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dennis100
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« on: May 20, 2018, 02:26:18 AM »

Model Number 103
Device Problem No Information
Event Date 10/05/2012
Event Type  Death   
Event Description
Cause of death information obtained from the (b)(4) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was cardiomegaly which was contributed by unspecified anxiety disorder and other, unspecified convulsions. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
A vns treating physician reported that one of his patient passed away. No further information has been received from the patient's treating physician. It was reported in their obituary that they died peacefully in their sleep. It is unknown if the patient passed from sudep and at this time given all the information available a probable sudep. Good faith attempts are underway for further information surrounding this patient's cause of death.
 
Manufacturer Narrative

Event Description
Good faith attempts have been made and no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075128
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dennis100
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« Reply #1 on: May 20, 2018, 02:26:56 AM »

Model Number 102
Event Date 06/04/2012
Event Type  Death   
Manufacturer Narrative
Analysis of programming history performed.
 
Event Description
On (b)(6) 2013 a sudep evaluation was performed by the manufacturer with the information available and it was determined that the patient¿s death is considered to be possibly sudep related.
 
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) 2012 and the patient's cause of death was: atherosclerotic heart disease; benign neoplasm of adrenal gland; myocardial degeneration; cardiomegaly; atherosclerosis of aorta. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that the patient had not been seen in a long time, and the treating physician was unknown. The company case manager searched online and found an obituary for the patient who passed away on (b)(6) 2012. The reason is unknown. The patient¿s previously treating physician moved a few years prior and no longer practices vns. The patient passed away outside of his care. Review of the company programming history database revealed the patient¿s last programming physician was another physician (on (b)(6) 2010). Attempts for additional information from this physician have been unsuccessful to date.
 
Event Description
Follow-up with the funeral home was done and they did not have the generator or lead for return.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3205872
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dennis100
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« Reply #2 on: May 20, 2018, 02:27:38 AM »

Model Number 102R
Device Problem No Information
Event Date 06/25/2011
Event Type  Death   
Event Description
The patient's obituary stated that the patient died in his home. According to the funeral home, the cause of death was: 1. Chronic arterial sclerotic heart disease, 2. Chronic diffused arterial sclerosis, and 3. Left ventricle hypertrophy and cardiomegaly. The patient's device was explanted, but it was not available for return from the funeral home. The patient's physician did not believe that the death was related to vns. The patient was a very sickly person and had heart issues before he had vns.
 
Manufacturer Narrative

Event Description
The article "long-term seizure and psychosocial outcomes of vagus nerve stimulation for intractable epilepsy" mentioned that 15 of the vns patients implanted at a certain hospital between 1997 and 2013 that the researchers attempted to contact were found to be deceased. This report will house one of 5 deaths of the known deceased patients that fit the criteria. The patient died on (b)(6) 2011 due to unknown reasons. Diagnostic history did not suggest any device malfunction. The relationship of the death to vns is unknown. Attempts for further information have been unsuccessful to date. The mfr. Report #s of the five deaths of known deceased patients are: 1644487-2015-06606 1644487-2015-06607 1644487-2015-06608 1644487-2015-06609 1644487-2015-06610.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5256304
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dennis100
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« Reply #3 on: May 20, 2018, 02:28:23 AM »

Model Number 103
Event Date 10/31/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, it was reported that the vns patient was experiencing an ectopic heartbeat that began on (b)(6) 2012, and resolved that same day. The patient recovered without sequelae. The patient was noted to have premature ventricular contraction and this ectopic heartbeat was moderate in severity. It was reported to not be related to the vns implant but the relationship to stimulation was probable; at the time of stimulation, the ectopic heartbeat was appearing. It was intermittent. The pulse width was reduced to 130usec and the output current was increased to 0. 5ma but the patient had frequent coughing and therefore the patient was kept at an output of 0. 25ma and pulse width of 130usec. It was also reported that the patient was experiencing a burning sensation in their eyes that began on (b)(6) 2012, and resolved on (b)(6) 2012. It was reported that the burning sensation in the patient's eyes was not related to the vns implant but possibly related to vns stimulation. The event was continuous. No actions were taken for the event and the patient recovered without sequelae. The patient had mild severity of burning sensation in both eyes and itching at the time of sensation. There was no decrease in vision at the time of the event and there was no gritty sensation, redness, watering, or discharge either. The patient did not go for consultation for this event but the patient used cineraria maritin schuade eye drops for two times at the time of burning sensation from (b)(6) 2012. It was later reported that patient also experienced giddiness and weakness that began on (b)(6) 2012, and resolved on (b)(6) 2012. These events were not related to vns implantation but were possibly related to vns stimulation and both events were mild. These events were continuous. No action was taken for the events and the patient recovered without sequelae. The patient was not subject to any consultation with doctors regarding the giddiness. No action was taken regarding the events. It was reported that on (b)(6) 2012 the patient had his second titration visit where the patient was increased to 0. 5ma but experienced a cough and the current was decreased back to 0. 25ma; the cough then disappeared. The patient was kept at an output of 0. 25ma. From the next day, (b)(6), 2012, the patient started having burning sensation in the eyes, giddiness, and weakness. No consultation was taken with an ophthalmologist, neurologist, or physician for the adverse events. The patient has a past medical history of dilated cardiomyopathy, mild mr, severe lv dysfunction (lvef-30%), acute decompensated heart failure (nyha class ii). The patient has no history of shortness of breath even on exertion and no history of chest pain, syncope, or giddiness. The patient had a coronary angiography in (b)(6) 2006 which showed normal coronaries. A 2-d echo cardiography dated (b)(6) 2012 showed a dilated lv, global hypokinesia of lv, severe lv dysfunction (lvef-31%), moderate mr/mild tr, mild pah/no clots. A chest x-ray dated (b)(6) 2012 had noted cardiomegaly. Additional information has been requested but no further information has been received to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the vpcs were too frequent so the ectopic heartbeat was moderate. The ectopic heartbeat was determined to be not related to vns stimulation.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2013 when the physician reported that diagnostics were within normal limits. The patient's settings were noted to be output=1ma/frequency=10hz/pulse width=250usec/on time=14sec/off time=1. 1min/magnet output=0ma/magnet on time=60sec/magnet pulse width=500usec. The patient was noted to have a history of dilated cardiomyopathy, severe lv dysfunction, no "ccf", and "nyha class ii".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870871
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dennis100
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« Reply #4 on: June 14, 2018, 01:04:01 AM »

Model Number 103
Event Date 03/31/2014
Event Type  Death   
Manufacturer Narrative

Event Description
The coroner reported that the cause of death was heart failure and epilepsy, right ventribular hypertrophy and transposition of great arteries. It was reported that although the death could be categorized as sudep, the degree of cardiac abnormality was considered to have been significant and likely caused an arrhythmia leading to cardiac arrest. Analysis of the lead was completed on 06/24/2014. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on 07/08/2014. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported that the vns patient passed away. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
The physician reported that the patient experienced a reduction in seizures with vns therapy. The patient was receiving vns therapy at the time of death. The generator was explanted after the patient's death. The believed cause of death was cardiac arrest - cardiomegaly. The death was reported to not be related to vns. An autopsy was performed which revealed the circumstances of death as seizure followed by cardiac arrest. The patient had a history of cardiac problems. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3767233
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