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Title: Explant Report


dennis100 - August 9, 2009 09:37 AM (GMT)
I requested and received the opererative report of my explant surgery and of course I found errors in it.

(1) It stated that I had received medical benifit from the VNS. - The VNS never helped control my seizures.

(2) It stated that I developed bradycardia during the stimulation cycles. - The VNS was causing asystole.

What really got me angry is that the hospital returned the device to Cyberonics against my wishes. About a hour before surgery I filled out a form that the nurse handed me. At the bottom of the form was an area where you can write your questions, concerns, or directives. I wrote clearly that the VNS was not to be returned to Cyberonics and that I wanted the hospital to dispose of it. I also told the surgeon the same thing on two occasions. The first time was during the pre-op appointment and the second time was 30 minutes before surgery when he questioned me about what I wrote on the form.

There has not been one single thing about my VNS experence that has gone right for me !

Dispatch - August 9, 2009 11:14 AM (GMT)
<_<

Those are serious errors there My Friend. Now CYBX can say what the docs are saying in this report, and not have to tell the truth about having no benefit and having asystole. In the end, outright lies like this changes the statistics about cardiac events and a person having no benefit.

I got lucky and my Neurosurgeon was very truthful about why he did my explant.

I wonder how a person can get an amendment done to their medical records. Is that even possible? I know records can not be changed, but am curious if a physician can add an amendment that the record is wrong.

Dennis I am so sorry that this whole VNS ordeal has been a bad ordeal for you.

B)

dennis100 - August 9, 2009 01:12 PM (GMT)
To set the record straight I decided to file a detailed MAUDE report. My first report was very vague, only a few sentences long.

The FDA might not pay any attention to the MAUDE reports but at least it made me feel good telling them the whole story.

Dispatch - August 9, 2009 06:36 PM (GMT)
QUOTE (dennis100 @ Aug 9 2009, 07:12 AM)
To set the record straight I decided to file a detailed MAUDE report. My first report was very vague, only a few sentences long.

The FDA might not pay any attention to the MAUDE reports but at least it made me feel good telling them the whole story.

:Great!: Good on you Dennis for submitting another MAUDE report that was detailed! Glad it made you feel better.

B)

dennis100 - August 11, 2009 05:50 PM (GMT)
QUOTE (Dispatch @ Aug 9 2009, 03:14 AM)
I wonder how a person can get an amendment done to their medical records.  Is that even possible?  I know records can not be changed, but am curious if a physician can add an amendment that the record is wrong.

I contacted the hospital about the errors. Below is an excerpt from the email I received today.


"I will be sending you a Protected Health Information Amendment form for you to fill out.

All the concerns that were listed in your initial e-mail will be documented on this document.

I then in turn will send it to the physician so that he can amend the Operative Report.

It’s my understanding that there will be no issue with this per the physician."


That shows why it is important to obtain your medical records. You never know what kind of errors are in it.






Dispatch - August 12, 2009 02:02 PM (GMT)
:D Hey Dennis! This is fabulous news! Thanks for doing the research, and glad it is going to work out for you to have your records straightened out with the facts.

So many people don't know avenues they can take to right the wrongs that have been done to them, so I want you to know you are greatly appreciated for all your research and sharing to help the other Members and Guests. You are ACE in my book! :yes2:

B)



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