Cyberonics has REMOVED the Physician and Patient Manuals from their servers.




I am trying to contact them to find out the reason. They may be just updating the manuals, but if this is a permenant situation, it will be the a terrible disservice this company does to it's customers.

Should that be the case, then I will be calling on my reporters and producers and it will the time to open up to the press.

Birdbomb


EDITED : THE MANUALS ARE ON-LINE AND AVAILABLE HERE-----> Manuals

:im_033: Please let us know when you find out what is going on. I've found that the general rule is that the patient's aren't given that information before or after the surgery, and you wre providing a vital and valuable service. :)

:im_033: Labrat :im_033:

Most patients aren't even aware there is a patient manual until they walk out of the hospital with the VNS already implanted. The online manuals are a way for people to make a more informed decision and to be aware of all the conditions and events that can happen, not to mention the warnings, and case studies staticics.

The manuals are an invaluable tool to patients and interested parties alike.

It would be a total lack of caring and irresponsibility to remove these from public access. Hopefully, this is only temporary. I will try to get some kind of answer by tomorrow afternoon.

Keep your fingers crossed.

Now what purpose would it serve to remove the manuals from public access? It's not like someone implants themself.

:wallbash: Ok I will make a comment. I find it funny the removal of those in this time only becuase of my own personal issues because I have physicians checking into them and running questions because of the statement of blood clot disorder. Physicians that do not normally get ahold of those because they are hemotologist and cardio/vascular, so their knowledge of the VNS is almost nill, they have no reason to know about it. They are wondering how and why. I have a team of specialists I work with now that has nothing to do with the siez disorder, which is a minimal issue to me and in my own case compared to the rest of the stuff. And birdbomb, you are right, at least in my case. I was not given a manual until after the unit was in me. I had no clue of all of the possible side effects. My seiz's are not bad enough to chance what I did. I was promised no meds needed, no seizures, no depression episodes (though nothing was said about manias) and weight loss..............SHEESH........ I have personally tried so hard to walk away from the VNS experience after the removal of it but it continues to show up in my life and daily I am reminded of it from the huge scar in my neck and the chunk of scar tissue in my chest that I feel with any arm movement. And mysterious medical mess that shows up, no I can not say it is directly linked yet, but it is being looked at. All I want is to make a true point on to anyone considering this, make a highly educated decision. It has helped many, but it has also done a lot of mess to those it didnt. Me, next time I will head to Vegas, I think the odds are better..........................
Anita

When Cyberonics "updated" their messageboard, they had it offline for over a month and then all the old threads were lost. Why they did not archive them into "read only" files is something they choose not to do. The following year their message board was shut down completely.

IMO this was a disservice done to patients with VNS, but because of it, this board was created. People may report any and all their experiances here without trepidation or interference.

The files were removed from the server.

It doesn't state they are updating, or up grading. Anyone with the smallest of programing skills can tell you it only takes a moments to change out a few files, especially PDF files.

:Please Note: BTW I have saved the PDF files of the Physician Manuals, Patient Manuals and the TRD Patient Manuals on all my computers.

I ran into a problem when I asked for related studies to use at an appeal. They would not send them to me but they would send them to the doctor.

I asked which of the studies D01 thru D06 had been published the dates and the publications for reference purposes at my appeal. They refused to give to me.

The response was they do not release clinical information on the studies and it was policy. I asked what dates and publications had to do with anything clinical.

It’s a little irritating. Like the patients are too stupid to understand the information provided. :angry:

Corporate culture eminates from the top.

WOO HOO! Back up again! :wavetowel2:

Now download them and keep them handy on your hard drive!

http://www.vnstherapy.com/epilepsy/hcp/manuals/default.aspx

Howdy Birdbomb!

Think maybe a Cyberonics lurker saw your comment about
taking it to the press? :wallbash:

BTW: When I was creating my VNS site, I talked to some folks
from Cyberonics and they sent me hard copies of both the
Patient's and Physician's Manuals.

I wonder if the people who talked to me are still working
at Cyberonics? :huh:

Gee that would be no surprise me. Either CYBX or a PR firm is trolling here almost as often as our little cyberstalker.

I will do what needs to be done to help others be INFORMED about the VNS.

Just for the record, should the manuals dissapear from the site again, I have all of them and will send any manual on request.

Great to know, I will let my physician know they are back up also. And will get them downloaded. And yes I had them and everything else at one point but after my mess was clear I trashed it all. Looking at the literature and all the paperwork I had honestly makes me sick to the stomach. The scar on my neck was enough daily reminder.
Birdbomb, thanks for the great job of keeping the board informed as always!!!!!!!!
You trully "be da bomb diggity" B)
Anita

Ah shucks, ma'am! :wub:

Now here we go. Mayhaps in their anticipation of aproval, someone prematurely pulled the plug.

Source

FDA Also Approves Next Generation VNS Therapy Model 250 Programming Software


HOUSTON, July 12 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX - News) today announced that it received FDA approval for a harmonized/modularized VNS Therapy™ System labeling format and FDA approval to market the VNS Therapy Model 250 Version 7.1.4 Programming Software in the United States.

The new labeling format combines the previously separate pulse generator manuals for the refractory epilepsy and treatment-resistant depression indications into a single manual. This new combined manual, the Pulse Generator Physician's Manual, includes all PMA-approved indications and clinical information in a modular format so that any future updates or expansions to the labeling will require amendments only to the specific, affected module. Since many of the contraindications, warnings, precautions and other information are the same for the pulse generator and the lead, the modular approach has also been applied to the Model 302 Lead Physician's Manual.

Cyberonics has also received FDA approval on modifications and enhancements made to VNS Therapy, Model 250, Version 7.1.4 Programming Software. This latest version of software is compatible with all approved VNS Therapy generator models and has several features specifically designed for the future DEMIPULSE™ (Model 103) single connector and DEMIPULSE DUO™ (Model 104) dual connector generators.

"Harmonizing the labeling and providing it in a modular format will help ensure that important product information is communicated to health care providers in a consistent, informative, and user-friendly manner. It will also make future labeling revisions easier to implement," said Richard L. Rudolph, M.D., Cyberonics' Vice President, Clinical and Medical Affairs and Chief Medical Officer. "The Version 7.1.4 Software is just the latest step in Cyberonics' efforts to continually refine and improve VNS Therapy," continued Dr. Rudolph. "These latest FDA approvals represent the Company's on-going commitment to assisting physicians in making informed treatment decisions and providing the best care possible for their patients."


I'll be watching for the new version and update the links as soon as it's available. :)

Were there any changes and modifications to the manuals though??? In my case specifically page 41 and blood clots lol..............

The new version isn't on line yet. They just got aproval today from the FDA.

:im_033: I was contacted by a media person from Cyberonics asking about an interview I was doing. They asked that Cyberonics be contacted when I was asked to do an interview with someone else. I told the person no problem, but reminded them that I WAS NOT under any kind of contract with Cybreronics.

I don't see a problem with Cyberonics visiting this site. After all, how many of them have the implant. They only find out about problems with the VNS through people that have them; example, I had never connected the VNS as having anything to do with my not being able to sleep, dispite sleep medications and anxiety medications, until I read about others having the same problem and they had connected it with the VNS.

This messageboard provides an valuable source of information and Birdbomb is on top of everything. When she informed us about the manuals being take off, I contacted my C. representative immediately. He said he didn't know anything about it..........I suppect otherwise.............


On another note, I got a fawn colored, tea cup Chihuahua yesterday! I have been wanting one so bad. He is a doll! And I only paid $250.00 for him. Yes, he is registered, not that it matters to me. He looks like a cut little mouse.

:im_033: Labrat :im_033: : party1 :

I was contacted by the New York Times for an interview............NOT Cyberonics, they blew my case and issues out the window after my problems, not even a follow up call that the removal surgery went well. Cyberonics is right down the road from me now where I have moved to, I do have this urge to have a talk with them if they let me in the door.................
Anita

I know this topic was started in 2006 and it is now 2008, but I have something to add. I no longer have access to the Cyberonics or VNS website from my computer. I think I raised enough discontent that I have been blocked. After I acquired internet search skills, I found bunches of stuff on their sites, and I called to request my information (as per their website under the privacy section, patients can request their records, etc.). Every one of the CYBX employees I spoke to asked me where did I get my information, so I told them off their site. They of course deined knowledge of knowing some of this stuff is on their site. I haven't had access to their site since shortly after my formal request for my records. I have adjusted my browser settings, security settings, etc., still not able to access their sites, but can access them off another computer. Interesting I say. As far as the media goes, I was contacted by CYBX's media outlet in Massachusettes for an interview some time ago. When it was disclosed I should have never been implanted, they dropped me like a hot potato.

Dispatch B)

So, there is a new and advanced model out of a new VNS. If the FDA supports something, then I don't see why then insurance companies do not pay for this device; without a fight.

As far as Cyberonics go, I do not trust them totally. I've read too much here on the negative experiences that people have had, and the deaths of some as well. It would be interesting to compare what they removed from their website, and what is in the new manuel as well. Maybe they left adverse events out of the new information (?). They don't want to look negative in the media/medical world.

Sincerely,
Bonnie

If CYBX is paying for the media services (like the one in Massachussettes), they won't interview anyone who has had any thing bad happen to them with VNS. Cyberonics gives this organization your name & phone # if they feel you could be a poster child for them. Someday, this all will come out in the media, and then Congress & Senate will get really involved, then the snow ball effect from that will be amazing. It is really sad that the media can be bought. That proves bias on some media organizations.

Dispatch B)

Media manipulation is nothing new for Cyberonic$, Skip Cummins the former CEO would call reporters and tell them to interview certain VNS patients. If the reporter wanted a more objective view, his article would be removed and/or edited until it reflected just the right spin.

I have this directly from several VERY seasoned and popular reporters. It's not what you know, or the truth or even fair reporting, it's who's greasing the palms.

They liked media from me because my response was quick and no problems. When my first battery went dead after 15 months, they dropped me like a hot potato. :D

<_< Now that's ridiculous, they shouldn't have done that to you. You are a success story, and battery depletion is expected. Geesh...

Dispatch B)

The media and Cyberonics is slimy and nasty. But they cannot prevent the truth from coming out if we keep reporting adverse events. The truth will be known, I just think it's illegal preventing/omitting what has happened to certain people. Every device has some problems, no matter what it is; even pacemakers have problems.

The truth about a device should not be hidden! Everyone should know all of the risks involved with getting a VNS put in.

Sincerely,
Bonnie

Is there anyway that I can get a copy of both the patients and physicians manuals? I have searched everywhere and cannot find them. Can you help? Thanks, Nancy B

This is the link to download the manuals
Manuals

You'll need to have Adobe Reader installed, just follow the prompts by clicking this----->