Pages: 1 [2]  All   Go Down
Print
Author Topic: Heart Attack  (Read 308 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 56287


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 56287


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 56287


« 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
Logged
Pages: 1 [2]  All   Go Up
Print
Jump to: