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vns therapy side effects

Wed, 02/15/2006 - 10:10
I joined this site yesterday and I'm interesting in touching base with anyone who has a vns. In particular I would like to find out if anyone has experienced any unusual side effects not mentioned by Cyberonics. I occasionally experience 'tingling' in my neck and shoulder - this is actually quite unpleasant and it has been severe enough to warrant having my vns temporarily turned off. At one point last summer it felt like I was being repeatedly stung by a bee or something like that (I'm not sure exactly how to describe it). Cyberonics claims that no one has ever mentioned anything similar to this. I have been quite happy with my vns - it has helped stop many seizures once they have started, which has meant fewer trips to the ER but if this problem became really severe again I wouldn't be able to keep my vns turned on. Please let me know if you have experienced anything like this - I would like to know - Cyberonics makes it sound like I'm crazy or something. Thanks!!!

Comments

Re: vns therapy side effects

Submitted by theathorne on Mon, 2009-11-16 - 10:34
Yes, Michael has definitely been through alot. They have also shoved him into the category of asthma. I know that he was fine before the VNS was turned up and I will never let them convince me otherwise. He has been to his pulmo, ENT and neuro and no one wants to admit the possibility even of the VNS being the culprit. They just want to say it is the progression of his disease process! Baloney! I know the truth even though that doesn't change anything. I just want them to think about Michael's symptoms and maybe the next time consider that as a possiblity for some other child and save their life. Thank you for the support and kudos. We all need a little of that every now and then to keep us sane. Best of wishes to you. Thea-mother of Michael

Re: vns therapy side effects

Submitted by nancyjudy on Thu, 2009-11-19 - 17:00
Nancy B  I have some news for everyone. It is 4:45, Nov. 19 and I just recieved a phone call from a woman who is the FDA Director of the Advisory Panel that handled the Cyberonics' vns device. She gave me the phone number of the Branch Chief of the Postmarket Branch that tracks adverse events. I am to call him tomorrow morning to discuss what happened to my sister, and I will also talk to him about all of you. Now is our chance to be heard. Anyone who has anything specific they would like me to tell him contact me either on this site or my home e-mail: nancybowling@att.net Once again, this is our chance to be heard by someone who can actually do something about it. Thea, mother of Michael, NOW IS YOUR CHANCE!!!

Re: vns therapy side effects

Submitted by nancyjudy on Sat, 2009-11-21 - 07:05
Nancy B  I am sending everyone some relatively easy instructions to walk you through the process of filing a Maude Report. First, go to http://www.accessdata.fda.gov/script...tch-online.htm That will take you directly to the Medwatch Online Voluntary Reporting Form [3500] Then you click on the BEGIN button to the right of the page. The Patient Identifier field can be left blank [I filled mine in so they could put a name to the person this device almost killed]On the next page, for #1 click on "Adverse Event", for #2 click "Disability or Permanent Damage", on #5 describe the problem. You can always leave screens blank and still move on from one screen to the next, however, you should be able to fill out most of the form using the steps above. Write down your report #, etc. and send that information to Mr. Doug Wood at:   doug.wood@fda.hhs.gov   He is Chief of the Product Evaluation Branch and reports directly to the President. This is extremely important. He will be collecting this information and bring it to the next Neurological Devices Advisory Committee Meeting and the more individual reports he can present, the better. If you didn't keep the model # or don't know the exact date of something, don't let that deter you. This is your chance to be heard, so take advantage of it.

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