Nancy B    Good morning, sweetums. I must say, I am quite surprised that your doctor told you that the vns could not have caused your psychosis or depression. It almost makes me wonder exactly how much he really knows about this device he is perscibing to people. Any doctor perscibing any kind of treatment should be fully aware of any possible side effects that treatment could cause, so that doctor can cease that treatment and try something else. If you google 'Maude Data Base', and pull that sight up, a page will come up that has a little line in the very upper right hand corner that says 'search______________'. Into that line, type 'psychosis caused by Cyberonics vns device' and several reports come up. [This is just a reminder for anyone who wants to see Maude reports, after you type into the search bar, hit search, then when the initial reports come up, see if at the bottom of the page it says 'repeat search with ommitted items included, if it does, then hit on that to view ALL of the submitted reports] One report id id=1667284 Event Date 01/01/2004  Event Type-Injury Patient Out-come-Required Intervention  Event Desciption: It was reported that the pt experienced psychosis in 2004 which was believed to be directly related to stimulation. The physician indicated that the pt's seizures were well-controlled by vns, however, the pt had psychotic episodes involving the desire to kill his parents. The physician indicated that the device was programmed off and THE PSYCHOSIS SUBSIDED. At a later date, the physician wanted to program the pt's vns device back on, however, the mother was adament that it might not be turned on due to the harm the pt may try to cause her. Report Source: Manufacturer [CYBERONICS] Reporter Occupation: Physician     You can also go to  http://www.accessdata.fda.gov/cdrh_docs/pdf/P970003S050b.pdf   which is Cyberonics Summary of Safety Data and Effectiveness. On page 6 [which is located at the bottom right, along with a hand written '13']  it is discussing clinical study D-01 which had 60 patients with vns in treatment resistant depression and says that in 38 subjects 77 events were rated as serious [10 in acute phase and 67 in long-term follow-up] including 34 reports of worsening depression and 12 suicide attempts or overdose.   In my sisters' case, her seizures became life-threatening, she became depressed and was never diagnosed with depression before, and now is permanetly disabled, all because she chose to get this device. I know there are people who sware up and down this device works, and maybe for some it does, but it is time that doctors and anyone else dealing with this device admit that it can also disable or kill you and recognize when this device is becomming the problem and REMOVE it before it is too late.

Nancy B    Dear Thea,  You know, your letter sure struck a nerve. Almost like God saw I needed encouragement and sent you to me. I do believe in God, and the Lord Jesus Christ with all my heart, which is where I am getting my strength from. My mom sometimes worries that I might be draining myself, or setting myself up for a big let-down. She's concerned that when you are dealing with the government and big industries that noone is going to pay attention to anything you have to say, it's all about money. Maybe for them it's all about money, but for me, it's all about what's right. In one weeks time the death toll on the Maude Data Base linked directly to the vns device went from 1,670 to 1,850. How many people have to die before something gets done? Thea, that could have been your son, Michael, among those deaths. It could have been my sister, Judy. How many innocent victims have to be slaughtered at the hands of this device before someone takes another look? One person dying is too many, but how many more before something gets done? Don't our lives matter to anyone who can do something about this? When the FDA approved this device they gave Cyberonics several "Conditions of Approval. That was back in 2005 when it was approved for depression. Among those conditions were a 450-patient post marketing dosing study and a 1,000 patient 5-year outcome registry. I found a Cyberonics, Inc F3Q09[Qrt End 01/23/09] Earnings Call Transcript in which Anthony Petrone, Daniel J. Moore, and Gregory H. Browne of Cyberonics are discussing whether or not they heard back from the FDA about changing the original conditions of approval. They want to modify, no, lets' be real here, they want to lesson the amount of people they were told they had to test. This would in turn save the company alot of money. First of all, I had no idea that when the FDA gives a company conditions to insure their device will be safe for public use that those conditions would even be open for discussion. This device is killing people. People are actually dying because they had this device implanted. Are their deaths in vein? This makes me question every single thing that has an "FDA APPROVED" sticker on it. Do we need to run every single item of food we put on our tables and every bottle of medicine through the Maude Data Base first before we eat it or take it? Is there even really an FDA or a CDRH, because if there is, they are not doing what the people of America are paying them to do. We are paying their salaries with our tax dollars, and have trusted them with not only our lives, but the lives of our precious children, and they have let us down. I have contacted so many people, sent e-mails to Senators, Congressmen, newspapers, you name it. It seems to me the only people who are really listening are the ones who are getting hurt by this device. But Thea, one thing about me. When I truly believe in something, I DO NOT LET UP!!! I will not stop calling, writing, or e-mailing before someone takes notice and decides enough is enough. There is a new FDA Commissioner, Margaret A. Hamburg, MD. Her address is U.S. Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm 2217, Silver Spring, MD 20993-0002, phone # is 1-888-463-6332. She is replacing Daniel Schultz who resigned in August 2009 over whistle blowers who exposed corruption in the agency that he and other FDA managers allegedly coerced and intimidated staff into modifying device evaluations. He happens to be the one who over-ruled the FDA's original refusal to approve this device. I think every single thing that was approved by this idiot should be re-evaluated. This man should face some serious jail time for all the deaths he is, as far as I'm concerned, responsible for. Or better yet, why don't they just implant him with one of these devices.

Theath,

You and Michael have gone thru a lot.  My Epileptologist initialy confronted me as being emotional about the trouble breathing and said it was asthma.  My oxygenation levels would vary, my speech level were common like others  w/ the VNS.  It was uncomfortable.  I thought I had a problem.  The Pulmonologist noted the variance in monitoring my oxgination levels and my speaking levels.  My Epileptologist, now, is sensitive in asking the questions does it hurt and now I am honest too.  I tell him it hurts and I still have the portable O2 in the house.  I am not so dizzy any more.  My seizures are still around but I feel I do not get so intimidated by my doctor.  I am afraid to speak to him, but I e-mail him.  I am grateful you're able to recognize the problem and address the problem right away!

I have pain that goes up my neck down my left shoulder too.  I really feel like a wacko.  THe thing it is not constant. It really makes me feel funny to mention it.

Thea you are blessing to Michael, a patient person.  I have worked w/ patients like, Michael,   and loved their smile as you work w/ them and they want to be on their own.  Michael, you are a great !

Sorry, forgot to add the link!

vns info

Epi_help