VNS Therapy?

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Hi Dennis! How are you? I almost feel like I'm at a class reunion or something. This is how this all came about. I was getting very fustrated because it seemed to me that although these sites are real good for people to find out information and compare notes, it just seemed that the people who should be reading our complaints and concerns weren't. I pulled up the minutes to the June 15, 2004 Neurological Devices Advisory Panel and decided to contact the people who attended the meeting to try to understand just what they were thinking by approving this device and to tell them on a one-to-one basis exactly what this device was doing to so many people. I recieved an answer so far from Michael Schlosser and then I called up Doug Woods' number and this woman Jerretta answered and I explained why I was calling and told her that the vns device almost killed my sister and a lot of other things. She gave me Doug Woods' phone number, so I called it up but it was just an answering machine. I left a message also explaining why I was calling, and 2 days later I get a phone call from Doug Wood. We spoke for quite some time, and that's when he asked me to put the word out that anyone who has filled out a Maude Report, he wants the number to the report sent directly to him and gave me his e-mail address, but when I tried to post it on this site, it said I couldn't. I'm not exactly sure why. Anyway, when I was getting ready to hang up, I thanked him for getting back to me because to be honest I didn't think he would. That's when he said that if he didn't, he'd never hear the end of it because the woman I spoke to, Jarretta, just happened to be his wife and she wouldn't let it go. He told me he heard about all that night and it was the first thing she brought up in the morning. She apparently kept telling him, "You're going to call that woman about the vns device, right?" If you know a way I can send this site a copy of the message on my computer from him, let me know. I have no idea how to do that.
 
I would just like to set the record straight in case anyone became confused by the reply to my post on pg. 2. The section of the manual shown in the reply deals with possible complications during implant surgery. The problems with my device occurred 6 years after surgery. I would like to also add that I have no history of cardiac problems and the lead test preformed during surgery showed no issues.


During the intraoperative Lead Test, infrequent incidents of bradycardia and/or asystole have occurred. If asystole, severe bradycardia (heart rate < 40 bpm), or a clinically significant change in heart rate is encountered during a Lead Test or during initiation of stimulation, physicians should be prepared to follow guidelines consistent with Advanced Cardiac Life Support (ACLS). Additionally, postoperative bradycardia can occur among patients with certain underlying cardiac arrhythmias. If a patient has experienced asystole, severe bradycardia (heart rate < 40 bpm) or a clinically significant change in heart rate during a Lead Test at the time of initial device implantation, the patient should be placed on a cardiac monitor during initiation of stimulation. The safety of this therapy has not been systematically established for patients experiencing bradycardia or asystole during VNS Therapy System implantation.
 
Hi Dennis! How are you feeling now? You know, in all of the Maude reports that I have read it said that the cardiac problems occurred AFTER the implant also. My heart breaks every time I hear about someone elses' problems with this thing. I know how painful it was for my family. We all still have our battle scars. We all still have our nightmares. I don't think any of us will ever really get over it. Some things you just can't forget. Write me any time you want. I will always be here for you if you need a shoulder! NancyB
 
Some VNS patients want their device out so bad they don't wait on the surgeon. Below are a couple of examples from the FDA maude database. You will find similar reports on the VNS Message Board.

Model Number 101
Event Date 01/11/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Rptr indicated that pt had explanted self. It was reported that the pt went into the restroom and when the pt came out, the generator was out of the pt's chest. The pt opened the healed incision. The pt had apparently pried the generator out with the pt's hands. The pt picked at it until the pt got it out. The pt's lead was explanted by surgeon and the pt was prescribed a prophylactic ten-day dose of amoxicillin. There are no plans for re-implant. Further f/u revealed that the pt was seen in 2002 at which time the pt's staples were removed and the pt was reported to be healing fine from the explant procedure. No further appointments are scheduled.

Report Number 1644487-2002-00055



Model Number 100
Event Date 08/27/1999
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Although the pt was receiving a reduction in seizures, she requested the device be removed. She stated that the stimulation "bothered her. " her physician scheduled an appointment to make some adjustments to her device. Subsequently, the pt took some sterile equipment from an area hosp and removed the device at home. The pt was instructed by her neurologist to go to the emergency room. The pt's wound was treated in the emergency room; a drain was put in place, and the wound was stitched.

Report Number 1644487-1999-00010
 
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Some VNS patients want their device out so bad they don't wait on the surgeon. Below are a couple of examples from the FDA maude database. You will find similar reports on the VNS Message Board.


Report Number 1644487-2002-00055



Model Number 100
Event Date 08/27/1999
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Although the pt was receiving a reduction in seizures, she requested the device be removed. She stated that the stimulation "bothered her. " her physician scheduled an appointment to make some adjustments to her device. Subsequently, the pt took some sterile equipment from an area hosp and removed the device at home. The pt was instructed by her neurologist to go to the emergency room. The pt's wound was treated in the emergency room; a drain was put in place, and the wound was stitched.

Report Number 1644487-1999-00010

How did the stimulation "bother her"? The stimulation initially bothered me too, but I'm not that stupid to take the device out on my own, only to have to go back to the ER to have the wound treated! Of course it was life threatening if she had tried to take the device out on her own at home, with the leads, etc. Anyone with common sense should know that. It's a wonder she didn't end up in the ER with Status instead.
 
As you will see in the report below the VNS can have a placebo effect on some patients. There is a good chance that the patient mentioned does not have E. Could be suffering from psychogenic seizures. My personal opinion is that this device should never be used in anyone until a definitive diagnosis of E has been made i.e., video-eeg., and all other treatment options have been exhausted.


Model Number 302-20
Event Date 04/28/2003
Event Type Malfunction
Event Description
Rptr indicated pt's lead was implanted in an inverted configuration. The pt was having good response to the vns therapy until such time that their family member was made aware of the inverted lead position. Since becoming aware of the inverted lead position, the pt's family member claims that the pt is not getting seizure control with the vns therapy. The implanting surgeon was inadequately trained and the vns labeling is inadequate.

Report Number 1644487-2004-00123
 
Hello everyone,

I had a VNS implant in June of 2007 because I was on 4 medications after trying about 10 and being switched around, none of them working. I had petit mal seizures just about every day but had never experienced a grand mal seizure. However, after I got down to 3 medications I began having a grand mal seizure every once in a while in addition to petit mal seizures still. I am still on 3 medications and my doctor continues to increase the dosage of those in addition to increasing the time the VNS goes off and voltage or whatever of it. I used to be a singer and my major at college was music education but I had to change my major to marketing due to the fact that I can no longer sing (my VNS comes on every 1.8 minutes for 30 seconds) and I cannot hold my breath as long as I used to be able to as a singer should. I also wheeze when I try to exercise so I can't do much cardio. Sometimes I just get auras but then I don't actually have a seizure and maybe that is due to the fact that the VNS prevents me from having the seizure but I am not sure. I hope this is helpful
 
Dear Mglynn2, My sister also was a singer, not a professional one, but a singer none the less. When she got the VNS device she could barely talk, much less sing. She sounded like she smoked 5 cartons of cigarettes a day, and she's never smoked before in her life. Now that she has had that device removed, she is starting to sound almost like her old self. She is also on different seizure medication and hasn't had a seizure since they took the device from hell out. I only wish there was a pill to remove the scars that device has left on her heart.
 
I know how your sister feels, I too sound like a cigarette smoker when my device goes off and I am in college and have to give a lot of presentations so it is embarassing whenever it happens and people do not know why my voice has suddenly changed. The whole singing thing has bothered me a lot more than I have let on to others in my life. I recorded a CD with my father in the past because he sings too and it would be difficult to do again( but I would love to) unless I turned it off. I think he only really knows how I feel. Singing has always been my passion and when it gets taken away it really hurts. I feel very sad for your sister. I hope she continues to be seizure free.
 
Thankyou so much. My sister continues to get better every single day, although right now she is having horrible financial struggles because of all this and might lose her house. It is very difficult for her, but we truly believe that God will see us through. I believe in miracles. I am very sorry about your voice. I know hers still sounds a little raspy, but every day it gets better. Are you yourself satisfied with the vns? Do you truly believe that it is helping your seizures enough that you are willing to sacrifice your singing to keep it?
 
I am glad to hear your sister is getting better. I believe the vns is helping me and I would be afraid to take the risk of just being on meds again since I have had this for almost 3 years and my meds though my seizures still are not controlled. It has hurt me more than I can say not to be able to sing like I used to but I dont know if I want to take unnecessary risks.
 
I am very glad that the vns is helping you. You and I both know that seizures are a very scarey thing. Always in the back of your mind, no matter what treatment you are using, lurks the fear of having one and not being able to control it. Before I was officially diagnosed as having a "seizure disorder", I had a pretty major one in a store, that to this day, I haven't been able to go back in. I have this wild vision of me being all twisted and contorted on the floor while a crowd gathers to see the spectacle. I know that's not what happened, but I still feel embaressed by it. I think I just have a vision of how seizures were portrayed in the movies way back when, and I can't get that out of my head. Sometimes when someone hears for the first time that I have a seizure disorder, I feel like they are watching me and just waiting for me to explode or something, do you ever feel that way? Only another person with seizures would really understand that.
 
I know exactly how you feel, I have close friends who have known me for years and know about my seizures so they know what to look for and don't really treat me like i'm going to break or something. However, people I just meet that I have to tell about it go on like high alert for awhile and freak out and watch me and Im just like..stop looking at me lol. I actually had a scary dream last night that I was with one of my roommates and I just collapsed and she put me in my bed and then I had a grand mal seizure and fell out of my bed and severely hurt myself which is a fear of mine. So it is always in the back of my mind.
 
Maybe, if nothing else, there is at least a little comfort knowing that we are not alone, that there is actually someone else out there who is experiencing almost exactly what we are and understands it better then anyone. It is always on my mind, too. Every time I shower or walk down steps, I think about it. Maybe oneday it will become routine for us, we won't even think about it anymore..... Somehow I doubt that....
 
I am very glad that the vns is helping you. You and I both know that seizures are a very scarey thing. Always in the back of your mind, no matter what treatment you are using, lurks the fear of having one and not being able to control it. Before I was officially diagnosed as having a "seizure disorder", I had a pretty major one in a store, that to this day, I haven't been able to go back in. I have this wild vision of me being all twisted and contorted on the floor while a crowd gathers to see the spectacle. I know that's not what happened, but I still feel embaressed by it. I think I just have a vision of how seizures were portrayed in the movies way back when, and I can't get that out of my head. Sometimes when someone hears for the first time that I have a seizure disorder, I feel like they are watching me and just waiting for me to explode or something, do you ever feel that way? Only another person with seizures would really understand that.

I've had some major T/C seizures in public places, too, but I have been able to go back and show my face in those places. Sure the seizures themselves are embarrassing, but I am not going to let this disorder, epilepsy, control me. The reason people watch may be out of curiosity, but mainly because they have no clue what to do and it may scare them, therefore it is our job to educate the public about seizures, what to do and not to do.
They embarrass us if we let them.

I have often been asked about the burn scars on my arm and I do tell people that I did have my 1st TC seizure on my way out of the shower. When I fell, I somehow bumped the hot water and was lying there, seizing long enough to suffer 1st and 2nd degree burns on my arm and back. I had to have skin grafts and several reconstructive surgeries, so why would I be embarrassed by a seizure when I am still alive? Oh yea, the VNS saves me too, since brain surgery made the seizures worse and NO medicine controlled the seizures for me!
 
I am so sorry about your burns. Here I am complaining about looking foolish, and you suffered such a horrible ordeal. Thankyou for the reality check. I understand about people asking you about your scars. I don't have anything even close to what you have suffered, but one of the conditions I also have is venus status disease which causes my legs to swell considerably. To make a long story short, my left leg swelled so bad that it split open and I had to go to the wound clinic for a year to close the hole up. It left a pretty large and not so pleasant looking scar on my leg, and I can't count the times that I've heard, "OH MY G--! What the heck happened to your leg? Did you get shot or something?" I have to wear those special hose, so all summer long I just wear long pants because I got tired of hearing it. Did you just hear about that massive attack we just launched over in Afganastan? This is getting scarey. Apparently it was launched on a major city which is mainly occupied by the Taliban, and it's some pretty serious stuff.
 
I can't count the times that I've heard, "OH MY G--! What the heck happened to your leg? Did you get shot or something?"

I think you should just tell them "Yeah, but you should have seen the other guy".
 
ha, epileric, that is a good answer! Nancy B and Cint I am sorry to hear about both of your troubles. The worst I have are the scars from my vns that people ask about all the time. btw my doctor is consulting with another doctor about putting me on another med (which means I'll now be on 4 if he does) so if he does I'll post the name of it up here and ask if you guys know anything about it.
 
VNS and all those meds

You see, this is what I don't understand. You have a vns device implanted, and you still take, what, now, four medicines? Exactly what is it that you think that device is doing? How do you know that it's the device that's actually causing you to have to take so many meds? Worsening seizures is a documented side effect, you know? That device might actually be working against your medicine. If you are taking more medicine now then you did before you had the implant, doesn't that tell you something?
 
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