HAVE YOU BEEN INJURED, OR KNOW SOMEONE WHO'S DIED FROM "VNS"

  My name is Nancy and my sister Judy almost died at the hands of a vns device. She is now permanetly disabled because of it, and this is what drives me to do something about the laws that prevent a company from being held financially responsible when their devices injure or kill, and to change the approval process of these devices to ensure that before a device is put on the market, it has been absolutely proven beyond a shadow of a doubt to be safe for our use. That brings me to the VNS device which is manufactured by Cyberonics. This device almost killed my younger sister. She is now permanetly disabled because of the device. I have personally studied the Maude Reports, the actual minutes to the meetings when it came up for approval, countless research articles, and many, many personal experiences with this device. I DO NOT like what I have found. This is a very, very dangerous device that has contributed to the deaths of many, [or should I say "caused?] and has left so many disabled for the rest of their lives. I have studied the clinical trial data and have no idea how this device even slipped through the cracks. I have made many phone calls as high up as Washington D.C. and was starting to wonder if anyone was ever going to call be back. Untill yesterday. Yesterday I recieved a very important phone call from a gentleman who can actually help and is willing to do so, but it will take a little effort on our part. His name is DOUG WOOD. He is Chief of the Product Evaluation Branch and reports directly to President Obama. He has asked me to have everyone who has been injured by this device to file a Maude Report and send the actual Maude Report case # directly to him. His e-mail is: doug.wood@fda.hhs.gov If you filed a Maude Report but did not keep the file #, you can log back onto the Maude Data Base and retrieve it like I had to do. Here are some instructions on how to do this. Go to: https://www.accessdata.fda.gov/scrip...tch-online.htm This will take you to Medwatch Online Voluntary Reporting Form 3500, then click on the BEGIN button to the right of the page. The patient identifier field can be left blank, but I filled mine in and I STRONGLY suggest you do the same. The more exact information they have, the better. On the next page, for #1 click on "Adverse Event", for #2 click "Disability or Permanent Damage" On #5 describe the problem. When finished, copy down the report number, ect. and e-mail that information to Mr. Doug Wood. If you have any questions and need some help with anything, contact me at nancybowling@att.net  You might not think that your one report will really make a difference, but when he walks into that room holding a stack of them, it will definetly raise some eyebrows. Thankyou everyone. You just might be saving someones' life.          Nancy