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dennis100
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« on: May 26, 2018, 12:35:33 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 #1 on: May 26, 2018, 12:36:17 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 #2 on: May 27, 2018, 01:09:38 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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dennis100
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« Reply #3 on: May 27, 2018, 01:10:11 AM »

Model Number 102
Event Date 10/27/2014
Event Type  Injury   
Event Description
It was reported that the vns patient was admitted to the hospital due to atrial flutter. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4273777
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dennis100
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« Reply #4 on: June 08, 2018, 03:50:01 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing an atrial flutter and it was suspected to be related to vns therapy. Follow up with the medical professional revealed the patient had an atrial flutter 2:1 and tachycardia about 130 beats per minute, or bpm. Ecgs were performed with the vns on, autostim off, and the vns disabled with no change in the readings. Further follow up with the medical professional revealed that they were unsure of the relation of the atrial flutter and vns, but that it was possible sympathetic rebound after stimulation. It was stated that no change in ecg was possible as the readings were taken in a short period of time and cardiac rhythm had no sufficient time to restore. It was reported that they were looking into long term side effects of aeds, but felt this was an unlikely cause. The patient's autostim mode was disabled upon observation of the atrial flutter. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7557819
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dennis100
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« Reply #5 on: June 12, 2018, 12:33:26 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 #6 on: June 14, 2018, 01:05:28 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/09/2017
Event Type  Injury   
Event Description
It was reported that when a vns patient¿s device is on it had an effect of av node block. Systems diagnostics were reported to be fine. The physician lowered the stimulation on time in the hope of resolving it. The physician then turned the device off and that resolved the symptoms. When the device was turned back on the problem returned. A holter monitor was used and seems to confirm that when vns is on there's a cardiac response. The device was left off to see what happens. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the treating provider indicated the patient is doing ok.
 
Event Description
Follow-up from the provider indicated the vns is believed to be causing the cardiac symptoms. The specific effect of the av node block was bradycardia as the patient¿s heartrate went down to 30 beats per minute. The patient was placed on an ekg/event monitor and was referred to cardiology. They dynamically adjusted the vns parameters guided by the ekg.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685430
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