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dennis100
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« on: May 20, 2018, 02:19:59 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative

Event Description
It was reported that a patient was experiencing pain in her chest and neck stiffness. The patient attributed her pain to vns. According to the patient, her pain had been occurring for a long time. The patient's generator was explanted due to the chest tightness. The explanting surgeon also reported that the lead had been placed on the phrenic nerve instead of the vagus nerve. The explanted generator was discarded and is unavailable for analysis. Follow-up with the explanting physician indicated that the patient's normal mode output current had been programmed off sometime prior to the surgery, indicating that the pain was not stimulation related. The patient had been seen by a cardiologist because she had experienced the chest pain, and the cardiologist said that the patient's heart was ok. The patient had experienced inflammation around the electrode site and laryngeal nerve irritation, but it did not appear that the lead had been explanted. No additional relevant information has been received to date.
 
Event Description
Additional follow-up with the nurse at the explanting facility indicated that the surgeon was unable to locate the patient's vns electrodes during surgery, even after dissecting 8 centimeters into the nerve. This led the physician to believe that the patient's lead had been implanted somewhere behind the sternocleidomastoid muscle, causing the tugging sensation and pain in the neck and chest. The lead was confirmed to have also been explanted. The surgeon's office could not determine whether the pain was chronic or related to the vns. Follow-up with the patient's following neurologist indicated that the patient had previously complained that she did not like the vns, stating that it caused her a lot pain. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6768932
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dennis100
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« Reply #1 on: May 20, 2018, 02:20:38 AM »

Event Type  Injury   
Manufacturer Narrative

Event Description
A vns presentation was given which included adverse events experienced by vns patients. One event involved a patient with skin necrosis with generator extrusion. One event involved a patient with recurrent laryngeal nerve paralysis. The presentation indicates that (b)(6) of a group of 17019 study patients developed infections. Some of the infection required explant of the device. Attempts for additional relevant information have been unsuccessful to date. This manufacturer report involves the reported skin necrosis event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4371455
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dennis100
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« Reply #2 on: May 20, 2018, 02:21:16 AM »

Model Number 103
Event Date 12/28/2010
Event Type  Injury   
Manufacturer Narrative
Describe event or problem; corrected data: additional information indicates that the patient was diagnosed with laryngomalacia in 2013. The initial manufacturer report stated that this issue was followed for many years.
 
Event Description
It was reported that the vns patient was diagnosed with laryngomalacia and had severe obstructive sleep apnea (osa). The neurologist did not comment on the patient¿s laryngomalacia diagnosis as it was made by another physician. The neurologist stated that the patient¿s osa got worse with vns and that it was occurring with stimulation. The neurologist is planning to change the device¿s programmed settings but has not occurred to date. No causal or contributory programming or medication changes preceded the onset of the osa. The patient has a medical history of osa. The patient¿s osa and laryngomalacia were followed for many years. Clinic notes were received for the patient¿s office visit with his neurologist on (b)(6) 2014. The notes indicate that the patient¿s parent was considering having the patient¿s device programmed off to alleviate his osa symptoms. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns is not believed to have caused the onset of laryngomalacia as it is usually a condition that one is born with. The patient was diagnosed with laryngomalacia in 2013 when attending a sleep apnea evaluation. The patient had a diagnostic bronchoscopy exam and was prescribed with reflux medications for laryngomalacia in addition to the medications for sleep apnea.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3725306
« Last Edit: January 13, 2019, 04:15:14 AM by dennis100 » Logged
dennis100
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« Reply #3 on: May 20, 2018, 02:22:00 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 12/29/2017
Event Type  Injury   
Event Description
It was reported that this patient was doing fine right after vns surgery, but about a week later complained of hoarseness, shortness of breath and was unable to speak. The ent stated that the patient had left vocal cord paralysis and leukoplakia. The left vc paralysis was stated to most likely be secondary to swelling and inflammation around the nerve after the vns was placed since the symptoms occurred 1 week after surgery. The patient was prescribed antibiotics and steroids due to the symptoms. The doctor stated it might take months for vcp to improve. The patient¿s vns device has not been turned on since surgery. It was also stated that this patient is a heavy smoker. The patient did also complain of numbness on the left neck at the neck incision. Additional information was received from the surgeon indicating that the patient's shortness of breath is likely due to left laryngeal weakness, and that the heavy smoking at approximately 1. 5 packs per day contributes to this as well. The vocal changes are due to laryngeal weakness, and the leukoplakia of the larynx is due to smoking. The patient's numbness at the incision site is an anticipated result of a neck incision. No other relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7230517
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dennis100
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« Reply #4 on: May 20, 2018, 02:22:43 AM »

Model Number 304-20
Event Date 07/31/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2012, a nurse practitioner reported that the vns patient's leads were implanted on the right vagus nerve instead of the left. On (b)(6) 2012, the surgeon reported that he could not find any place on the left vagus nerve to place the lead, therefore it was placed on the right vagus nerve. They turned on the device shortly after surgery and programmed the patient to an output current of 2. 0 ma and the patient started experiencing more spasms. The patient's output current was then lowered to 0. 25 ma. Then when the settings were increased up a level, the patient started having spasms again. The surgeon stated that he was considering taking the patient back to surgery as he was wondering if the patient's spasms were due to the lead placement. The surgeon then later reported that he did not think he could get another lead on the left side so they went for right side replacement even though he knows the manufacturer's labeling is for left side placement only. With the device on the left side the patient was able to tolerate settings of up to 2. 5 ma. However, once placed on the right side the patient was only able to tolerate a setting of 0. 25 ma. A setting of 0. 5 ma, which is what the magnet mode was set to, resulted in the patient experiencing significant laryngospasms. The patient was not scoped to make sure it was contraction of the laryngeal cord causing the issue and not something else as the surgeon did not think it was necessary since swiping the magnet, set to 0. 5 ma, resulted in significant choking. The nurse stated that the patient immediately had adverse events with stimulation as the patient had been programmed to his original settings of 2. 0ma without giving the nerve a chance to acclimate to the stimulation. The patient is now being titrated up slowly and all his adverse events have stopped. The nurse later reported that after surgery on (b)(6) 2012, was the first time the laryngospasms/coughing were first observed. The nurse believes that it is due to the high stimulation from vns being turned on to 2. 0 ma after surgery. The events occurred with stimulation. Diagnostic results were within normal limits but the specifics were not provided. The patient does not have a medical history of laryngospasms prior to vns. The laryngospasms ceased after turning the settings down.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2713825
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dennis100
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« Reply #5 on: May 20, 2018, 02:23:21 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
The patient reported that she was diagnosed with left vocal cord paralysis by an ent in 2012. It was reported that the patient's neurologist has not programmed the device off to assess whether or not the paralysis is related to vns therapy. The patient reported that her neurologist "performed something that shocked her" in 2011 and since then she has had voice changes. The neurologist's office indicated that the patient¿s vocal cord paralysis could be related to vns therapy, but that the device has been very effective in helping to control the patient¿s seizures so they are not changed any device settings at this time. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Follow up with the physician's office confirmed that the patient's left vocal cord paralysis was diagnosed by an ent. The patient's last appointment was in (b)(6) 2012. The patient has a history of myasthenia gravis (neuromuscular disease leading to fluctuating muscle weakness) that is not related to vns. Per clinic notes, the nurse noted that it looks like the patient "is developing increasing hoarseness. She had an ent evaluation which did show left vocal cord paralysis. " she also has eye droop which is from myasthenia, not vns. The nurse noted that they cannot ruled out the myasthenia as the potential cause for the difficulty swallowing and left vocal cord paralysis. The physician notes that they could remove the vns, but he indicates that he has discussed this in length with the patient and he cannot state that the laryngeal nerve would return to function even after vns removal. Per notes, "although it is possible that the vns electrodes have caused corrosion on the left laryngeal nerve, i have never experienced this in my cases" and the physician does not suspect this is the case. The patient understands and does not want surgery. She would rather keep vns because it seems to be controlling her seizures. Between (b)(6) 2013, the patient did not have any seizures. The patient is reportedly at "appropriate" settings (not specifically provided) which are helping her with her seizures so they do not want to change the settings. The physician confirmed that since the patient's seizures are well controlled, they do not want to try and change the patient's settings to see if it affects the vocal cord paralysis. At this time, the patient's voice is not worse but still scratchy. They performed an x-ray which showed the vns system was not broken. Copy of x-rays will not be provided to the manufacturer for review. It was indicated that the patient's medications were adjusted to a dose that would help her with myasthenia, but the patient is kind of self-adjusting on her medications. Diagnostics are within normal limits, and the nurse again indicated that they interrogated the device and "settings are where they need to be. The nurse was unsure of what the patient was referring to when she said she was "shocked" at her last visit, but stated that the vns cannot be ruled out it was in relation to the nerve. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3272783
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dennis100
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« Reply #6 on: May 21, 2018, 12:58:05 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 12/22/2016
Event Type  Injury   
Event Description
Follow-up from the physician on (b)(6) 2017 provided that the patient claims ¿being back to normal¿ and does have a vns now. The patient¿s mother claims that replacement of vns fixed the problem. Diagnostics were reported to be ok.
 
Event Description
It was reported by a patient¿s provider that the patient had recently fell and was having some discomfort so he went to the er. Device settings were checked and found to the same. Since the fall, the generator had migrated significantly downward. A call was received from the patient¿s caregiver also reporting that the generator had migrated to the sternum. He reported that the lead is now visible through the skin. He stated that his son has always had voice alteration with the device, but it now seems worse. He has since seen a surgeon about performing a revision surgery. It was also stated he was going to have his vocal cords checked to evaluate for any potential damage that may have occurred with the shifting of the generator and lead. Clinic notes were received from a visit to the surgeon on (b)(6) 2017 for replacement referral. The notes provide that the patient was seen at the ed for pain surrounding his vns battery. X-rays were done and labs did not reveal any sign of infection, so he was discharged home. He returned again to the ed. He did not feel his vns activate for several hours. His vns was found to be working appropriately. The battery was in an uncomfortable position for him, and was at the very superior aspect of the sternum. The skin overlying the battery and nearby lead is thin. He feels significant discomfort when lying down or on his side. He is concerned that the battery moves, but it was reported the battery has always been in this approximate position. He said it may have even been a little higher in the neck right after surgery. He has hoarseness to his voice constantly, and the patient denies any hoarseness prior to surgery. The battery is slightly mobile, but not more than expected. The skin overlying this area is thin but intact. Palpation and manipulation of the battery causes some pain. X-rays reviewed showed the vns generator overlying the superior aspect of the sternum. The lead is in an expected location. There is no evidence of fracture. It was provided the vns is in an unusual position. It was stated that the vns is functioning properly in the current location, but that it is not in the most common site for generator placement and is causing the pain. It was stated they are concerned the patient may have vocal cord paralysis from injury to the recurrent laryngeal nerve. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Generator replacement surgery occurred. The explant facility does not return devices to the manufacturer and the explanted device has not been received by the manufacturer to-date.
 
Manufacturer Narrative
Suspect medical device lot#, corrected data: the lot# was inadvertently not provided in the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309855
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dennis100
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« Reply #7 on: May 21, 2018, 12:59:15 AM »

Model Number 103
Event Date 04/07/2010
Event Type  Injury   
Event Description
It was initially reported that a pt was experiencing urinary retention as a result of a change in the pt's duty cycle for stimulation. The pt was previously noted to be experiencing larynx constriction caused by the stimulation when she was programmed to higher than 0. 75ma. At this time the pt's duty cycle was adjusted to accommodate for the intolerable higher settings. The pt was known to be experiencing efficacy from the duty cycle with the lower output current. Her physician ran some tests (specifics are not known), and it was observed that when the device was disabled, the pt was able to urinate properly. The physician has changed the stimulation off-time to see if this will resolve the issue and still maintain the seizure control. There is no other known cause for the event. The pt's diagnostic tests are said to be within normal limits, but no specifics were made available. The pt is expected to return to the physician for follow-up on the issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1678646
« Last Edit: June 15, 2018, 01:50:43 PM by dennis100 » Logged
dennis100
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« Reply #8 on: May 28, 2018, 01:45:13 AM »

Event Date 06/08/2009
Event Type  Injury   
Manufacturer Narrative
Article citation: bhatt, y. M. , and hans belloso. "airway compromise secondary to vagus nerve stimulator: case report and implications for otolaryngologists. " the journal of laryngology & otology 3rd ser. 1 (2009): 1-3. Print.
 
Event Description
It was reported in a scientific article that a vns pt presented via the emergency department following a series of six to eight seizures over 24 hours. The pt remained in an uncharacteristically protracted post-ictal state, and developed intermittent stridor associated with respiration embarrassment and hypoxia. Intercurrent vomiting episodes, coupled with widespread pulmonary crepitations, led to a provisional diagnosis of aspiration with laryngospasms. Treatment with continuous positive airway pressure ventilation, intravenous steroids and nebulised bronchodilators improved oxygen saturation, and normal consciousness returned. The stridor continues and was noted to be intermittent and not associated with desaturations. The pt was also noted to be aspirating on feeding. Furthermore, flexible laryngoscopy at rest revealed both vocal cords to be lying in a paramedian position during quiet respiration. During stridulous episodes, the glottis was noted to narrow further, with adduction of the left vocal and vestibular fold. It was suspected that vagus nerve stimulation was contributing to laryngeal dysfunction so the device was programmed off. Subsequent flexible laryngoscopy revealed a fully mobile left vocal fold but persistent right vocal fold palsy. At the moment, it is known that the vagus nerve stimulator remains programmed off and alternative medical therapy was initiated for seizure control. However, 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=1520362
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« Reply #9 on: June 16, 2018, 01:40:54 AM »

Model Number MODEL 250
Device Problem Device operates differently than expected
Event Date 09/22/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Addition information was received indicating that the physician confirmed she programmed the generator to 0ma of output current and 180 min off times, following several patients adverse events already reported. The physician indicated that this was done intentionnally. It was reported that no device issue occurred.
 
Event Description
It was reported that a vns patient's device had an abnormal change in programming parameters / settings during 19 months after implant. It is not clear if the parameters were changed voluntary. It was reported that the patient experienced several adverse events during that period, that were said to be possibly or probably related to stimulation (abdominal cramps, larynx spasms, coughing and voice alteration with social impact). It was reported that these events may have led to the change in programming settings. The site indicates an off time of 180 minutes on the last recorder parameters with 0ma, on (b)(6) 2015. This was double-checked and confirmed by the physician. The normal mode stimulation parameters were as follows: output current, 0ma / frequency - 20hz / pulse width - 130usec / on time, sec / off time, 80min. No additional relevant information was received to date.
 
Event Description
Further information was received indicating that the reported 0ma (device disabled on (b)(6) 2015) was due to the adverse event: voice alteration. That event started on (b)(6) 2014 and the severity was mild. It was reported that the event was probably related to vns implant and probably related to vns stimulation. It was reported that the event was not a serious adverse event and it did not cause the subject to discontinue from the study. No further information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5321978
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dennis100
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« Reply #10 on: June 16, 2018, 01:41:30 AM »

Model Number 63850
Event Date 06/17/2013
Event Type  Injury   
Event Description
I had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3305360
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dennis100
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« Reply #11 on: June 16, 2018, 01:42:12 AM »

Event Date 03/06/2015
Event Type  Injury   
Manufacturer Narrative
Evaluation codes; corrected data: the previously submitted mdr inadvertently lacked the required evaluation codes. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that a patient with a partially explanted vns system (approximately 6 cm of lead remaining implanted) experienced a hot, painful sensation in the left side of the neck and was getting stuffy while having an mri performed on (b)(6) 2015. The scan was interrupted but then started back up again. After the mri was completed, the patient was hoarse and experienced coughing and choking for the next few days. The neurologist couldn¿t find anything that could be contributing to these events. The patient had an ent evaluation where it was found that the patient had decreased sensitivity of the larynx however; the vocal cord movements were intact. The ent evaluation was performed on (b)(6) 2015. It was concluded that there was significant heating of the vagus nerve during the mri. Follow-up revealed that the scan was performed according to the new vns guidelines however, the ¿old¿ low sar epilepsy protocol was followed. The gradients are increased quickly which may be the cause of the issues the patient experienced. The physician indicated there was a stimulation of the vagus nerve because a stream is going to run in the remaining leads under the influence of rapid changes in the diffusion gradient despite the short duration of the series (approximately 1 minute). It is suspected that perhaps the spatial gradient field may have exceeded 720 gauss/cm. No additional relevant information has been received to date.
 
Event Description
X-rays images were received by the manufacturer. Review of the images revealed a 6cm portion including the electrodes still implanted in the patient. Further information was later received indicating that the facility uses an mri rx/tx head coil which has been successfully used on vns patients previously.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4757324
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« Reply #12 on: June 16, 2018, 01:43:01 AM »

Event Date 06/03/2011
Event Type  Injury   
Event Description
It was reported that the vns patient has been experiencing "vocal cord issues" since implant. The patient was seen by an ent physician who indicated that he believes the lead was implanted too close to the vocal cords. It was also noted that the patient has not seen much efficacy since implant. The patient was reportedly going to see the implanting surgeon for further evaluation however the surgeon's office indicated that the patient has not been seen or made an appointment. Attempts for further information from the neurologist's office have been unsuccessful to date. Attempts for the product information were unsuccessful.
 
Event Description
Additional information was received indicating the patient's vocal cord issue has resolved.
 
Event Description
On (b)(6) 2012, additional information was received indicated that the patient had hoarseness and awakening at night with vns stimulation noted in (b)(6) 2011. It was confirmed that vocal cord issues were related to electrodes being placed too close to the larynx. No hoarseness was noted (b)(6) 2011. On (b)(6) 2011, the hoarseness was intermittent but then constant on in (b)(6) 2011. A note indicated the hoarseness appeared to have resolved following the thyroidectomy. The thyroid issues were not believed to be related to vns.
 
Manufacturer Narrative

Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".
 
Manufacturer Narrative
Event date, corrected data: previously submitted mdr indicated an incorrect event date. The patient's physician believes that the vocal cord issues are related to the electrodes being placed too close to the larynx at the time of implant; therefore, the event date is the date of implant: (b)(6) 2011. This report is being submitted to correct this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2603575
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« Reply #13 on: June 16, 2018, 01:43:48 AM »

Model Number 300-30
Event Date 07/27/2005
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient or patient's representative reported on (b)(6) 2005 that the patient's vns implant lead migrated over the larynx, and the left vocal cords were not working. The patient had generator replacement for re-implant with a smaller device and leads were repositioned at that time. The generator replacement due to migration of the device was previously reported in manufacturer report #: 1644487-2005-00735. The surgeon's notes further reported that the device's lead had gradually migrated medially. Another reason for generator replacement was persistant mild trouble swallowing (dysphagia) that occurred intermittently. The persistent dysphagia was possibly related to the medial migration of the lead. Consult notes from the surgeon dated (b)(6) 2001 reported that at that time, the patient had normal vocal fold mobility. Some reflux was noted. The surgeon documented that it was possibly globus symptoms related to reflux. He was not sure how the vagal nerve stimulation would exacerbate some reflux, but nevertheless he indicated that it could be possible. However, notes dated (b)(6) 2005 reported that "on fiberoptic examination today reveals normal moving cords bilaterally whereas just in couple of months she had no movement of the left vocal fold. There may have just been a temporary neurapraxia from the stimulator. " a study nurse reported that the patient had began exercising and losing weight and the lead migration and dysphagia occurred as a progression of the patient's improved physical conditioning. The generator replacement and lead repositioning was considered by the surgeon to also be cosmetic. Follow up with the patient's currently treating vns physician in (b)(6) 2014 revealed that he is not aware of the patient ever having vocal cord paralysis. He has never noticed any symptoms from the patient that would suggest vocal cord paralysis. He reports that he does vaguely recall where she has talked about that she does talk lower and slower with the physician. However, she does not have voice alteration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3774139
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« Reply #14 on: June 16, 2018, 01:44:30 AM »

Event Date 01/01/2003
Event Type  Injury   
Event Description
During the review of an article titled "treatment of vns-induced laryngospasm with botulinum toxin", it was noted that the vns patient in the observational study experienced severe sleep obstructive sleep apnea. "a polysomnogram (psg) revealed an apneahypopnea index (ahi) of 25, indicating moderate to severe obstructive sleep apnea. The respiratory events resulted in frequent arousals, oxygen desaturations, and significant sleep disruption (sleep efficiency 78%; expected values 90%). The psg showed periodic chin emg activity that coincided with airflow limitations. This pattern lasted 30 seconds and repeated approximately every 80 seconds, with normal intervening respiration. Thus, vns-induced laryngospasm appeared to cause sleep apnea in this patient. " the patient was prescribed use of cpap/bpap to help with the reported event but the "positive airway pressure was unsuccessful in alleviating sleep-disordered breathing. " it was indicated that adjustments to vns settings were made to decrease stimulation to help with the reported event but the suboptimal seizure control made the approach impractical. "first direct laryngoscopy verified that the vns caused the laryngospasms. Following deactivation of the device, the left thyroarytenoid muscle was injected with 0. 4 ml botulinum toxin (0. 125 u/0. 1 ml saline). The vns was then reactivated. Within a few weeks, symptoms improved markedly. A psg performed 1 month after injections revealed an ahi of 3, few oxygen desaturations, and a 90% sleep efficiency. The characteristic emg artifact seen previously did not occur. Thus, botulinum toxin injections ameliorated sleep-disordered breathing to clinically adequate levels. This effect lasted approximately 4 months, when symptoms recurred (ess 21). " although, it was not stated if the patient received repeat injections of the botulinum toxin, it was indicated in the article that they may be needed as the treatment loses effectiveness. Good faith attempts to obtain additional information from the primary authors have been made, but no additional information has been received to date.
 
Manufacturer Narrative
Article citation: kumar, s; sharafkhaneh, a; edmonds, j, et al. Treatment of vns-induced laryngospasm with botulinum toxin. Neurology. 73. 1808-10. 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1567250
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« Reply #15 on: June 16, 2018, 01:45:18 AM »

Model Number 303-20
Device Problem No Known Device Problem
Event Date 11/02/2016
Event Type  Injury   
Event Description
It was reported that the patient¿s left vagus nerve was damaged. The patient¿s treating ent physician stated that it appeared to occur during a surgery, but it was not clear if vns surgery or a prior brain surgery was responsible. It was believed the site of the damage was slightly higher than the level of the vns leads, specifically referencing damage at the palate region of the nerve. The ent physician reportedly performed a laryngoscopy and showed the patient had reduced sensation of the larynx, and muscle activations were delayed and less forceful. A modified variance swallow study was performed, and the tongue muscles and general pharyngeal muscles were found to not perform as well as they should. The physician¿s assessment of the issue was that since the left vagus nerve innervates the left palate, and the patient¿s left pallet did not elevate, the results signified damage to that vagus nerve. However, patient¿s vocal cords were reported to be normal. Knowing that left palate is innervated higher up on the vagus nerve, the damage was assessed by the physician to possibly have happened prior to vns. The patient was confirmed to have multiple other brain surgeries, including brain tumor removal, over the course of his life. However, the patient's vns surgery could not be ruled out as a contributing factor.

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« Reply #16 on: June 16, 2018, 01:46:12 AM »

Model Number 302-20
Event Date 07/30/2012
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2012, when the explanted generator was returned for product analysis but that the lead had been discarded by the hospital. It was later reported that the high impedance was first observed on (b)(6) 2012. Product analysis on the explanted generator was completed on (b)(6) 2012. The generator had been replaced for prophylactic reasons. The data in the memory locations revealed that 72. 275% of the battery had been consumed and the battery had a voltage left of 2. 837v. The results of bench diagnostic testing indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Product analysis on the generator also showed that on (b)(6) 2012, the impedance value went from 11986 ohms to 20446 ohms, both of which are high impedance values.
 
Manufacturer Narrative
Date of event; corrected data: additional information was received which changes the event date that was reported on the initial report.
 
Event Description
Additional information was received on (b)(6) 2012, when it was reported that on (b)(6) 2012, the lead had been fully explanted, as it was reported that the patient had his vns explanted previously on (b)(6) 2012, it appears that only a portion of the lead had previously been explanted and the rest of the lead was explanted on (b)(6) 2012. The lead was reported to have been discarded by the hospital and therefore could not be returned for product analysis. The explanted lead however was returned for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed.
 
Event Description
Additional information was received on (b)(4) 2012 when product analysis was completed on the explanted lead. A small portion of the (+) white electrode quadfilar coil was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 29mm portion the end of the (+) white electrode quadfilar coil appeared to be burnt. Scanning electron microscopy was performed and identified the burnt area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). What appeared to be spatter was found on the surface of the quadfilar coil strands. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. However, based on the observed mechanical and thermal damage to the coil ends, it cannot be determined whether the discontinuities are explant or product related. During the visual analysis of the returned 29mm portion the (-) green electrode quadfilar coil appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found at the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no other discontinuities identified.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient had a full revision surgery on (b)(6) 2012, due to "spasms. " the surgeon later stated that the spasms were laryngospasms as well as choking. The patient's nurse practitioner later reported that the reason for surgery was in fact not "spasms" but a lead fracture. The patient did not have "spasms" prior to surgery. The generator was replaced for prophylactic reasons and the lead due to a lead fracture. The nurse stated that the lead was discarded after surgery and therefore, would not be sent back for product analysis but the generator would be sent back. The generator has not yet been received by the manufacturer for product analysis. The manufacturer's consultant stated that the high impedance was observed prior to surgery, upon interrogation during a clinical visit. There was no trauma or patient manipulation that occurred which could have caused or contributed to the high impedance. Attempts for further information have been made but have been unsuccessful.
 
Manufacturer Narrative
Describe event or problem; corrected data: inadvertently did not include this information on supplemental report #1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2715100
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« Reply #17 on: June 16, 2018, 01:47:05 AM »

Model Number 300-20
Event Date 04/24/2001
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient had generator and lead explant surgery on (b)(6) 2014 to undergo other indication treatment. The explanted products were discarded.
 
Event Description
Clinic notes dated (b)(6) 2014 reported that by the patient¿s report, she had occasions of unilateral vocal cord paralysis following vns procedure. Subsequently, she seemed to stabilized after undergoing a vocal fold injection procedure. The vocal folds were evaluated to be bilaterally mobile with exhibition of mild edema. The patient presented with report of progressively worsening breathing difficulties. The vns generator was programmed off to 0ma which the physician evaluated may provide some immediate relief with respect to the breathing issues. It was previously reported that the patient had vns programming changes made due to tolerability issues including with subtle hoarseness during stimulation but was tolerated. A note from (b)(6) 2007 indicated the patient had increasing breathing problems and was unknown if related to a recent increase in settings. Later in (b)(6) 2008, the patient felt the breathing issues were related to vns and as a result did not want to increased settings. In (b)(6) 2008, the treating physician indicated the patient¿s asthma was worse and unknown if related to vns at that time. The patient's previously treating physician who managed the vns treatment has retired.
 
Event Description
Operative notes from explant surgery on (b)(6) 2014 were received and indicated that the pre- and post-operative diagnoses was dyspnea and chronic laryngitis. The indication for procedure detailed that the patient developed chronic laryngitis with symptoms of constriction of the larynx after vns implant, which may be related to the vagal nerve stimulator lead. The surgeon noted that they had concerns that the vagal nerve stimulator may be ¿inappropriately activating the recurrent laryngeal nerve. Because of this, the device will need to be removed. " the generator (including surrounding scar tissue) and majority of lead were explanted; all of the electrodes were not explanted, ¿recognizing the risk of additional dissection was certainly not warranted by any benefit of harvesting additional nerve lead wire. ¿.

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« Reply #18 on: June 16, 2018, 01:47:44 AM »

Model Number 102
Event Date 12/01/2009
Event Type  Injury   
Event Description
It was initially reported by the physician, the patient was seen in the office due to severe neck pain which is located slightly lower than neck incision. Pain is associated with stimulation and started after she was wrestling with her children, and they were pretending to choke her around her neck. Physician wants to replace the whole system since he feels the battery needs to be changed anyway. Patient also had coughing and choking sensation with magnet stimulation. Device is currently been turned off due coughing and laryngospasm. Good faith attempts to obtain additional information has been unsuccessful.

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« Reply #19 on: June 16, 2018, 01:48:23 AM »

Model Number 302-20
Event Date 03/12/2008
Event Type  Injury   
Event Description
Reporter indicated a pt had developed left vocal cord paresis that was diagnosed by an ent physician. The pt's vns system was previously explanted for pt lack of efficacy. Reporter indicated the cause of the left vocal cord paresis was unk, but that the pt was experiencing dysphagia, dyspnea, and voice alteration prior to vns explant surgery. The reporter stated the pt has had vocal cord injection and speech therapy interventions for the left vocal cord paresis. The pt continues to have difficulty with hyperfunction of larynx and poor voice. The explanted devices were returned for product analysis. The lead and generator performed per specifications and no anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1155248
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« Reply #20 on: June 16, 2018, 01:49:03 AM »

Model Number 302-20
Event Date 12/05/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient has been diagnosed with left vocal cord paralysis by an ent after full vns system replacement. Both the lead and generator were replaced. It was reported that the patient will be referred to speech re-training. It was reported that the patient has benefitted from vns therapy. It was reported that the patient experienced dysphonia upon return from surgery. The dysphonia was initially attributed to disorders resulting from intubation (laryngitis post intubation), but with continuing unrest, despite correct treatment, the situation has been reevaluated and paralysis of the recurrent laryngeal nerve was confirmed. It was reported that the device was not programmed on until (b)(6) 2013 which was after the dysphonia problems. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3546950

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« Reply #21 on: June 16, 2018, 01:49:44 AM »

Model Number 302
Event Date 05/01/2008
Event Type  Injury   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, vns placement appeared normal.
 
Event Description
It was reported that a vns pt was referred to an ent surgeon due to his dyspnea during stimulation. The pt indicated the surgeon scoped him and told him his larynx is scarred. The surgeon diagnosed him with "spasmotic dysphoria. " his larynx spasms and tightens during stimulation. This condition constricts his airway making it difficult to breathe. Taping the magnet over the device to stop stimulation resolves the dyspnea. The ent recommended the pt see a speech pathologist to assist in decreasing the muscle spasms. The neurologist sent x-rays to the manufacturer for review to assess the vns placement. Review of the x-rays showed placement of the vns device to be normal. No discontinuities were observed on the lead body. The neurologist also indicated the pt's vns device would be programmed off. The pt is currently being seen by a speech pathologist and is reported to be doing much better. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1120669
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« Reply #22 on: June 16, 2018, 01:50:28 AM »

Model Number 103
Event Date 05/18/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient presented on (b)(6) 2015 as an emergency to adjust his vns output current. For three weeks, he had experienced constrictive larynx and was unable to breathe in the morning, per the physician. The output current was decreased from 0. 75ma to 0. 25ma. Additional information was received that the patient was experiencing pain in the throat and jaw with stimulation. The plan was to obtain x-rays of the leads and to discuss the symptoms with the surgeon. Lead impedance was okay with impedance around 3700 ohms. Good faith attempts for additional relevant information have been unsuccessful to date.

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« Reply #23 on: June 16, 2018, 01:51:16 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 07/06/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported through a study adverse event form that a patient's vns was disabled due to laryngospasms. The severity of the laryngospasms was marked as severe and life-threatening. No clarification as to why the event was considered life-threatening has been received to date. As a result of this event, the patient discontinued the study. After the vns was disabled, the problem resolved. No further relevant information has been received to date.
 
Event Description
It was reported that a patient in a study had experienced laryngospasms with stimulation. It was reported that the reason that they were considered life-threatening was because they were a danger to the airway and causing breathing difficulties. There was no prior history or other factors that could have contributed to the event. System diagnostics of the device were within normal limits. No further relevant information has been received to date.

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« Reply #24 on: July 06, 2018, 10:59:09 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing laryngeal problems after vns stimulation began. It was stated that voice alteration began about three months after surgery and persisted after stimulation was turned off. An ent evaluation concluded laryngeal immobility, "meaning a recurrent damage". It was suspected that the problems were due to stimulation, and not surgery. Follow up from the physician's office provided a timeline of events. The vns device was implanted with ok diagnostics. Two weeks later, the device was titrated up to 0. 25ma. About three weeks after this titration, the patient was titrated up to 0. 5ma. Since this titration, there was a report of pain at the generator site. The vns was checked and was found to be ok. A week later, it was reported that the patient was vomiting with intense pain radiating along the neck, and the vns was turned off as a result. Voice alteration was confirmed to have been noted in mid (b)(6) and to have persisted after the device was turned off. The device was checked in mid (b)(6) and confirmed disablement. No device malfunction or impedance issue was noted from this visit. An ent assessment then found vocal cord paralysis. The physician believed the events were due to vns stimulation, and planned to have the device explanted. No surgery has occurred to date. No further additional information has been received to date.

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« Reply #25 on: July 18, 2018, 03:29:34 AM »

Model Number 102
Event Date 07/30/2010
Event Type  Injury   
Event Description
It was reported that the pt was experiencing a lot of side effects due to the vns stimulation. F/u with physician reveals side effects included sleep apnea, arrhythmia, pain, laryngismus, skin reaction, and possible nerve damage. The physician attempted changing the settings, but the side effects persisted. The vns has been turned off to date. X-ray were taken of the device which revealed no anomalies, per physician. No device malfunction was reported. The pt would like to have the vns removed, but no surgery has occurred to date. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830809
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« Reply #26 on: October 30, 2018, 12:49:08 AM »

Model Number 300-20
Event Date 01/01/2012
Event Type  Injury   
Event Description
Additional information was received, in the form of an ent evaluation, on (b)(6) 2012. The ent noted that the patient presented with respiratory insufficiency and hoarseness, but described the symptoms as mild. It was noted that the left vocal cord was immobile. Additionally it was noted that there was a questionable growth in the area of the voicebox. The patient was referred for a direct laryngoscopy esophagoscopy and biopsies. Attempts for additional information from the ent physician have been unsuccessful to date.
 
Manufacturer Narrative
Additional information was received which corrects the date of event. This report is being submitted to correct this information. Additional information was received which corrects the date of event. This report is being submitted to correct this information.
 
Event Description
Additional information was received from the ent. It was indicated that it was unclear if there was an actual growth on the voice box, however he stated that if there was, it was likely not related to vns. The ent stated that it was possible that the paralysis was related to vns, but indicated that it was unclear if the paralysis was occurring with stimulation on times, if there had been any manipulation or trauma, or if there were any programming or medication changes which preceded the events. The ent noted that the patient had not returned for follow up care, and the he was unaware of any prior history for this patient.
 
Manufacturer Narrative
 
Event Description
It was reported by the physician on (b)(6) 2012 that the patient had developed vocal cord paralysis in (b)(6) 2012. The patient was last seen in (b)(6) and diagnostics at that time were within normal limits with an impedance value of 2571ohms. The patient saw another physician who indicated that the patient had left vocal cord paralysis. The physician feels that the paralysis is related to vns. No trauma or manipulation to device was reported and there had been no change in the patient's settings. The generator was left on. The patient had also experienced idiopathic right vocal cord paralysis. He had a tracheostomy and the airway is protected. The patient was being seen again by the physician where he planned to re-perform diagnostics. Additional follow up was performed with the physician. It was indicated that the physician could not explain how after years of safe and tolerated stimulation, this patient would suddenly develop dual vocal cord paralysis, but stated that vns must be the cause. The patient also developed pneumonia in (b)(6) and saw an ent for the vocal cord issue. The paralysis was not occurring with stimulation and he had no history of vocal cord paralysis prior to implant. The diagnostics which were performed were again within normal limits and the physician decreased the duty cycle and lowered the patient's output current. Results of the ent evaluation were pending.
 
Event Description
It was reported that the patient's vocal cord paralysis may have been caused by the patient's pneumonia that developed in (b)(6) 2012.

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« Reply #27 on: January 05, 2019, 03:45:02 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/18/2018
Event Type  Injury   
Event Description
It was reported by a patient that his vocal cord was nicked during surgery, causing his voice to be "out" for almost 6 months. It was stated that his voice did not return until a surgical procedure was performed on his vocal cord by an ent (ear, nose, throat) surgeon. The surgical procedure was performed after two other attempted treatments, including a "dose of liquid in his nose". It was stated that at the post-op follow up appointment for vns surgery, the patient had spoken to the surgeon's nurse practitioner. He had reported to her that he was more hoarse than when he had last replaced his lead and she stated that his hoarseness would last a week. He was diagnosed with laryngitis, and the patient stated that the loudest he could speak was a whisper. Operation notes from the patient's ent office regarding the patient's vocal cord paresis surgery. Left vocal cord paresis was diagnosed and the surgeon performed a microlaryngoscopy with left intracordal prolaryn injection. It was noted that the patient tolerated the procedure well and recoverd in good condition. No additional relevant information was received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.

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« Reply #28 on: January 07, 2019, 03:26:21 AM »

Model Number 302-20
Event Type  Injury   
Event Description
On (b)(6) 2014, the nurse reported that the patient has vocal cord paralysis, but the patient has not been seen yet. Follow up with the physician found that the patient was supposed to bring in their old clinic notes to their appointment, but the patient was a no-show. No other information was provided.
 
Event Description
The patient reported permanent vocal cord paralysis. The patient has not been evaluated for vocal cord paralysis, but did report to her currently treating physician that her vocal cord does work on the left side. The patient does have a medical history of unrelated health issues, such as fibromyalgia and laryngeal cancer.
 
Manufacturer Narrative

Manufacturer Narrative
Brand name, corrected data: the initial report inadvertently reported the incorrect data. Model #, serial #, lot #, expiration date, corrected data: the initial report inadvertently reported the incorrect data. Device manufacture date, corrected data: the initial report inadvertently reported the incorrect data.

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« Reply #29 on: January 13, 2019, 04:16:17 AM »

Model Number 105
Event Date 01/16/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the ent physician that the vns patient had laryngeal spasms with stimulation. Additional information was received from the neurologist stating that the patients' vns device settings were decreased to decrease symptoms. The patient did not have a prior history of laryngeal spasms prior to vns. The patient cannot tolerate even low levels of stimulation and his seizure frequency has not changed with vns; however, the patient is experiencing an improved recovery from his seizures with vns therapy.

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« Reply #30 on: January 17, 2019, 03:03:58 AM »

Model Number 304-20
Event Date 01/01/2014
Event Type  Injury   
Event Description
Additional information was received stating that the vns patient was referred for surgical consult due to dysphonia. The patient experienced a significant deterioration in voice quality following vns implant on (b)(6) 2011. Upon examination using a flexible fiberoptic, it was noted that the patient had periodic hyper-adduction of the left vocal cord. The left arytenoid excessively rotated medially preventing the right vocal fold from closing appropriately which caused the deterioration in voice quality. During stimulation off times, the vocal fold would return to midline position but did not move normally. When the device was disabled using the magnet, the phenomenon would stop. The surgeon stated that the event was due to vns stimulation. Laryngeal adductor botox administration improved the patient¿s symptoms but did not eliminate them. The patient was taken to the or to cut the recurrent laryngeal nerve by performing an ansa to rln reinnervation.
 
Event Description
It was reported that the patient indicated that he was to undergo neck surgery due to laryngeal nerve damage from vns. It was reported that the patient was experiencing laryngeal spasms post vns implant. The surgeon indicated that the patient experienced "unusual vocal spasms during device stimulation"; however, no specific details were provided. Attempts to obtain additional relevant information have been unsuccessful to date.

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« Reply #31 on: January 21, 2019, 11:56:07 AM »

Model Number 302-20
Event Date 05/06/2013
Event Type  Malfunction   
Event Description
On october 3, 2013, the manufacturer received a letter from the food and drug administration (fda) providing a report from the fda's medwatch program. Based on the nature and timing of the reported pain, dyspnea, and muscle spasms, it is possible that the event is related to the high impedance event. Below is the quoted event description from the medwatch report (mw5031542): "volun 27-aug-2013: i had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013. ".
 
Event Description
On (b)(6) 2013 it was reported that the lead impedance after surgery was noted to be ¿ok¿. Attempts were made for the return of both the lead and generator but neither product has been returned for product analysis to date.
 
Event Description
On (b)(6) 2013 ap neck and chest and a lateral chest x-rays were received for review. The images were dated (b)(6) 2013. The generator was seen in normal orientation in the left chest area. The filter feedthru wires and lead at the connector pin appear intact. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator. A portion of the lead appeared to be present behind the generator. The electrodes were observed in the neck and appeared to be in proper alignment. Based on the x-ray images provided, the cause of the high impedance is unknown; however, it could be related to a possible lead pin insertion issue. The presence of additional micro-fractures in the lead also cannot be ruled out.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2013 the nurse reported that pa and lateral chest x-rays have been performed and will be sent for review; however they have not been received by the manufacturer to date. The nurse also stated that around the time the patient started to notice voice changes and tightness with stimulation, her seizure frequency increased from 1-2 times per week to once per night. During this time the patient was also not sleeping well therefore it was unclear what was causing the increase in seizures. The surgeon noted that he suspects a malfunction of the vns as her chest x-ray revealed the vns to be in continuity. The patient underwent a full revision surgery on (b)(6) 2013. Attempts were made for the return of the explanted generator but it has not been received by the manufacturer.
 
Manufacturer Narrative
Follow-up report #1 should have stated that attempts were made for the return of both the lead and generator, instead of just the generator.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient was experiencing tightness and in her neck that started about two weeks ago. The nurse also stated that the patient has been experiencing an increase in seizures that started around the same time, two weeks ago. The device was interrogated on (b)(6) 2013 and the settings were output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1ma/magnet on time=30sec/magnet pulse width=500usec. High impedance was observed on (b)(6) 2013 with output=limit/lead impedance=high/dcdc=7/eos = no. The patient¿s vns was disabled due to the high impedance. The nurse stated that almost immediately after the device was disabled, the tightness that the patient was experiencing improved. There has not been any recent trauma and the patient denied any device manipulation. X-rays were ordered and the patient was referred for surgery. It was reported that the patient previously was followed by a different physician but that physician has left the practice. The patient was last interrogated in (b)(6) 2012 and per the patient¿s chart, device diagnostics were not performed at that time. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The nurse later reported that the patient had also been experiencing voice changes during the same time as the tightness in the neck. She stated that they do not have a copy of the patient¿s x-rays but that the patient might have a copy that could be sent to us; she stated she would follow-up with the patient regarding this. No further information has been provided 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=3167236
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dennis100
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« Reply #32 on: January 21, 2019, 11:57:10 AM »

Model Number 101
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Notes dated (b)(6) 2013 indicated that the patient may have had a seizure on (b)(6) 2013. The device was interrogated at 1. 75/20/130/30/5/1. 75/30. The impedance was ok (dcdc=3), the output status was ok, and the battery was noted to be functioning well. Notes dated (b)(6) 2013 indicated that the patient presented with a 2 year history of voice changes and hoarseness. The patient did not experienced any hoarseness following vns implant, except when it fires. A flexible videostroboscopy was performed with mild atrophy and supraglottic contraction but otherwise normal results. The event was determined to be muscle tension dysphonia for which the patient was referred for speech therapy. Clinic notes dated (b)(6) 2013 stated that the patient felt that her device was no longer working. The patient had three grandma seizures during the year. Prior to that, the patient had not had any seizures in 12 years. The patient also noted that her voice felt weak at times and thought the events might be related. A flexible laryngoscopy was performed: bot, vallecula, and piriform sinuses were clear and normal. Both true vocal cords showed good mobility, but there was possible slight bowing with a 1 mm gap. Moderate arytenoid erythema and mild edema were present. It was reported that the patient has possible mild age related atrophy and mild laryngitis contributing to her voice changes. The patient was referred for generator revision. The vns generator replacement was performed on (b)(6) 2014. The explanted vns device was discarded and therefore cannot be returned. Attempts are being made for additional information; however, no other information has been provided.
 
Event Description
It was reported that the generator battery was dying and the patient experienced more seizures. The physician reported that the patient is doing much better since generator replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3606821
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dennis100
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« Reply #33 on: February 08, 2019, 01:15:13 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported via social media that the vns caused the patient to have cysts on her thyroid and that the vns put a lot of pressure on her voice box and thyroid. She reported that she had her thyroid removed a month prior. The vns was explanted due to unrelated reasons prior to the thyroid removal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8294394
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dennis100
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« Reply #34 on: February 09, 2019, 03:37:19 AM »

Model Number 101 NCP PULSE GENERATOR
Event Type  Injury   
Event Description
Was implanted with cyberonics vns. They put in a recalled device and the //ong model. It would not stop going on and very quickly caused dramatic problems. I lost use of my vocal cords for over 8 months and then partially for many years, and began having laryngo spasms many times a day. After a long time, they have finally lessened a lot but still occur. They are quite terrifying as my throat is completely closed when they happen. No air can get in or out. Also, my oxygen levels dropped and stayed low, very low, and have remained on oxygen ever since. Was a straight a student moving through a doctoral program but could not complete due to inability to think and organize logically. I was always a very joyful person, but since the implant, i fight depression every day. Sometimes very serious depression, i was always interested in everything. Since the surgery, i mostly wait to die. It's been years since the device was implanted but it has taken this long to fight my way back to enough health to know to make this complaint. I can't take legal action because within the legal time limits i was fighting for my life and could not act. One of their neurosurgeons told me later that i was never a candidate for the implant and that i was nothing more than a customer to them.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8273950
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dennis100
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« Reply #35 on: February 12, 2019, 03:25:39 AM »

Model Number 304-20
Event Date 11/20/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient visited an ent due to difficulty swallowing following surgery and was diagnosed with left laryngeal paralysis. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4535913
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