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SCS Trial - Medtronic Stimulator - TRIAL ONLY and a Consequential Paralysis

jlukejjluke Posts: 17
edited 02/22/2016 - 10:18 AM in Spinal Cord Stimulation

I went for the outpatient trial of the subject device prominent on
many forums and in these discussion boards. I suffered an unusual complete
lower body paralysis within 1 hour of the SCS trial (trying to get relief from
a pinched nerve). The wire lead at the T8 area somehow created a blood leak
(epidural hematoma) that allowed blood to travel up to the T5 and pooled around
the L3. After all the emergency issues that follow such a problem, I now have
some feeling after 4 weeks and attempting at learning how to walk and do other
things completely foreign to my body. What will return or the outcome for me is
unknown. My over emphasis of the words “SCS Trial” is simply the fact of it
being so unusual. The pain clinic DR had an excellent 25 year past performance
record and no problems found from our pre-screening efforts.

This is bit off topic but so imperative to me. I very recently had
another issue from a small blood clot in my left calf (the leg that has the
utmost inferior problems from the hematoma).It was discovered at
the 4 week time frame and should have been found sooner from my daily talk of
my left foot puffiness not reducing. I was given an option of an IVC filter
immediately or bed rest with monitoring the small clot for growth and would
require the filter if the latter transpired. The vascular DR placed a tight
compression wrap normally used for a clot concern. But I and the
nurse/assistants were never elucidated about the wrap requiring constant
monitoring for removal to restore circulation. After 14 hours I told the floor
DR during rounds my left leg feelings had disappeared. It’s now 24 hours later
and I have zero feeling in my left foot. This negligence will make any
improvement I have achieved in my walker progress obsolete. Sorry for this
paragraph so off topic to the SCS trial info I am seeking, but it’s relieving
to get this out of my system since the DR’s here are reluctant to discuss it. I
am at one of the best rated rehab facilities in the USA so this should never
have occurred.

Back on topic now - Has anyone heard of a paralysis incidence from
a stimulator trial due to some form of negligence of the wire lead
placement during the trial procedure alone? My wife and I have searched the web
and cannot find a like problem. Would like to know of others is possible.

Any info greatly appreciated!

Thanks all.



  • Hi Jluke,

    I hope your feeling some relief at this point.  I too went thru something like you. Here's my story.

    I have CRSD following Bilateral Tkr and my pain is in both knee.  I do have spinal stenosis, DJD and permanent nerve damage thru out my body. I didntt have any spinal surgery as they felt it would not help me.  So my concern was with not being able to walk up and down steps, bend or knell.

    I tried the Nervo SF10 SCS in May (the unit has no pain and since I cant use a Tens unit due to pain and its implanted in the lumber area) I went for the trial and it worked great on my waist and up but no effect on the waist down, so I choose to not have implanted, as it wasn't worth the surgery if I couldn't walk, so back to med adjustments.

    So on Tuesday May 17 I choose to use the Medtronic SCS which goes thru the dorsal/lumber area and I knew there was pain involved, but it had great results on CRSD for the knees.  So I was sedative and put to sleep, once the piece for the lead implants were put in I was waken and was find as it was going in then all of a sudden I got the worse pain and charge in my life in both feet, I was screaming bloody murder in the OR and so they removed everything and rushed me to recovery, where there they tried morphine and any other meds to help, but they didn't.  So I was sent for emergency. x-rays to the dorsal and lumber spine, then for MRI of dorsal and lumber spine to make sure that something was left in or there was any damage or Blood clot.  All came back ok, but the pain during the MRI was unbelievable  and unbearable.  My doctor and the rep from Medtronic have no idea what happened.  They all think that due to my sensory and nerve root damage that maybe a electrical charge happened straight to my feet. 

    I was admitted to hospital and spent 2 more days there unable to walk, touch or move my feet, just the smallest tap on the bed was horrible.  My doctor felt the longer I stayed in Hospital, the more things they would find wrong with me so now I am home on 3 types of morphine, lyrica and prednisone.  My doctor has spoken to specialists around the usa and it seems that no one else has gone thru this and they don't know how to treat.  Some Dr. are stating that with the use of Morphine, lyrica and  prednisone it could be a week or up to 8+ weeks. 

    its now 4 days and I can wiggle the tips on my left toes a little with tingle nerve pain, and I still getting what feels like electrical shocks in both feet, more in the right side. I can walk on my heels with the help of a walker.  But on the upside my knees feel good and so does my back and neck, but if you check my blood pressure with is normally 112/78 is now 179/94, they think everything in my body is going to fight my pain in the feet to protect them.

    My doctor feels horrible and so does the Medtronic rep.  I don't think they did anything wrong, but like you I cant find anyone that is going thru the same thing to get a idea of what did happen.

    I truly hope you are feeling better and hope my saga of a story helps as you are not alone out there,  Just keep up the spirit and don't let it get you down.  Thru everything I am going thru on a daily basic.  I have to remember it could be worse and I happy to be alive and be with my family.

    good Luck

  • jlukejjluke Posts: 17
    edited 09/14/2016 - 5:35 PM

    Thanks for the reply. 

    for you situation and hopefully you will improve. I can now walk with a cane
    but only 100 feet or less due to chronic left foot pain, so there is some hope
    that you will get rid of the walker (I was so glad to not use that thing anymore).

    I have a theory on why
    nothing is published for people like us whose life gets destroyed by a SCS trial.
    Lawsuits published about trial errors would be a huge drop in Medtronic sales,
    so all lawsuits are probably settled with a solid no disclosure clause. I know
    of one case that the law firm published the settlement amount for a SCS implant
    problem but the truth is the verdict was from an actual SCS trial and no implant
    was ever done. Therefore, there may be many more, but Medtronic keeps them silent.

    But you are right, you have
    to remember it could be worse and happy to be alive and be with my family.

    Best of luck on your recovery.

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  • Jluke I had a very similar experience.  I am new to the site and messaged you my experience.  

    In my message I didn't include that in my case there was no negligence or faulty leads. In fact I just had a third lead added to help with nerve pain in my foot. Feel free to message me if you have any questions or just want to talk about it. I know 100% how frustrating and painful physically and emotionally it can be. 
  • Hello. I am new to this site. I am so sorry for all of you who have had negative experiences. I, too, am having them now.  Heres my story.

    I had my scs trial last month and it worked great. So i went ahead with the implant which was done on 10/13/16. About 3 days ago, i started shaking and whenever i lay down, both arms and legs go completely numb. Today, the shaking has greatly intensified and i can barely walk. Feels like im gradually becoming paralyzed. Went to see dr today for me to be told that they dont know whats going on and to go home and wait for a call back.
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  • Hi, my mom had a surgery to implant Syncromed II  for cronicle pain, february  2016, she arrived at the hospital walking, her doctor said it was a very simple procedure, with no risks, but she is paralysed since them! The doctors told me that there was no explanation for what happened to her, what I see that is reported in other cases in this forum!!!  I leave in Brazil and I couldn't find much about it in portuguese, but when I tryed in english, I was really sorry to find out that this was a very predictable risk. She has passed through several consequences for her situation, and nobody assumes the responsability,, they say that was an accident! They never told her or the family the risks in this procedure. I really think it is important to register what is happening, so we can prevent other people for being paralysed. I understand that that are success cases too, but I think that the patient has the right to know the risks before the implant. I feel that the doctors are very well connected to Medtronic and are not worried about the cases that doesn't work, for them it is just an statistics. 
  • amcalaamcal Posts: 1
    edited 12/16/2017 - 3:53 AM

    Would like to know more about the wire they used for the trial if anyone knows. 

  • I had the same experience with the trial. The lead wire during the installation. I can’t say much about it but I too had blood in the spinal canal. I’ve spent the past year learning to walk again half of which was in a wheelchair . Still in rehab in one of the best in So. Cal. I’m on meds just so I can still be able to go the restroom because my nerves are no longer functioning. I was never told anything about the risk. I was told that’s it like an epidural and a TENS unit so you won’t feel the pain anymoreI’ve been looking around the internet for others that were effected. There might be a defect in the lead wire according to my PI. Trying to get more info.

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