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Author Topic: Voice/Speech  (Read 177591 times)
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dennis100
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« Reply #690 on: March 27, 2019, 07:08:18 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2015
Event Type  Injury   
Event Description
It was reported on (b)(6) 2015 that the patient has reported left vocal cord dysfunction. The onset of the event is unknown. The patient has consulted with an ent surgeon on whether or not any intervention needs to be taken.
 
Event Description
It was reported that the patient saw a local ent and the neurologists have yet to see the patient in the office. She was not complaining at all when they previously saw her. Further follow-up showed that the patient has been wheezing, having shortness of breath, and difficulty walking short distances. She thought her asthma was flaring up so she saw her primary physician. He noticed that the wheezing was coming from her throat. She was sent to ent and had further testing done. She was told she has vocal cord dysfunction most likely from the vns.
 
Event Description
(b)(6) 2016 notes state that the patient is here to have the vns settings decreased. Since having her duty cycle increased in august, she has been experiencing problems related to her vns. She has been wheezing, has shortness of breath, and cannot tolerate walking short distances or going up a flight of stairs. She saw an ent and was told she has vocal cord dysfunction. The md decreased duty cycle from 35% to 29%. (b)(6) 2016 -patient left to do stairs and walk briskly; came back and is still having problems with wheezing and shortness of breath. Turned device off and repeated, wheezing and shortness of breath gone totally. She feels much better. But with device off feels like she is having muscle spasms near vagus nerve, could feel the quiver of left neck which also affected her speech. Device was then decreased to 0. 5 ma then back to 1. 5 ma. So patient was set back to 1. 5 ma and will be seen in a few weeks to reduce if necessary. (b)(6) 2016 notes state the home pulmonary and ent specialists state that the wheezing while exercising is related to vns. When the vns was stopped she was able to exercise quite well without difficulties. They state that may indicate significant airway obstruction related to vagus nerve stimulation. Notes state they will get her down to 1 ma and cycle 30 sec on and 5 min off and see if that becomes more manageable in terms of her breathing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5341090
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dennis100
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« Reply #691 on: March 31, 2019, 07:23:12 AM »

Model Number 302-20
Event Date 02/16/2016
Event Type  Malfunction   
Event Description
It was reported that the patient experienced pain in the neck area. Device diagnostics resulted in high impedance (dc dc code 7). The patient refused to have the device programmed off. The patient was referred for surgery. No known surgical interventions have been performed to date.
 
Event Description
Clinic notes dated (b)(6) 2016 note that the patient is losing her voice more and cannot eat solid foods much. The patient underwent generator and lead replacement on (b)(6) 2016. The explanted devices have not been received for analysis to date.
 
Event Description
It was reported that the explanted devices were discarded; therefore, no product analysis can be performed.
 
Manufacturer Narrative
Date of event: this information was inadvertently reported incorrectly on initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5495368
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dennis100
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« Reply #692 on: April 02, 2019, 01:27:36 AM »

Model Number 102
Event Date 04/15/2016
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing coughing, intense stimulation, headaches, and pain in his neck. System diagnostics showed that the device had high impedance. The patient was programmed off after the high impedance was found. X-rays were taken and reviewed by the manufacturer. The x-rays did not show any gross lead fractures that could have contributed to the high impedance. The lead pin did not appear fully inserted to the connector block. No surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was sent to a speech pathology specialist and the medical professional has determined it is possible that the patient has a damaged vocal cord due to increased stimulation. The physician wants to see what will happen with the patient's recovery with the vns off. The patient feels that the device stimulation continues even though the device has been programmed off. It was reported that the patient desired explant of the vns and was scheduled for surgery. The patient underwent surgery on (b)(6) 2016; however, explant could not be confirmed. It was reported that the patient was also experiencing difficulty swallowing and that the patient had been followed by an ent. No additional relevant information has been received to date.
 
Event Description
It was reported that the explant occurred and the device was discarded by the explanting facility; therefore, no product analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5661432
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dennis100
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« Reply #693 on: April 04, 2019, 01:54:50 AM »

Model Number 302-20
Event Date 05/31/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance (>=10000 ohms. ) was observed on vns patient's system. It was reported that the patient had been feeling pain at neck for two weeks. On (b)(6) 2016, the patient's device was programmed at output current 1. 5ma, pulse width 500¿sec, frequency 30hz, on time 30sec and off time 5min. It was reported that the generator was turned off that day. It was reported that x-rays will be performed to see a possible lead discontinuity which could probably be due to a fall. A complete surgical revision will be scheduled but no known surgical interventions have been performed to date. Additional information was received indicating that x-rays have not yet been done, because the parents are quite reluctant about that. It was reported by the physician that in theirs records, there is a notification of the electrode wire-protuberance under the patient¿s skin on the neck; this was on (b)(6) 2014. No coincidental trauma and pain were observed; the device was working normally. It was reported that ultrasound investigation was performed that time, and no structural changes were described: the lead did not look interrupted.
 
Event Description
Further information was received indicating that the patient underwent lead revision surgery on (b)(6) 2016. The lead was replaced due to high impedance. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits with 1480 ohms. Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution. It was reported that the explanted lead will not be returned to the manufacturer for analysis as it was disposed. Additional information from the physician indicated that the patient is now ok with a new e lead in place. It was reported that the patient never had any fall, blow or any other trauma in the neck region or area of vns generator. The lead protuberance appeared suddenly on (b)(6) 2010, under the skin on the lower part of her neck. When this happened, an ultrasound investigation was performed and no other intervention was taken; the patient was doing well, had no pain and very rare seizures and her mother reported that vns works well (hoarseness of patient voice). Later in (b)(6) 2016, the protuberance disappeared; the physician thinks that it was the moment when the electrode finally slipped completely from the vagal nerve. As it turned out during the revision, this protuberance was a part of electrode (a non-active one, the ground) that slipped from the vagal nerve. X-ray performed before the surgical procedure, indicated that one electrode was not in the correct place. It was reported by the physician that the reason must be an inappropriate position-fixation of electrodes when implanted.
 
Event Description
Additional information was received from the physician indicating that the day of the implant, on (b)(6) 2014, the device was tested and system diagnostics returned impedance results within normal limits with 1480 ohms. It was reported that on (b)(6) 2014 (after the lead protuberance appeared on (b)(6) 2014), the vns system was still ok and system diagnostics returned impedance results within normal limits with 2194 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5731782
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dennis100
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« Reply #694 on: April 06, 2019, 02:36:04 AM »

Model Number 302-20
Device Problem High impedance
Event Date 02/20/2019
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Patient underwent generator replacement and impedance was noted to be ok post-operative. Two days later, the patient began to experience a scratchy voice and coughing. The patient was seen by a neurologist and high lead impedance was observed. The patient was seen by the surgeon and x-rays were performed. The surgeon reviewed the x-rays and noted that nothing was wrong with the device. The patient was seen by the neurologist's nurse practitioner. Upon interrogation, lead impedance was ok. The patient was programmed to the same settings prior to device replacement and began to experience coughing, gagging, crying, and dry heaving. The patient's settings were decreased until the patient was stable. By the end of the programming session, high impedance was again observed. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8444541
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dennis100
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« Reply #695 on: April 15, 2019, 01:46:55 AM »

Model Number 302-30
Event Date 02/01/2016
Event Type  Malfunction   
Event Description
It was reported that in (b)(6) 2016 the patient reported erratic stimulation. It was reported that in (b)(6) 2016 the patient reported that he had fullness in his head, continuous stimulation for 2 hours, voice hoarseness, and painful stimulation. The patient reported that it started when he turned his head a certain way, and demonstrated it to the physician. Due to these symptoms, the patient's device was disabled in (b)(6) and the patient was referred for generator replacement surgery. After disablement, the patient continued to report feeling intermittent stimulation, pressure in his head, and painful stimulation. The patient reported that when he turns his head, he can feel his voice change and stimulation, despite the fact that the output currents were off. The painful stimulation was reported as occurring in the neck and the head. Impedance was reported to be normal at 1171 ohms. A review of ap chest x-rays identified a potential lead fracture located on the upper left side of the generator. The treating physician also believed that there was a lead fracture. There was no known trauma or manipulation at the site of the fracture. The patient has had anxiety in the past, and this was indicated by the physician as a possible reason for the patient's symptoms post-generator disablement. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
Further programming/diagnostic history from the physician's tablet was reviewed. All reported impedance values were within normal limits. Internal data was reviewed and found that, given the small values of impedance, the changes in impedance detected could be normal. No additional relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5980471
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dennis100
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« Reply #696 on: April 16, 2019, 01:02:38 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/11/2016
Event Type  Injury   
Event Description
It was reported by the physician, through clinic notes, the patient has had an increase in seizures, along with a jerkiness and aura that the magnet does not always stop. The physician stated the device was nearing end of service and a new generator would be helpful. The physician noted the device diagnostics were within normal limits on (b)(6) 2016. A blc was performed showing the vns had approximately 9. 5 years remaining. However, it should be noted that the last information came from 09/26/2012 and the patient was only at a 9. 3% duty cycle. If the patient's settings had been increased between 2012 and now, it could greatly change the battery life calculation. Attempts for additional relevant information have been unsuccessful to date. No known surgeries have occurred to date.
 
Event Description
An implant card was received which showed the patient had a generator replacement on (b)(6) 2016. It is unknown whether or not the device was discarded after surgery. The generator replacement was noted to be prophylactic, although it was also marked at neos = yes (near end of service). The neos = yes condition would still be delivering the intended amount of therapy and it was confirmed that the impedance value was within normal limits and not malfunction was suspected with the device. Additionally, it was reported by the patient's physician that the patient was not actually having an increase in seizures, but she was having anxiety symptoms of twitching and stuttering. There was no indication the anxiety was related to vns. The physician stated that once she treated the patient's anxiety, the symptoms stopped.
 
Event Description
Additional clinic notes were received after the patient's replacement surgery had already occurred. The clinic notes were from before the patient's surgery. These notes mentioned the patient's generator was at ifi = yes on (b)(6) 2016 and it was noted the patient would need her battery changed in the near future. It was further explained in the clinic notes that the patient was losing her voice. This was mentioned along side the report of stuttering. The physician noted she lowered the vns settings, but this did not help the patient's voice issues. It was noted that the settings were increased again within the same visit (back to the patient's therapeutic levels) and the patient left the office at her normal settings. These notes provided additional information as it appears the speaking issues were also related to the patient's anxiety. It was reported in the supplemental #01 mfr. Report that the patient's anxiety was treated and the symptoms of stuttering and twitching stopped. The notes were simply received out of order, but provided additional information regarding the patient's anxiety symptoms, which were not related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5966294
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dennis100
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« Reply #697 on: April 16, 2019, 01:03:41 AM »

Model Number 304-20
Event Date 08/23/2016
Event Type  Malfunction   
Event Description
It was reported by the physician's office that high impedance was observed with the patient's vns device. It was noted that due to the high impedance, the output current delivered to the patient was less than the intended programmed settings. It was later noted by the physician's office that x-rays were taken an came back negative. The patient was referred for surgery; however, no known surgeries have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient had both his lead and generator replaced on (b)(6) 2016 due to high impedance. After the patient was replaced, his vns was checked and it was confirmed that his device was working as intended with an impedance value of 1939. It was later confirmed by the physician that the patient's pain over the generator site was due to the high impedance observed prior to the vns revision. The device is not expected to be returned as the explanting facility will not return to the manufacturer.
 
Manufacturer Narrative
This information was inadvertently left off of the initial mfr. Report.
 
Event Description
Clinic notes were received and it was noted the patient had voice alteration with stimulation; therefore, the settings were adjusted to try to resolve the voice alteration. The voice alteration appeared to begin at the same time as the high impedance occurred. Additionally, it was noted the patient was having a sharp pain over his generator periodically and sometimes with movement of his arm.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5965755
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dennis100
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« Reply #698 on: May 09, 2019, 07:17:33 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2016
Event Type  Injury   
Event Description
It was reported by the patient that he had been ¿going out¿ and that he wasn¿t sure if the vns was causing it. He said that he could also just be falling asleep, it could be a seizure or it could be his medication, but he was concerned that the vns and/or the vns and his pacemaker could be causing it. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: the following information was inadvertently not reported on the initial mdr "it was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. " event problem cds, corrected data: the patient codes were inadvertently not included in the initial mdr (b)(4).
 
Event Description
It was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. The patient reported his device was being explanted because it wasn't working because he could now feel stimulation. The patient also indicated that he had a pacemaker for atrial fibrillation. The patient then called and said that his painful stimulation was definitely occurring more often than what he expected it to and that he wanted the company representative to come disable it. The patient then reported to the company representative that nobody had programmed off the device or interrogated it since the last, but that he had talked to his primary care physician and the painful stimulation had resolved. No further relevant information has been received to date. No related surgical intervention has occurred to date.
 
Event Description
It was reported by the physician's office that the patient did not have a good memory. It was also indicated that sometimes he "sometimes just needed to speak to someone to calm him down" after his call to the manufacturer was described. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6503540
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dennis100
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« Reply #699 on: May 11, 2019, 03:13:08 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing an increase in seizures due to lowered vns settings. The increased myoclonic seizures were causing headaches, inability to focus, sore and tight muscles and sleeping issues due to the constant movements. The patient stated that the generator tested ok, but questioned if there could be issues with the generator. The patient stated that in february, the patient was admitted to the hospital as the physicians were concerned that the patient was having a stroke due to the patient's face muscles drooping, voice changes, and chest pains. After vns settings were lowered, the symptoms resided, and then further tests were performed confirming that there was no stroke. The patient reported their neck was twitching and was swelling, and there was severe issues with talking. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8557527
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dennis100
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« Reply #700 on: June 08, 2019, 06:31:09 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2019
Event Type  Injury   
Event Description
Clinic notes were received referring patient for generator replacement. The clinic notes indicated that the patient's seizure control was "pretty good" up until last year. The clinic notes indicate that the patient reported an aching pain in her left chest, near the vns. The patient also reportedly had a hoarse "grovelly" voice. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8626047
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dennis100
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« Reply #701 on: June 09, 2019, 01:14:08 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that since the patient's battery replacement surgery, she was experiencing neck pain. It was stated that right before her battery change due to battery depletion, she had a large seizure where after she felt a "pull in her neck". Since then, there had been a "lump" in her neck and pain with stimulation. She was going to obtain x-rays. There was no reported impedance issue. The patient stated that the vns helped her for years and that she would prefer to keep the device controlling her seizures rather than having it turned off for the pain. The physician did not know the cause of the lump and believed that an exploratory surgery or revision may be needed to know. It was clarified that this surgery would be for patient comfort, and not to preclude a serious injury per the physician's assessment. Diagnostics were indicated to have been within normal limits with ok battery life. X-rays were received for review. The connector pin was seen coming through the second connector block, indicating complete pin insertion. Based on the images provided, the cause of the painful stimulation could not be determined. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. Clinic notes were later received. It was stated in the notes that the patient experienced painful stimulation, mainly in her neck, but associated with dysphagia, hoarseness, chest pain, and shortness of breath. The events are non-radiating and only occur with vns stimulation. The pain became so significant that the "voltage" (likely referring to output current) had to be decreased, with increased dosages of seizures meds and pain meds. It was stated that since decreasing settings and increasing meds, the patient stated that she was still getting 2-3 grand mal seizures per week. Further updates were received and the patient reported that she was "now having 2-3 seizures per day" and has very painful stimulation for which she is on medication for. Output current and duty cycle were lowered for the pain. The vns surgeon and breast surgeon agreed to wait to schedule vns surgery until after the patient's mastectomy. No known vns surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8621049
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dennis100
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« Reply #702 on: July 05, 2019, 11:35:38 PM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/14/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
A report was received that a patient was hospitalized and stopped being able to walk, eat, or talk. It was stated the patient was on a feeding tube. It was stated that the patient is now able to walk however eating is still an issue. The patient's father who left the report on social media alleged the patient's inability to eat to the vns. Further information was received that the patient was hospitalized due to pneumonia and autoimmune disease which was not stated to be related to vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8721948
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dennis100
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« Reply #703 on: July 05, 2019, 11:36:28 PM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/07/2015
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by the neurologist that the patient's father indicated that the patient did not speak for a week following previous generator replacement surgery. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8744453
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dennis100
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« Reply #704 on: July 11, 2019, 01:31:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by the doctor that the patient was complaining of side effects of coughing and voice alteration and needed an mri of her breast, so they were going to do a full explant. The reason for explant was primarily the mri but the adverse events contributed. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8745590
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« Reply #705 on: July 11, 2019, 01:32:45 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/13/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported event of infection is not related to the functionality or delivery of therapy of the device. (b)(4).
 
Event Description
It was reported by the patient¿s mother that the patient was initially implanted with vns and then had it explanted a week later. She asked whether the device was supposed to programmed off prior to having it explanted and was informed there was no information available to indicate this had to be done. It was discussed whether the lead should be left in and was informed of fibrosis being a possibly occurring. How much of the lead should be left in was also discussed. It was stated the patient had a (b)(6) infection which worsened since it was not seen by the doctor after missing two appointments. Once the patient was seen by the physician, he was admitted to the hospital and could not move his legs. The patient was released with high sodium levels. The mother indicated the patient was in critical condition and was having kidney failure and other unspecified adverse events. The mother of the patient was asked whether the patient was not having any of these events prior to having surgery and stated he was not. Per the mother, the patient could previously talk and such indicating he was no longer doing this and was having a speech impediment. It was not specified whether this was after the implant or explant surgery. The device history record's of the lead and generator were reviewed. The generator and lead passed final quality and functional specifications prior to release. Sterilization of the products was verified prior to release. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8679069
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« Reply #706 on: August 10, 2019, 01:48:25 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
The patient reported via social media that she had side effects after her vns implant a year prior. She said that she could not speak and had heart palpitations. The physician reportedly disabled her device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764619
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« Reply #707 on: August 10, 2019, 01:49:04 AM »

Model Number 304-20
Device Problem High impedance
Event Date 06/20/2019
Event Type  Malfunction   
Event Description
It was reported that the patient's device has high impedance. It was also reported that the patient's voice is changing more than usual. The patient's device has been disabled. Device history records were reviewed for the patient's lead and the device passed all functional specifications and quality tests and were sterilized prior to distribution. Though surgery is likely, no surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8798578
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« Reply #708 on: August 10, 2019, 01:50:11 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported by an implanting surgeon that the patient was referred for a generator change, assumed to be replacement, due to long standing hoarseness. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8829283
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« Reply #709 on: August 10, 2019, 01:51:02 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/16/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the hospital with hoarseness, electrical pain in the back of throat going up to the patient¿s teeth, and hand spasms. The er (emergency room) physician indicated that he assumed the events were related to vns. Further information was received that the patient was seen the week prior to the hospitalization and per the neurologist the device was working fine. It was noted that impedance was ok, but that the exact value could not be recalled. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8776992
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« Reply #710 on: September 07, 2019, 01:32:29 AM »

Model Number 7103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/27/2019
Event Type  Injury   
Event Description
It was initially reported that a clinical trial patient experienced hoarseness possibly related to both the implant and stimulation. It was later reported that per an ent evaluation the patient had weakness of the right vocal cord. It was noted that the weakness was present while the device was off and therefore possible related to the implant procedure. The event was also noted to be possibly related to the vns stimulation as it began after implant. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8937294
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dennis100
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« Reply #711 on: September 07, 2019, 01:33:19 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/25/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's spouse reports that the physician has not been able to program the vns to therapeutic settings due to the patient experiencing head jerks at higher output current settings. The patient's spouse reports that x-rays were performed and that the neurologist believes the vns electrodes may have been placed on the muscle in the neck, instead of on the vagus nerve. She noted that the vns is not efficacious for the patient as the output current cannot be set to a therapeutic range. It was also mentioned that the patient has a fever, and according to the patient's spouse, the neurologist believes there may be an infection at the electrode site. The patient's wife later reached out to their sales representative reporting that the patient was recently discharged from the hospital due to increased seizures. The patient's wife mentioned that the physician informed them that the vns was not "installed correctly" and that the electrode can be seen protruding underneath the skin in the neck. It was noted that the physician cannot increase patient's settings as this would worsen patient's hoarseness, increases pain at neck , and causes the patient's neck to jerk. The patient has been referred to a surgeon. No known surgical intervention has occurred to date. Multiple attempts have been made to the physician for additional information; however, no other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8878845
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dennis100
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« Reply #712 on: September 07, 2019, 01:34:00 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/20/2019
Event Type  Injury   
Event Description
It was reported by the patient's sister that they recently received a generator replacement and since then the patient has lost their voice completely, has not been able to communicate, and has difficulty breathing. The patient's settings were turned down to relieve the symptoms but there has been no success and the device has now been turned off a week. The patient has still not been able to speak and easily becomes short of breath. Additional information was received during follow-up with the physician's office by the nurse indicating they are still in the process of trying to determine if the patient has vocal cord paralysis. No surgical intervention regarding the reported event has known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8896961
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