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dennis100
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« on: January 10, 2011, 10:04:27 PM »

A sonogram revealed that the scar tissue from the electrodes has built up to a point where it is compressing my carotid artery. My doctor is weighing her options and i'll see her again in March. If that damn vns can't kill me by stopping my heart 40 times it will try killing me another way by blocking my carotid artery. One way or another that device is bound and determined to kill me.
 
« Last Edit: January 11, 2011, 06:22:21 AM by dennis100 » Logged
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« Reply #1 on: January 11, 2011, 10:55:09 AM »

I'm sorry to hear that, Dennis. I hope you doctor can come up with a solution. How far under the skin are the coils located?  I see two bumps under my skin, but I'm not sure if those are the coils, or anchors that I have seen in some of the diagrams. Maybe you can answer this for me since you've had the sonogram.
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« Reply #2 on: January 12, 2011, 12:20:36 PM »

The electrodes aren't deep enough to prevent dissatisfied customers from yanking them out.

Event Description
Reporter indicated that the vns electrodes had been "pulled out" by the patient and that there was an infection at the site of extraction. The ncp generator and lead were explanted as a result of the events. Attempts to obtain additional information from the physician have been unsuccessful to date. Product analysis was completed on the ncp generator and lead, although the electrode portion of the lead was not returned for analysis. No anomalies were identified with the generator or portion of the lead returned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=902907

Event Description
Reporter indicated that patient picked at neck incision site in the pt's sleep and pulled lead off the nerve, out of the generator, and out through the neck incision. The patient's family members discarded the lead. Revision surgery was performed in 2001 and a new lead was implanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=353517

Event Description  
It was reported a vns therapy patient "had growth on neck, continued to pick at growth, and then pulled lead coils out. Surgery performed to remove entire vns system. " the patient was hospitalized and both generator and leads were explanted. Good faith attempts, to obtain the product for analysis, have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1520021



« Last Edit: January 10, 2018, 12:44:39 PM by dennis100 » Logged
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« Reply #3 on: January 16, 2011, 12:43:16 AM »

OMGWTF?  Are you shitting me?
Is this a warning that should be sent to those who've had that damned thing removed?
Dennis what were your symptoms? Hearing your own heartbeat? Dizzy? Lack of concentration?
As if removing would end the suffering......
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« Reply #4 on: January 16, 2011, 04:23:46 AM »

Hi everyone, long time to talk to!

I just wanted to say that I am still having issues with low blood pressure.

I have had every test done on my heart and head!! lol

I was told to eat more salt and drink more water!!! (and I could take a pill to make me retain water)

My MD, said she called Duke and Chapel Hill, and was told they couldn't/wouldn't help me.

(I have already been to Wake Forest, and they said No, on the coil removal)

Anyway, I still have really bad neck cramps and near fainting spells (low blood pressure)
and brain zaps and more!! (remember I have no generator, just the crap left on my nerve!)

I believe scar tissue and or vagus nerve damage will be the cause of my death!

I WISH I HAD KNOWN! I WISH I HAD BEEN TOLD! angry

Anyway, sorry, I am so angry. It just bothers me so much to read that there are so many people suffering just like I am, and NO ONE CAN HELP US!!

Maybe one day, before it is too late!

MissJennie

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« Reply #5 on: January 16, 2011, 07:27:20 AM »

Welcome back MissJennie!!

Quote
A sonogram revealed that the scar tissue from the electrodes has built up to a point where it is compressing my carotid artery.

Quote
Anyway, I still have really bad neck cramps and near fainting spells (low blood pressure)
and brain zaps and more!! (remember I have no generator, just the crap left on my nerve!)

Quote
but I still have a poking or pinching sensation around the base of the coils.  

Quote
However, since the surgery I've had terrible, continuous headaches (its been 3 1/2 weeks now) particularly on the left side of my head.  There is about 8 cm or so of coil left in my neck but nothing else.  

This is horrible! The vns residual effects are just as bad as when it's there!  Now I know scar tissue is an issue from any surgery but if this is the norm then every patient SHOULD have been told! In graphic detail.



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Electrodes are in me for LIFE!
dennis100
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« Reply #6 on: January 16, 2011, 07:51:37 PM »

I believe scar tissue and or vagus nerve damage will be the cause of my death!

This poor child's vagus nerve was fried.
  
Event Description  

An article about the histological appearance of a chronically stimulated vagus nerve in a pediatric reporter indicated vns therapy moderated a patient's atonic episodes, but the patient experienced "occasional hospitalizations for status epilepticus. " the patient passed away due to asphyxiation (reported on medwatch 1644487-2008-02703). The vns therapy system was explanted with "1. 5 cm of unstimulated nerve superiorly and inferiorly. " the electrodes were dissected from the nerve "revealing grossly normal nerve above and below the stimulator. " "abundant inflammatory cells were present around the stimulated nerve section. " "severe myelin loss and occasional myelin digestion chambers were seen in the nerve fibers. With modified trichrome and luxo fast blue stains, this loss was estimated to be nearly 90%. " good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1241164

« Last Edit: January 16, 2011, 07:56:26 PM by dennis100 » Logged
dennis100
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« Reply #7 on: January 16, 2011, 10:28:43 PM »

Dennis what were your symptoms? Hearing your own heartbeat? Dizzy? Lack of concentration?

I have had dizzy spells for a long time and recently I've started to feel faint while standing and have had to sit down before I fell down. I started Zonegran in October and that drug has whole slew of possible side effects.....confusion, fainting, trouble concentrating, etc. Don't know if the problem is related to the drug or the artery. I'm weaning off of the Zonegran now.
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« Reply #8 on: January 18, 2011, 12:16:18 AM »

 Smiley HI Dennis & MissJennie!

Sheesh, I've been a hit and miss (as usual), but it's great to hear from you both!  I AM SO SORRY you both are still in such a position that your health is still compromised even after the VNS is shut off and/or removed.

Me too--

I feel both your pain and anger.  I have been a sick lady too all because of VNS.  Remember seeing me in March 2010 on KXAN, and the chubby wubbums I was?  I don't look like that anymore, I am about 30 pounds lighter (weighed in at 132 a couple days ago).  My husband says I gasp for air at night when it seems I'm in a deep sleep.  I had him demonstrate because that so freaked me out and I am a smoker, so shhesh, I got concerned.  Well, the sound he made was the same sound I've heard myself make when my VNS was in and activated.  It is a choking sound, not lung related (although I need to put the ciggy's down).  OK, so, my Neuro (who also does VNS and promotes it--no, I am not liking her right now) is very bold and tells me there's not much to do with the damage with the vagus nerve causing mild gastroperesis, NO I most likely will not walk normal again, I will always have to take high blood pressure meds, NO, NO, NO on everything, but YES to VNS and dylantin.  I said NO, and am still not on that med to address the absence seizures that VNS caused.  I can't find a doc who doesn't do VNS.  I want one who doesn't do it because then I know they have no ties to Cybersucks, and that doc may be my lucky doc and want to make me better.  If a doc promotes the use of VNS and doesn't want to treat what problems may arise from VNS, then I don't need that doc on my team.  My conditions as yours is life threatning and it's scarey, and it's not right that docs ignore the hell patients are going thru so they don't russle the feathers of the almighty one with the pen and checkbook at Cybersucks.

Dennis, sounds like your doc is being dilligent over the carotid artery-THANK GOD, and please please let us know what can be done to correct this.  It could be your med Dennis, but, sonograms don't really lie, and if it can see the scar tissue, it's there.

And MissJennie--all my hugs to you too Darlin'.  PLEASE do keep us in the loop so others can know and learn from your experiences.  Although very awful and heartbreaking, I sure do hope all of our experiences are thought about before a person takes a leap into this.

Be well!
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« Reply #9 on: January 18, 2011, 02:41:14 AM »

Dispatch...honey you have sleep apnea.  Gasping in deep sleep is the main feature. You need a sleep study.
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« Reply #10 on: January 18, 2011, 08:11:30 AM »

Dispatch...honey you have sleep apnea.  Gasping in deep sleep is the main feature. You need a sleep study.

EEEWWW NOOOO  Sad That would be the last thing I want to take on right now (OR EVER), especially with the home situation with my husband being very ill.  Birdbomb, I see my family doc in March, I will definately be speaking with her 'bout it, especially since my husband was the one who noticed it and was concerned enough to bring it up.  I wonder if this is why I'm not feeling too swift in the morning and having such restless sleep.  Doing ok in the depression area though which is ace for me, especially during the winter.

HUGS to ya My Friend!
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« Reply #11 on: January 18, 2011, 09:08:54 AM »

All the classic symptoms, honeybunch.  Tongue   Sleep Apnea was a lovely gift bestowed upon me.   Sure wish I could return it.
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« Reply #12 on: January 18, 2011, 09:56:39 AM »

 rolleyes I need to put the ciggy's down...would that help keep me off a CPAP if that's the issue?

How come I haven't picked up on the choking feeling?  Well duh, maybe that's the restless sleep stuff 'eh?

I just want to be at a point that more stuff doesn't keep being added to my health history due to using VNS.

I want to give all my gifts back to Cyberonics too!!!  I don't think these gifts are worthy of re-gifting LOL!

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"I reckon it's again my turn to win some or learn some..." Jason Mraz

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« Reply #13 on: January 18, 2011, 05:59:40 PM »

I have Severe Obstructive Sleep Apnea I rarely ever wake with the events, but others tell me about them.  Just like your hubby is doing. The vns affects the focal folds, throat muscles, facial nerves and muscles, you know it also causes swallowing problems (more little presents).  All these things come into play.  I know someday vns will kill me.  I will die in my sleep because if the damage that thing did to me that I was NEVER made aware of.

Quote
As air flow stops during a sleep apnea episode, the oxygen level in your blood drops. Your brain responds by briefly disturbing your sleep enough to kickstart breathing—which often resumes with a gasp or a choking sound. If you have obstructive sleep apnea, you probably won’t remember these awakenings. Most of the time, you’ll stir just enough to tighten your throat muscles and open your windpipe. In central sleep apnea, you may be conscious of your awakenings.

Quote
Major signs and symptoms of sleep apnea

    * Loud and chronic snoring
    * Choking, snorting, or gasping during sleep
    * Long pauses in breathing

    * Daytime sleepiness, no matter how much time you spend in bed


Other common signs and symptoms of sleep apnea include:

    * Waking up with a dry mouth or sore throat
    * Morning headaches
    * Restless or fitful sleep
    * Insomnia or nighttime awakenings

    * Going to the bathroom frequently during the night
    * Waking up feeling out of breath
    * Forgetfulness and difficulty concentrating
    * Moodiness, irritability, or depression

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« Reply #14 on: January 18, 2011, 11:33:23 PM »

 Shocked Birdbomb!

I knew you had the sleep apnea from VNS, but heck, I never knew how involved that is until just recent.  I have a few things going on that were listed in your last post, and I'm sure grateful I have a doc appt. in March.  Fortunately for me, my family doc knows about VNS (has a few patients it has worked for to a degree and then there's the patients like me who were torn up by it), but she knows it can hurt someone, and she doesn't really blow me off when it comes to this VNS stuff.  Last I saw her, I gave her a big smile because I'm doing so well with depression, and she was floored that even though all this yuckie has came about, I still smiled and told her it'll be ok...

Dennis, my family doc spoke with me about scar tissue build up in my neck when I first moved here and she took me on.  She was doing the usual feel around the neck, and upon pulpatation, it was tender in the carotid area on the left.  She mentioned she was glad all of mine was out because who ever knows how much scar tissue their body is going to produce to protect the area it thinks is injured (or actually is injured).  She mentioned also if cardiac issues were to present, most docs wouldn't look past my heart/arteries at first, but now that they know I had VNS, she said they would immediately look to the vagus nerve to make sure the damage didn't cause the cardiac issues.  Oh, and she read your Reader's Digest article WHOOT!!!
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« Reply #15 on: January 21, 2011, 03:51:32 AM »

Thanks for being there, everyone! It means so much, just knowing that there are others that believe me when I tell them the VNS is killing me!!! I just wish my doctors would listen and do something. I believe the only time anything will ever be done for me is when I show up in the ER, unable to breath, or my blood pressure is so low, they will have to do surgery to remove the crap on my nerve!!!
I have told my son, what to say to the Doctors in the ER if this happens>"YOU NEED TO REMOVE THAT SHIT OF HER VAGUS NERVE!!!"  :'(
----------------------------------------------

Dennis, please keep us posted!! You are in my prayers!
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« Reply #16 on: January 23, 2011, 09:22:37 AM »

MissJennie it's all we've ever done was VALIDATE the reality of the side effects. Doctors on the payroll or handouts of big pharma, or medical device companies are no different than crack addicts.  Normal people know crack is harmful and kills but the crack addict is in denial UNTIL he's been clean and sober for a while.  There doctors don't want to believe the suffering we go through because the benefits are sweet.

I took my daughter to see her cardiologist last week and asked his recommendations for a decent surgeon.  This guy is a wonderful doctor and has the best treatment of patients I have ever seen so if he says so-and-so stinks, then it's the gospel.  I told him I needed to find one with-out ties to Cyberonics and he was in 100% agreement with that but could only give me 2 names and both were iffy.  In a city of over 3,000,000 can't find a decent doctor NOT affiliated or ties with big pharma, or medical device.

That is just disgusting and down right sad.
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« Reply #17 on: January 23, 2011, 09:40:46 AM »

Birdbomb, you would think will all the reports sent to the FDA, some one would take a second look at Cybersucks by now. I guess not enough people have died yet  :'(,for them to do something!

I would have thought that Duke, or Chapel Hill (NC) would have been good changes for me to find a doctor to remove my "crap", but no such luck. (<according to my MD)

Oh well, such is life.

Good luck on your search for a "Honest" Doctor.

Jennie


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dennis100
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« Reply #18 on: July 29, 2011, 10:17:56 AM »

I hurt my neck during a seizure. Two years later the pain was still there so I asked for a x-ray. My epitologist read the x-ray report and realized the radiologist had made a mistake. The x-ray report showed the electrodes attached to my carotid artery. We both thought it was amusing. She then ordered the sonogram just to amend the radiologist's report.

When the results of the sonogram came back my doctor realized how the radiologist could have made that mistake. The scar tissue from the electrodes had encased the artery.

If i hadn't asked for that x-ray I would have no idea that my carotid artery is being constricted.

My epitologist has ordered sonograms of the carotid artery every six months to keep an eye on any further growth. So far so good.
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« Reply #19 on: September 18, 2011, 10:49:30 PM »

Hey, Dennis and everyone else! Grin
I wanted to say thank you Dennis, I found my MAUDE reports, thanks to you:
I also wanted to ask how you are doing, and I wanted to ask you about the Zonegran (Zonisamide) you were taking. What side effects were you having? I am still taking it. I am on a very low dose. 50 mg in the
morning and 50 mg at bedtime. It seems to "calm my mind", but my migraines are back. If I try to increase the dose I feel like I am going to jump out of my skin! It helps with the manic side of bi-polar, but not the depression side of bi-polar. I am still having low blood pressure problems, but dealing with it. Still having neck cramps, but dealing with it. I have no other choice.

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    Re: Shocking sensations
« Reply #6 on: May 20, 2011, 03:01:28 AM »    Quote

________________________________________
Event Date 07/23/2008
Event Type Injury Patient Outcome Disability;
Event Description
Vagus nerve stimulator implanted: 2006, turned on: the following month, explanted the following month: coil/electrodes not removed. Er visit: infection at incision site on my neck: a month after the original month. I told the nurse practitioner that something felt wrong with the lead in my neck. It felt like something had moved, it just didn't fell right. The first time i told her was in five months later, i believe. Er visit: nerve stimulator malfunction: the following month, no one there knew what to do, taped my magnet on and went home. Had x-ray, that was sent to cyberonics i had it turned off for at least a month. I was so afraid of turning it back on. Once i had it turned back on, i started having migraines almost everyday. I put up with it for several more months, then i asked for it to be turned off, and i asked about getting it removed. I believe it was turned off in 2007. After it was turned off, i started getting severe cramps in my neck. I had an appointment with dr at medical center in 2008 to discuss removal of my vagus nerve stimulator. He said the surgery was too dangerous, there could be scar tissue entangled around the carotid artery and or jugular vein. Surgery could result in a stroke or even death. He also said surgeons do not like to remove items implanted by other surgeons, because he doesn't know how it was put in. He suggested i do some stretching exercises. He said a muscle relaxer might help, but would not be good for my bi-polar. He said if it were him, he would leave it in until i couldn't bear the pain any longer. He also said, he thought there may be something else going on, the leads may not be causing the spasms. I told him that if i were not able to stretch my neck and get the cramping to stop, i would have to go to the er. I am afraid of that happening more, so now after what he has said about the surgery. I had to go to the er after an adjustment caused severe electrical shocks. The doctor in the er didn't have a clue what to do, and had never heard of the vns. They told me to go to the doctor that implanted it. That doctor is in missouri! the cramps/spasms are becoming more frequent. What happens if i do have to go to the er, are they going to have a doctor-neurosurgeon- there to do emergency surgery! my asthma is worse. I have to use inhaler every night. As soon as i lay down, i start to wheeze and cough. I wake up coughing and have to use the inhaler again. I don't need the inhaler during the day? - my abdomen has sharp pains when i turn over during the night. -the abdomen pain comes and goes - happened during the day only a couple of times - i am having terrible sneezing attacks that last 12-15 hours per day. But, if i sit completely still, i will not sneeze. These attacks are about every other week, or more. They completely wear me out! i have not felt well for a couple of months, fatigue, nausea and lots of bouts of diarrhea. I have pain - comes and goes - in both my breasts, like electrical shocks from the top all the way to my nipples. They are sore to touch, comes and goes. May be: the vagus nerve stimulator has aggravated my vagus nerve - and who knows what else - and is causing some of the problems i listed above. I called the surgeon in missouri - i live in nc now - and the nurse told me the doctor said the leads should not be removed. She said the doctor said surgery would cause more scar tissue. I was never told that the complete device couldn't be removed. Had to remove device approx four months later. Dates of use: 2006 -- 2007. Diagnosis or reason for use: depression.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1100549


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    Re: Shocking sensations
« Reply #1 on: May 19, 2011, 02:31:52 AM »    Quote

________________________________________
Event Date 11/01/2006
Event Type No Answer Provided Patient Outcome Other;
Event Description
Reporter indicated that she was experiencing "shocks" and an increase in migraines. Patient's device was turned off, however, the patient "neck still cramp up when she yawns. " it was reported that the patient had to tilt her head back in order to get the cramp out. In addition, the patient has previously experienced tingling sensations in the neck with device stimulation, voice alteration with stimulation, and protrusion of the lead body at the neck site. Patient indicated that she is considering removing the vns system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1010154
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« Reply #20 on: September 19, 2011, 12:51:33 PM »

Hi MissJennie. Good to hear from you. I can't really remember why my doctor took me off Zonegram. If I had to guess it was due to irritability because she added Xanax to the drug regimen. Vimpat, Lyrica, Sertraline, Clonazepam & Xanax, and i'm still having about 100 partials a year (that i'm aware of). Well so much for my sob story. I hope you are doing well. Don't be a stranger to the board  MissJeanne.
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