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Old 12-11-2009, 06:42 PM
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Default Patient must have Medtronic CD Horizon spinal system Removed

from: Lawsuits & Legal News, Settlements, Verdicts, Legal Issues, Labor Laws, Class Action Lawsuits


Patient must have Medtronic CD Horizon spinal system Removed
October 1, 2009. By Jane Mundy

Denver, CO:Richard had a CD Horizon spinal system Medtronic device implanted two years ago, just around the time the FDA recalled all lots of the MedTronic CD Horizon Spinal System Agile Dynamic Stabilization Device. "I am furious," says Richard, "because I need to go through another surgery to take it out and a fourth surgery to repair the damage caused by this defective stablization device," he says.
"Apparently this [CD Horizon spinal system] device spilled over into my nerve column and has now caused even more nerve damage than I had two years ago," says 33-year-old Richard. "I had a fusion in my lower back—L5 S1—and I had the disc shaved in two separate surgeries. After the second surgery I had the fusion and that's when this cable was attached. But it just doesn't work.

I am having so many complications and I still have extreme lower back pain as well as continuous nerve damage that goes down my leg. My doctor told me that the next surgery—that'll be the third-- they have to take out this hardware and they have to go back in and shave the bone protein that has grown like a cyst in my spinal column to relieve pressure in my lower back.

I am furious that I need yet another surgery to have this Medtronic device taken out. My doctor hasn't said outright that it isn't working but why am I already scheduled for a fifth surgery because of more nerve damage? It is obvious this device has caused problems, otherwise they wouldn't be removing it. My doctor did say they won’t know for about one year how much damage it has caused. If it has caused enough, I need another surgery to cauterize the nerve.

I am in so much pain I have to take 80mg of Percocet a day and I could probably use more but I am not a pill popper. And it has affected my work. I am an electrician so you can imagine how hard it is to do my job. When I first had surgery for this problem it was supposed to be a wham bam, in and out. Instead I've had 5 years of hell.

No one has come right out and told me this CD Horizon Spinal System is defective; I found out because my wife works in the medical field and a pharmaceutical rep brought it to her attention. We looked into the Medtronic spinal cable further and found out my doctor took part in promoting this device--the pharmaceutical company paid my doctor to use their product!

Not only am I worried about my back, I'm worried about my liver because of all the pills I am taking and all the anesthetics. I might come out looking like Michael Jackson..."
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Old 03-13-2010, 12:56 PM
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Default cd horizon agile

I also have the Agile in my back. I had my first surgery in feb.2007. It was a stabilization at l3,4 and 4,5 with the agile. after a few months a screw came loose and I had to have a fusion at 4,5 and they left the agile in at 3,4in july 2007. I had a brief period in the summer of 2008 when I thought I was going to be alright but the pain came back and has gotten progressivly worse. it's much worse than before the surgeries. i'm basically disabled. now they're telling me i need a fusion at 3,4. i'm so turned off to any more surgeries. i think my doctor may also have been paid to push the agile. i'm on the strongest pain meds available and they barely touch the pain. it has been a disaster.
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Old 05-08-2010, 11:42 AM
ans ans is offline
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Alan, I'm so sorry to hear this. You deserve compensation at mininum.

Have your doctors considered an intrathecal pain pump where they can give pain killers that probably would help you? I don't know the efficacy of a spinal stimulator but maybe others know.

Also, and this is sick but avoid this pump system:

http://www.pharmacypracticenews.com/...ticle_id=15107

Please give an update. There are doctors whom I would trust in a horrible situation like this. Actually one: Dr. Carl Lauryssen in LA.

My best, ans
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Old 05-08-2010, 11:43 AM
ans ans is offline
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And Dr. John Regan does heroic surgeries.
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Old 07-08-2010, 12:27 AM
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Default This

makes me sick! My friend had scoliosis and had a rod put in and got a call it was defective. Rod broke in her back and she had to have it replaced front and back, nine hours. I believe she had it fixed in NY at Beth Israel. It was put in in Boston. Anyone filing a class action suit?
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Chemically sensitive disc/Annular tears, DDD, mild bulging, facet arthritus

Dancing accident in 96. tried PT, acupuncture, pilates, pain mgmt. nothing worked. Epidurals, facet blocks, caudal blocks, discogram. Opiates for ten years, oral prednisone, toradol inj. & more.

Two level spinal fusion with BMS, cages, hardware. due to bone density problems from chemotherapy, they had to go in front and back. Surgery Nov. 6, 2010. So far no regrets.
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Old 07-22-2010, 09:22 PM
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Quote:
Originally Posted by ans View Post
Alan, I'm so sorry to hear this. You deserve compensation at mininum.

Have your doctors considered an intrathecal pain pump where they can give pain killers that probably would help you? I don't know the efficacy of a spinal stimulator but maybe others know.

Also, and this is sick but avoid this pump system:

www.pharmacypracticenews.comindex.asp

Please give an update. There are doctors whom I would trust in a horrible situation like this. Actually one: Dr. Carl Lauryssen in LA.

My best, ans
I've seen Dr. Lauryssen for a second opinion and he agreed that I need a fusion at l3,4. Right now I'm looking into a much less invasive surgery called the XLIF. It's starting to look like I don't have a choice. I did put a lot of thought into the pain pump, but I've heard horror stories about that also.
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Old 07-22-2010, 09:34 PM
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As far as a class action, I believe there is some talk about that. However, the recall of the agile was related to the cables fraying or breaking. Since my Agile isn't technically broken, I 'm not sure if I would qualify to be part of the class. My problem is that the Agile isn't strong enough to hold the spinal segments in alignment. My feeling is that because there was too much pressure on the system instead of the cables breaking or fraying, the screws are coming loose. I had one screw come loose after my first surgery and now another screw has come loose. It all comes down to Medtronic claiming improper installation as opposed to a bad device, even though the device had an emergency recall and was immediately taken out of commerce. If anyone has any thoughts about how I could pursue compensation I would greatly appreciate it. This has been a disaster for me and my family.
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cd horizon spinal system, disc, fda recall, medtronic, removal, spinal

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