Hardware failure in vagus nerve stimulation therapy.

Acta Neurochir (Wien) 2008 Feb;

Authors: K Rijkers, M W Berfelo, E M J Cornips, H J M Majoie

Department of Neurosurgery, Maastricht University Hospital, Maastricht, The Netherlands, kimrijkers@gmail.com.

A 20 year old male patient who had been successfully treated for epilepsy with vagus nerve stimulation (VNS) for 7 years (50% seizure frequency reduction), had experienced multiple episodes of severe hoarseness, throat pain and impaired breathing during physical exercise. As malfunctioning of the pulse generator was suspected, it was decided to replace the device. During surgery, the pulse generator was found to have broken in two, due to an unstable connection between the battery subunit and the connector subunit. With a new pulse generator seizure frequency reduction was restored. No side effects occurred.

It broke in two? This is really scarey! I am surprised there was not more damage done.

I wonder if they are making the units in China now.

:excl: Oops... did I say that? :unsure:

:im_033:

Signs of excessive stimulation

Duh! Interrogation of the unit is suppose to show any abnormalities.

If this connection was unstable, then logic says not full and/or regular stimulation is occuring, yet he's being fried. To me this makes little sense.

Someone who knows a little about electronics want to expand on this?






P.S. God help us is they were being made in China!!

The FDA inspects their production facilities, so I'm pretty sure they are not being made in China. ;)

If I understood correctly, they are saying that the generator, which is supposed to be hermetically sealed, actually cracked/separated? That is scary.

You think that`s scary! This doctor(Majoie) is our doctor! That is scary! :fear:

But she is a good doctor! We are very pleased with her.

That's your doctor! How neat! What a small world this is!

My VNS nurse told me that the generator was pretty well indestructable. She told me of one child who had such a nasty fall, the generator flipped over, but managed to remain in working condition.

To have broken in two, and not immediately picked up, makes you wonder what sort of doctor was keeping an eye on the patient. THAT is more scary than the breakage itself.

Boy, this is really scary. I've never heard of this before.

Sincerely,
Bonnie
:mellow:

Seen our doctor today again.
I think she is a very good and honest doctor.
At this moment Nino is not going very well, but i write a message about that another time.

So i asked here, is it possible that some one becomes a new vns and have big problems with it?

And she told me this story about the hardware failure.
She also told me, that they asked cyberonics about this. And their answer was, this young man was doing too much sports and was too active for the vns.
Our doctor answered him, if that wasn`t possible with the vns, they better did not advise the vns for people with seizures because they often fall. :excl:

Well, that was not the meaning of cyberonics of course.

The doctors decided to publicate this because there may be more of those
bad generators.
And they didn`t like this at all. Like we don`t.

WOW!

Thank you Mom. I am so glad you are here to add the european prospective. Your doctor thinks too many bad units may be out there. This is very bad if the unit is breaking apart. The batteries are highly toxic and from what I understand fatal if leaking into the body.

Active people must take extra precaution so as not to hit, bump, strike the VNS unit.

Sometimes a fall from a seizure can cause a hit to the unit too.

Our doctors publicated it, in case of there are more of these bad generators.
Who know`s ?

Thanks for finding out more on this, Mom. Is there a chance you can get a link for us on their publication? I would love to share this with my neuro as he is extremely concerned about what problems VNS can cause and wants to know of publications so that he makes sure his patients are fully aware of all the risks involved.

I think it is a crying shame that their response would be that this patient was "too active"... my goodness, do they expect VNS patients to not live life? I do not intend to be held back from living life to it's fullest by my epilepsy or any device. I agree with BB that we have to take extra precaution but to what degree does that cut into the quality of life? Isn't that what the VNS was supposed to give us, a better quality of life... or was that just propoganda from a manufacturer who wanted to sell units and then not take responsibility when patients had problems?

I think we all know that Cyberonics is not going to admit their units are flawed and are going to lay the blame at the feet of the patient, but there will come a time when the truth will be known, unfortunately though some patients like this one will suffer in the process. This to me is the unacceptable part of this whole problem, Cyberonics' lack of responsibility. That to me is unexcuseable.

:im_033:

gel

For those of us who have been around for a few years dealing with Cyberonics, know this is their normal operating proceedures.

It's "buyer beware"

It's especially difficult for those who implant the device in a child under the age of 12 years. Since it does NOT have FDA approval for any age under 12, it becomes user error! Even though this comapny paints a glowing picture and really pushes for child implantation. I don't understand how they have not been pulled into the carpet for selling off-label.

I am seeing that, BB, and that is what is so disturbing to me. I know companies have to paint the rosey picture or they would not sell their products, but there comes a time when their lack of responsibility will kick them in the @ss. Just look at the insurance company that got hit when they cancelled the woman with breast cancer, they got socked with a $9 million dollar settlement. Many pharmaceuticals have had to eat their own words about how great some of their drugs are, and there will come a time that Cyberonics will too. I just pray that is is sooner than later.

I think that is where this board can be so beneficial for people. My own doctor has asked me to send him links of FDA reports I find on here after I told him of some of the ones you have posted because he knows the propoganda but at the same time is concerned for his patients. I just sent an email to him today with the links that Dennis listed so that he can not only inform his patients who have VNS but also present this picture to new patients prior to implantation so they are more aware. I hope others on here are sharing this information with their doctors as so many don't have the time or patience to do the searching, or in some cases choose to believe the fairy tale.

As I have said from the "gitgo"... research research research!!!! I went in with open eyes because I was able to see here on the board prior to my surgery. And I am grateful for that, to the extent that I don't think others realize.

:im_033:

I just came across this thread and it made me wonder, what (if any) type of testing was done on the devices to see what kind of damage they could take. Every time I get into the car (driver's seat) and put on my seatbelt, I wonder what would happen if I were to get into a car accident and/or my seatbelt were to lock up and hit the generator. I don't know about the rest of you, but the seatbelt goes directly over the generator on me and like I said, it's scary to think about.

Impact from an accident has the potential to rip the generator from the chest, and the leads and vagus nerve from the neck. I have heard of this happening but I cannot substanciate this claim.

I know from my own experiance with just a cervical collar how easily the generator can be ripped loose.

Avoid placing any restraining harness over the generator ot across the leads. As for my seat belt in the car, I'd run it under my arm.

Geez, thanks for putting my mind at ease...LOL.

And good idea about putting the seatbelt under your arm.

I put my seatbelt under my arm, too. My seatblet rubs my neck and irritates my incision. If I'm a passenger, I can wear my seatblet correctly, but driving is different.

Dispatch B)

:Yeah That:

I started slipping the seatbelt under my arm on the way home from the hospital after the implant...

Also used to carry my purse over my left shoulder.......no more.

Same thing with me and the seat belt.

The thing splitting apart is scary.

You know, I still wear my seatbelt under my arm most of the time. My unit was explanted last November but the sensation of the belt on my neck is VERY uncomfortable. Since I still have the electrodes on the nerve, I am leary of anything hitting my neck. It's still sensitive.

We've been in 2 auto accidents in the past 6 years and both times hit by some dumbass not paying attention totaling the car each time. I just hate the thought of it happening again!

Do you guys think that severe vomiting could cause any damage to the Vagus nerve? I had a really bad stomach bug and was throwing up for the entire night. My neck feels ok now, but was very tender where the lead is attached to the vagal nerve after I had stopped getting sick.

Do you think the vomiting did anything to the lead?

Sincerely,
Bonnie

Bonnie there's no way to tell unless someone can see a change in an x-ray but I imagine anything is possible. Remember when Bill Clinton passed out from eating a pretzel? The pretzel pressed on his vagus nerve and caused him to faint.

Wow at the trivia we get on this board!!!! :D