Pages: 1 [2]  All   Go Down
Print
Author Topic: Cyberonics determines cause of death  (Read 19479 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #30 on: September 24, 2015, 07:51:48 AM »

Model Number 103
Event Date 04/01/2015
Event Type Death
Event Description
It was reported that the vns patient passed away in (b)(6) 2015. The cause of death and its relationship to vns are unknown. Attempts for additional relevant information have been unsuccessful to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. A battery life calculation using the available programming history showed > 10 years remaining. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4824699
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #31 on: September 24, 2015, 07:52:55 AM »

Model Number 102
Event Date 05/20/2014
Event Type Death
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The cause of death and its relationship to vns are unknown. No further information relevant to the death has been received to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4775834
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #32 on: September 24, 2015, 07:53:55 AM »

Model Number 102R
Event Type Death
Event Description
It was reported that the patient had passed away about a year prior per the neurologist. Follow-up with the neurologist revealed that the patient had not been seen for approximately eight years, and the cause of death was unknown. No additional information was provided by the neurologist. Follow-up with the county of residence coroner¿s office was performed, but they were unable to locate information regarding the patient¿s death. (b)(6) attempts for additional relevant information have been unsuccessful. With the available information, the death was reviewed by the manufacturer and classified as possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4743812
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #33 on: September 24, 2015, 07:55:29 AM »

Just some examples. There are hundreds of them. A medical device company has no business offering their opinion as to the cause of death and the FDA should not allow Cyberonics the opportunity to do so. Something else besides SUDEP might be killing these people.

Check it out for yourself.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
« Last Edit: September 24, 2015, 09:05:21 AM by dennis100 » Logged
Birdbomb
Head Cheese
Administrator
Hero Member
*****

Karma: +9/-1
Offline Offline

Posts: 7792


Head Cheese


WWW
« Reply #34 on: September 30, 2015, 09:49:03 AM »

UNKNOWN cause of death means it cannot be determined

SUDEP is a cause of death
Heart attack is a cause of death
Cancer is a cause of death
Old age is a cause of death
Obstructive bowel is a cause of death
Asthma is a cause of death
Bee sting is a cause of death
Sepsis is a cause of death
Stroke is a cause of death
Gunshot is a cause of death...


UNKNOWN cause of death is unknown. PERIOD

Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
Pages: 1 [2]  All   Go Up
Print
Jump to: