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dennis100
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« on: June 14, 2010, 11:34:11 AM »

Model Number 103
Event Type Death
Manufacturer Narrative

Event Description
It was reported that a patient implanted with vns had passed away in her sleep. The patient's nurse practicioner stated that the death was believed to be sudep. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5694406
« Last Edit: November 28, 2016, 12:06:29 PM by dennis100 » Logged
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« Reply #1 on: June 14, 2010, 11:35:20 AM »

Model Number 103
Event Date 01/30/2015
Event Type Death
Manufacturer Narrative

Event Description
It was reported that a vns patient had passed away on (b)(6) 2015. The cause of death was determined as sudep by the patient's nurse practitioner. There was no indication of a device malfunction with the available device programming/diagnostic history. The np also stated the death was not related to vns and the patient had experienced very good results prior to her passing. The patient was in a reasonable state of health at the time of death, and it was unknown if the death was related to a seizure. The patient was reportedly buried with the device still implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5697346
« Last Edit: July 09, 2016, 01:13:12 AM by dennis100 » Logged
dennis100
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« Reply #2 on: June 14, 2010, 11:36:43 AM »

Model Number 103
Event Date 10/26/2008
Event Type  Death  
Patient Outcome  Death;
Event Description
Reporter indicated that the patient was found unresponsive and later passed away. Per reporter, patient had a lot of neurological problems, but was doing well with vns with respect to seizures. An autopsy was performed and the autopsy report was obtained by the manufacturer. X-rays were taken and no anomalies were noted. The autopsy report noted the patient died of natural causes ascribed to a seizure disorder due to cerebral palsy. Due to the autopsy being an external examination versus complete autopsy and the circumstances surrounding the patient death,the manufacturer has classified this death as a probable sudep event. Product has been requested, but has not been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1246223
« Last Edit: February 15, 2015, 11:56:43 PM by dennis100 » Logged
dennis100
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« Reply #3 on: June 14, 2010, 11:38:07 AM »

Model
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« Reply #4 on: June 14, 2010, 11:39:48 AM »

Model Number 101
Event Date 10/09/2009
Event Type Death
Patient Outcome Death;
Event Description
It was reported that the pt died in 2009 at his group home. Per reporter, the pt was found by his attendant, nude in a dry bathtub, and was dry to the touch. Pt was transported to the hospital, but was pronounced dead. The death was not witnessed. Per the reporter, the pt's vns was turned off at the time of death. Follow-up with the medical examiner reveals that the cause of death is undetermined at this time. Based on the info received to date, the event has been determined to be a possible sudep by a manufacturer medical professional. The product was explanted from the pt and returned to manufacturer, but analysis is pending. A voluntary medwatch was submitted to fda regarding this event. Attempts to contact treating physician for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRfoi__id=1581925
« Last Edit: February 15, 2015, 11:58:35 PM by dennis100 » Logged
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« Reply #5 on: June 14, 2010, 11:41:25 AM »

Model
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dennis100
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« Reply #6 on: June 14, 2010, 11:42:46 AM »

Model Number 101
Event Date 01/20/2007
Event Type  Other  
Patient Outcome  Other;  
Manufacturer Narrative  
Reporter stated the ncp system was unrelated to the death event.
 
Event Description  
Reporter stated patient was found dead in their bed by caregiver. Cause of death is unknown; an autopsy is pending.Manufacturer has determined that sudep is probable. Product analysis of the returned generator and lead found no anomalies that could have caused or contributed to the death event. The reporter has stated the ncp system was unrelated to the death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=831124
  

« Last Edit: February 16, 2015, 12:00:14 AM by dennis100 » Logged
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« Reply #7 on: June 14, 2010, 11:44:09 AM »

Model Number 101
Event Date 12/29/2008
Event Type  Death  
Patient Outcome  Death
Event Description
It was reported that the patient was deceased. No cause of death or other information was given. Attempts for further information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
This death event has been reviewed by a manufacturer nurse and with the available information has been determined to be possible sudep. The patient had epilepsy and died, but no other information is known. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2403060
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dennis100
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« Reply #8 on: June 14, 2010, 11:45:30 AM »

Event
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« Reply #9 on: June 14, 2010, 11:46:48 AM »

Model Number 102
Event Date 10/01/2006
Event Type Other
Patient Outcome Other;
Manufacturer Narrative
Reporter stated ncp system unrelated to death event.

Event Description
Reporter stated that patient was found dead in their bed by caregiver. Cause of death is unknown and no autopsy will be done. Manufacturer has determined that sudep is probable. The reporter has stated the ncp system was unrelated to the death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=773005
« Last Edit: February 16, 2015, 12:02:16 AM by dennis100 » Logged
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« Reply #10 on: June 14, 2010, 11:49:51 AM »

Event
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« Reply #11 on: June 14, 2010, 11:51:13 AM »

Model
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« Reply #12 on: June 14, 2010, 03:18:33 PM »

Model Number 101
Event Date 10/09/2009
Event Type Death
Patient Outcome Death;
Event Description
It was reported that the pt died in 2009 at his group home. Per reporter, the pt was found by his attendant, nude in a dry bathtub, and was dry to the touch. Pt was transported to the hospital, but was pronounced dead. The death was not witnessed. Per the reporter, the pt's vns was turned off at the time of death. Follow-up with the medical examiner reveals that the cause of death is undetermined at this time. Based on the info received to date, the event has been determined to be a possible sudep by a manufacturer medical professional. The product was explanted from the pt and returned to manufacturer, but analysis is pending. A voluntary medwatch was submitted to fda regarding this event. Attempts to contact treating physician for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRfoi__id=1581925
« Last Edit: February 16, 2015, 12:05:05 AM by dennis100 » 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!
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« Reply #13 on: June 15, 2010, 01:21:15 AM »

Model
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dennis100
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« Reply #14 on: July 08, 2010, 08:07:45 AM »

Event Date 05/26/2011
Event Type Death
Patient Outcome Death;
Event Description
It was reported that the pt had passed away on (b)(6) 2011. The physician is attributing the death to sudep, but it is unk how or why the physician came to that conclusion. The pt died in her sleep. The pt was last seen by physician on (b)(6) 2010 and eri was no on this date (other diagnostics/settings are unk). Evaluation by manufacturer nurse reveals that the event is a probable sudep. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2229026
« Last Edit: February 16, 2015, 12:06:22 AM by dennis100 » Logged
dennis100
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« Reply #15 on: August 06, 2010, 04:07:18 AM »

Model Number 102
Event Date 06/09/2005
Event Type  Death  
Patient Outcome  Death
Event Description
It was reported that the pt was deceased. No cause of death or other info was given. Attempts for further info have been unsuccessful to date.
 
Event Description
This death event has been reviewed by manufacturer nurse and with the available information has been determined to be possible sudep. The patient had epilepsy and died, but no other information is known. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405539
« Last Edit: February 16, 2015, 12:06:53 AM by dennis100 » Logged
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« Reply #16 on: September 11, 2010, 09:23:29 AM »

Model Number 103
Event Date 11/16/2011
Event Type  Death  
Patient Outcome  Death
Manufacturer Narrative

Event Description
It was reported that the patient passed away. No other details given. Attempts for further information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician indicating that the death was not witnessed and no details are available regarding the exact cause of death, but the physician does not feel the death is related to vns. The patient had a reduction in seizures with vns and was receiving therapy at the time of death. Then patient was compliant with aeds, but was "poorly compliant with required follow-up and maintenance visits", per physician. This death event has been reviewed by manufacturer nurse and with the available information has been determined to be possible sudep.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378374
« Last Edit: February 16, 2015, 12:07:41 AM by dennis100 » Logged
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« Reply #17 on: September 11, 2010, 11:28:54 AM »

I'm almost too scared to ask this, but are these deaths in about a months time or a years time? Still pretty darn scary if it's in about a years time but something is really, really wrong if this many people are dying in about a months time cause of their vns and nothings being done about it. Of course you already know this.....
« Last Edit: July 07, 2011, 10:22:08 AM by dennis100 » Logged
dennis100
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« Reply #18 on: September 11, 2010, 10:54:27 PM »

The VNS is only killing epileptics and people with severe depression so investigating those deaths may not be a high priority for the FDA. They have more important things to do, like cracking down on the labeling of Fruit Loops.

http://www.thedailygreen.com/healthy-eating/blogs/healthy-food/front-of-package-label-50102109
« Last Edit: July 07, 2011, 10:24:05 AM by dennis100 » Logged
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« Reply #19 on: September 13, 2010, 01:03:29 PM »

Don't confuse acting like Fruit Loops with reading the label on the box.
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« Reply #20 on: September 15, 2010, 12:47:35 PM »

This is a question I have that is burning in my heart, and it's something I just don't understand and wanted to know if any of you, like you, Dennis, or Donna or Laura, who have been going through this for so long, I do not understand why this seems to be ignored. How many people have to die or become seriously injured before something gets done in this country? They will put you in jail for stealing a candy bar, but you can put a device on the market and sell it to people who are so desperately seeking for answers, people who are so completely vulnerable, and nothing happens to you. You get warning slips, slaps on the back of your hand, a scolding, but other then that, NOTHING. I still to this day have nightmares about what happened to my beautiful sister Judy, and how it almost killed my Dad with his weak heart, and caused my Mom to almost have a breakdown, and it just seems like noone cares. Every day I read through the Maude reports and just weep for the families who have lost their loved ones, or the ones who are so ill from this device and I feel so helpless. I try so hard to reach out and contact people every day to bring attention to this, and I get answers which seem like they want to help, but how long does it take? How many innocent victims are going to die before someone in power actually does something, not just pass the buck to someone else, but actually DOES something. What else can I do to help these victims? What do I have to do to let their voices be heard who are crying out from their graves for justice? What am I doing wrong? If I didn't have all of you to talk to, I think I would lose my mind. You all have been through so much and even though I didn't get the device, I DO have a serious seizure disorder, so I understand the need to just feel secure and safe and not afraid to walk out of your house because you might have a seizure in the middle of the road. What else can I do? What am I doing wrong? I'm sorry to vent, but you all understand this, you all have been going through this for so long and you seem to have the strength of Goliath to 'keep on trucking' but there has to be something else I can do. Not a single morning do I wake up and say to myself, 'I wonder who died last night from this 'thing'. Am I the only one who feels this way?
« Last Edit: July 07, 2011, 10:25:58 AM by dennis100 » Logged
dennis100
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« Reply #21 on: October 09, 2010, 11:58:51 AM »

Model Number 102
Event Type  Death  
Patient Outcome  Death
Manufacturer Narrative

Event Description
This death event has been reviewed and with the available information has been determined to be possible sudep by manufacturer nurse. The only known factors are that the patient had epilepsy and died. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date and the physician has no further information on the event.
 
Event Description
It was reported that the patient had passed away. No other information is known at this time. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378305
« Last Edit: February 16, 2015, 12:31:43 AM by dennis100 » Logged
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« Reply #22 on: November 04, 2010, 10:02:47 AM »

Model Number 102
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative

 
Event Description

This death event has been reviewed and with the available information has been determined to be possible sudep by manufacturer nurse. The only known factors are that the patient had epilepsy and died. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date and the physician has no further information on the event.
 
Event Description

It was reported that the patient had passed away. No other information is known at this time. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378305

The manufacturer's nurse who determined this patient's death was probably SUDEP with absolutely nothing to base it on other than  "the patient had epilepsy and died. As such, sudep cannot be ruled out as a possible cause of death"

Well let's see, I can think of thousands of things that can't be ruled out as a possible cause of death. Just because people have epilepsy doesn't make them immune from all the other ways to kick the bucket.

I guess if you work for Cyberonics the only likely cause of death had BETTER be from SUDEP.
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« Reply #23 on: November 05, 2010, 09:23:23 PM »

 Smiley HEY Dennis!

I have avoided this thread simply because it is depressing to read about all the suffering, and unnecessary suffering at the very least.  THANKS Dennis for doing the "ugly" work, it must be so draining on you to read all of this, then stiill be able to keep up your advocacy, etc.  You are amazing!

Yesterday I read some nonsense press release from CYBX regarding the recent negative media blitz about VNS, the FDA & MAUDE.  Please click below to read how they are unaware of any deaths.

http://www.forbes.com/feeds/prnewswire/2010/11/05/prnewswire201011051228PR_NEWS_USPR_____DA96110.html

I find this article yet another attempt by CYBX to use media sensationalism to once again LIE about the safety and efficacy of VNS.  The statement is just another way for them to continue their cover-ups.

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« Reply #24 on: March 08, 2011, 11:29:52 PM »

Event Date 01/15/2011
Event Type Death
Patient Outcome Death;
Event Description
It was reported that the patient passed away. Per physician, the death is thought to be a sudep. The generator was explanted, but will not be returned to the manufacturer. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2009748
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« Reply #25 on: March 08, 2011, 11:35:35 PM »

 :'( This makes me sad & angry  angry

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ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
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« Reply #26 on: March 10, 2011, 03:12:49 AM »

10 deaths in latest update (1/20/11 thru 2/18/11). Add 3 more SUDEP to our list.

233) pt died one month after vns implantation from sudep.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1982468


This one! Dennis, Is this the only one you've found who died one month post-op?  Could this be the husband who died?  The wife from Cyberonic$ own message board, looking for answers for his death? This is so tragic.

Read this one Nancy, it will be of GREAT interest to you

Quote
An article was received for review called: vns in pts with previous unsuccessful resective epilepsy surgery: antiepileptic and psychotropic effects. In the article, it mentions one pt died one month after vns implantation from sudep. No further info was reported on the pt in the article. Exact date of death unk. Article reporting on pt implanted with the vns between 1994-1999. The relationship of their death to the vns is unk.

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"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!
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« Reply #27 on: March 13, 2011, 11:52:26 PM »


This one! Dennis, Is this the only one you've found who died one month post-op?  Could this be the husband who died?  The wife from Cyberonic$ own message board, looking for answers for his death? This is so tragic.

There's very little detail in most of the death reports except to make it clear that the vns played no role in the patient's demise. I'll go through the death reports and see how many I can dig up that actually show where a patient has died within a month of surgery.


« Last Edit: March 13, 2011, 11:55:54 PM by dennis100 » Logged
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« Reply #28 on: May 05, 2011, 03:29:55 AM »

Event Date 03/17/2011
Event Type Death
Patient Outcome Death;
Event Description
On (b)(6), 2011, the country manager of (b)(4) reported that the vns pt had passed away that night during sleep. Info received states that the pt's vns will not be explanted, therefore, no product analysis can be performed on the pt's vns. According to the physician, the pt's death is not related to vns. The pt passed away during sleep and his mother found him the next day. No autopsy was performed and the death was not witnessed. A sudep eval was performed and it was determined to be a probable sudep case. It is unk if death was caused by a seizure or status epilepticus. If add'l info is received, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2055660
« Last Edit: February 16, 2015, 12:33:18 AM by dennis100 » Logged
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« Reply #29 on: July 07, 2011, 03:25:34 AM »

Event Date 01/01/2011
Event Type Death
Patient Outcome Death;
Event Description
A vns treating physician reported to our country manager that they had a pt who recently died from sudden unexplained death in epilepsy. Further investigation is underway to gather more details surrounding the pt's death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2139087
« Last Edit: February 16, 2015, 12:34:27 AM by dennis100 » Logged
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