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dennis100
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« on: May 24, 2018, 02:24:01 AM »

Model Number 101
Event Date 01/01/2004
Event Type  Injury   
Manufacturer Narrative
Article: srinivasan, balaji, and ashish awasthi. "transient atrial fibrillation after the implantation of a vagus nerve stimulator. " epilepsia (2004): 1-1.
 
Event Description
It was reported in a scientific article that a vns patient experienced palpitations the day after having vns implantation surgery. The patient was taken to the emergency room and telemetry studies showed intermittent runs of atrial fibrillation, atrial flutter, and frequent premature atrial complexes. The patient was hemodynamically stable during the arrythmia. The patient had no history of dysrhythmia or other cardiovascular disease. The patient's generator was programmed off, but the patient continued to have paroxysmal runs of atrial flutter and fibrillation for 24 hours, but thereafter remained in sinus rhythm. The device was turned on at a later date and the arrhythmia did not recur. Currently, the relationship of the arrhythmia to vns therapy is unknown as good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1402706
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dennis100
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« Reply #1 on: May 24, 2018, 02:24:35 AM »

Model Number 102
Event Date 01/25/2010
Event Type  Injury   
Event Description
It was initially reported that the patient was scheduled for battery replacement due to an end of service condition, but was then postponed due to atrial fibrillation. There was no indication that the issue was related to the vns therapy, but no further details have been made available at this time. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1616532
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dennis100
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« Reply #2 on: May 24, 2018, 02:25:05 AM »

Model Number 102
Event Date 07/27/2009
Event Type  Injury   
Event Description
A medical student called to report that he had a vns patient who had atrial-fibrillation that had developed since being implanted. Per the student, the atrial-fibrillation is occurring with stimulation according to the patient's 30/5 duty cycle. The patient has not had any seizures since being implanted with the vns. The event did not occur during vns testing. Good faith attempts are being made for further details and thus far have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1788757
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dennis100
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« Reply #3 on: May 24, 2018, 02:25:39 AM »

Model Number 103
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was initially reported that the pt is having possible cardiac events, described as "triples" and "pcas" on the ekgs by the treating neurologist. The pt was referred to a cardiologist for eval. The neurologist indicated that the patient is currently on high doses of benzo medications and also depakote, so he believes the pt may possibly having reactions to the high doses of medication and causing the problems with her heart. Diagnostics were said to have been within normal limits, but no specifics were available at that time. Further f/u indicated that the pt is still having afib issues with occasional episodes of passing out (not associated with stimulation on-times or seizures). The pt is wearing a holter monitor for 22 days to evaluate her issues. The patient is bipolar/depression and is on several medications. The patient has very low weight and body fat, so the neurologist believes that the issues she is experiencing are due to her medications in relation to her physician condition. Last known diagnostics available in the mfr's programming history database were at the time of implant, which were within normal limits. Good faith attempts to obtain add'l info are still in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774910
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dennis100
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« Reply #4 on: May 24, 2018, 02:26:16 AM »

Model Number 103
Event Date 11/21/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient was seen at the hospital and was experiencing atrial fibrillation, it is unknown if this is related to vns. The patient is planning on seeing a cardiologist. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2372880
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dennis100
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« Reply #5 on: May 24, 2018, 02:26:48 AM »

Model Number 102R
Event Date 03/03/2015
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The cause of death was unknown by the physician's assistant. The funeral home director indicated that the patient was buried with the device and that the immediate cause of death was heart failure due to atrial fibrillation >3 years, due to or as a consequence of atrial fibrillation >3 years, due to or as a consequence of sleep apnea >5 years. The death certificate noted other significant conditions contributing to death, but not resulting in the underlying cause was serious anemia. No autopsy was performed. The manner of death was listed as natural, and tobacco did not contribute to the death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4641033
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dennis100
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« Reply #6 on: May 24, 2018, 02:28:06 AM »

Model Number 103
Event Date 11/21/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient was seen at the hospital and was experiencing atrial fibrillation, it is unknown if this is related to vns. The patient is planning on seeing a cardiologist. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2372880
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dennis100
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« Reply #7 on: May 25, 2018, 01:13:18 AM »

Model Number 102
Event Date 11/30/2009
Event Type  Death   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
Outcomes attributed to adverse event: death, corrected data: the initial report indicated the date of death was (b)(6) 2009 however, it was (b)(6) 2009. The information has been corrected in this report. Date of event, corrected data: the initial report indicated that the date of the event was (b)(6) 2009 however it was (b)(6) 2009. The information has been corrected in this report.
 
Event Description
Additional information was obtained and it was found that the patient¿s date of death was actually (b)(6) 2009 and the patient passed away at the hospital. The patient was admitted to the hospital on (b)(6) 2009 with acute atrial fibrillation with fast response, hypotension, and probable pneumonia. The history of present illness details that the patient had serial life threatening problems over the last two months which included an intracerebral hemorrhage with resulting hemiparesis and marked cognitive and physical deficits. A feeding tube was placed a week prior to the hospital stay because of dysphagia and recurrent aspiration. The patient had an acute mi, pneumonia, svt, and blood pressure difficulties prior to placement. Tachycardia at a rate of 180 led to him being sent to the er. The svt proved quite difficult to control as he was found to have a large intraventricular clot that they did not anticoagulate because of the intracerebral hemorrhage. The physician wished to move the patient to hospice due to the poor prognosis, but his brother wanted gentle care. In a progress note addendum, the physician convinced the patient¿s family to move the patient to hospice care because ¿his prognosis is essentially zero. ¿ the patient had another mi while in the hospital, but the patient's heart rate and blood pressure somewhat stabilized. The patient was eventually discharged on (b)(6) 2009, the date of death.
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2009. The cause of death is unknown. Review of the available programming and diagnostic history showed normal diagnostic results through 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3673246
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dennis100
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« Reply #8 on: May 26, 2018, 12:37:45 AM »

Model Number 102R
Event Date 01/24/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that a patient had a prolonged seizure and was taken to the hospital. The patient felt the seizure coming on and attempted to take depakote and went in to generalize tonic/clonic seizure. It was noted that it may have been a few seizures back to back rather than a single seizure but this has not been confirmed. While that the hospital the patient was experiencing atrial fibrillation with rapid ventricular rate. The ekg report documented atrial flutter with variable av block. He has had sinus tachycardia with his seizure before and has heart palpitations, and there is no history of cardiac pathology as far as they can tell. The following day the patient was back to baseline and ready to go home. There was no relationship to vns provided for the prolonged seizure or arrhythmia. Good faith attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician that the patient is very non-compliant. The patient has not reported any adverse events to her so she had no information. The physician has not information to provide on the seizures or arrhythmia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3156815
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dennis100
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« Reply #9 on: May 26, 2018, 12:38:27 AM »

Model Number 103
Event Date 01/01/2013
Event Type  Injury   
Event Description
A cardiologist reported that the vns patient was going to undergo a cardiac ablation to correct an arrhythmia. She indicated that the arrhythmia may be related to vns but it also be related to the patient's seizures. She was not certain. Follow-up was performed with the cardiologist following the cardiac ablation. Clinic notes dated (b)(6) 2013 reported current diagnoses of seizures with epilepsy, syncope and collapse, and palpitations. The patient was noted to have ongoing problems with seizures progressing so the treating vns physician contacted the cardiologist. The patient was evaluated by the physician and cardiologist in the hospital and had a monitor. In spite of all of the efforts, she has was having ongoing seizures. She also was having palpitations on an almost daily basis which last up to 30 minutes. She had a treadmill stress test on (b)(6) 2013 and it did not show any evidence of ischemia. She did have questionable atrial arrhythmias on the treadmill at maximal stress. On her event monitor last summer, she had episodes of underlying sinus rhythm and she did have repeated episodes of atrial arrhythmias with atrial cycle lengths around 200 ms, some of which looked like flutter and some more looked like atrial fibrillation. Her rate would be in the 100-120 range. She said she was not taking anything at the time including an episode where her heart rate went to 150, and she says that she was absolutely not doing anything that would have caused that from a physiologic standpoint. Her echocardiogram last (b)(6) showed normal left ventricular function with no significant abnormalities. The vns physician indicated to the cardiologist that if nothing can be offered from a cardiac standpoint, she will need to see a neurosurgeon to resolve the issue. Review of the ecat strips, which the vns physician has performed on his patients who have underlying sinus bradycardia, with rates in the 60s and then tachycardia with rates around 100-120 with a:a intervals at times that look consistent with atrial flutter or atypical coarse atrial fibrillation. The patient has no previous history of significant trauma, and no previous interventional or invasive cardiology procedures. The patient had an event monitor in (b)(6) 2012, echocardiogram (b)(6) 2012, treadmill test (b)(6) 2013; left ventricular ejection fraction: via echo. Cardiac analysis shows regular rhythm, s1 and s2 normal, no s3 or s4, apical impulse not displaced, no murmurs, no gallops, and no rubs detected. The cardiologist's impression indicated atrial arrhythmias, possible atrial flutter, and palpitations. The patient had a scheduled electrophysiology study and possible ablation scheduled for the next week. The cardiologist suspected that the patient may have a tendency to atrial fibrillation. The patient had (b)(4) study for atrial arrhythmias, possible atrial flutter, syncope, seizures, palpitations, normal lv fxn, and vns. She had successful ablation for avnrnt and aflutter. Follow up was indicated for patient to have a 24 hour holter monitor in 2 months with office visit to follow in 3 months. Additionally, the cardiac cath report dated (b)(6) 2013 was received. She was "referred as she was having clinical events of tachycardia related to her seizure medications. At this point intervagal nerve stimulator at this point. She is also having recurrent symptoms that are concerning for possible arrhythmia, and monitors have shown abnormalities including tachycardia consistent with an arrhythmia, possibly atrial flutter. If there is not an arrhythmogenic component to her symptoms, then it is felt that she would be facing neurosurgery to try and address the focus of her seizures. Subsequently, after discussion and documentation of arrhythmias, she has elected to proceed with ep study and possible ablation. It is felt that if there is no arrhythmias induced, then the following consideration would be anatomical ablation of atrial flutter". During the ablation procedure, "atrial tachycardia was seen that had rates of 140 beats per minute. Due to this uncertain clinical scenario as it should not be reinduced. The patient underwent successful ablation for two forms of psvt (avnrt and aflutter). The cardiologist indicated in the notes that it is believed the patient was having both of these arrhythmias clinically and would benefit from ablation. The patient's medications were continued at that time. Attempts for additional information regarding these events to the treating vns physician have been unsuccessful to date. The relationship of the arrythmia, increased seizures and syncope to vns are unclear to date.
 
Event Description
A letter was received from the treating vns physician who reported that the physician is not aware of any evidence implicating that the patient's vns caused a cardiac dysrhythmia. The patient had structural abnormalities (as described in her ep study) that responded well to the ablation procedure on (b)(6) 2013. Since he is not convinced that there is a correlation between her cardiac rhythm and her vns, he was unable to provide additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3018075
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dennis100
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« Reply #10 on: May 26, 2018, 12:39:10 AM »

Model Number 103
Event Date 01/01/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, information was requested regarding vns and atrial fibrillation. The patient is treated for refractory major depression. The patient recently had the vns unit replaced due to battery depletion. The previous week, the patient presented to the physician's office to have her device programming and indicated that she had felt palpitations. Upon examination, the patient had an irregular pulse. An ecg earlier confirmed that the patient had atrial fibrillation. Follow-up with the patient's physician showed that the patient was a (b)(6) woman who suffers from refractory major depression. She was not responding to antidepressants, and was implanted with vns for the first time three years prior with good response to vns therapy in the treatment of the depression. In november 2012 the patient communicated that she was going to move to (b)(6) due to her husband's job and requested information to her doctor on how to proceed with vns. The physician interrogated the device and found it to be at eos. On (b)(6) 2013, the patient had her device replaced. Shortly after revision, the patient's settings were increased to half of her pre-revision settings. Normal hoarseness was noted. No diagnostics were run. During the week of (b)(6) 2013, the patient presented for a dosing appointment. The patient stated that she had palpitations. The patient had not presented a previous history of such; however, the patient was unsure whether she might have had palpitations before. The device was programmed off at that visit. Two days after the appointment, another medical professional reported that the patient was presenting atrial fibrillation detectable even 48 hours after the device was disabled. The patient was moderately obese and was treated for hypertension with amlodipine. The physician believed that it was possible that the present atrial fibrillation was related to the patient's hypertension and not vns, but this is still being investigated. The patient was seen by a cardiologist; however; no outcome from the cardiology study was available. No intervention is planned or taken so far. The atrial fibrillation is asymptomatic so far. It was detected by means of an ekg 48 hours after the device switch-off. The patient's antidepressants had not been modified. Of note, two months prior to revision, the patient underwent an ekg for a routine health check and anomalies were noted; however, these were regarded as technical problems of the ekg equipment.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2013 that the clinical concerns about this patient seemed to have diminished / resolved. The initial suggestion that the patient had atrial fibrillation was incorrect, and the patient had been deemed medically fit by a cardiologist. The patient has atrial ectopics that are considered to be of no functional or pathological significance, and not related to her vns. The vns was restarted a couple of weeks ago without incident. Diagnostics were satisfactory.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2986119
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dennis100
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« Reply #11 on: May 26, 2018, 12:39:54 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 10/03/2012
Event Type  Death   
Manufacturer Narrative

Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2013 and the patient's cause of death was: unspecified dementia (record axis 1) and other lack of expected normal physiological development (record axis 2). There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported by the patient's mother-in-law that the vns patient passed away on (b)(6) 2012. Follow-up with the patient's last known treating physician was performed. The physician had not seen the patient since (b)(6) 2008, and therefore, he was unable to provide an assessment on the relationship of the patient's passing to vns. The patient died due to 'failure to thrive,' per the obituary, so the physician reported that it was unknown if it was sudep related. The patient had a seizure reduction from vns therapy, but it was unknown from the physician if the patient was receiving vns therapy at the time of death. The patient had a history of concurrent illness/diseases; sick sinus syncope, pacemaker, and atrial fibrillation as reported in mfg report number: 1644487-2013-00363. The death was reviewed by the manufacturer in-house nurse. It was reported that the patient died from failure to thrive. Since a cause of death was reported sudep is not suspected to be the cause of death. Follow-up with the funeral home manager revealed that the vns devices were not explanted prior to burial.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2955761
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dennis100
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« Reply #12 on: May 26, 2018, 12:40:37 AM »

Model Number 102
Event Date 05/01/2006
Event Type  Injury   
Manufacturer Narrative

Event Description
A cardiologist called and asked for labeling on the vns and cardioversion. She had a patient who had a vns implanted, hospitalized in icu that was in afib and she needed to cardiovert them before putting a pacemaker in. The patient was having cardiac pauses as well and she did not think it was related but was not sure. Actual start date of event unknown. Said that it occurred during the off time so that she did not think so. She said that the patient was elderly so most likely related to that but could not be 100% sure. It was asked if she had tried to disable the device to rule out the vns and she said no, since she was not having it during the on time. She felt that she did not need to do that and that it was most likely related to her age. Patient was set to 7 secs on time 3 mins off time. The patient had sick sinus syndrome with severe bradycardia requiring their pacemaker placement (b)(6) 2006 in the right chest area. No interactions with their vns were reported. During this time frame, the patient was also found to have paroxysmal atrial fibrillation and was placed on coumadin. After implant with their pacemaker, the vns device and pacemaker are reportedly were working well and the patient doing fine as well. The patient had been implanted since (b)(6) 2005, and there is no indication that this event coincides with vns stimulation. No further information will be provided in regards to their cardiac event from their physician's office. It was later reported in (b)(4) 2013 that the patient had died. (b)(6).

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dennis100
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« Reply #13 on: May 26, 2018, 12:41:14 AM »

Model Number 102
Event Date 03/13/2013
Event Type  Injury   
Manufacturer Narrative
Inadvertenly listed the date as (b)(4) 2013 on follow-up report #1, the date should have been (b)(4) 2013.
 
Event Description
Additional information was received on (b)(6) 2013 when the patient's implanted product information was provided by the hospital.
 
Event Description
On (b)(6) 2013 it was reported that the physician lowered the patient's off time that day to 1. 8min and thinks the patient is having atrial fibrillation. No further information was provided. Good faith attempts for further information from the physician have been unsuccessful. Good faith attempts for the patient's implanted product information have also been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3037242
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« Reply #14 on: May 27, 2018, 01:11:57 AM »

Model Number 103
Event Date 01/25/2014
Event Type  Injury   
Manufacturer Narrative
Type of device product code: this device was implanted to treat chronic heart failure, which is currently an unapproved indication that is currently undergoing active clinical trial.
 
Event Description
It was reported that the vns patient who is enrolled in the (b)(6) clinical study presented with syncope which required hospitalization. The treating physician believes the syncope event is probably related to stimulation of the vns device. The patient was implanted with the device in (b)(6) 2012, and the syncope events began on (b)(6) 2014. During hospitalization, the patient regained consciousness in about five minutes without any episode, but had sudden onset of loss of consciousness on the same day, while still in the hospital. The patient regained consciousness and an ecg showed intermittent atrial fibrillation. The ecg also revealed sustained monomorphic ventricular tachycardia. The physician does not believe that the tachycardia event is related to vns stimulation. An electrophysiologist advised for aicd (automatic implantable cardioverter defibrillator) implantation which was done on (b)(6) 2014. The patient was hemodynamically stable during and after the procedure. The patient was discharged in a stable condition on (b)(6) 2014. To note, this patient is enrolled in the (b)(6) clinical study sponsored by the manufacturer and the patient has a known medical history of hypertension & coronary artery disease and moderate left ventricular dysfunction (35%). In addition the patient presents with history of shortness of breath functional classification iii as of the prior 2 ¿ 3 months.
 
Event Description
Information was received that clarified the events. The patient was admitted to hospital with history of loss of consciousness. On further observation and investigation, it was diagnosed as ventricular tachycardia which was not believed to be related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3647069
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dennis100
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« Reply #15 on: May 27, 2018, 01:12:46 AM »

Model Number 102
Event Date 06/16/2014
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized for five days on (b)(6) 2014 for rapid ventricular rate, atrial fibrillation and flutter. On (b)(6) 2014 the patient was admitted to the hospital for chest pain. The patient underwent transesophageal echocardiogram on (b)(6) 2014 and no clots were observed. The patient received cardioversion on (b)(6) 2014 and the heart rate returned to normal. The patient indicated that his inr was high and he had undergone pulmonary and gi testing. The patient's inr dropped below 2 and the patient underwent cardiac catheterization. The patient was released from the hospital on (b)(6) 2014. The relationship of the cardiac events to vns are unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
The patient's cardiologist reported that the patient has a history of mitral valve regurgitation with replacement and cardiomyopathy. There were no medication changes or other factors that could have caused or contributed to the arrhythmia. The patient also has a history of first degree av block and sinus bradycardia. The patient the patient experienced atrial flutter with a heart rate of 122 bpm. The patient experienced dyspnea and palpitations during the atrial flutter. The patient underwent tfe with cardioversion. The atrial flutter did not recur. The patient's neurologist indicated that there is no relationship between the atrial flutter and vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166277
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« Reply #16 on: May 27, 2018, 01:13:27 AM »

Model Number 103
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
This event was previously reported in manufacturer report number # 1644487-2011-02834.
 
Manufacturer Narrative

Event Description
A pacemaker vns case study was reviewed which showed that a vns patient was found to have frequent episodes of atrial fibrillation on the ecg telemetry. The emergency room physician ordered a holter monitor which detected not only many short episodes of atrial fibrilation, but also frequency episodes of sinus bradycardia associated with 2:1 av block. The patient was referred for cardiology consultation. It was noted that review of the holter tracing revealed more episodes of sinus bradycardia with 2:1 av block during the night time than the day time. In contrast, there were more episodes fo af during the day time than the night time. Analysis of the holter tracings suggested possible correlation of the arrhythmias with vns stimulation because of the intermittent nature of the arrhythmias. It was noted that the patient adamantly declined further alteration to her vns. The patient was implanted with a pacemaker because of the well-documented symptomatic bradycardia. It was noted that the patient's symptoms resolved with pacemaker implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3905904
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« Reply #17 on: May 27, 2018, 01:14:05 AM »

Model Number 103
Event Date 09/04/2014
Event Type  Injury   
Event Description
It was reported that during sinus surgery on (b)(6) 2014 unrelated to vns, the patient had atrial fibrillation. The patient received a cardiogram at that time and was stabilized. Follow-up revealed that no issues were seen with the patient¿s device and normal mode device settings. It is unknown if the patient¿s device was disabled for the procedure. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Clinic notes were received indicating that the vns patient underwent gallbladder removal surgery and not sinus surgery as initially reported. Three hours following surgery, the patient reported experiencing shooting pain up on the left side of her neck and coughing. Additionally, a lump was located in her left breast below the generator.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
Clinic notes were received stating that the vns patient had been hospitalized the week prior to her office visit on (b)(6) 2014 due to atrial fibrillation and underwent cardioversion in the or. Three hours following surgery, the patient experienced coughing due to shooting pain up the left side of her neck. The magnet was used to temporarily disable the device. The patient¿s device settings were increased following the cardiac events. There was concern that the cardioversion may have somehow altered the patient¿s device settings. The patient subsequently experienced throat irritation at the higher device settings which resolved when the settings were reduced.

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« Reply #18 on: May 27, 2018, 01:15:00 AM »

Device Problem Electrical issue
Event Date 02/25/2015
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
It was inadvertently not provided in follow-up report#6 that the surgery had occurred on (b)(6) 2016. The explant date of the device was inadvertently not provided.
 
Event Description
Additional data was received and review of the programming/diagnostic history shows that the device is still functioning within normal limits. Additional information was received that the patient underwent the cardioversion procedure on (b)(6) 2015. There were no precautions taken during the procedure. A magnet was not used to disable it during the procedure as the operators thought the device was end of life.
 
Event Description
An abstract written by the patient's physician was received on 12/10/2015. The abstract stated that the patient was admitted to the hospital for new-onset atrial fibrillation. Chemical cardioversion was attempted, but was unsuccessful. After being cleared with a tee for an intracardiac thrombus, the patient underwent dc cardioversion to sinus rhythm. Shortly after the dc cardioversion, the patient experienced persistent dysphagia and periodic (in synch with stimulation) throat irritation, dry hacking cough, and symptomatic bradycardia with heart rate dropping to the 20s. The periodic symptoms resolved after the device was deactivated with the magnet, but the patient remained dysphagic. On fluoroscopy for swallow evaluation, the vns leads could be seen exposed in the soft tissue of the neck. The physician believed that the patient's nerve was burned, which caused the persistent dysphagia, and that the vns lead was "naked" and was shocking the patient's neck soft tissue and causing the periodic issues. There were still no plans to replace the generator, as this would aggravate the patient's condition.
 
Manufacturer Narrative
Date received by manufacturer: 12/20/2017. (b)(4).
 
Event Description
The patient was referred for full revision surgery. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explant facility does not return devices to the manufacturer per policy, and it was reported the product may have been discarded.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient sustained damage to his vocal cords following a cardioversion procedure.
 
Event Description
It was reported that the patient experienced sharp painful stimulation every 90 seconds after undergoing an electrical cardioversion for atrial fibrillation with rapid ventricular rate. Prior to the cardioversion, patient had a transesophageal echocardiogram but was reported to be able to swallow without issues following this procedure. After the cardioversion, the patient was having significant and periodic bradycardic events with a heart rate drop from the high 90's into the 30's. Patient would simultaneously moan, bear down, and complain of severe neck pain. Once the vns was turned off, the events ceased. When a system diagnostic test was attempted, the patient again had bradycardia and the programming wand was quickly removed. I didn't think it wise to try that again. With the device off, the patient was tested with modified barium swallow and found to have a complete dysphagia. This test will likely be repeated within a few days to assess any improvement. It is unknown if the device was programmed off when the patient had the cardioversion procedure. X-rays were taken of the neck and there were no obvious anomalies identified in the images received. The physician believes there may be a micro fracture in the lead and stimulating the neck near the vagus nerve causing the pain that triggered a vagal response in a physiologic manner as opposed to via direct vagal stimulation. The physician is concerned that the patient now has a vagus neurapraxia due to electrical injury. It was also reported that there is no definitive way to test for this to be sure. Additional relevant information have not been received to date.
 
Event Description
It was reported that the patient still experienced pain in neck area due to the cardioversion procedure. It was also mentioned that the vns therapy was working well for the patient until the cardioversion incident. The patient also underwent surgery on the throat and reported to have probably burnt his vocal cords. The physician mentioned the theory that the lead passed the energy to the nerve during the cardioversion procedure, which resulted in the patient's adverse events. Review of the programming and diagnostic data for this patient indicates that the impedance value was 2107 ohms on (b)(6) 2015 and has been consistently between 2100 and 2400 prior to cardioversion procedure. On (b)(6) 2015, the impedance value was 1350 ohms. The impedance value on (b)(6) 2015 is 1379 ohms.
 
Event Description
Additional information was received that the patient still has pain despite vns being off. A report on the cardioversion procedure was also received stating that the procedure occurred on (b)(6) 2015 at 15:02. Synchronized bi-phasic cardioversion was performed with a medtronic lifespak 12 cardioversion device. Adhesive patches were used and 200j of energy was used to shock. The patient has a history of hypertension, a vns for seizure disorder, restless leg syndrome, and a new onset of atrial fibrillation. Echo findings showed no laa thrombus. The ejection fraction from the echo was 65%. During the procedure, the patient was brought to the electrophysiology lab in a fasting state after informed consent was obtained. Hemodynamic monitoring was established, and anesthesia was administered. Synchronized biphasic cardioversion was performed, the patient was reassessed, and the patient left the lab in a stable condition. Results showed that pre-rhythm was atrial defibrillation, and the post-rhythm was sinus. 200j of energy was delivered externally. There were no noted complications, and the dc cardioversion was deemed successful. Clinical course was to be observed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4618197
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dennis100
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« Reply #19 on: May 28, 2018, 02:05:11 AM »

Model Number 102
Event Date 05/04/2015
Event Type  Injury   
Event Description
The patient's following physician is aware of the situation and that the device was turned off by the icu. The patient has not seen the patient since the event and is unwilling to provide any additional information. Therefore, attempts for additional information have been made but no relevant information has been received to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported on (b)(6) 2015 that the patient is experiencing very severe bradycardia with no evidence of asystole. This was diagnosed on (b)(6) although it may have started earlier. The patient is showing signs of atrial fibrillation followed by bradycardia as low as 20bpm. The device was deactivated with a pacemaker magnet and the patient showed no bradycardia after the magnet deactivation. The patient's device was then disabled to 0ma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4802826
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dennis100
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« Reply #20 on: May 30, 2018, 03:55:53 AM »

Model Number 103
Event Date 04/28/2015
Event Type  Injury   
Event Description
It was reported that the vns patient was scheduled for prophylactic generator replacement surgery on (b)(4) 2015. The patient was put under anesthesia and subsequently experienced a drop in heart rate from 40-50 bpm to 0 bpm. The patient was given epinephrine to restore the heart rate. It was noted that the patient had number health issues and was normally taking blood thinner medication but was not on the medication the day of surgery. The surgery was aborted and the patient¿s device was not replaced. Follow-up revealed that the patient had a prior history of bradycardia and atrial fibrillation. The event is not believed to be related to device stimulation on-times. The patient¿s device remained programmed on and the cardiac events have not reoccurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4795612
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dennis100
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« Reply #21 on: June 12, 2018, 12:34:52 AM »

Model Number 102
Device Problem No Information
Event Date 09/27/2011
Event Type  Death   
Event Description
It was initially reported that the patient passed away. The physician reported that the patient had been in hospice care in (b)(6) 2011 and they had not heard from the patient since then. The reason the patient was in hospice was unknown by the office. Search of the social security death index revealed that the patient had passed away. The physician's office was unaware of this. This death event has been reviewed and with the available information has been determined not to be sudep. The patient was under hospice care at the time of death due to an undisclosed terminal illness. As the patient was in a poor state of health at the time of death, the death was likely not unexpected. Good faith attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient had died on (b)(6) 2011 due to causes of other forms of chronic ischemic heart disease; other forms of chronic ischemic heart disease; unspecified mental retardation; atherosclerotic heart disease; ischemic cardiomyopathy; atrial fibrillation and flutter; congestive heart failure. Underlying cause of death was provided as major cardiovascular disease. There is no allegation or other information indicating that the death is related to vns.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: inadvertently not provided in follow-up report #01. The received date for follow-up report #01 was 03/03/2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2516883
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dennis100
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« Reply #22 on: June 13, 2018, 12:56:40 AM »

Model Number 102
Event Date 03/09/2012
Event Type  Injury   
Event Description
It was reported on (b)(6) 2012 that the vns patient was going to be implanted with a cardiac recorder device. Additionally it was reported that the patient is pre-syncopal likely due to atrial fibrillation. Attempts to obtain additional information have been unsuccessful to date. At this time it is unknown what is the relation of the arrhythmia to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2512933
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dennis100
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« Reply #23 on: June 13, 2018, 12:57:34 AM »

Model Number 102
Event Date 06/06/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient's device was unable to be communicated with. The physician used two different programming systems that had been working without issue, but the generator was still unable to be communicated with. The patient's generator was able to be palpated and was closer to the midline than in an axillary position. The patient had been cardioverted on (b)(6) 2016 due to atrial fibrillation (not related to vns), and the patient immediately stopped feeling stimulation after the procedure. The patient's generator was implanted on (b)(6) 2016 and programmed on during the surgery without issue. The generator had not been communicated with since implant. Troubleshooting was performed, including ensuring the wand battery was not depleted, the handheld was not plugged into the wall, and two generator hard resets. However, the generator was still unable to be communicated with. The company representative also attempted to communicate with the patient's device on (b)(6) 2016, but was unsuccessful. Another hard reset was performed, but the device was unable to be communicated with. The physician's programming system was confirmed to be functioning properly with a demo generator. Further information was received clarifying that the patient had cardioversion performed on (b)(6) 2016 and also had heart attack (not related to vns) on (b)(6) 2016 with subsequent cardiac catheterization that showed no blockage. System diagnostics showed good lead impedance and proper functionality of the device during implant surgery on (b)(6) 2016. The patient was referred for generator replacement. No surgical intervention has occurred to date.
 
Event Description
The patient had generator replacement surgery due to the generator not communicating. The explanted generator was discarded. Therefore, no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5847816
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« Reply #24 on: June 13, 2018, 12:58:52 AM »

Model Number 105
Event Date 05/10/2012
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative

Event Description
Initially, it was reported that the patient was scheduled for explant due to unknown reasons. It was later reported that the patient experiences multiple side effects which were worsened after generator replacement in 2012. It was noted that the patient experienced dysphonia with device activation and dysphagia to pills. The patient also noted atrial fibrillation with seizures, submandibular tenderness, gastroparesis, left-sided breast pain and left-sided jaw pain. It was noted that the symptoms continued after programming the device off. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the patient underwent vns explant. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5526231
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dennis100
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« Reply #25 on: June 13, 2018, 12:59:29 AM »

Model Number 103
Event Date 01/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a vns patient's caregiver that the patient had atrial fibrillation and received cardioversion for the atrial fibrillation (b)(6) 2016 which was successful, however the procedure was reported to have caused his vns therapy to stop working. The vns was reported to have reduced the frequency and severity of the patient's seizures, however the seizure frequency and severity were reported to have increased since the vns stopped working. After surgical consult, generator replacement surgery was scheduled as the device was found to be at near end-of service. Lead impedance was reportedly okay after diagnostics. The device was interrogated and the output current was 1. 5ma and had not been found to be disabled. No known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Event Description
Generator replacement surgery occurred on (b)(6) 2016. The explanted device has not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5577796
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dennis100
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« Reply #26 on: June 13, 2018, 08:59:19 AM »

Model Number 102
Event Date 11/20/2011
Event Type  Death   
Event Description
Additional information was received on (b)(4) 2013 when the physician reported that there is no relationship between the cardiopulmonary arrest, atrial fibrillation, and congestive heart failure to vns. The events did not occur with stimulation. No causal or contributory programming or medication changes preceded the onset of these events. The physician stated that he believes the patient had a pre-vns medical history of atrial fibrillation and congestive heart failure. The patient had a previous risk factor of "l/v smoking and hypertension" which may have predisposed the patient to myocardial infarctions according to the physician.
 
Event Description
Additional information is received on (b)(4) 2013 when the physician reported that it is unknown when the patient passed away and the relationship of the patient's death to vns. A copy of the patient's death certificate was requested from the department of vital records in the state the patient passed away in but it has not been received to date.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient has passed away on (b)(6) 2011. Additional information has been requested from the patient's physician but no further information has been received to date. Based on the information received to date, the patient's death is possibly sudep at this time.
 
Event Description
Additional information was received on (b)(6) 2013 when the patient's death certificate was received. The patient passed away on (b)(6) 2011 and the immediate cause of death was noted to be cardiopulmonary arrest, congestive heart failure, atrial fibrillation, and aortic stenosis. The approximate interval between the onset of these events and death was minutes for the cardiopulmonary arrest and years for the congestive heart failure, atrial fibrillation, and aortic stenosis. An autopsy was not performed and the manner of death was stated to be "natural". Good faith attempts for further information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2892949
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dennis100
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« Reply #27 on: June 13, 2018, 11:57:56 AM »

Model Number 102
Event Date 08/01/2011
Event Type  Injury   
Event Description
It was initially reported that patient had been having recent arrhythmia events. She had been having some atrial fibrillation, which was being treated with medication. Then the patient began having asystole events that last about 6 seconds and well as some bradycardia. The patient had an emergency pacemaker placed and then underwent surgery to have a pacemaker implanted. The relationship of the cardiac events to vns is unknown. Good faith attempt with both the neurologist and the cardiologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2261210
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dennis100
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« Reply #28 on: June 14, 2018, 01:06:47 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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