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dennis100
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« Reply #270 on: July 05, 2018, 08:47:03 AM »

Model Number 103
Event Type  Injury   
Event Description
It was initially reported by the physician's office that a pt mentioned that it seems that her pulse rate seems to drop at night. It was unk if this was occurring with stimulation. The pt was going to be referred for further evaluation on the issue. No further details have been made available on the issue. Good faith attempts to obtain additional info on the issue have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1671547
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dennis100
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« Reply #271 on: July 05, 2018, 08:48:00 AM »

Model Number 103
Event Date 10/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient has some episodes of a slow heart rate in the 50¿s ever since the vns was turned on a couple of weeks ago. The patient had no reported heart issues prior to vns. There was no report of cardiac issues on diagnostics during implant. The patient¿s current settings were noted to be output=0. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 75ma/magnet on time=60sec/magnet pulse width=500usec. The patient was taken to the er but everything was fine so he was not admitted into the hospital. They have not diagnosed the patient to have bradycardia. Since the patient has only had episodes, they have not seen a direct correlation to vns or stimulation. Good faith attempts for further information from the physician have been made but no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3485598
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dennis100
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« Reply #272 on: July 06, 2018, 11:34:56 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/31/2018
Event Type  Injury   
Event Description
It was reported that during the lead replacement surgery for high impedance, which is reported in mfg. Report #1644487-2018-01042, an erratic heart rate was observed when the vns was programmed to the pre-op settings. The in-pocket vns diagnostics were within normal limits and heartbeat detection was verified within 1 beat per minute, or bpm, at 70 bpm. It was stated that there was slowing and increasing of the heart rate. The surgeon stated that this was likely the result of stimulation on a "fresh" portion of the nerve. It was decided to disable the vns and allow the patient's physician to titrate the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7626459
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dennis100
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« Reply #273 on: July 06, 2018, 11:35:43 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/21/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was hospitalized due to low heart rate. The cardiologist stated that the low heart rate correlated with magnet mode. However, the neurologist believed that the low heart rate was not caused by vns but could have been exacerbated by vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7594811
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dennis100
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« Reply #274 on: July 16, 2018, 01:42:53 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 08/25/2008
Event Type  Injury   
Event Description
Information was received that the patient did have re-implant surgery for vns therapy.
 
Event Description
It was reported that the patient had too much scar tissue in the past from vns. No additional or relevant information has been received to date.
 
Event Description
It was reported that a vns patient would experience shortness of breath with exercise. The device was programmed off however the patient continued to experience shortness of breath and the patient was scheduled to have the device removed. The shortness of breath occurred sporadically and was not related to stimulation on times. Additional information received indicated that the patient suffers from anxiety and that was why the device was explanted. The anxiety is not related to vns and is pre-existing however the physician believed that due to the patient¿s anxiety, she could not handle being implanted with the device. The physician indicated that the shortness of breath could be related to the anxiety but was not sure. Additional information was provided that the device was explanted due to syncope and other complications. The explanting surgeon stated that at the time he noted that it was causing intermittent traction of the vagus nerve. It was noted that the patient also had increased heart rate. Clinic notes dated (b)(6) 2008 (a few months after implantation (b)(6) 2008), it was noted that since vns was implanted, before it was turned on, the patient has complained of shortness of breath and exercise intolerance (this may have been why the patient had increase in heart rate). There was a note that the patient did have exercise induced asthma prior to vns implantation. However, the patient states that it specifically causes problems with her breathing and believes it is all because of the vns. The notes then go on to state that vns was interrogated and settings were 0. 5ma (changed from 30sec on to 60sec). Notes indicated that the physician tested the patient¿s pulse oximetry and pulse before turning the vns on. There were no notable changes and the physician stated that based on the results the physician did not think there was any obvious change both with exertion and at rest whether or not the vns was on. The patient was still quite upset so they elected to turn it off. Notes dated (b)(6) 2009 indicate the device has still been off since (b)(6) 2008 and the patient still has had problems of a sense of pulling in her throat, difficulty breathing, exercise intolerance, syncopal episodes, left facial numbness, all of which she reports are intermittent. She can reproduce some of these problems when she turns her head to the right for prolonged periods of time or when she pushes upon the sternomastoid muscle a few cm from the incision. This would be at the location of the lead itself. The surgeon assessed the patient and attributed that there is excessive traction on the nerve with turning of her head and most of not all of her other symptoms are likely related to intermittent traction on the vagus nerve. Surgeon offered surgical intervention to possibly increase the size of the strain relief loop in an attempt to ameliorate the traction that she suspects caused these issues. He also offered a more extensive option to remove the vns if she preferred. The patient decided to remove the device entirely on (b)(6) 2009. The entire system was removed including all 3 helical coils. Notes dated (b)(6) 2009 did state that the patient has had none of the symptoms she had previously. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data. Supplemental mdr 31 inadvertently listed incorrect aware date, correct aware date is 03/23/2018.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7237189
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dennis100
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« Reply #275 on: July 25, 2018, 06:09:07 AM »

Model Number 102
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that the patient went to the er due to choking, shortness of breath, chest pain and an accelerated heart rate. The er physician placed the magnet over the device and the events resolved. Patient visited his treating physician after that and his device was disabled and patient was referred for removal surgery. Physician stated that the patient had no history of heart problems. Physician stated that the patient was set at 01/30/1000/60/180. Additional information received stated that the patient underwent a vns explant surgery. Explanted products were returned to manufacturer for analysis. Analysis is currently in progress for the explanted products.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888980
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dennis100
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« Reply #276 on: August 10, 2018, 04:16:47 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient had a defibrillator put in. The patient was having atrial fibrillation. The neurologist didn't think the vns was the cause of the atrial fibrillation and thought the patient had atrial fibrillation before being implanted with vns. A cardiologist though wanted the device disabled. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7726058
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dennis100
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« Reply #277 on: August 20, 2018, 03:41:57 AM »

Model Number 105
Event Date 09/01/2010
Event Type  Injury   
Event Description
Cyberonics vns - for epilepsy patients. Two surgeries. Two separate devices, worsening, depression. Device malfunction could be fatal. First vns - implant constantly malfunctioned left scar tissue caused death/resuscitation in operating room. Caused stroke 2 times, caused permanent damage to heart/body, second device caused permanent damage and could be end by death to my life. Nerve damage, permanent sensitivity to touch, damaged nerves/pain, heart problems, scar tissue. Neuropathy could result in death. Cyberonics recently called, and they stated the surgery never should have been done. Pt id: (b)(6). Chart # at operating room: (b)(6). Surgeon: (b)(6). Surgical operating room/extended adm: (b)(6) 2015. Csn: (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5700328
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dennis100
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« Reply #278 on: August 21, 2018, 08:51:24 AM »

Model Number 102
Event Date 03/15/2006
Event Type  Injury   
Event Description
It was reported by the pt that she was having a lot of gastric reflux problems and thought it may be due to her vns. She also reported a pain in between her vagus nerve and esophagus. The pt did want the vns explanted as it had not been beneficial for her. The device had been turned off due to the pain, but the pain was still present when she eats. Furthermore, the pt claimed to have an irregular heartbeat, which she did not know if it was related to vns. All of the pt's problems supposedly began after she was implanted. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2141185
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dennis100
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« Reply #279 on: August 25, 2018, 06:08:52 AM »

Model Number 102R
Event Date 07/01/2008
Event Type  Injury   
Event Description
It was reported to mfr that the vns pt was experiencing an irregular heartbeat. The pt reported that when the physician attempts to increase the device settings, the arrhythmia occurs and the physician has to turn the settings back down. The pt reported that follow up was performed with a cardiologist, who attributed the irregular heartbeat to vns therapy. Attempts to obtain additional info from the treating physician are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1098147
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dennis100
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« Reply #280 on: August 27, 2018, 11:32:30 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury   
Event Description
It was reported that the patient was having chest pains. It was unclear if the pain was due to the vns. The patient was taken in an ambulance and abnormal ecg was observed. The patient had no past abnormal ecgs. It was recommended to the patient to contact her neurologist to run diagnostics. Follow up with the physician's office revealed that the patient had contact the office. It was reported that they were aware of the event, but did not have information. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6684184
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dennis100
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« Reply #281 on: September 05, 2018, 08:26:16 AM »

Model Number 103
Event Date 03/01/2016
Event Type  Injury   
Event Description
On (b)(6) 2016 it was reported that the patient was scheduled for prophylactic generator replacement on (b)(6) 2016. The clinical reason is that his seizures have increased in number and severity with the current generator. The surgeon has noted heart rate variability in this patient and suggested this new generator model as the "next step". The patient underwent the generator replacement on (b)(6) 2016. The lead impedance for the new implant was ok, 1618ohms. The explanted generator cannot be returned for product analysis per the hospital.
 
Manufacturer Narrative

Event Description
The surgeon stated that the increase in seizures and increase in severity of the seizures were not related to vns. They were believed to be due to the patient¿s medicine, drug regimen, and disease progression.
 
Event Description
On (b)(6) 2016 it was reported that the patient has been having "multiple breakthrough seizures" and the physician is considering implanting him with a model 106 generator as he thinks it may help with the patient's seizures, though it was noted that this would be considered a prophylactic replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5570936
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dennis100
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« Reply #282 on: September 07, 2018, 11:42:33 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/11/2018
Event Type  Injury   
Event Description
It was reported that during the patient's generator replacement surgery, following the removal of the old device and implant of the new device, the new device was interrogated and diagnostics were performed, which were ok. The device was then turned back on to the previous device¿s settings. After programming was complete, the patient experienced heart block. The anesthesiologist monitored the patient and when the generator cycled again, and the patient again experienced heart block. The timeline of this was confirmed by the anesthesiologist who reviewed the cardiac monitor after the completion of the case. The surgeon turned the generator off and the anesthesiologist monitored the patient¿s heart rate for approximately 5 - 10 minutes. No abnormalities were observed during this time period. The device was turned back on, but at a lower output current of 1. 00ma for normal and magnet mode. After turning the device back on at this lower current, her heart rate was monitored for approximately 10 minutes, again no abnormalities were observed and the surgeon contacted the patient¿s neurologist office and they collectively decided to leave the device at the lower output current. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7738864
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dennis100
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« Reply #283 on: September 08, 2018, 01:22:21 AM »

Model Number 102
Event Date 01/18/2013
Event Type  Injury   
Event Description
It was initially reported that a patient had and ekg done which demonstrated concerns for atrial fibrillation. There was no relationship to vns provided. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3156370
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dennis100
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« Reply #284 on: September 13, 2018, 02:25:07 AM »

Model Number 102
Event Date 12/07/2009
Event Type  Injury   
Event Description
On november 7, 2011 clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2009 revealed that the patient had her pacemaker interrogated that year and that the patient has obstructive sleep apnea. No relationship between the patient's arrhythmia and the obstructive sleep apnea to vns was provided in the clinic notes. Good faith attempts for additional information from the physician have been made but no further information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2350933
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dennis100
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« Reply #285 on: September 13, 2018, 02:25:51 AM »

Model Number 103
Event Date 08/05/2011
Event Type  Injury   
Event Description
It was reported by the pt that she had experienced an arrhythmia while in the hosp for her vns initial implant. She did not specify what kind of arrhythmia it was but only stated that it "was not there before. " it was not clarified if it occurred during the surgery or post-implant. F/u with the neurologist's office found that the site had not heard of any adverse events and the pt was doing well at the visits following vns implant. Per the site, the pt's vns is functioning normally however specific vns diagnostics were not provided. A staff member at the surgeon's office said she was not aware of any of the events but would confirm with the surgeon. The pt also reported hotness and swelling at the wound site, nausea, visual disturbance, difficulty swallowing, and choking following surgery as well however none of these events were able to be confirmed with the neurologist or surgeon at this time. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2249204
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« Reply #286 on: September 19, 2018, 01:42:02 PM »

Model Number 102
Event Date 12/07/2011
Event Type  Injury   
Event Description
All attempts to the reporter for additional information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
Reporter indicated that a vns patient was having increased depression and was waiting for a heart transplant. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2428146&pc=MUZ
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dennis100
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« Reply #287 on: September 20, 2018, 10:45:57 AM »

Model Number 1002
Event Date 07/01/2011
Event Type  Injury   
Event Description
Reporter indicated that she began having some "heart related issues", where it feels like her heart is skipping beats, and her blood pressure drops, which started occurring about 6 months ago. The reporter questioned if this may be related to her vns device. Attempts for additional information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2423087
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dennis100
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« Reply #288 on: September 26, 2018, 06:23:39 AM »

Model Number 102
Event Date 08/29/2011
Event Type  Injury   
Event Description
Additional information was received from the surgeon who reported that the patient's reported additional health problems are not related to vns. The patient has been referred to a vascular specialist, but the patient has not followed up.
 
Manufacturer Narrative
The supplemental report #1 inadvertently did not include that the patient now reportedly has seven blood clots.
 
Event Description
It was reported that the patient has seven blood clots and has swelling in the legs and left arm, and the patient did not have these blood clots and swelling prior to vns. Attempts for additional information from the surgeon's office have been unsuccessful to date.
 
Event Description
It was reported that the patient had the generator and lead explanted on (b)(6) 2014. The explanted products have not been received by the manufacturer to date.
 
Event Description
The patient reported that the patient wants to the vns device explanted because it caused him to have blood clots. The patient indicated that he has had the device disabled 'for a period of time. ' the patient is reportedly now on coumadin, and continues to report that his health has declined with vns. He plans on reducing coumadin in anticipation of vns explant. Attempts for additional information on the device disablement have been unsuccessful to date.
 
Event Description
It was reported by the explant hospital that the explanted products were discarded.
 
Event Description
Additional information was received from the epileptologist's office which revealed that they are unable to provide an assessment regarding the relationship of the patient's heart conditions to vns. It was noted that the patient's vns system has been working properly and no changes have been made to the patient's medication or the vns settings. They are unaware if any interventions have been planned or if the patient had a medical history of blood clots or heart problems. The surgeon's office reported that the patient's blood clots, swelling and heart valve problems are not related to vns. The patient has been referred to a vascular specialist regarding these events. No causal or contributory medication changes precede the onset of these events, and the patient does not have a medical history of these events. Patient manipulation or trauma may have occurred to have caused/contributed to the swelling. No additional information was provided by the surgeon. The patient further reported that he has seven blood clots, and has swelling in his legs and left arm, which he didn't have before vns. The patient says that with vns, he is having more health problems than what he wants. Attempts for additional information from the surgeon have been unsuccessful to date.
 
Manufacturer Narrative
Date of birth, corrected data: the initial report inadvertently reported the date incorrectly. Date received by manufacturer, corrected data: the supplemental report #7 inadvertently reported the date incorrectly. It should have reported the date as 10/24/2014.
 
Event Description
It was reported that a vns pt had swelling in his arms and legs around the time of vns implant on (b)(6) 2011 through (b)(6) 2011. The pt went to the er in (b)(6) 2011, and the physicians found that he had a blood clot in his arm and one in his leg. He was hospitalized at that time. During this hospitalization, the pt was diagnosed with one of his heart valves not opening. The pt indicated that he thinks these events are all related to vns. The pt has reportedly not had his vns checked in a while and probably will not until the blood clots and heart valve problem resolve. Attempts for add'l info from the physician have been unsuccessful to date.
 
Event Description
Information was received from the neurologist¿s office that in clinic notes dated (b)(6) 2012, it was documented that the device was off. The nurse was unable to find when it was first turned off. An additional attempt for information has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465251
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dennis100
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« Reply #289 on: September 26, 2018, 06:24:46 AM »

Model Number 102
Event Date 06/13/2014
Event Type  Injury   
Event Description
It was reported that the vns patient¿s device was programmed back on during an office visit on (b)(6) 2014 and began affecting the patient¿s heart rate. The patient also had asthma and choking sensations. The patient¿s device was disabled on (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3927782
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« Reply #290 on: September 27, 2018, 10:26:08 AM »

Model Number 102
Event Date 04/04/2011
Event Type  Injury   
Event Description
It was reported by a vns pt that after she allergic reaction to antibiotics prescribed by neurosurgeon, captured in mdr# 1644487-2011-00975, she was told by hospital physician that she has an abnormal ekg. She was referred to cardiologist but the name of cardiologist was not provided. Good faith attempts to obtain additional information from pt's neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082987
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« Reply #291 on: September 30, 2018, 12:22:52 PM »

Model Number 102
Event Date 01/01/2012
Event Type  Injury   
Event Description
All attempts to the reporter's treating neurologist for further information have been unsuccessful to date.
 
Event Description
Reporter indicated that since his vns settings were increased in (b)(6) 2012, he had been experiencing dyspnea and "heart racing. " the reporter was advised to follow up with his physician. Manufacturer follow up with the treating physician revealed the reporter had not notified the physician about the reported issues. The physician will attempt to follow up with the reporter. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2507314
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« Reply #292 on: October 03, 2018, 07:27:18 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/10/2018
Event Type  Injury   
Event Description
A research article hypothesized the risk factors to determine a relationship between vns and clinically-significant arrhythmias. The case study central to the article discussed a patient who was admitted to the facility with symptomatic bradycardia associated with vns stimulation. The patient's medical history was reviewed. It was noted that the patient did not exhibit heart rate changes related to vns stimulation during the vns implant procedure; however, 3 years after implant, the patient occasionally exhibited loss of consciousness initially presumed to be related to a change in seizure type. It was later determined that the patient experienced momentary bradycardia, av block, and a brief cardiac arrest during sleep. The patient was implanted with a cardiac pacemaker, which resolved the bradycardia. Previous literature was also reviewed in the context of this article. The literature review identified 21 patients documented across 14 studies exhibited arrhythmias presumably induced by vns. Several of these events are discussed in the following mfr. Report #s: 1644487-2014-01653, 1644487-2006-00148, 1644487-2008-01907, 1644487-2008-01792, 1644487-2008-01919, 1644487-2009-01201, 1644487-2008-01648, 1644487-2008-03112, 1644487-2009-02887, 1644487-2011-01081, 1644487-2011-01081, 1644487-2012-02233, 1644487-2012-00993.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7779058
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« Reply #293 on: October 05, 2018, 01:17:12 PM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient's mother reported via social media that her son's vns had caused him to have heart problems. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7900685
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« Reply #294 on: October 06, 2018, 06:37:36 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/17/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient felt that her heart was "skipping beats" and that this worsened with stimulation. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7887874
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« Reply #295 on: October 06, 2018, 06:38:23 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/01/2018
Event Type  Injury   
Event Description
It was reported by a patient through social media that she was the first live patient for the surgeon implanting her vns and now had "heart blockage". The patient further stated that she had vns implanted in (b)(6) 2015 and was having heart problems attributed to the vns by (b)(6) 2018. She stated she was seeking vns explant. Programming history was reviewed, however data was only available from the date of implant up to (b)(6) 2016, which noted no device issue. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7889910
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« Reply #296 on: October 08, 2018, 01:55:46 PM »

Model Number 102
Event Date 08/15/2014
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was seen by the neurologist and it was determined that the cardiac event has no relation to vns.
 
Event Description
It was reported that the vns patient was diagnosed with heart disease. The patient¿s cardiologist stated that vns may be affecting the patient¿s heart. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4085358
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dennis100
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« Reply #297 on: October 09, 2018, 01:30:29 PM »

Model Number 104
Event Date 10/04/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
No further information has been attained after good faith attempts have been made.
 
Event Description
It was reported that the patient continues to have left shoulder pain with stimulation. The patient¿s caregiver would like to have the patient¿s lead replaced. She reports that the patient saw the surgeon a year ago about the pain and other events, and the surgeon reported to them that the patient did not need replacement.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.
 
Event Description
Additional information was received from a company representative indicating the patient was to undergo surgery as a piece of a foreign object was detected under the patient's shoulder area and believed to be associated with initial vns surgery. Moreover, the patient was reported to have an increase in seizures. Interventions taken were to increase the medication doses. At the moment, attempts to obtain further information regarding the foreign object have been unsuccessful to date.
 
Event Description
It was reported by a patient's mother that the vns patient had recently undergone generator replacement surgery and since then, the patient has experienced an increase in seizures, started having cardiac issues, and constant left shoulder pain. The patient's mother did not know if the reported increase in seizures was above pre-vns baseline, but did mention the patient underwent medication and parameter changes to reduce the seizure frequency. At the moment the relationship of the reported cardiac issue, pain, and increase in seizures to vns therapy is unknown as good faith attempts to obtain further information from the treating epileptologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2540783
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dennis100
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« Reply #298 on: October 10, 2018, 03:38:56 AM »

Model Number 102R
Event Date 05/03/2011
Event Type  Injury   
Event Description
Reporter indicated via clinic notes received to the manufacturer on (b)(6) 2012 that the patient had increased seizures on (b)(6) 2011. The patient had been seizure-free for two years, and then had 3 seizures on (b)(6) 2011 that were suspected to be drop seizures. Vns diagnostics were within normal limits and the vns was not at end of service. The patient had ans testing (study of the sympathetic and parasympathetic nervous system) performed, which was abnormal. Attempts for further information regarding the increased seizures have been unsuccessful to date.
 
Event Description
Reporter indicated via clinical notes received to the manufacturer that a vns patient had a possible arrhythmia. The patient was prescribed a holter monitor for use at home to analyze his heart rhythm on (b)(6) 2011. All attempts for additional information from the reporter regarding the possible arrhythmia have been unsuccessful to date.
 
Manufacturer Narrative
Information from the reporter was inadvertently omitted from the initial mdr report.
 
Event Description
Reporter indicated the patient did not have a pre-vns history of an arrhythmia, but an arrhythmia was not confirmed. The reporter referred all additional questions to the treating surgeon. All attempts for further information regarding the possible arrhythmia from the surgeon have been unsuccessful to date.
 
Manufacturer Narrative
Information from the reporter regarding the increased seizures was inadvertently omitted from the initial mdr report.
 
Manufacturer Narrative

Event Description
Additional information was received to the manufacturer from the treating surgeon. Per the treating surgeon, the patient did not have an arrhythmia. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2556909
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dennis100
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« Reply #299 on: October 10, 2018, 03:39:40 AM »

Model Number 102
Event Date 04/28/2008
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported on (b)(6) 2012, that a patient has felt a ringing in his left ear since surgery and indicated it interferes with his hearing. He has a scar at the generator site which is sensitive and painful. The scar at the generator is large and there is no scarring at the neck site. The patient is experiencing an irregular heartbeat with stimulation. He stated his heart has been observed as "skipping a beat" and states the device affects his memory in that he is unable to remember some things. He can also feel stimulation in his leg at times. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(6) 2012 when the neurologist's office reported that they have not seen the patient since 2008 so they would not be able to comment on the events reported by the patient. It is unknown who the patient will see at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2581381
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