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dennis100
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« Reply #30 on: June 13, 2018, 01:12:35 AM »

Model Number 106
Device Problem No Information
Event Date 12/01/2015
Event Type Death
Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
It was reported that the patient passed away on (b)(6) 2015. The nurse reported that the patient has a history of dementia and depression. The coroner reported that the patient drowned in the river by his home. The coroner's office indicated he may have fallen by his home as evidenced by blood found on the porch of his home and he was not seen alive thereafter, but no foul play was suspected. The preliminary autopsy findings indicate the patient suffered from two prior heart attacks with 50% blockages in several coronary arteries but no thrombi. The autopsy authorization form was received which reported that the patient vns therapy has reduced the length of the patient's seizures, and he had not had a known seizure since (b)(6). The patient was found in the river over a mile from his home. He was caught on a pier, and he had been reported missing the previous evening. He lives in an apartment in from of his brother's home. He usually brings the mail at a particular time of day. When he didn't, his brother went to look for him, eventually calling police. The found the mail strewn on the front steps of the home with a small blood spot on the first step. The patient was found in the river by police. The cause of death is unclear. The explanted products were received by the manufacturer for analysis. However, analysis has not been completed to death.

Event Description
Analysis was completed on the explanted devices. The pulse generator performed according to functional specifications throughout all testing in the analysis lab. The battery showed an ifi=no condition. There were no performance or any other type of adverse condition found with the pulse generator. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No other anomalies were identified in the returned lead portion.

Event Description
The coroner reported that it is assumed that the patient became confused post-ictally and walked in the opposite direction of his brother's home in the direction of the lake. They assume that he then inadvertently walked into the water and was taken by the water.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5312869
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dennis100
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« Reply #31 on: June 13, 2018, 01:17:09 AM »

Model Number 102R
Event Date 11/14/2012
Event Type Death
Event Description
Multiple attempts for the patient's explanted product have been made and at this time no further information is known if it will be returned for analysis. Multiple attempts have been made for further information in regards to the patient's death but thus far no further information has been attained. The patient lived in a very rural area and was not seen by a regular physician.

Event Description
It was reported to our local partner in ecuador that a vns patient died on (b)(6) 2012, from a heart attack. It has not yet been confirmed that the event was not related to vns therapy. Their vns system has been explanted and is pending being returned for analysis. The patient was in (b)(6) and our local partner is in (b)(4). It could take several weeks to get the product returned for analysis. It was reported per the patient's brother that they had no history of any drug or alcohol abuse, no history of cardiac or respiratory problems. The patient was compliant with their medications. The patient did have a reduction of their seizures with the vns. The device was programmed on at the time of death. The patient's death was reported to be from a heart attack. Their death was not witnessed. No report of any trauma. The patient died during their sleep. No other information has been provided in relation to their death from a medical professional. Based on that sudep cannot be ruled out at this time. The patient does have nocturnal seizures, simple partial complex partial.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2886214
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dennis100
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« Reply #32 on: June 15, 2018, 02:00:20 AM »

Model Number 103
Event Date 05/05/2014
Event Type  Death   
Event Description
It was reported that the vns patient passed away in her sleep on (b)(6) 2014. The physician suspected sudep. The patient¿s device was not explanted prior to cremation.
 
Manufacturer Narrative

Event Description
A copy of the autopsy report was received where the cause of death was listed as atherosclerotic cardiovascular disease (hardening of the arteries of the heart) and a seizure disorder. At autopsy, there were focal areas of myocardial fibrosis indicating that the deceased had suffered multiple myocardial infarctions (heart attacks) in the remote past. The deceased also suffered from a seizure disorder which also contributed to her death. The manner of death was listed as natural. An internal sduep evaluation was performed and it was determined that the death was unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840356
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dennis100
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« Reply #33 on: June 28, 2018, 12:46:42 AM »

Model Number 102R
Event Date 01/17/2012
Event Type  Injury   
Event Description
It was reported on (b)(6) 2012 that a patient implanted with vns in 2005 was going to be implanted with a defibrillator on (b)(6) 2012 due to arrhythmia. The patient presented in the er with arrhythmia and it was determined he needed a defibrillator implant. Good faith attempts to obtain additional information were unsuccessful as the physician has moved and his current residence is unknown.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient had a heart attack in (b)(6) and defibrillator paddles were used. The patient now sees a new physician however good faith attempts to obtain additional information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2438667
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dennis100
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« Reply #34 on: June 28, 2018, 12:47:48 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 12/21/2011
Event Type  Death   
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient's cause of death was acute myocardial infarction, (unspecified), essential (primary) hypertension, gastrointestinal hemorrhage (unspecified), and other and unspecified convulsions. There is no allegation or other information indicating that the death is related to vns.
 
Manufacturer Narrative

Event Description
The manufacturer reviewed the national death index information and the cause of death for the patient was reported to be acute myocardial infarction (unspecified).
 
Event Description
It was reported to a manufacturer representative in passing at a health system that the patient passed away. No further details were known by the hospital staff. The last known treating vns physician did not report the death. The last known treating vns physician reported to the manufacturer in (b)(6) 2014 that the patient was lost to follow-up. Therefore, they were not aware of the death. Good faith attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4340246
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dennis100
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« Reply #35 on: June 28, 2018, 12:48:33 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/25/2017
Event Type  Death   
Event Description
Follow-up from the hospital where the patient expired provided that the patient presented to the er from hospice. She presented with respiratory distress. She was experiencing respiratory difficulty which was new for her and she was complaining of chest pain that had a bradycardia episode, developing to a heart attack. The patient declined into respiratory failure, agonal respirations, and eventually cardiopulmonary arrest.
 
Event Description
It was reported by a physician that a vns patient was deceased. The patient passed away at a hospital, and was a resident of a group home facility. An online obituary found the patient had died (b)(6) 2017. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6362787
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