns output current as decreased. The family felt that the patient's vns was firing longer than normal. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7545787
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dennis100
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« Reply #274 on: June 09, 2018, 02:28:33 AM »

Model Number 302-20
Device Problem Fracture
Event Date 04/16/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by a provider that a vns patient has high lead impedance. The provider stated she had last checked the generator in (b)(6) 2017 and no issues were seen. The family denies any kind of traumatic event that may have damaged the system. They deny that the patient fidgets with the device or picks at it. They reported that the patient recently had gall bladder surgery and the family was worried that the device may not have been functioning correctly after that and wanted to follow up and have the device checked. Clinic notes were received indicating the patient has more clearing of her throat and diagnostics showed high impedance. No known surgery has occurred to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7507299
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dennis100
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« Reply #275 on: June 09, 2018, 02:29:13 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 04/22/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
The explanted devices were received. Analysis is underway, but has not been completed to-date.
 
Event Description
It was reported that a vns patient will be having their device explanted as they have not had good response with vns. Follow-up from the physician provided that the patient stated she felt the vns was making her seizures worse and causing throat discomfort. Follow-up from the company representative who attended the explant surgery also provided that the physician believed she had some psychiatric issues prior to vns and that she complained of receiving stimulation even after the device was turned off, which was why she wanted it explanted. Additional relevant information has not been received to-date. The explanted devices have not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7500598
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dennis100
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« Reply #276 on: June 09, 2018, 02:29:53 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/11/2008
Event Type  Injury   
Event Description
It was reported in 2012 that the patient's father called asking for the patient's records from time of implant until when the device was turned off. He believed that the vns almost killed her. Per the father, the patient had aspiration pneumonia and had been admitted to the emergency department. When follow-up was conducted with the physician¿s office in 2012, the physician¿s office stated that the patient had a past history of problems with aspiration even prior to the vns, so they didn¿t believe it was related to the vns or stimulation. The vns was turned off at the family¿s request approximately two months after implant. In 2018, further information from the father was received. He reported that the patient was now in respiratory failure and had had quite a few aspiration and pneumonia events. He stated that the patient hadn¿t had aspiration events prior to the vns. The father believed that one instance of aspiration pneumonia, that had occurred ¿a while ago,¿ had been caused by a feeding tube that he said was needed because the patient couldn¿t swallow due to the vns. Since then, the patient had had multiple instances of aspiration pneumonia due to influenza, which the father did not suspect were related to the vns. Later he indicated that the patient had had multiple aspiration pneumonia events due to the vns. The father reported that the patient had issues with the vns such as throat pain, inability to speak, and inability to swallow food. He said that the patient¿s vns had been disabled permanently between 2012 and 2014 because the patient¿s ent had attributed the dysphagia to the vns. Per the father the ent had looked at the patient¿s throat while the magnet was swiped and the patient¿s throat did not close. Per the father, because the patient¿s throat remained open, fluid and other things could get into lungs, leading to pneumonia. Finally, the father reported that the patient¿s physician had told him that there had never been any problem with the vns. Further follow-up with the physician¿s office found that this father frequently reported this complaint to them and that the patient was recently admitted to the hospital with pneumonia. The physician indicated that he couldn¿t provide an assessment of the events reported by the father until he saw the patient again. No further relevant information has been received, to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7497099
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dennis100
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« Reply #277 on: July 05, 2018, 07:40:59 AM »

Device Problem Electrical issue
Event Date 02/25/2015
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
It was inadvertently not provided in follow-up report#6 that the surgery had occurred on (b)(6) 2016. The explant date of the device was inadvertently not provided.
 
Event Description
Additional information was received that the patient sustained damage to his vocal cords following a cardioversion procedure.
 
Event Description
It was reported that the patient experienced sharp painful stimulation every 90 seconds after undergoing an electrical cardioversion for atrial fibrillation with rapid ventricular rate. Prior to the cardioversion, patient had a transesophageal echocardiogram but was reported to be able to swallow without issues following this procedure. After the cardioversion, the patient was having significant and periodic bradycardic events with a heart rate drop from the high 90's into the 30's. Patient would simultaneously moan, bear down, and complain of severe neck pain. Once the vns was turned off, the events ceased. When a system diagnostic test was attempted, the patient again had bradycardia and the programming wand was quickly removed. I didn't think it wise to try that again. With the device off, the patient was tested with modified barium swallow and found to have a complete dysphagia. This test will likely be repeated within a few days to assess any improvement. It is unknown if the device was programmed off when the patient had the cardioversion procedure. X-rays were taken of the neck and there were no obvious anomalies identified in the images received. The physician believes there may be a micro fracture in the lead and stimulating the neck near the vagus nerve causing the pain that triggered a vagal response in a physiologic manner as opposed to via direct vagal stimulation. The physician is concerned that the patient now has a vagus neurapraxia due to electrical injury. It was also reported that there is no definitive way to test for this to be sure. Additional relevant information have not been received to date.
 
Event Description
Additional data was received and review of the programming/diagnostic history shows that the device is still functioning within normal limits. Additional information was received that the patient underwent the cardioversion procedure on (b)(6) 2015. There were no precautions taken during the procedure. A magnet was not used to disable it during the procedure as the operators thought the device was end of life.
 
Event Description
It was reported that the patient still experienced pain in neck area due to the cardioversion procedure. It was also mentioned that the vns therapy was working well for the patient until the cardioversion incident. The patient also underwent surgery on the throat and reported to have probably burnt his vocal cords. The physician mentioned the theory that the lead passed the energy to the nerve during the cardioversion procedure, which resulted in the patient's adverse events. Review of the programming and diagnostic data for this patient indicates that the impedance value was 2107 ohms on (b)(6) 2015 and has been consistently between 2100 and 2400 prior to cardioversion procedure. On (b)(6) 2015, the impedance value was 1350 ohms. The impedance value on (b)(6) 2015 is 1379 ohms.
 
Event Description
Additional information was received that the patient still has pain despite vns being off. A report on the cardioversion procedure was also received stating that the procedure occurred on (b)(6) 2015 at 15:02. Synchronized bi-phasic cardioversion was performed with a medtronic lifespak 12 cardioversion device. Adhesive patches were used and 200j of energy was used to shock. The patient has a history of hypertension, a vns for seizure disorder, restless leg syndrome, and a new onset of atrial fibrillation. Echo findings showed no laa thrombus. The ejection fraction from the echo was 65%. During the procedure, the patient was brought to the electrophysiology lab in a fasting state after informed consent was obtained. Hemodynamic monitoring was established, and anesthesia was administered. Synchronized biphasic cardioversion was performed, the patient was reassessed, and the patient left the lab in a stable condition. Results showed that pre-rhythm was atrial defibrillation, and the post-rhythm was sinus. 200j of energy was delivered externally. There were no noted complications, and the dc cardioversion was deemed successful. Clinical course was to be observed.
 
Event Description
An abstract written by the patient's physician was received on 12/10/2015. The abstract stated that the patient was admitted to the hospital for new-onset atrial fibrillation. Chemical cardioversion was attempted, but was unsuccessful. After being cleared with a tee for an intracardiac thrombus, the patient underwent dc cardioversion to sinus rhythm. Shortly after the dc cardioversion, the patient experienced persistent dysphagia and periodic (in synch with stimulation) throat irritation, dry hacking cough, and symptomatic bradycardia with heart rate dropping to the 20s. The periodic symptoms resolved after the device was deactivated with the magnet, but the patient remained dysphagic. On fluoroscopy for swallow evaluation, the vns leads could be seen exposed in the soft tissue of the neck. The physician believed that the patient's nerve was burned, which caused the persistent dysphagia, and that the vns lead was "naked" and was shocking the patient's neck soft tissue and causing the periodic issues. There were still no plans to replace the generator, as this would aggravate the patient's condition.
 
Manufacturer Narrative
Date received by manufacturer: 12/20/2017. (b)(4).
 
Event Description
The patient was referred for full revision surgery. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explant facility does not return devices to the manufacturer per policy, and it was reported the product may have been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4618197
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dennis100
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« Reply #278 on: July 15, 2018, 03:21:48 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 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.
 
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.
 
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
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
(b)(4).
 
Event Description
Further information was received that the patient believed she had new issues with vns. Specifically, she complained of having "charlie horses in throat" on the left side vocal cord when she yawned or opened her mouth to sing. She also reported that she has experienced pain in the chest that extends down to her left arm. This pain was reportedly not constant (it "comes and goes"). The patient also reported having continued issues that were previously reported such as dysphagia, erratic stimulation, speech impediment, and ambulatory issues. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698649
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dennis100
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« Reply #279 on: July 18, 2018, 03:34:11 AM »

Event Date 09/27/2011
Event Type  Injury   
Event Description
Reporter indicated via a physician's internet website that an unknown number of vns patients had experienced pharyngeal paresthesias, voice alteration, coughing, dyspnea, and vocal cord paralysis which required explant of the vns. The reporter did indicate that the number of patients was a small portion. Attempts for further information were unsuccessful, as the reporter could not recall specifics on the cases, or when the events occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2296638
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dennis100
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« Reply #280 on: July 18, 2018, 03:34:46 AM »

Model Number 302-20
Event Date 07/30/2011
Event Type  Malfunction   
Event Description
It was reported by a physician that x-rays of the pt's device appeared to show a lead discontinuity. The pt has pharyngitis 3 weeks prior and the physician suspected the lead issue may have been involved. The pt presented to the physician with neck pain at the lead site. The pt's last known programming info was from the date of implant and showed proper device function. Attempts for further info have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2257284
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dennis100
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« Reply #281 on: July 18, 2018, 03:35:21 AM »

Model Number 302-20
Event Date 03/02/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a company representative that a vns patient experienced dysphonia during vns stimulation. The patient went to the er and was diagnosed with pharyngitis. The patient was referred to an ent in which fiberoptic laryngoscopy was performed. The results were indicative of left vocal cord hypomobility with no major injury. At the moment attempts for further relationship to vns therapy have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2548208
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dennis100
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« Reply #282 on: July 18, 2018, 03:35:56 AM »

Model Number 302-20
Event Date 10/17/2011
Event Type  Malfunction   
Event Description
The patient underwent full revision surgery due to the high impedance on (b)(6) 2011. Per hospital policy, the explanted devices cannot be returned to the manufacturer for analysis.
 
Event Description
It was reported that the patient had high impedance and was being referred for a full revision surgery. Patient has had no seizures with loss of consciousness since (b)(6), 2010 and then possibly a mild seizure without definite loss of consciousness on (b)(6), 2011 associated with pharyngitis. Has had declining memory and cognition in recent months. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2337738
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« Reply #283 on: July 22, 2018, 02:24:02 AM »

Event Date 01/01/2014
Event Type  Injury   
Event Description
An article titled ¿an electrical cause of stridor: pediatric vagal nerve stimulators¿ was received which reported that the (b)(6) year old child patient initial presented with difficulty sleeping, apneic episodes, frequent awakenings, and noisy breathing during the day. These symptoms began after implantation of a vns device. Polysomnography (psg) demonstrated mild osa with an apnea-hypopnea index (ahi) of 3 and the patient subsequently underwent tonsillectomy, adenoidectomy and inferior turbinoplasty. At his (b)(6) month post-operative appointment, the patient¿s symptoms had improved, but apneic episodes continued during the day and at night. Postoperative psg demonstrated persistent osa with an ahi of 1. 5. On physical examination, the patient demonstrated episodic stridor and increased work of breathing. The patient¿s nasopharyngoscopic examination was notable for intermittent decreased motion of his left tvc. Airway evaluation in the operating room, in conjunction with a pediatric neurologist, revealed adduction of the left tvc and contraction of the left supraglottis during stimulation on-times. The patient¿s device output current was decreased to 1. 75 ma and device on-time was changed to 3 min. The patient¿s tvc and supraglottic contractions ceased, his stridor and osa resolved, and he continued to have excellent seizure control 3 years after these adjustments. The other patient involved in this article was reported in manufacturer report # 1644487-2015-03618. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4425832
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dennis100
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« Reply #284 on: August 07, 2018, 01:26:39 PM »

Device Problem No Known Device Problem
Event Date 05/25/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from an er physician that a vns patient was in the emergency room (er) presenting with seizures and was coughing rhythmically. The physician stated that the parents put the magnet over the stimulator and that stopped the seizures. She thought that it might be the generator that might be causing the coughing and wanted to have it checked. The company representative went to the er at request of the physician. The patient stated it feels like the device is going off continuously and giving painful stim in the throat. The physician thought the coughing was related to the stimulation. He indicated that the physician thinks it may attention seeking as when the magnet is removed from the generator, the patient coughs and reports difficulty breathing from the coughing. The patient was worried that if the magnet was used to inhibit stimulation her seizures may increase. The next day, the patient had been moved to a new room and didn't seem to be having the issues reported earlier. The magnet was not being used at that time. It was reported that when the magnet is in place she seems to be ok. Then she seizes, the magnet moves off, and cough reflex starts again. She stated that they think the settings may be too high. The company representative was requested to turn off the device. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7617895
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dennis100
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« Reply #285 on: August 10, 2018, 04:08:27 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Event Description
It was reported that a patient was to have her device replaced due to pain at the site. Clinic notes were received indicating that patient has had severe left neck pain, dysphagia and hoarseness with stimulation. The device had been turned off and the patient had experienced an improvement of symptoms since having the device off. It was indicated the patient previously had a left thyroid lobectomy. It was noted from a recent office visit that the patient felt pain in her neck and throat that radiated into her jaw and left face. The patient had difficulty swallowing and had been eating less as a result. She stated she had been to the er at least once for the pain. The device output was lowered, and the patient still felt pain. Both output and magnet current were turned off. Diagnostics indicated no issues and battery life ok. The physician plans to have the battery replaced and possibly lead revised. From follow up with the neurologist, it was stated that the patient had not experienced any trauma to the site or other events that may have led to the adverse events. No surgery has occurred to date. No other additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7709600
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« Reply #286 on: August 11, 2018, 01:31:20 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient has neck swelling and that the patient had a recent placement of the vns on the left. The patient also has sensation of throat tightening. The patient was assessed left vocal cord paralysis was identified and abnormal asymmetric thickening of the left aryepiglottic fold which lies cephalad of the paralyzed left vocal cord. There was also a 13 mm solid nodule at the inferior pole of the left thyroid lobe. The patient¿s device has not been programmed on yet. Information was received from the patient that she can barely talk or breathe. The likely cause of the paralysis was from the surgical procedure. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7678836
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« Reply #287 on: August 11, 2018, 01:32:02 AM »

Model Number 106
Event Date 06/23/2018
Event Type  Injury   
Event Description
Due to excessive throat irritation, my daughter was taken to the emergency room after not eating for over a week. She was diagnosed with dehydration through blood work at the hospital. Required two large iv bags of fluid. My daughter was unable to eat for about two weeks total and lost a lot of weight.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7681233
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« Reply #288 on: August 11, 2018, 01:32:34 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2011
Event Type  Injury   
Event Description
It was reported that the patient wanted the vns device to be explanted due to voice hoarseness and device not working (lack of efficacy). The patient complained of hoarseness and feels like she is getting a sore throat at times, so she uses the magnet to turn it off. Settings were adjusted to help with the hoarseness follow-up with the physician reveals that the hoarseness and sore throat are related to vns stimulation. No causal or contributory programming or medication changes precede the onset of the events. No patient manipulation or trauma occur that is believed to have caused or contributed to events. No known surgical intervention have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7692430
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« Reply #289 on: August 11, 2018, 01:33:19 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/25/2018
Event Type  Injury   
Event Description
It was reported that the patient has complained of constant stimulation and her device had to be disabled as a result. The physician did not run diagnostics on the device, but stated that the patient had a fall and hit her neck before her visit. As a result the patient will be referred for a full revision. The patient also reported a sore neck, ear, and throat due to the vns. The physician programmed the device off on (b)(6) 2018. Notes state she feels like she has a crick in neck and ct reported as normal. The patient had a full replacement on (b)(6) 2018 and the devices were discarded per the explanting facility's protocols. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7699860
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« Reply #290 on: August 12, 2018, 12:17:37 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury   
Event Description
Clinic notes from were received providing the patient feels there may be something wrong with the vns wires. The notes clarified that when she yawns she feels like something is stabbing her in the throat, at her left neck. She states it has been occurring over the last year. There are no problems during stimulation. She is not sure if she has moved the wire during a seizure. She was referred to surgery for repositioning or revision of the lead wire. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7686990
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