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St.Jude spinal cord stimulator failure after 2 months
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mvpmj23 posted:
Hey all I had my St.Jude stimulator implanted on June 28th. All went well then I started having surges that would blast me, even tossed a cup of coffee. So I went in for reprograms, and I was told it was interesting, they re imagied me and said everything looks right. So reprogram and sent me on my way. Then I tried for a week but the thing kept surging. So I called and Dr. had me come in. He then told me I had 4 leads fractured somewhere inside and need to have a complete re implant. UGGG. Dr told me he had seen this in like year 4 or 5, but never at 2months. I do exactly what i'm told and nothing more. So really need to know if anyone has also had same issue, or could it be the implant it's self having a recall issue or something. Oh also I have a 3 lead implant for cervical and the large generator if that makes a differance. Thanks and Blessings to you all.
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annette030 responded:
Electrically, I cannot see how having broken (fractured) leads could cause the problem you are having, but I am no expert of course.

This is one of the problems that you sign on for when you get to the point of having surgically implanted devices. Things can go wrong, and you may have to have more surgery.

I think there is a way online to check for recalled devices, try your search engine or call the company that made your device, and ask to speak to someone who deals with adverse events. I think they are like drug companies and have to keep track of people who call or write to them.

Take care, Annette
 
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cstout1221 responded:
hi i just joined. I also had a spinal cord stimulator placed and had the same surged you did about a month after first implant knocked me back about 3 feet.Was told couldnt happen but when done xray stimulator had came out. the doctor did revision,This time made it about a year , stopped working had another revision 3 total, then no longer worked at all. so now wont respond to computer. then by this time pain is horrible, went to another dr. to remove since the dr. i had just wants to keep revising. found out it took 4 surgeries to remove all the pieces in my back and sides. the stimulator just came apart, with worse pain then when i started. Thanks I pray no one else has to go through this,
 
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cstout1221 replied to annette030's response:
when i signed on for my stimulator, Its really funny the dvd i have didnt show any of these problems. and yes it can happen with broken lead.
 
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cweinbl responded:

The long term success rate for the spinal cord stimulator (SCS) is 40-60% (here is the latest research: http://www.painphysicianjournal.com/2009/july/2009;12;699-802.pdf ). So you can't be too surprised when it fails. What? Your doctor (who earns many thousands of dollars from implanting and then again for removing the device) didn't tell you about the odds? What a surprise! Of course, surgery is required to implant the mechanism and to remove a defective device. All surgery entails morbidity. This should be something that everyone has agreed with before undergoing the surgery.

The primary reason why SCS fails is leads that are improperly placed (they are not near the correct nerve root) or leads that are correctly placed, but later move away from that sweet spot. One a lead has moved away by even a millimeter, the device can be rendered inoperative.

Physicians will try to convince you that his or her service is perfect. When I had four spine surgeries, I was told each time that there was a 90% chance of success. After all of those surgeries failed, I had the chance to examine the research. It turns out that the success rate from spine surgery, even today, is much closer to 60%. The same applies to the SCS and the intrathecal infusion pump (IT Pump).

This is not in any way similar to the success rate for something like the cardiac pacemaker (95% ) or even the implanted defibrillator (80 %). It simply adds to the wealth of data that suggests that spinal interventions are a virtual crap shoot for most patients. If you've had prior failed spine surgery, the success rate is more like 40%. I don't know about you, but I'd rather consume mind-numbing pain medication every day than take my chances on the SCS or IT Pump at a success rate of 40-60%. Do not trust your fate to physicians who benefit greatly for each implanted device. Instead, trust your future to your own research. Anyone with access to the Internet can read the latest, greatest research. Make your own decision based upon facts, not what your physician (who has a financial vested interest in the procedure) tells you.

cweinbl
csw2@bex.net
 
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khs0805 responded:
Sorry to hear about the problems. I had a St. Jude scs implanted in Feb. 2006 (the company was called ANS then) for RSD in my right arm/shoulder. During my trial, I had a lot of problems with positionality of the lead, so it was decided that I should have a paddle lead instead of a percutaneous one. The surgery was done by both my pain doctor and a neurosurgeon due to the paddle lead, which is positioned at C1-C2, so pretty high up in my neck. I recovered from surgery fairly quickly with no complications. In the following months, I was able to stop 3 of 5 meds completely and decrease the dosage on the remaining 2. I was never without pain, but the significant decrease in pain allowed me to resume many activities I had been unable to do for the 11 years I had suffered with the condition before the surgery.

Fast forward to Dec, 16, 2010. I suffered a very bad fall on the ice and received a number of injuries, including fracturing the T-9 vertebrae in my back, fracturing the lead for my scs, tearing ligaments in my left shoulder, a concussion, whiplash, sprained wrist, elbow, and shoulder,and 2 broken fingers. I quickly developed the RSD symptoms in my left arm following this. In Sept 2011, I finally got a new stimulator put in, also a St. Jude model, this time using the newer penta lead which was placed by a neurosurgeon. Unfortunately, I developed MRSA and had to have the entire unit explanted. In Jan 2012, we put in yet another new unit. I had trouble getting the incision over the IPG (battery) to heal up again this time, but after being sent to a Wound Center for several months finally had a healed incision and avoided another explant. I did develop MRSA several more times and am still taking the antibiotic. However, everything else is going well and I am once again experiencing pain relief.

Just this past Monday, however, I received a notice from St. Jude regarding an issue with the battery and/or the charging unit. I have lots of questions right now, but I see the neurosurgeon on this coming Monday and the St. Jude rep will also be there, so I hope all of my questions will be answered by the time I leave there.

Despite being unsure of what will happen with b/c of this product recall, I do not regret having had any of my stimulators implanted. The improved quality of life has definitely been worth it all. Yes, there was a serious complication with the Sept surgery, but that had nothing to do with the device itself. MRSA is a risk of any surgery, yet is still very rare. It was just one of those things.

I will also say that the doctors involved in these procedures (the 2006 surgery was in Texas and the 2 recent ones were in NC) have all been very open with me about potential risks vs benefits (plus I ask a boatload of questions any time I see a doctor!). I feel like it is impt as a patient to do all the research you can do (which is pretty easy in today's age of Google!) and then ask lots of questions of your doctors, regardless of what procedure you are thinking about having done. I do feel fortunate that I have had doctors who have been very honest with me about my chances and are also open to answering all my questions. I wish everyone was as fortunate as I have been with my experience.
 
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mvpmj23 replied to khs0805's response:
Well It's me the original poster, I had the replant, and it went well for nearly a year. But I sat up in bed and had incredible arm surges, it went on for about 5 minuets, then stopped. I then realized, the unit stopped working. I called St.Jude, and went in then next day for a evauation, once again the leads are fractured. The Dr. now has reffered me to get a nerosurgeon to implant a bar type in mr cervical, in the next couple weeks. I hope this works, not wanting the meds again. Has anyone had better results with the bar system. Thanks and Blessings
 
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chronic1008 replied to mvpmj23's response:
I had a Boston Scientific stim placed jan 2010. I didnt get surges but dips. Every time I took a step, moved a little differently the stim would shut off. It would immediately turn back on. I stopped using it for a while. I was told by everybody this never happened before. When the engineer hooked my remote up to his laptop it clearly showed as soon as I barely touched the under skin battery pack, the stim stopped. Remove my finger and it went back to previous setting. Never surged above setting. I had the battery pack replaced surgically on Dec 26, 2011. All is well now. I returned to work May 29, 2012 after almost 7 years off having 6 back surgeries. Now I have to turn my stim up so high during the day ( I typically max it out) that I have to charge it every other day. The battery will drain within 3 days. Hooked me up to laptop again. It was determined that I just use it at a very high setting. It has been working good for leg pain but my setting for lumbar pain seems to aggravate pain more. I only use it for leg pain.
 
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chronic1008 replied to chronic1008's response:
I forgot to add. When my neurosurgeon took out the old battery pack he said it was scar tissue that impacted the lead/battery connection. He did extend the lead. Boston scientific rep didn't think he had enough looped. He was afraid if I fall or get hit, the lead may pull out. After 8 back surgeries, if I fall or get hit, the lead pulling out will be of my least concern.
 
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jackie1054 responded:
Hello,
I had the same implant in my back and i had nothing but trouble and alot of pain with it it stayed in about a year and it got so bad that you could not even touch my back and it was always red and inflamed. I went to my DR. again and he said it had to come out immediatly so we went to surgery on 11/16/12 and what was supposed to take about 25 min. to remove ended up takeing 4 hrs. it was so rapped around and knotted in to my nerves and scare tissue it was realy bad. I thank God it is over but back is in alot of pain. I wish you well
 
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evanob responded:
I am a spine surgeon and I recently had a patient with a fractured lead wires. I was not previously aware of this type of failure. The wires are integral to the paddle electrodes and the percutaneous leads. This means that when the wires fail, additional surgery must be performed to remove the bad implant and replace with new. There is risk of dural tear, nerve injury, and infection. I was disappointed to learn than all three manufacturers (Medtronic, St. Jude, and Boston Scientific) only warrant the wires for one year, even though the generator is warranted for longer. If pacemaker leads were this fragile, patients would die. This wire fragility needs to be addressed by the FDA to force manufacturers to solve this problem. One year warranty on the wires is ridiculous.
 
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Tana46 replied to evanob's response:
Hello Spine Surgeon. I am an RN with Chronic Pain Syndrome, Fibromyalgia, MS, Adrenal Fatigue, Cervical Radiculitis, and 3 bulging discs in my neck which shows multiple bone spurs on my discs(nerve pain), which my PM Dr. believes to be the cause of my neck, shoulder, migraines, hip pain, and thus the reason for the SCS. I have a huge amount of hip pain last 3 1/2 years. I now have been approved for a SCS with my Insurance Company and was actually approved back in 2007 for same. If I had of known what the last 5 years would have been like, I would probably have had it done then. I am very conservative, want off pain meds, or decrease atleast. After hearing about the leads fracturing, I am now having the same ole doubts again. I go every two weeks for last 2 years faithfully for nerve blocks( and want my life back! I am NOT asking for expert advice as to my specific condition, only to let you know why I am doubtful, especially after reading your post! I honestly would like to know HOW FREQUENT IS THIS LEAD FAILURE?? And the surging as well? My parents are totally against it, and feel as if I am running out of options here. How do the patients complain regarding lead failure to the FDA? I have appt with PM Specialist tomorrow and I will be asking a lot of questions! Thanks for any help out there in advance! Also, St. Jude is the manufacturer my MD will be using. ( Out of the three, does one manufacturer have more general problems than the others?)
 
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evanob replied to Tana46's response:
You should consider an intrathecal opiate pump. I am doubtful that a SCS would cover all of those areas. I do not know the frequency and/or rate of lead fracturing by the different companies. I only recently became aware of the wire failure issue.


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