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dennis100
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« Reply #30 on: January 25, 2019, 09:44:26 AM »

Model Number 105
Event Date 07/13/2014
Event Type  Injury   
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 because the patient was unable to disable her device. The patient was experiencing chest pain, voice alteration, and tightening of the chest. It was later determined that the reason why the patient was unable to disable her device with her magnet was likely due to improper technique. The patient stated she also had bradycardia while in the er. The patient¿s device was disabled, but the patient continued to experience voice alteration and shortness of breath. The physician stated that these issues were not related to vns. Ekg and ct were reported to be normal except for the bradycardia. The relationship between the bradycardia and vns is unknown. The patient was referred to see a cardiologist. The patient¿s device was disabled prior to being discharged. The patient¿s parent stated that the patient¿s blood work was abnormal; however, it is unclear what was abnormal with the blood work results. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.
 
Event Description
Clinic notes were received indicating that the vns patient was scheduled to undergo surgery on (b)(6) 2014 to explant her device. The patient had been hospitalized due to vomiting, diarrhea, sinus bradycardia, and voice hoarseness. The patient was given new medication and her device was disabled. It was noted that the patient¿s voice issues continued despite device disablement. The patient¿s device was tested and showed normal device function. The patient was seen by a cardiologist who determined that the patient had a history of nighttime bradycardia. The patient stated that she also had recently experienced bradycardia during the daytime. The patient had a history of chronic chest pain and was unable to tolerate stimulation at high settings due to the chest pain. The patient wanted her device explanted because it was uncomfortable and reportedly did not help with her seizures. Follow-up revealed that the patient¿s anxiety, nausea, voice alteration, vomiting and diarrhea were all related to vns stimulation. As the patient¿s device settings were increased, the patient¿s bradycardia had worsened and the patient was a non-responder to vns. The neurosurgeon stated that the patient did not have a prior history of cardiac events nor any pre-existing conditions susceptible to cardiac events. Additionally, the neurosurgeon indicated that the patient developed bradycardia following implant surgery. The patient underwent surgery on (b)(6) 2014 to explant her device. The explanted device has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013497
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dennis100
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« Reply #31 on: January 27, 2019, 10:04:31 AM »

Model Number 304-20
Event Date 03/07/2014
Event Type  Injury   
Event Description
Further follow-up revealed that the patient was not reimplanted. It was reported that the patient reported neck tightness and pulling at the nerve attachment site of the lead.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis, which did not revealed any anomalies.
 
Event Description
It was reported that the patient underwent generator and lead explant due to painful stimulation. The generator and lead were received for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator was completed on (b)(4) 2014. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. No additional relevant information havs been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4128688
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dennis100
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« Reply #32 on: February 03, 2019, 04:04:03 PM »

Model Number 103
Event Date 05/01/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2013 it was reported that due to the patient's experience with irregular heart rhythms the cardiologist did an ablation. Following the ablation the patient began to have a low heart rate and a pacemaker was implanted. After having the pacemaker implanted the patient started to become dizzy, sleepy, with trouble eating (weight loss), and vomits with dizziness. It was also reported that the patient experienced their shoulder and neck tightening up when they swiped the vns magnet across the generator. Good faith attempts are currently being performed.
 
Event Description
Follow up with the physician found that he was not under the impression that the patient's complaints of experiencing irregular heart rhythms, dizziness (which led to vomiting), sleepiness, inability to eat (leading to weight loss), or tightening of shoulder and neck area were related to the patient's vns. The physician stated that the patient has had extended periods in which he was asymptomatic with his device turned on, and, conversely, he has reported the above symptoms with his device disabled. It is the physician's understanding that the patient is currently undergoing a cardiac workup to explore a cardiovascular etiology for his complaints. Lastly, the physician stated that as he believes none of the patient's problems are caused by his vns, he is unable to provide any additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3212285
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dennis100
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« Reply #33 on: February 04, 2019, 03:10:31 AM »

Model Number 102R
Event Date 04/01/2014
Event Type  Injury   
Event Description
Additional information was received that the patient underwent replacement of the generator and lead on (b)(6) 2014. The portion of the lead that was explanted was discarded by the explant facility. The explanted generator was received on (b)(6) 2015. 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. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. During the product analysis, there were no anomalies found with the pulse generator.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient began experiencing pain in her chest during stimulation on-times after falling into a glass table. The pain resolved when the magnet was used to temporarily disable the device. The device was programmed off during an office visit on (b)(6) 2014. Diagnostic results did not indicate any issues with the patient¿s device. The patient previously reported occasional tightness in her chest, erratic stimulation and stimulation on-times not perceived. The patient was referred for surgery but no known surgical interventions have occurred to date.

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dennis100
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« Reply #34 on: February 09, 2019, 04:03:23 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury   
Event Description
Information was received that the patient's device was spontaneously going into magnet mode whether the device was enabled or disabled the patient was reported have painful stimulation and tightness at the generator site. It was also reported that the device was cycling every seven seconds despite parameter changes. Diagnostics from the physician was reported to be fine. Information was later received that the patient's generator was replaced. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8265182
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dennis100
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« Reply #35 on: February 13, 2019, 03:04:56 AM »

Model Number 102R
Event Date 01/12/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received indicating that the magnet mode output current for the vns patient¿s device was decreased because magnet mode stimulation on-times caused the patient¿s seizures to last longer. The patient achieved seizure reduction with increased duty cycle and better tolerance with decreased normal mode output current. It was noted that the patient was coughing and had tightness in the throat during stimulation on-times. No further information relevant to the event has been received to date.

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dennis100
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« Reply #36 on: February 14, 2019, 02:23:45 AM »

Model Number 104
Event Date 04/01/2015
Event Type  Injury   
Manufacturer Narrative
Conclusions; corrected data: the code was incorrectly reported on the initial mfr. Report.
 
Event Description
It was originally reported that the patient was experiencing pain in the neck at the site of the electrodes and in the chest at the site of the generator. The generator was programmed off on (b)(6) 2015. It was reported that the patient underwent surgery to replace the generator on (b)(6) 2015. Pre-operation diagnostic results were checked on the original generator and lead and the results were within normal range. Once the new generator was attached to the original lead, diagnostics were checked and impedance was above normal range. The pin of the original lead was reinserted into the generator and during this process the lead broke. The broken lead is reported under mfr. Report # 1644487-2015-04830. It was noted by the surgeons that the original placement of the lead was not well done and seemed "tight" (no slack) before the lead finally broke. Due to the lead break, a full revision was performed and diagnostics were run and the results were within acceptable ranges. The generator and lead have not been received to date.

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dennis100
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« Reply #37 on: February 26, 2019, 02:26:12 AM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Connection Problem
Event Date 05/12/2012
Event Type  Malfunction   
Event Description
Product analysis (pa) for the returned generator was completed. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications, with the exception of the test "backup cap neg to can", which has already been captured in mfr. Report 1644487-2017-03534. There were no additional performance or any other type of adverse conditions found with the generator. Pa for the returned lead was completed. Allegations of lead fractures were confirmed. The electrodes were not returned for analysis; therefore, a complete evaluations could not be performed on the entire lead product. During the visual analysis, the outer silicone tubing appeared to be twisted and compressed in several areas. Fractures were identified and scanning electron microscopy found that they were stress induced fractures. Additionally, pitting was observed on the surface of some of the breaks. Abraded openings found on the outer silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on one of the deposits and identified the deposit as containing silicon, phosphorus, sodium, magnesium, and calcium. With the exception of the observed discontinuities and the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Based on the findings in the pa lab, there is evidence to suggest discontinuities in the returned portion of the device, which may have contributed to the stated allegations of lead fractures. Note that since the electrode array section was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported the patient has been referred for replacement surgery; however, no surgical intervention has taken place to date.
 
Event Description
Clinic notes dated (b)(6) 2015 note that the patient and her mother feel that the vns was injured or disconnected the year prior and that device diagnostics were within normal limits. It was noted that there was a tightness in the lead that the neurologist was concerned about. The surgeon noted that there is no unusual tightness of the lead. An x-rays assessment was received indicating that the lead wire was disconnected from the device in the left neck. It was reported that device diagnostics performed on (b)(6) 2014 were within normal limits (1704 ohms). The neurologist believes that scar tissue is the reason for the lead tightness feeling that the patient experiences. The neurologist indicated that the patient's parents have asked for the generator and lead to be replaced. X-rays were sent to manufacturer for review. X-rays identified that the lead appeared to be fractured near the electrodes. It was later reported that high impedance was observed and that revision surgery was planned. A fluoroscopy was performed by the surgeon who found that the lead could not be seen clearly and concluded that the lead may have never been connected. Recent diagnostics were found in the physician's programming system that showed that device diagnostics were within normal limits at one time which showed that the device was at one time connected. The patient was seen on (b)(6) 2015 at which time device diagnostics were within normal limits. It was reported that the device was functioning normally and was programmed back on. The cause of the diagnostics being within normal limits is a believed short circuit situation with the patient's tissue. A device decoder was performed which identified that the lead break likely occurred as early as (b)(6) 2012. The patient was referred back to surgeon. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Age at time of event; corrected data: this information was inadvertently reported incorrectly on initial mfr. Report.
 
Event Description
The explanted generator and lead were received by the manufacturer on 03/02/2017. While analysis is expected, it has not been completed to date.
 
Event Description
Additional x-rays were sent to the manufacturer for review. X-rays identified that the lead appeared to be fractured near the electrodes confirming a lead break.
 
Event Description
The patient underwent a full vns revision on (b)(6) 2016. It was noted when the lead was removed, it appeared to be fractured and the lead wires were twisted together. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4749594
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dennis100
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« Reply #38 on: March 18, 2019, 02:19:31 AM »

Model Number 103
Device Problems Generator; Loss of or Failure to Bond; Migration or Expulsion of Device ; Material Protrusion / Extrusion; Lead
Event Date 04/07/2015
Event Type  Injury   
Event Description
It was reported that the vns patient's generator had migrated under her armpit a few weeks ago and causing pain at the generator site. The generator later moved back to the original implant site but it was noted that leads were protruding at the generator and electrode sites. The patient underwent surgery on (b)(6) 2015 to reposition the device. During the procedure, the surgeon did not observe a suture securing the lead. Patient manipulation or trauma is not believed to have caused or contributed to the event.
 
Event Description
It was reported that the vns patient continued that have issues following repositioning surgery. The patient stated that her neck area was still tight and painful. She described the issue had started as a small lump in her throat but then became ¿the size of a golf ball¿ that caused pain when eating, swallowing, or moving her neck/throat. Follow-up with the surgeon¿s office revealed that the patient had a post-operative appointment on (b)(6) 2015, and no issues were noted at the patient¿s neck region. Attempts for additional relevant information have been unsuccessful to date.

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dennis100
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« Reply #39 on: March 23, 2019, 12:27:27 AM »

Model Number 302-20
Device Problems Break; Disconnection
Event Date 11/02/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 the patient had full replacement surgery. The implant card received states that the lead was also replaced for lead discontinuity. It was stated that during surgery the lead appeared to be tethered. The surgeon could tell it did not look right, that it seemed tight so he made the call to replace the lead. The site explanted the lead after surgery.
 
Event Description
Product analysis for the generator was completed and approved on (b)(6) 2015. The generator battery was confirmed to be depleted due to normal current consumption. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5289083
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dennis100
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« Reply #40 on: March 24, 2019, 03:05:58 AM »

Model Number 106
Device Problem Insufficient Information
Event Date 11/02/2015
Event Type  Injury   
Event Description
It was reported that a patient, recently implanted with vns system, had pain and hoarseness. The patient was stating that it was tight and hurting a lot. It was reported that the patient was seen by a nurse and her physician, where she received antibiotics because the incision looked red. But the patient's throat was sore and her voice was still hoarse. It was reported by the nurse that the device had not been turned on yet, so the pain and soreness was likely a result of the surgery. Further information received indicates that the patient was again seen in clinic and she was doing well; the pain has stopped and her wound was dry. The patient's voice has been settled. It was reported that the device is now turned on. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. The device history records showed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Additional manufacturer narrative and/or corrected data, corrected data: (b)(4). The suspect device udi was inadvertently not provided in the initial mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5260052
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dennis100
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« Reply #41 on: March 28, 2019, 08:29:54 AM »

Model Number 103
Event Date 06/01/2015
Event Type  Injury   
Event Description
It was reported the patient was scheduled for a full revision on (b)(6) 2016. The full replacement is planned because the physician thought there may be something wrong with the system; however, impedance was not high. An x-ray was taken which was reportedly fine. When the vns was programmed off, because the physician thought there was a lead issue, the patient had an increase in seizures, so the device was programmed back on. The patient's family indicated the issue may be related to karate, but there were no issues on what was wrong with the device. It was noted the x-rays would not be released to the manufacturer. Clinic notes were received due to the replacement referral. It was noted the patient sustained an injury during karate sometime in (b)(6). Since the injury in (b)(6) 2015, the patient had intermittently experienced tightness and discomfort in his left pectoral region. The tightness is described as squeezing and occurs every five minutes though this was not observed by the physician while the patient was being evaluated on (b)(6) 2015. The physician was able to recreate the pain by palpating the tissue overlying the vns generator. Diagnostic testing showed an impedance value of 2083 ohms and an ifi = no condition. It was also mentioned at the visit on (b)(6) 2015 that the last pain the patient experienced was 4 days ago. On (b)(6) 2015, the physician decided to program the vns off to attempt to isolate the cause of the pain. It was later noted in clinic notes dated (b)(6) 2016 that the patient's seizures worsened after programming the vns off. Due to the worsening of seizures, the vns was programmed back on. The physician further described he believed the pain was mechanical because the pain does not occur with stimulation, but the pain did occur when the physician palpated the device. Based on this information, along with the impedance value that is within normal limits, the physician believes there is no malfunction with the lead, and only a generator replacement will be needed. The physician explained his plan to revise the generator pocket and secure the new generator more robustly than typical to prevent migration laterally, which is believed to be the etiology of the patient's discomfort. No known surgical intervention has occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Age at time of event; this information was inadvertently incorrectly reported on the initial mfr. Report. Outcomes attributed to adverse event; this information was inadvertently incorrectly reported on the initial mfr. Report.
 
Event Description
It was reported, through the receipt of an implant card, the patient had generator replacement on (b)(6) 2016 due to mechanical discomfort.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5446691
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dennis100
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« Reply #42 on: April 01, 2019, 01:02:32 AM »

Event Date 01/01/1990
Event Type  Injury   
Event Description
An article titled "complications and safety of vagus nerve stimulation ¿ 25 years¿ experience at a single center¿ was published and the abstract was reviewed, which included adverse events involving 14 vns patients. In many procedures performed between 1990 and 2014, patients suffered from complications related to vns surgery. It was reported that patient underwent reoperation 3 months after primary implant with lead placement correction because of discomfort and tightness on the throat.

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dennis100
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« Reply #43 on: April 02, 2019, 01:24:37 AM »

Event Type  Malfunction   
Event Description
It was reported that a vns patient with tuberous sclerosis complex had a lead break. It was reported that the patient had a new generator recently implanted. The lead became too tight and has now snapped after the patient contracted whooping cough and possibly pulled it with the extreme coughing. It was reported that the patient's seizures have increased due to that suspected lead break. It was reported that the patient's generator was switched off. No known surgical interventions have been performed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5675255
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dennis100
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« Reply #44 on: April 08, 2019, 02:32:13 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
The patient reported she developed tautness in the lead wire and underwent surgery to remove part of the coil. Multiple follow up attempts were performed with the patient's last known follow up physician and the implanting surgeon but no additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8401190
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dennis100
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« Reply #45 on: April 12, 2019, 01:20:06 AM »

Model Number 250
Event Date 07/14/2016
Event Type  Malfunction   
Event Description
It was reported by the company representative that the patient had come in for a vns replacement surgery. Upon interrogation of the device, the settings were found to be indicative of a faulted diagnostic test. It was explained to the surgeon that the settings found during interrogation were indicative of a faulted diagnostic test. The neurologist's physician's assistant was notified and stated the last time the checked the device was (b)(6) 2016 and he was able to provide the intended settings. The physician's assistant noted that when performing diagnostics on that date, the patient had a weird tightening sensation in her chest, so the diagnostics were interrupted. Due to the patient's tightness, they were unable to perform a final interrogation to verify the settings. It was explained to the physicians at that time that the patient would have been programmed at the unintended settings since (b)(6) 2016 until the day of surgery (2 weeks). After the implant was complete, the surgeon decided to program the patient back to the intended settings.

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dennis100
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« Reply #46 on: April 21, 2019, 03:42:35 AM »

Model Number 302-30
Event Date 10/31/2016
Event Type  Malfunction   
Event Description
It was reported the patient was seen by her physician and high impedance was observed on the vns. The patient was referred for full revision. The vns was programmed off. It was noted the patient had a seizure in (b)(6) 2016 and fell off her toilet and smashed her head on the floor resulting in a laceration. Since that point, the patient had felt a tightening in her throat when the device stimulated. The patient underwent full revision surgery on (b)(6) 2016. The surgeon noted that he identified an area in the lead which was damaged and replaced the lead. The generator was noted to be a prophylactic replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6117676
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« Reply #47 on: May 03, 2019, 02:28:41 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that a vns patient was experiencing an increase in seizures. The patient was referred for surgery. The physician stated the generator was interrogated and confirmed the device "is functioning well". Follow-up from the patient on (b)(6) 2017 also provide that she has had issues with different seizure types and frequency since last replacement. She stated seizures now happen every 2 weeks when they were happening every 4-5 weeks, lasting up to 2. 5 minutes and her recovery can be up to a week. Follow-up from the physician provided that the most recent diagnostics were normal with no error and the device was not at end of battery life. The patient¿s husband has reported increasing seizure frequency and severity past 3-6 months. The physician provided it is unclear if the increase in seizures was related to vns and mentioned the device is likely needing replacement. There is high suspicion for non-epileptic seizures co-existing with her epilepsy. Battery status indicator was reported to be normal. The change in seizure pattern and post-ictal duration is unclear if it is related to vns. It is suspected that the patient has pnes (psychogenic non-epileptic seizures) as well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the patient provided that she was still experiencing seizures and that she can no longer feel the magnet swipe.
 
Event Description
Follow-up from the patient provided that the generator has migrated close to her armpit due to her weight loss and is bothersome. The patient reports that she has had increased seizures within the last year and does not feel the vns is working. The patient also stated she had a really rough week as she has had a lot of seizures.
 
Event Description
It was reported by the patient that her device was turning on every 10 seconds, and staying on for about 10 seconds. The stimulation was very strong and painful and making it difficult to swallow. She reported that generator location makes it difficult to access with the magnet to disable the device. It was indicated by the surgeon that the patient's replacement surgery was due to battery depletion and her migration would be fixed at this time. Per the surgeon, the surgery was not to preclude a serious injury. No surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient underwent replacement due to battery depletion. The explanted product was returned. The patient reported that she had been having sleep apnea, buzzing in her neck during sleep since 2011. She also indicated that she had felt stronger stimulation in her neck and that she gagged with magnet swipes which had led to weight-loss in the past. The patient's treating physician indicated that this patient was a high anxiety patient. It was found that the patient had multiple complaints requiring investigations of increased seizures, pain with stimulation, dysphagia with stimulation, and perception of stimulation since 2011 that were previously considered separate events. Three reports regarding seizures of this patient were submitted since 2011. In mfr. Report #1644487-2012-00443, the patient reported that she'd had an increase in seizures in january 2012, a tightness in her neck, a decreased range of motion of her neck, and pain and clicking in her throat with stimulation. The physician said that the patient's increased seizures were not related to vns. The physician stated that he believed that the patient¿s pain and ¿tightness¿ or limited range of movement, were psychiatric in nature and not related to vns. In (b)(6) 2015, mfr. Report #1644487-2015-04964, captures a report from the patient that she had a new type of seizure while having her vns settings adjusted. This seizure was later indicated not to be related by the physician and the physician indicated that the patient's seizures had decreased in severity since having the vns. Mfr. Report #1644487-2015-05446 reported that in (b)(6) 2015 the patient had experienced an increase in seizures due to her "levels being low. " the physician indicated that the patient had an extremely variable seizure pattern and that her history is not reliable. Further relevant information to these reports will be captured in the current manufacturing report as these reports appear to be related. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr 4 inadvertently reported that the generator was returned when it was actually discarded.
 
Event Description
The physician indicated that the relationship of the following symptoms---sleep apnea, buzzing in neck, stronger stimulation in her neck, and gagging with magnet swipes which had led to weight-loss in the past--- was unknown. The patient's explanted product was discarded. No further relevant information has been received to date.

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dennis100
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« Reply #48 on: May 03, 2019, 02:29:30 AM »

Model Number 304-20
Device Problems Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 03/08/2017
Event Type  Malfunction   
Event Description
It was reported that a patient was having lead problems related to her clotting disorder. The patient believed that her physician told her that this was the case and stated that she needed to undergo full revision surgery to resolve the issue. No further relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. The lead was not replaced as the surgeon reportedly did not feel it necessary to replace the lead. No additional relevant information has been provided to date.
 
Event Description
It was reported that the patient was actually experiencing a tethering sensation accompanied by pain and discomfort when she turned her head. The lead was only repositioned during generator replacement surgery. The lead repositioning was for patient comfort. The surgeon believed that scar tissue formation, and not a clotting disorder, was the cause of the patient's lead issues. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6449279
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dennis100
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« Reply #49 on: May 06, 2019, 03:38:15 AM »

Model Number 302-20
Event Date 11/01/2009
Event Type  Injury   
Event Description
It was reported that a vns pt experienced pain during stimulation at the neck site. The pt had recently had a full system replacement as she was initially implanted in 2009 and shortly after surgery, she developed vocal cord paralysis. The vocal cord paralysis is now resolved, but the pt presented pain. Additional information was received from the treating physician indicating the pt was having muscle spasms with stimulation and the probable cause was vns implantation which topped connective tissue in the sternocleidomastoid muscle. The implantation of vns gave massive tension and spasms in the muscle at each stimulation of vns. Interventions taken were to reduce the pt's settings (decrease pulse width to 130 usec) to ameliorate the event. Moreover, the physician stated the pt reported horner syndrome and recurrence paresis in (b) (6) 2009 directly after initial vns implant. At the moment surgical intervention has not been planned and good faith attempts to obtain additional information have been unsuccessful to date. At the moment the muscle spasms are not present anymore and were related to stimulation as parameters were reduced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1779177
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« Reply #50 on: May 07, 2019, 07:23:00 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Injury   
Event Description
Upon further follow up with the nurse, it was revealed that the patient is experiencing pain and a "shocking sensation in chest due to wires being bunched up". The lead appears to be protruding from mid-neck to the collarbone with a "knot" felt at the lead body. The only intervention taken to date is assessment by the surgeon. Both the surgeon and the treating vns physician tested the device, and it was reported to be working okay. The patient's severe body spasms are believed to be the likely cause of the lead protrusion and caused the extreme pain and feeling of being shocked. No other physiological changes are believed to have contributed to the lead protrusion. Since the surgeon is afraid the lead wires may break if not replaced and due to the length of implant, the patient is referred for full revision surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported on (b)(6) 2013, that the patient is experiencing lead wires "bulging" accompanied with tension/pain in the neck that occurred right after she had a severe episode of body spasms about 10 days prior. The patient has a variety of physical illnesses, one of which includes these body spasms. The treating rn believed the body spasms may have been experienced as an extreme case due to stress as the patient was on her way to her brother's funeral. She also thought that the protrusion was due to the spasms that the patient experienced. The rn also mentioned that the patient's depression had been worsening recently, but that she believes that the patient's stress (brother passing away, dog being ill) have contributed to this recent increase in depression. The patient was evaluated again by the treating vns psychiatrist on (b)(6) 2013. Diagnostics on the patient's vns are within normal limits. The psychiatrist reports that the lead "bulging out a little bit like a vein" but was unsure if this bulge has always been there all along. Later, it was reported that the patient has also been experiencing pain and swelling in the tongue due to little cuts on her tongue which occurs with stimulation, and the surgeon believes this is related to vns. The patient has been experiencing this for a while; however, it has worsened lately with the other events. The treating rn did not have further details at that time. Clinic notes from the surgeon dated (b)(6) 2013, indicate that the patient complains of tension/pain in the left neck/leads and had been worsening over the past few years. The surgeon indicated in the notes that he can offer operation for lead revision for severe excess lead tension and generator change for end of life which the patient agreed. The patient was scheduled for surgery for possible generator and lead revision due to pain and swelling with stimulation. The surgeon reportedly believes the patient does not need an x-ray because he can see the wires bunched "where it goes into the vns. " as of (b)(6) 2013, the rn reported the patient indicates that she has a "white line in her skin going along the vagal nerve" and a knot at the electrode site which the patient and physician can feel. The rn also indicated that the patient has a lot of accompanying medical, physical and psychological problems. Although surgery is likely, it has not occurred to date. Attempts for additional information from the treating psychiatrist's office ( rn) have been unsuccessful to date. Follow up with the surgeon's office revealed that per the psychiatrist's notes, the patient "denies any pain or discomfort from vns. She has been diagnosed with major depression disorder and major psychotic disorder which may be a psychotic manifestation of her symptoms. Would like to rule out psychotic or psychological disorder. " the nurse indicated that the surgeon appears to be due to not to preclude a serious injury as the notes indicate that she denies pain or discomfort and the symptoms appear to be thought to be related to her other mental/physician illnesses. However, it remains unclear at this time.
 
Manufacturer Narrative

 
Manufacturer Narrative
The initial report inadvertently reported the age incorrectly as the date of event was listed incorrectly. The initial report inadvertently reported the event date incorrectly as it was reported that the tension and pain in the neck was worsening over the past couple of years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027374
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« Reply #51 on: May 07, 2019, 07:23:56 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received that the patient was experiencing pain in the left neck up to the ear with vns stimulation that was described as a burning sensation. The patient has concurrent ear problems that are being treated by the pcp, but the patient noted this burning as independent of the ear problems. It was also noted that the patient's generator had migrated, which created tension on the vns lead, resulting in protrusion, a lead pulling sensation, and discomfort. The patient was referred for vns replacement surgery. Follow up with the physician's office revealed that the intervention was for both the patient's comfort and to preclude serious injury. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
The patient underwent vns generator replacement surgery. The explanting facility, historically, does not return explanted products.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7572226
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« Reply #52 on: May 07, 2019, 07:24:55 AM »

Model Number 103
Event Date 12/10/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2016 it was reported that the patient felt a lump and tension in the neck and generator site. This was reported as beginning the day after the last appointment on (b)(6) 2015. It is believed that the device may have migrated which was causing the difficulty interrogating the patient previously. It was noted that the patient was able to be successfully interrogated at this visit. Diagnostics were noted to be within normal limits and ifi-no. The patient has been referred to the surgeon for consult. The patient underwent a prophylactic replacement on (b)(6) 2016. The pre-op diagnostics were within normal limits and ifi-no. The patient had complaints of pulling sensation and migration of generator. The lead was reported to be uncoiled and the generator only was replaced. During surgery it had appeared that the generator had dropped in the chest and it looked like the lead was coiled almost as if the patient had manipulated the device but it was stated the patient did not. It was confirmed that non-absorbable sutures were used to secure the previous generator. The reported lump that the patient felt was determined to be the coiled lead in the chest. The lead pulling sensation was thought to be due to the generator dropping in the chest (reason is not known as manipulation or trauma is not suspected) and due to the lead being coiled (also reason unknown). The explanted generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5413064
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« Reply #53 on: May 07, 2019, 07:26:02 AM »

Model Number 304-20
Event Date 01/21/2016
Event Type  Malfunction   
Manufacturer Narrative
Suspect device udi#: (b)(4).
 
Event Description
It was reported by the physician that the patient developed twitching in her neck with the use of the vns magnet. The physician suspects the twitching is due to a lead fracture and has advised the patient not to use the magnet as the patient has no other symptoms and the normal vns output current is not causing the same symptoms as magnet use. Settings were adjusted due to the discomfort with the magnet stimulation, which occurred prior to the observance of the muscle twitching. No settings were changed due to the reported muscle twitching.
 
Event Description
The patient underwent vns explant surgery. During attempts at product return, it was revealed that the facility, historically, does not return explanted products.
 
Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #1 inadvertently left out information. (b)(4).
 
Event Description
Clinic notes were received by the manufacturer and indicated that the patient had difficulties with pain at the neck and chest where the vns was implanted. It was stated that she developed issues with tension at the neck when trying to do sit-ups. When the vns activated, she experienced contractions of the laryngeal musculature. The patient reported twitching in her neck muscles with magnet stimulation. The vns magnet mode was programmed off. It was stated that since the magnet mode was disabled, the patient was getting the warning for complex partial seizures for shorter lengths of time, which she did not get before. The operative notes from the initial implant were included and no complications were reported. It was noted that the lead was secured to the surrounding subcutaneous tissues with 4-0 sutures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5453369
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« Reply #54 on: May 09, 2019, 07:33:12 AM »

Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
It was initially reported that the patient was referred for surgery due to the device slipping. Diagnostics are fine but the patient feels pain. Clinic notes dated (b)(6) 2013 were received due to the patient being referred for surgery. The generator was disabled due to currently experiencing "pain in her neck over the scm muscle as it did once prior in 2006 when revision was needed, because the device had slipped out of place". The events in 2006 were previously reported in mfg report number: 1644487-2013-00840. It was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. It was further indicated in the notes that the patient had noted pain with vns stimulation on times for the past month described as focal pain at the electrode site. The patient's seizures are under good control, but the vns device was turned off due to "lead impedance problems and elevated dc code and pain". However, diagnostics were within normal limits. System diagnostics showed dcdc=2, and normal mode diagnostics showed dcdc=3. Additionally, the lead impedance was indicated as "ok". The physician also stated the generator is not at eos, "but we believe it is disconnected. " x-rays were ordered, and the patient was referred for vns replacement surgery due to painful stimulation which the physician indicated the pain could preclude injury. Upon follow-up with the treating physician, it was reported that they are unable to establish communication with the device currently but then it was later indicated that the device could be interrogated to show the impedance. Current x-rays do not show any obvious discontinuities, but they have not been provided to the manufacturer for review to date. The x-ray report indicates the x-rays were compared to those dated (b)(6) 2006 and there were no evidence of lead disruption or significant displacement identified. Additionally, there was no gross discontinuity involving the stimulator although evaluation was reported to be quite limited. No patient or manipulation is believed to have contributed to the events. The physician does not believe the leads are disconnected and does not believe that there is lead migration at this time. There were no causal or contributory programming or medication changes that preceded the onset of the events. After the device was turned off due to pain in the generator and lead area, the pain stopped. Although surgery is likely, it has not occurred to date.
 
Event Description
An analysis was performed on the returned lead portions which identified observed abraded openings on the outer and inner tubing sections have the potential for contributing to the painful stimulation allegation. The abraded opening found on the outer and one inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and one of the inner silicone tubes. For the observed inner tubing fluid remnants found inside the second inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Other than the abraded openings of the outer and inner tubing, no additional obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. One set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is evidence of an abraded opening in the inner tubing, which may have contributed to the stated painful stimulation complaints. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Manufacturer Narrative
Suspect medical device, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device manufacture date, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device failure occurred, and may have contributed to the patient's pain. Review of lead manufacturing records confirmed that all quality tests were passed prior to distribution.
 
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2013 due to painful stimulation and the patient felt as if the device was flipping. The explanted products were received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027440
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« Reply #55 on: May 11, 2019, 02:53:31 AM »

Model Number 300-30
Device Problem Low impedance
Event Date 12/13/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received indicating that the patient was not feeling stimulation like she did before. She was now feeling pain in her ear and jaw when stimulation was delivered along with an increase in gagging and choking sensations. The patient also reported that she was experiencing a shocking sensation when she turned her head to the right occasionally which resulted itching at the electrode site. The patient also reported that the muscles in her neck would tense up for 30 seconds and then relax. The patient's generator was disabled and the tension resolved. Diagnostics showed that the impedance on the patient's generator was at dcdc 0, which could be indicative of a short circuit issue under certain circumstances. The patient then had her device prophylactically replaced in (b)(6) 2017. No additional relevant information has been received to date. The explanted generator and lead have not been received to date.
 
Manufacturer Narrative
Device information, corrected data: the initial report inadvertently reported the incorrect device information. Implant date, corrected data: the initial report inadvertently reported the incorrect implant date. Device manufacture date, corrected data: the initial report inadvertently reported the incorrect manufacture date.
 
Event Description
The generator and lead were received. Analysis on the generator was approved. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis on the lead has not been approved to date.
 
Event Description
Analysis on the lead was approved. Note that the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed with no discontinuities identified.
 
Manufacturer Narrative
Follow-up report #2 inadvertently listed the incorrect results and conclusion codes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6404233
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« Reply #56 on: May 14, 2019, 01:06:53 AM »

Model Number 302
Event Date 01/26/2014
Event Type  Malfunction   
Event Description
The patient's explanted product was received on 08/12/2016. It is unclear why the device was explanted or the date the explant occurred. Product analysis was completed on the lead. The analysis concluded that there was a stress induced fracture in one of the strand that occurred while the product was implanted. The strand on the negative coil were also found to have stress induced fractions thought to be from tension. Evidence that body fluid had once been in the inner and outer tubing was found at the torn openings. Pitting and erosion also occurred at the ends of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5971640
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« Reply #57 on: May 14, 2019, 01:07:42 AM »

Model Number 103
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was reported by a patient through a company representative that the patient's generator suture in the chest pocket had broken loose. The event happened when the patient was laying down on the ground and had a dog jump on her chest. The patient's treating neurologist performed diagnostics on the patient's device and were within normal limits (no specifics). Moreover with movement, the patient has vocal cord paralysis and possibly due to the strain of the lead pulling on the nerve. Per the patient, she has to manually hold the generator in the pocket by herself. Also, if the patient looks upward she coughs because of the weight of the device pulling on the nerve. Patient is scheduled to see the surgeon for evaluation. Additional information was received from a company representative indicating the patient underwent revision surgery. Upon surgery, the lead was twisted and pulled tension on neck; the strain relief was broken as well. The surgeon placed new pocket in chest above old pocket and sutured to fascia. He then recreated strain loop in neck. Currently, the patient called and said she is no longer feeling need to vomit or cough with neck movement. No new lead or generator was needed. Stimulation was not turned on. Patient still has vocal cord paralysis from this event so her treating physician will determine when vns will be programmed on. Mfr. Report #1644487-2010-02742 was submitted to report on the event of vocal cord paralysis. Moreover, good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919363
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« Reply #58 on: June 07, 2019, 05:31:11 AM »

Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/28/2019
Event Type  Injury   
Event Description
It was initially reported that the patient was scheduled for a possible lead and generator replacement surgery, and information was later received that the surgery was being taken due to tightness/pain in the neck area. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8574755
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« Reply #59 on: June 08, 2019, 06:42:27 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2018
Event Type  Injury   
Event Description
A week before a patient's battery replacement surgery, which was initially indicated to be a prophylactic upgrade replacement surgery, the patient's device reportedly stopped working and caused the patient to develop uncontrolled grand mal seizures and tense neck muscles. The patient was previously experiencing no problems or pain with her vns and it was noted that the device was working as intended with no impedance issues. The patient's battery replacement surgery occurred. It was stated that the device was discarded per hospital policy, and would therefore not be available for return for analysis. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8620941
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