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helenpe1

vns therapy side effects

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

I am going to be leaving this particular post because as of two weeks ago a decision has been made to remove the VNS. Not because of the bad reaction I have been getting from it but due to the fact, I no longer need it. We are still in preliminary discussion on shut down and removal time but it has already been decided that this will take place.

Suebear

Re: vns therapy side effects

I have a VNS but it was turned off because it didn't help. However, I had no unusual side effects when it was on.

Re: vns therapy side effects

I have a VNS but it was turned off because it didn't help. However, I had no unusual side effects when it was on.

Re: vns therapy side effects

  hi,

  I had the vns since about 1999.  I had the battery replaced twice.  Yesterday I had it turned off.  Before the vns my seizures were complex-partial and petit mal with and aura with them always.  After the implant, my seizures had gotten worst over the years, to where I was having drop seizures with no warning.  I ended up having to get a seizure helmet, because of them.  I would fall backwards hitting my head.  Four times I have ended up with staples in my head, along with other injuries from splitting my ear and fractured ribs and other bruises.   Mainly, though it was head injuries.  I figured even if I have more complex partials with the vns shut off, I don't injure myself like I do with the drop seizures.   It might not effect everyone that way, but looking up on the internet, I found where it caused a lot of drop seizures not related to epilepsy.  I found a lot of similar cases on the vns board on-line.   I don't mean to scare you, but rather caution you incase something like that happens.   You might try going on there, because they are people who have the vns.  So, they can tell you from experience what others are only guessing at.   Hope things get better with you.   

 

Re: vns therapy side effects

I too suffer from tingling in my neck , sholder and jaw. I had my VNS turned off and I'm still experiencing these uncomfortable symptoms.  Sometimes I feel like the wires are too tight.I'v had my VNS for 16 months and I had it turned off after 13 months. I also experienced breathing problems that seemed to get worse as time went on no matter what setting it was on. I'm athletic and I do triathlons and well as 1/2 marathons and it was really affecting my training. Even when I'd use the magnet to turn it off it didn't make a difference.

 I have complained and the response I recieved was no one else seems to have those problems. I am considering having the pace maker part removed.

Stayc

Re: vns therapy side effects

As for this test, it can be done. Part of the problem are two things, one being there are patients who are not in an area that can perform it and the other issue is there are administrators or health workers who do not know the protocol. There are some patients who cannot manage this test because of their health which is unfortunate. Because each patient is different, there is always going to be that slim chance of having this occurance. 

Here is the documentation that I have:

9.4.4. Magnetic Resonance Imaging
If you plan to have magnetic resonance imaging (MRI), make
sure your doctor has the following information:
! Magnetic resonance imaging (MRI) should not be
performed with a magnetic resonance body coil in the
transmit mode. The heat induced in the Lead by an MRI
body scan can cause injury.
If an MRI should be done, use only a transmit and receive
type of head coil. Magnetic and radiofrequency (RF) fields
produced by MRI may change the Pulse Generator settings
(change to reset parameters) or activate the device.
41
Stimulation has been shown to cause the adverse events
reported in the “Adverse Events” section of this manual.
MRI compatibility was demonstrated using a 1.5T General
Electric Signa Imager and Model 100 Pulse Generator only.
Testing on this imager as performed on a phantom indicated
that the following Pulse Generator and MRI settings can be
used safely without adverse events:
¨  Pulse Generator output programmed to 0 mA for the MRI
procedure, and afterward, retested by performing the
Lead Test diagnostics and reprogrammed to the original
settings
¨  Head coil type: transmit and receive only
¨  Static magnetic field strength: £ 2.0 tesla
¨  Specific-rate absorption (SAR): < 1.3 W/kg for a 70-kg
(154.5-lb) patient
¨  Time-varying intensity: < 10 tesla/sec
Use caution when other MRI systems are used, since adverse
events may occur because of different magnetic field
distributions.
! No scan in which the radiofrequency (RF) is transmitted
by the body coil should be done on a patient who has
the VNS Therapy System. Thus, protocols must not be
used which utilize local coils that are RF-receive only,
with RF-transmit performed by the body coil. Note that
some RF head coils are receive only, and that most other
local coils, such as knee and spinal coils, are also RFreceive
only. These coils must not be used in patients
with the VNS Therapy System.

Courtesy of www.cyberonics.com 

Re: vns therapy side effects

Hello everyone,

My Beautiful daughter Mariah received the VNS in January of 2000. I was given hopes and promises of a "better life" for my child. Over the years, the frequency of the seizures and the E.R visits decreased. The problems started when her voice began to change to wrapsy. The docs said it was a normal side effect. In late August of 2009 her seizure activity increased. We went to the doctor in September and the physician said her settings were still low and there was room to increase the settings. He did. Later that day my daughter complained of hiccups and they lasted a really long time. I was told by the docs that this was a normal side effect. My daughter's hiccups lasted until the day she died- October 25, 2009.

I am devastated.

Re: vns therapy side effects

Hello everyone,

My Beautiful daughter Mariah received the VNS in January of 2000. I was given hopes and promises of a "better life" for my child. Over the years, the frequency of the seizures and the E.R visits decreased. The problems started when her voice began to change to wrapsy. The docs said it was a normal side effect. In late August of 2009 her seizure activity increased. We went to the doctor in September and the physician said her settings were still low and there was room to increase the settings. He did. Later that day my daughter complained of hiccups and they lasted a really long time. I was told by the docs that this was a normal side effect. My daughter's hiccups lasted until the day she died- October 25, 2009.

I am devastated.

Re: vns therapy side effects

How long have you had your VNS in for as I've had mine in for 4 months and only in the last week have I started experiencing very sharp pains in my neck that only last approx 2 mins and are 3-4 mins apart, my neurologist has no idea what this means is this what your pain problem is too?

Re: vns therapy side effects

How long have you had your VNS in for as I've had mine in for 4 months and only in the last week have I started experiencing very sharp pains in my neck that only last approx 2 mins and are 3-4 mins apart, my neurologist has no idea what this means is this what your pain problem is too?

Re: vns therapy side effects

How long have you had your VNS in for as I've had mine in for 4 months and only in the last week have I started experiencing very sharp pains in my neck that only last approx 2 mins and are 3-4 mins apart, my neurologist has no idea what this means is this what your pain problem is too?

Re: vns therapy side effects

How long have you had your VNS in for as I've had mine in for 4 months and only in the last week have I started experiencing very sharp pains in my neck that only last approx 2 mins and are 3-4 mins apart, my neurologist has no idea what this means is this what your pain problem is too?

Re: vns therapy side effects

Hello,

 I am so happy I found this site!  I really need some help and advice.  I am the aunt of a 16 year old and she is mentally delayed.  She has no verbal skills and cannot walk, crawl or talk or use sign language.  But she does have very severe seizers.  She has been on almost every medication her whole life and has exhaused all combos of medications, and she still has severe seizers.  The problem she has now is that all the meds make her tired and non-responsive.  She sleeps alot and is not alert.  Her doctor has recommened VNS and we are a bit scared to do this.  I read some blogs here and there seems to be a lot of pain with this.  But she cannot tell us if she hurts, so we would never know.  We dont want her in pain from this, but we dont know what else to do to help her.   This is my sisters only child and my only niece, she is so loved, we dont want her hurting, but we want her "back".  We dont want her to sleep all the time.  Do you think we should try this?  Please help!  Thank you.

Re: vns therapy side effects

My girlfriend got a VNS in early July, at first she was certain this was one of the best decisions she had made and was very happy with it other than it was extremely hard to talk. She had it turned up and get sharp pains in her chest and it made it unbearable for her to talk with it on and difficult to breath, and on top of that was not doing very much at all to help her seizures at all. She was talking to me about getting it taken out or turned off for good. I went and researched the side effects of getting it taken it out and found this thread. when i saw some of the stories on here i realized she was not alone with this and it scared both of us. On August 19th our fears came to life when friends of hers that she was staying with woke up to find her not breathing with no heartbeat. Of course an ambulence was sent and upon arriving at the hosptal had emergency surgury to remove it. Since its been removed even with the soreness she feels so much better and much less burdened and has decided not to take any more gambles with surgury. The device was either incorrectly installed or had broke but the wires were only partially wrapped around the vagus nerve and were sending shocks to her chest which eventually stopped her heart. Her neurologist as i had found out had pushed her into it and glamorized the device and all but set up the surgury for her with less than a week to consider it. This device may work for choice few people but from what ive seen and heard from other people the vns is not the best road to go down and seems to malfunction easily. If you decide to get this surgury know that it can be painful , it can completely change your life style and the device does have to potential to kill you, however rare the side effects may be so is getting struck by lightning and it happens and people that it happens to definetly don't expect it to happen. I never expected to get a phone call that my girlfriend was almost killed by a so called miracle device, if it sounds to good to be true it likely is.

Re: vns therapy side effects

Hi

I've had my VNS for almost 6 years now and yes I know what your talking about. When I first got the implant it was really bad and my doc had to make some ajustments and it made a world of difference.  It only happens to me now if I lay down with my head at a certin angle when the device goes off.....if I just move out of that position it goes away. and after my doc ajusted the VNS that feeling is not nearly as severe when it happens. :)  So my advice is talk to your doc and get that VNS ajusted until its comfortable for you.

Good luck, look me up if you need anything,

~Amanda Lynn~

Re: vns therapy side effects

I had the VNS from 2000 to 2004 when I had it turned off for shoulder surgery. I was experiencing a great deal of shortness of breath. I am physically active. I play handball, bike, run, and various other sports. The problem was making me VERY uncomfortable. When I had it turned off for the surgery it was like coming home from an agonizing trip. I was so happy with it off that I never had it turned on again.

Re: vns therapy side effects

VNS therapy update...

It's been a long time since I've been able to connect onto the forum between daily life and other activities that are happening. At any rate, I had to give an update on what has been going on with the VNS.

1) I'm still using the VNS at this time however there have been new changes.

2) As of Oct 2011 I actually got an update to the latest version including another addition because the seizures were totally out of control -- four or five a day. Because the VNS could no longer handle my seizure activity with the settings it was best to go the next step and go with a Deep Brain Stimulator. The VNS was updated to the smaller device as the battery needed to be replaced while I was in the hospital.

3) Once we found the correct settings for the DBS the medication dosage was slowly dropped. I am now taking next to nothing. The next step we have been discussing is to begin removal of medication but we are not quite ready to do that just yet.

4) As of this month it has been a year for my DBS surgery. Not only that, the VNS device has been left at default settings so there now is consideration for what to do with that device at this time.

Oh, in the process of all the above, I had to leave my doctorate studies due to the medical surgery then due to recovery. In the end, I felt it was best to stop classes over all and focus on my health. =)

S. Elvins

Re: vns therapy side effects

Nancy B    THIS IS VERY IMPORTANT!!!   I have just gotten off the phone with Doug Wood who is the BRANCH CHIEF of Post Market Branch that tracks adverse events and deaths that are either linked to or caused by medical devices. He has asked me to ask each of you who has filed a Maude Report to send him your individual report #'s. If you do not know what your case number is you can log back onto the Maude Data Bases and with a little effort can find that out. He wants each indivual case number sent to him. For those of you who have been seriously injured by the vns device , or worse yet, those of you who have either lost a family member or know of someone who has, contact them and ask them if they have filed a Maude Report. If you, or they, have not done so yet, please do so immediately and send him the information. Please, people, this is vitally important. You will be possibly saving lives. His contact e-mail is: doug.wood@fda.hhs.gov  If anyone needs assistance in this, I will help any way I can. Contact me at: nancybowling@att.net 

Re: vns therapy side effects

Nancy B   I have just spoken to DOUG WOOD, who is the Branch Chief of the Postmarket Division in Washington, DC which tracks adverse events and deaths caused by medical devices. He has asked me to have each of you who have filed a Maude Report to e-mail him your actuaL REPORT NUMBER. If you did not keep this information, you can log back on to the Maude Data Base and with a little work can find that out. His e-mail address is doug.wood@fda.hhs.gov You can very well be saving lives, so please send this man your information. If anyone is having difficulty retrieving this information, e-mail me @ nancybowling@att.net and I will help you. Thankyou for doing this. You might very well be making the difference that saves someones' life.

Re: vns therapy side effects

I have had uncontrolled seizures for almost eight years after a TBI. I am on four medications now and my doctor keeps pushing the VNS on me, telling me that is my only option. Your posts have opened my eyes.

 I was never enthusiastic about this "therapy" to begin with, but now I am terrified.

 I send out my deepest condolences to everyone who has lost someone or who has lost part of themselves because of this device. Thank you to everyone that helped me become aware of this information, if it hadn't been for you I never would have known about these risks. My doctor sure hadn't told me about them....

Re: vns therapy side effects

Hello,

Could it be the level on which the vns is set? Mine has worked fine and even has stopped a few seizures. I know the last time I had my doctor adjust the setting I couldn't stand the feeling of the new level and asked him to go back. It's standard that he increases the level. I'm not sure what he'll do next but this for me is fine now.

Hope all goes well

Re: vns therapy side effects

I had this implant a year ago
I have had nothing but problems as this device was put in to help with organic headaches, Complicated migrains, Clusster headaches
I have lived with daily head pains for over 20 years, which are realted to seizures

I had not had a seizure in over 5 years before the implant nbut told this should help the daily head apins

The stimulator has caused nasua every day, Fatquie, trouble swallowing, cold sweats and it would freeze up in air condtioning
it was adjusted numerous times by my nuerologist of 17 years it was over 5 months and the doctor hasnt returned calls or emails

I was then referred to another nuerologist to have this looked at
I saew him today and when they went to shut this down
I was told there was no out put as it read zero as it was shut off already

I was shocked as I knew this thing was working just a few days ago, but have had problems with it for a year now
I asked them how is it possible that its turned off already hopw would the out put be zero

They did not know, but they turned everything off now they said

I am so confused and scared ,
The Docotor said i did not need to see him any more as I was just there to get this device turned off.

I really thought this was the hope i was looking for,
They made it sound so good and now the doctor who turned this on the one i have been seeing for 17 years is no longer on Cyberonics list either.

Do I have a leaking battery, a bad lead, a faulty device
I year of being sick to my stomach, tired all the time, sweating and I am a thin man but would sweat as a over worked person,
choking on whatever i ate at times even water.

Now today find out some how this device shut down its out put all by its self and not even told they wopuld look into the matter

Has anyone suffered as this
Thanks

Re: vns therapy side effects

I have had some very odd issues with my implant
not sure why but it has given me a upset stomach now for months as it comes and goes
its seems as maybe its due to surgery and that a lead may be pinching a nerve I have found at times i Can stop this at times if i lift a object with my left arm enough to put strain in the neck which then the nasua stops, but it comes back often and its hard to get the muscle or nerve back to the point for the upset stomach to cease

I also notice it seems as the leads may be pinching my chest as i can feel the leads at times.
the sensation of swiping the magnet is the worse its as someone is choking me and it feels as my lower jaw and teeth are burning as if some one is pushing a hot spike into my lower jaw for 15 seconds then it eases
so i do not swipe the magnet much at all.

Its been a few months since i had it adjusted and cant get ahold of my nuerologist to check this all out
I have been his patient for 17 years and the last few months he doesnt call me back or reply to my emails

When i saw him last he tested the leads and when he did that it felt like a hot poker going thru my jaw it was so bad i almost went into tears
I told him about it , he did not seem it was anything to worry about.

I had this implanted to help with whats called intractable headpains , complicated migrains and cluster headaches which have brought on untypical seizure which are produced by head pain i have suffered for 20 + years.

The head pains I describe are pains that are everyday but because of the medications i am on the pain is still everyday but only last a day now instead of day or weeks where at times i was bed ridden from the massive pain in the head.

I will try anything the medical profession to come up with to stop these head pains
It does depress me as to wake and go to bed with a headache as it never fails
I havent had one day in over 20 years where i havent had a headache, but at least the severity is not as it once was, but this was the case when they put me on a cocktail of many medications which makes my life more normal then it has been in years

I raised 5 children and a grandaughter with this condition
I attened college to get my associates degree but that was a slow process since at the time i was going thru doctors misdiagnosising me and treated me for everything but what i had.

one doctor had me beliveing I was crazy and the pain was from me thinking to much about the pain

but one knows when a migrain comes on how useless the migrain makes you then a cluster headache on top of the migrain and the stress headaches make a presesnce.
the day after recovering from a masive head pain my body is wore out as if was was hit by a car

Re: vns therapy side effects

i have always gotten severe migraines from siezure activity. the worse the activity the worse the migraine. if i have a tonic clonic siezure i get very severe migraines. migraines = nausea. i was changed to topamax as one of my siezure meds since they use that siezure drug as a migraine drug as well.

personally if my doc wasnt returning my calls , its time to fire him and get a new doc, go to an epi specialist since you do have siezure activity causing your migraines. they are more skilled and more simpaphtic. any doc that doesnt take your pain serious ly, is not a good doc. my epi doc will return my calls promptly on the same day, usualy with in a hour. good luck on your doc search

God Bless,

banffgirl

life is fragile, handle with prayer.

Re: vns therapy side effects

Hi Marcy,

I understand your concerns. I had many of my own before I had the surgery. Being that she cant make the call for herself, talk about the pros and cons with her doctor. If you are talking about pain with the surgery, the pain at the incision site is very intense the first day but they give you strong enough pain killers to stop it. it does get much better every day after that. the pain killers they give you does take care of it though.  

the only discomfort i get now is when i am stressed and tense my neck muscles, i do have some discomfort, not pain, in the left side of my neck when it goes off, but if i just settle down and relax, then it goes away. some people do have side effects, some have no problems at all. like with anything you are going to find people that are happy with it and those that are unhappy with it.

So talk it over with the doctor and get all the info. Ask questions on anything you dont understand. Best of wishes to you and your family.   

God Bless,

Banffgirl,

I have a electric personality, my brain is self charging!

Re: vns therapy side effects

Something that I have noticed with a lot of the subjects who get this product are they should not.

In other words. Persons who had received the VNS were still experiencing uncontrolled seizures however those seizures were not breakthroughs, they were full blown. There is a difference between the two. For example, I was seizure free for seven years before mine came back which put me into a category of having breakthrough seizures and made me a candidate for the VNS surgery. 

What I am seeing now is there are some neurologists taking advantage of this surgery without considering the fact that it may not work due to VNS is not made to bring seizures to a halt. It is only made to decrease and manage their frequency. I was even told that from my neurologist and neurosurgeon before going into the OR. Lastly, VNS only works in conjunction with a medication regimine and changes will not occur immediately as it takes time for the correct settings to be made to the patient's body type and their seizure habit. For myself, it took six months to find the correct setting. Now I visit the dr every month to check up and ensure it is running correctly. I have gone from four small seizures a day to one seizure occurrance every 10 to 15 days, sometimes 20 days depending.

Regards,

S. Elvins

PS. I am studying for my Doctorate so my response time may not always be the greatest as I am busy with school work and a huge writing project.

 

 

Re: vns therapy side effects

Viv Sheets-  Did you ever have the device implanted in your niece?  I am really curious.  My son is 19 and will be having the implant put in next week.  All you read is negative, negative!  I am trying to tell him to keep an open mind.  People don't usually write about stuff when they are satisfied.  They only write to complain about things.  I hope you had it implanted in her and that things are going well.  I know we have an excellent doctor and am very hopeful that it will make it so he can come off of some of his meds!  Good luck, please let me hear from you or anyone that has something good to say. 

Re: vns therapy side effects

Hi, I just now joined this site and you may have already made a decision by now BUT it is a decision that only you can make. As a RN I have taken care of a little girl that it worked well for and she had no side effects. As a mom, my son almost died from the VNS. So, no one can make that decision for you and I know it is a hard one. We make hard decisions every day for our children and in the end you have to realize that you tried to do the best you could. Good luck and best wishes. Thea Thorne-mother of Michael:)

Re: vns therapy side effects

Nancy B   Tadybug, I am going to repeat something that I have said in a previous reply, but I think it needs repeating. Type 'Maude Data Base' into your google search bar, and when it comes up type 'death caused by Cyberonics vns device'. When that page comes up, go to the very bottom where it says 'repeat search with ommitted items included' and read some of those reports. You can also type into that very same searc bar 'serious, or lifethreatening injuries caused by Cyberonics vns device' and read those reports, again, 'with the ommitted items included'. You can also type in 'warning letters sent to Cyberonics re: vns device' and read those. My sister almost died from this device, and she will be disabled now for the rest of it BECAUSE OF THIS DEVICE. This is a very dangerous device, and yes, there will be people who sware it has helped them, but there are many others who it has either killed or mamed, You need to know ALL the facts in order to decide if that is a risk you are willing to take. Good luck in your decision.

Re: vns therapy side effects

I have the VNS but it is turned off. I didnt experience that problem at all. I would contact your neuro and maybe they can do xrays or whatever in your neck area. I would contact them right away.

take care
lisa
http://health.groups.yahoo.com/group/epilepsyapproach/

Re: Re: vns therapy side effects

May I ask you why you decided to have your VNS turned off? Mine was implanted in June of '06, so I am still getting my adjustments. I have thought more than once in having it turned off. What was your final reason to have yours turned off?

Thanks,
Lindsay

Re: Re: Re: vns therapy side effects

re: vns therapy side effects
I'm sorry I think my message was confusing. I had my vns temporarily turned off last summer for about 3 weeks when the 'tingling' was really severe (like continuous bee stings) but it was turned back on at a lower frequency and it has not been as bad. That was the only time I had it off and I have had it since May of 2004. Overall I have been happy with my vns but I do find the 'tingling' uncomfortable and I worry that it might get bad again. The bee stinging sensation was absolutely unbearable. However as I said before I find that I have fewer trips to the ER thanks to my vns which is great and therefore I hope that the 'tingling' will remain manageable. How are you doing with your vns? Why have you thought about having it turned off - I'm curious.
Thanks,
Helen

Re: Re: Re: Re: vns therapy side effects

Helen,

I am doing well so far with vns. I do not like the vocal change, that is my main reason. I am a stage actor, so I can hide the change slightly while on stage, but I am not a fan of it. I am still seeing my neuro once a month, and I have two more time when my "voltage" is turned up as I call it. I don't know quite yet if it is working. The seizures have stopped for now but I still have auras.

Lindsay

Re: VNS Side Effects

I got into a study and got the VNS this time last year with no problems. 2weeks later it was turned on and had my first adjustment. Everything was great until I went in for next adjustment and the technician or the adjustment device screwed up and I was hit with the max voltage several times within a 15 minute period. Everytime she reset it it hit me again. Finally she called cyberonics tech dept and was told how to do it. That was Feb 21st and I have been sick as a dog ever since. I spent most of this year homebound. Headaches EVERY day since, neck pain, body pain, several mentioned toothaches. I had those alright bad ones but Shortly after my teeth litterally turned black on the edges and became brittle as chalk. I just spend 5000 last year on my teeth and they were in great shape when the implant was installed. Once they turned black it was like wildfire through my mouth. All my teeth were like less than 4 months later. I think it a bit unusual for every tooth you have to all go bad all at the exact same time and exact same way in a 4 month period. Has anyone experienced the max voltage shock ? If so what were your experiences. Has anyone had anymore teeth problems except pain ? I am having an eeg and a pet scan this week and a four hour cognitive test.
The interesting thing is within 2 weeks of the shock they pulled me out of the study once they found out I called Cyberonics ( never returned call or e-mail) and then the FDA to file a complaint.
In the prestudy paperwork they do mention all these side effects you guys and myself are expering. The side effect list was staggering. I hate to take extreme issue with Herbs statement that no one has died from it. Also in that paper work was adverse advents and since the beginning of testing there has been over 30 deaths. He is right in saying cyberonics said the vns had nothing to do with them. Some were suicides, I can attest it can make you very suicidal, unknown causes, siesures, and heart attack and of course the group " death by unknown causes". Don't tell me the VNS has never contributed to deaths.
I have faith in this device. I don't know why but I do. The problem is if the thing malfunctions there is really very few dr's who have seen the symptoms or know what to do about it. The dr's need much more training in all aspects of VNS so they can properly handle all problems that arise. I would recomend anyone interested in this thing, especially for depression, wait 2 - 5 more years. Your chances of getting the results will be much more in your favor. I thought I had nothing to lose but instead I lost a whole year in severe physical and mental pain not to mention 5200 in dental work and another 500 co-pay for surgery. Keep in mind if you get on a study they don't tell you that you have no access to an MD. Your dr is blind to the study and will not break the protocol. They never checked me out to see if I could drive or walk or hurt in any way. I could barely do either. Also you sign all your rights away. Sorry for being so long winded ! Peace to All !
Echo04

VNS nearly killed me

I had the surgery on 7/21/00. The device never helped my condition but I did not regret my decision to try it, that is until 7/02/06 when the device malfunctioned and nearly killed me. On that date I started to experience what I thought was a new type of seizure. The episodes began with a sudden sharp pain to the throat followed by choking and then unconsciousness. I was not alarmed by this because I have several different types of seizures. My parents happened to stop by that sunday morning for a visit. They realized that something was wrong and called my neuro and ems. My last memory of that morning was being inside of an ambulance. When I regained consciousness I was in the ICU. What was actually happening is the device was stopping my heart (asystole) during the 30 second on cycles. Once my neuro realized that the problem was cardiac in nature and not seizure activity he had to rush to his office to retrieve the equipment to deactivate the device. Once the VNS was turned off I regained a normal heart beat. My VNS was programmed at 30 sec/3 min and I had approx 40 episodes of asystole. It was a miracle that I survived that ordeal.

Re: vns therapy side effects

i want to thank every one of u for the input on the vns i have not had it put in yet but something in me said dont do it my nuero made it out so good not mentioning any of these probs i had tens machine put on me in physical therapy once and went into a gmal instantly , so i have decided against the vns. there is supposed to be a t-vns out in 2012 that dont require surgery so i think ill wait till then wish you all the best  

Re: Re: vns therapy side effects

Mine was implanted in Jan of 01. It was on for eight months. There was no change for me at all. Unless I swiped it when I needed when a seizure was going to occur. It was turned off because I got sleep apnea from it, which is very rare, but it does happen. I really like the VNS now even better. For I can swipe it on again when I needed.

It is like a security blanket for me, I have something to help me out if a grand mal was going to happen. Plus I hated it, when it was turned on. My voice is very deep as it is, and when the VNS would turn on it was very noticeable.

But I would not do without it now.
take care
Lisa
http://health.groups.yahoo.com/group/epilepsyapproach/

Re: Re: Re: vns therapy side effects

Lisa,

How do you turn it off? I still have a lot of time to think about it, but I might have mine turned off. I am a stage actor, and I do not like the vocal change.

Thanks,
Lindsay

Re: Re: Re: Re: vns therapy side effects

Lindsay,
The doctor has to turn it off for you. But it sounds like yours is working for you, why would you want to turn it off. Having an aura is nothing. It is not going to catch everything. Unless the setting is more often.

Take care
Lisa
http://health.groups.yahoo.com/group/epilepsyapproach/

Re: Re: Re: Re: vns therapy side effects

Hi Lisa,

I hope the vns is working well for you. You can tape the magnet directly over the battery on your chest (under your clothing), to put the stimulation on pause while you are singing. I know someone who is an opera singer and that is what he does. w/o stimulation, you shouldn't have any voice alterations. After you are done, take of the magnet, and the vns will start working with a gradual ramp up again.

Re: vns therapy side effects

Hi ! I had the VNS implanted in October, and am still going thru the process of having it gradually turned up. In March, it will finally be turned to the low end of the therapeutic range. I haven't had any problems with it, and certainly not the "bee sting" effect you seem to be having. I do feel the tingling in my neck quite a bit, and feel like the next adjustment will be a bit harder to get used to. Each time i have had it turned up, it has taken me a few days to get used to it. This last time (about a month ago), it has taken a bit longer. I have used the magnet a few times this past few weeks, and noticed that it is definitely stronger, and although not "painful", it is uncomfortable.

I would definitely have the neuro check it out, and see if the leads have shifted. Lots of people react differently to it, and your feelings should not be discounted by Cyberonics. I hope they have filed a "side-effect" report on your issue.

Good luck, and keep us posted,
Barbie

***************************************
"We are each of us angels with only one wing, and we can fly only by embracing each other." -lucian de crescenzo

Re: Re: vns therapy side effects

re:vns therapy side effects
Thanks for responding to me - I appreciate it. It sounds like you understand the tingling sensation at least, if not the bee stinging!
I have had the leads checked and all is ok. I don't think Cyberonics filed a 'side-effect' report on this ( I'm not sure they really want to!) but now that you bring it up, I'm going to follow up with them and make sure that they do. Thanks for bringing that thought to my attention.
By the way I love the quote at the end of your reply - it's beautiful.
I will keep you posted.
Thanks again,
Helen

Re: Re: Re: vns therapy side effects

Being the odd one out but let me tell you my experience with the one and only CYBERONICS and VNS!! I DISLIKE THAT COMPANY and feel very betrayed by them.

I have intractable epilepsy after undergoing the removal of a malignant brain tumor in 2003. I was told my seizures where going to get better but they got worse.

I was 25yrs old married and had two beautiful children. I actually worked worked two blocks away from CYBERONICS BLVD. where the lovely "miracle devices" are being made.

So,I was convinced after a year of pure hell and not being able to return to work and my life taking a complete 360 to have the VNS installed. I went to the Houston Medical Center and within a matter of 2hrs I was admitted for a night stay in the hospital. Surgery was over and done with and the next a.m. I went home.

Well, what was the % for someone developing a post-op infection or there body trying to reject the device. If I recall it is like 0.4%. I was lucky enough to be one of those people!!! I had to get a picc line put in and 5 weeks of I.V. antibiotics because my body was literally trying to push the device back out. It was rejecting it. YOU SHOULD SEE MY SCAR!! IT IS GORGEOUS!!!

6 weeks later I had my device turned on. The moment it went on I noticed something was not right. I continued having it turned on for 6more months every week. I got it turned up to a pretty high and rapid cycle. I noticed it helped with my gran-mal seizures but the amount of pain it was causing me was making me a living night mare to live with. Sometimes I would tape my magnet over my device just to shut it off.

After about 8 months of this I just had it turned off. Then 3 months later I decided after my many fights with my husband to call Cyberonics and ask them what they thought about why it was hurting so much. My nuerologist didn't care and I refused to go back to my surgeon who come to find out by cyberonics was no longer allowed to put the devices in anymore. They suggested I go and see another doctor. So,I did.

I got to the appointment and he immediatly looks at my throat,my chest,and my armpit area and says "Your device isn't implanted right." Something Just Isn't Right There! I was rescheduled to go back under the knife exactly a week later for a revision or possibly to take it out. He said the surgery will take an 90 minutes. It took 8hrs!! 8hrs to clean up the mess the other surgeon left behind and to clean up the mess from the defective lead wire that was broken out of its protective casing wrapped around my vagus nerve.

I still have my VNS in because I am meeting again with a plastic surgeon to see if any of this scar tissue can be cleaned up from the moronic surgeon who tore me apart. However,there was a defective lead wire that caused damaged too and that bee stinging that you describe. More like a million in my case. I still don't think to highly of this thing and I think I will feel better when other manufactuers start making it and CYBERONICS stops holding the Monopoly on it.

However,look it up on the FDA website about the casing on the wire on their devices. It is not something they are proud to let know they have been cited for and have a problem about.

Good Luck!!

~~Amanda

Re: vns therapy side effects

how long after the placement of your vns did you develop the infection?  i too had this problem.  my placement was in january & my wound was totally healed.  in april i developed a 'hole' in my incision line.  to make a long story short, after 4 surgeries (the last one being where they removed the wires from the vagus nerve), lengthy  hospital stays,too many doctor visits to count &  4 months of continuous iv antibiotics at home.  i had picc lines twice, because the first one developed an infection, then i had a central line put in for the iv antibiotics.    the lead wire actually was coming through my neck.  it is hard to find info regarding other's having this problem.  i changed neurologists & spent 5 days in the hospital to track my seizure activity, only to find none. 

Re: vns therapy side effects

The only problem that I have is when it is set real high,  I get a tooth ache.  So what i did was I went to my Dr.  told him it was too high,  he turned down but kept to where if I or someone swiped my magnet,  I feel the tooth ache.  Also  when it is set high.  It sounded like I had been running, and out of breath, when I talked.

Re: Re: Re: Re: vns therapy side effects

Amanda, I have also been having lots of problems. My doctor and ER doctor have said that it is because of where the VNS is placed at this point. I have been going through pain. I can't seem to catch my breath at times. It is contracting on my left hand said of my neck. My surgeon said it would need to be repositioned but has taken a different stance this last time I talked with him. He says there is nothing he can do. I can't use it right now because of all the trouble it is causing for me. My neurologist office said that were going to call Cyberonics a couple of days ago and I haven't heard anything more. This is turning out to be a nightmare.

I hope that not many people have this problem. I hope you are better.

Denise

Re: Re: Re: Re: Re: vns therapy side effects

These side effects are NOT uncommon and Cyberonics IS aware of them. They do not want the public to know of them. I went thru the same thing in 03 and had mine turned off. It was not a lead impeadance. It was not a generator malfunction.

I was in contact with Cyberonics and they were aware of several other people who have had the same problem. If you read the MAUDE reports from the FDA, you will see several that have been filed.

Even though the unit is off, I still have terrible pain in my neck, jaw. Stinging sharp, often sudden. This is damage to the Vagus nerve and/or facial verve. A lifetime souvenier from a temporary fix.

Please understand, VNS Therapy has been FDA approved for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. There is no guarentee it will work, or how long it will work for.

It is permanent! The generator and leads can be safely removed, but NOT the electrodes that wrap around the Vagus nerve. I know of only one doctor in Texas who even attemps to remove them and that is on pediatrics only.

You CANNOT have an MRI. The FDA and Cyberonics have very specific guidelines for recieving an MRI but many places will refuse to do an MRI is there is a generator still in the body. You should NOT wear any kind of bone stimulator. You should avoid electromagnetic fields and that INCLUDES metal detectors. They can cause malfunctions of the unit. It is not recommended for those with sleep apnea or asthma, because it makes those conditions worse.

If this implanted in a child younger than 12 and the child experiances adverse effects or has become damaged, Cyberonics will claim USER ERROR! Be sure, VERY sure you are willing to put your child at these risks.

At the present time, I have been made aware of several children who have had their pitutary gland damaged from the VNS. This gland controls growth and these kids are living at both ends of the extreme, from zero developement to unbelievable growth. This may be a rare phenomenon, or may just be coming to light.

Children do however, on a whole, respond better to the VNS than adults.

Find out all the information you can and go with your intsincts. Do not allow yourself to be pressured by marketing fluff or sales reps.

Read the Patient and Physician Manuals. They are downloadable and available at http://www.vnstherapy.com/epilepsy/hcp/manuals/default.aspx

I also recommend http://www.vnsmessageboard.com
This board is devoted only to VNS patients with over 500 members.

To the readership, I am late

To the readership,

I am late to responding to this thread as I just happened upon it. While I cannot share experiences and/or knowledge from the standpoint of Epilepsy I am experienced, knowledgeable and continuing in my research as it relates to the VNS Therapy as it is utilized for TRD (Treatment Resistant Depression).

I am not a patient but I am a very long-time support person and health care advocate and activist and I share our experiences with the VNS Therapy in an informed proactive website and message forum I use as a repository for my research, thoughts and opinions and the sharing both of the pro’s and con’s of this treatment option.

The site name is: VNSdepression.com

The link to the site is: http://www.vnsdepression.com

As I read through a number of these personal experiences I find the individuals discussing the amplitude and increasing the amplitude settings and yet no one is discussing the other parameter settings such as the pulse width and/or the frequency.

From our experiences many of the side-effects such as jaw and neck pains etc experienced by my spouse were overcome by adjusting and lowering the pulse width and/or frequency settings, for instance, while attempting to increase amplitude.

As part of my advocacy I encourage education of the patient and/or his/her support persons to make informed and un-coerced medical decisions in collaboration with a compassionate, trusted, knowledgeable and licensed health care practitioner.

While I do read here of individuals lambasting Cyberonics my position is that the relationship is between the patient and his/her physician and any additional assistance from the manufacturer is a plus. I’m curious if any of these participants when encountering side-effects from their medications contacted the pharmaceutical company and lambasted them for their product? As a knowledgeable and informed support person and having seen my wife through numerous treatment options I am well aware of the many side-effects and complications but the fact remains that the nature of her illness is life threatening and our attitude is “Nothing ventured, nothing gained” as we enter into the “Trial and Error Approach to Wellness.”

My wife has experienced many serious side-effects from several AED which are crossover medications being used for TRD (Treatment Resistant Depression) and unlike some we do not alarm and bash any therapies knowing full well while our negative experiences are also to be shared others are obtaining efficacy and benefits from the very same therapies.

I think it is also incumbent to separate in this instance the surgical procedure and potential side-effects from the therapy itself to be able to better understand and to make an intelligent and objective assessment. While there are reporting to the FDA and recordings of experiences in the MAUDE report one also has to carefully assess and understand what they are reading. As one particular individual I am aware of continually cites this document and has made allegations of deaths from the therapy the fact remains that no deaths have been attributed to the VNS Therapy and many of the MAUDE reports go unanswered in terms of being able to gather further and more detailed information.

I also wish to point out that the prosthesis allows for the interrogation of the lead by a lead test which when properly executed by a trained physician should document a break and/or malfunctioning of the lead.

What I feel is necessary are calm, education, careful assessment and collaboration with one’s physician(s) and them making informed decisions.

My wife has been implanted almost 7 years with one replacement surgery for the pulse generator. Both her surgeries have been uneventful experiences with the surgical scars being minimal and of little concern to her aesthetically. She also experiences no sensations as the prosthesis cycles 24/7/365. I've also listed her settings for informational purposes only and not to suggest one follow suit.

Most importantly of all after some 37 years of searching, pain and anguish my wife has been obtaining almost continuous efficacy and benefit from this therapy like no other.

If one has some time try perusing the website and the various articles of information I’ve researched and collected. Maybe there’s some information one might have missed to assist in achieving one’s wellness.

Warmly,
Herb
VNSdepression.com

VNS Settings
Output Current (milliamperes) 2.25
Signal Frequency (Hertz) 20
Pulse Width (microseconds) 130
Signal On Time (seconds) 60
Signal Off Time (minutes) 3
Magnet Current (milliamperes) 0
Magnet On Time (seconds) 7
Magnet Pulse Width (microseconds) 500

.

Re: To the readership, I am late

"Herb" does not have epilepsy, or depression. "Herb" does not have VNS in his body, therfore cannot speak FIRSTHAND of side effects of problems with side effects, surgeons, the company, etc. One thing "Herb" has failed to mention, he and his wife lied and decieved Cyberonics just to get her into the studies.

"Herb" also omitted, he owns stock in Cyberonics. Conflict of interest?

Re: To the readership,I am late

I do agree he should not of been permitted to be involved in the testing unless someone in his family had documentation stating he or she had the VNS in his or her body, period. 

 

 

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