Spinal Cord Stimulators – Paralysis, Adverse Effects


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In April 2014, the Wall Street Journal published an analysis of adverse events associated with spinal cord stimulators:

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When Spine Implants Cause Paralysis, Who Is to Blame?

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These events were submitted to the FDA or were obtained from medical malpractice law suits. “In many cases, the injuries occurred after patients’ spinal cords were punctured or compressed by the stimulator electrodes….The FDA’s database contains 58 unique reports of paralysis with report or event dates from 2013, compared with 48 in the prior year.” The spinal cord stimulators were made by various companies.

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“Researchers at Duke University medical center recently found that nearly one in every 100 spinal stimulator patients experienced some degree of spinal cord or spinal nerve root damage, said Shivanand P. Lad, a Duke Neurosurgeon and the study’s lead researcher. The study, based on insurance claim records of 12,300 stimulator patients has been submitted for presentation at an upcoming medical meeting.”

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“A 2011 study based on adverse event reports submitted by device makers found the rate of paralysis or motor weakness in patients implanted with a commonly used type of stimulator was considerably lower, at around 3.8 per 1000, with about 60% of patients eventually experiencing complete or partial recovery.”

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Medtronic updated its product label in February to note “that scar tissue can form around device electrodes and cause nerve damage, including progressive quadriparesis, or gradual weakening of all four limbs.”

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“Medtronic estimates that as many as 50,000 people in the U.S. are implanted with spinal stimulators each year from all device makers.”

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“Stimulators cost between $20,000 and $60,000 each and have estimated global sales of $1.5 billion annually….”

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The FDA “cautions that the agency’s database cannot be used to ascertain comprehensive rates of adverse events because the events are under reported [my emphasis] and often contain incomplete or incorrect information.”

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The article describes a man with 40 years of back pain who had a spinal cord stimulator implanted at the University of Texas Southwestern Hospital, Dallas. He complained of numbness in his legs. A blood clot was removed on an urgent basis, but damage was irreversible. He was paralyzed from the waist down and left in a wheelchair.

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Spinal cord stimulators, abbreviated SCS, can cause many more problems that paralysis. They can cause pain, tethering of the cord, scarring of the battery pack that can slide across the back, infection that may cause death, and many other complications. Electrodes may not always be able to be removed and remain permanently scarred into the cord. Deeply troubling is that an MRI can never be done again even if the patient has cancer or stroke —none of my patients remember being told about this. Where are the five year studies that show benefit? Even with no complications, how long do they continue to relieve pain? Electrodes move and/or they malfunction. There is little to no federal investment in medications that relieve pain, but these devices are garnering sales of $1.5 billion annually without showing lasting benefit. This is a very big source or income for pain specialists, but what is the gain for patients? How can we weight the pros and cons of this money generating device?

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So many of my patients that have failed the small handful of medications now available for chronic pain were given only one choice by every major pain center: spinal cord stimulator. One choice. This is a very big business but where is the five year data?

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One of my patients with Complex Regional Pain Syndrome, in remission since 2010, submitted a comment on this my site:

 

06/07/2012 at 11:25 pm   I have been a surgical nurse for 40 years and have seen many patients receive SCS…and many, many fail, or return to surgery for fractured electrode wires, misplaced wires, or infected battery pockets, besides complicated problems, or “lack of positive results, or battery revisions, or electrode repositionings.” Some patients have even developed spinal fluid leaks when the spinal dura layer has been torn during implanting the electrode wires, and they develop severe headaches, and have to return to surgery for the leak to be repaired. Many pain management doctors are convincing patients that this is a great way to treat their pain, and they find out in 2-6 months that they wish they never had agreed to it. Sure, there are some patients that get some relief, but this procedure has been pushed on the population of chronic pain patients, when they are at their worse condition, and willing to try anything….at any expense, and the companies and implanting doctors are getting the money. More patients need to learn the truth about these devices! Anonymous…. and never allowed them to put one of those things in me…but many tried!

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Elsewhere on my site, Traci writes a very sad comment:

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03/29/2011 at 6:01 am I posted on your main blog, but haven’t heard back. I know you wanted information regarding issues or problems with Spinal Cord Stimulators, so here is some information that you can add to your file. I can also be contacted for additional information because this issue continue to date.

In one of your posts you asked for input from patients that currently have a SCS. I currently have a Medtronic SCS it was implanted early 2010 and I ended up having swelling in my Lt (affected) foot/ankle every time I would charge the “re-chargeable battery”. No one at Medtronic could figure out the issue. I turned into their “human lab rat”. After several months of this I was told to switch from a rechargeable battery to a non-rechargeable batter. Thus another operation… which I did. After this surgery (I have a paddle with 16 electrodes) all 8 electrodes on the Lt side that used to supply stimulation to my Lt foot/ankle now hit my pelvic area – thus I can no longer utilize these electrodes. And out of the 8 electrodes on the Rt 2 are providing stimulation to my Lt foot and the other 6 are hitting the wrong areas. In addition to this I have had continual instances where I am getting a very sharp pain/ sharp twinge (like a jolt) around where the electrodes area. When this happens if I turn off the SCS the pain immediately stops. I’ve been on a conference call with a Senior Engineer of Medtronic and a local Rep in person with me to do reprogramming… The Engineer only wanted to know if the electrodes were putting out stimulation. He didn’t want to know what the amperage was at before I could feel it or in what part of the body the stimulation was felt. These should have been critical pieces of information. All he wanted to state was that the electrodes were working. As for the Sharp Pain / Sharp Twinges that continue to occur in the electrode area their Senior Engineer has no idea what is causing this. He asked me to run an experiment the next time it happened – I did exactly what he wanted and reported back the findings. I have yet to hear back from Medtronic. They do not want to back up their product and they are not willing to admit that their is a problem. Although I have 2 doctors including a Neurosurgeon that feel there is some type of fault in their product or that it is faulty. Hopefully this gives you some additional information you were seeking. Please feel free to email me if you would like to discuss further. I am continuing my uphill battle with Medtronic.

I have spoke with Medtronic as recently as yesterday and they can not explain the continual sharp pain/sharp twinge that I continue to get where the paddle that holds the electrodes is placed. The “Patient Relations Rep” that has been assigned to me, (at one point she tried to tell me she was from their “Legal Department” and she was later introduced by a team member as a “Patient Relations Representative”), doesn’t feel this is a big issue. She told me yesterday that this is “just medicine” and sometime they can get it right and other times it just doesn’t work out… The Senior Engineer at their company can not figure out what the problem is, so he just wants to reset the “INS”. I asked exactly what the “INS” was and the Patient Relations Rep couldn’t answer that question. I have already had my system reset numerous times (too many to count) and reprogrammed numerous times.

The trial was aproximately $25,000; the hospital expenses alone and cost for the SCS implant were over $150,000 and the secondary surgery to replace the rechargeable battery with a non-rechargeable battery was aproximately $53,000. This is all for a system the now has 2 out of 16 electrodes that hit the correct area, creates an intermitent sharp pain/sharp twinge in the spinal area where the electrodes/paddle is placed, and they aren’t sure how to resolve this issue. But I was told yesterday that their system was working properly by their rep.

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The material on this site is for informational purposes only.

It is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me

to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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25 Responses to “Spinal Cord Stimulators – Paralysis, Adverse Effects”

  1. Traci Patterson Says:

    Hello, this is “Traci” from the above referenced post on your site on the SCS issue with Medtronic. I thought I would give you the final update. I did have the Medtronic SCS explanted. Medtronic could NEVER explain why their unit was having issues and I even released it to their lab for processing.

    My pain management doctor, neurologist and neurosurgeon all told me they had nothing more to offer me accept to try a different type of SCS, so I was convinced to have a ‘Boston Scientific’ SCS implanted as a replacement. This was back in 2012. This particular SCS was only in for a couple of months and I began to have issues with the stimulation that was being delivered. I had their top reps working with me. I also had some other odd sensations happening that I was very aware of. Thus, I had my Neurosurgeon do some searching online to see if their were any write-up on scar tissue build up due to ‘Spinal Cord Stimulators’. He had never heard of any issues and had never seen any literature on this problem, but he was willing to do the research. I knew I was in trouble when I received a person email back from my Neurosurgeon within 24 hours of my request for information… He found 2 articles in medical journals about scar tissue from Spinal Cord Stimulators causing paralysis in patients. We then did what imaging we could do as no MRI was possible with a SCS. We found that I was within this category after just a few months! Please keep in mind that the surgery to input the SCS(s) in my back also caused my CRPS to move into my back. This was a huge issue for me. Now on top of that I had to go through yet another surgery to have the SCS removed immediately to prevent paralysis from my waist down.

    I was never told about any possibility of build-up of scar tissue around my Dura. I was never told about a possible complication of paralysis. I asked if I needed to be concerned about my CRPS moving into my back with the implant of the SCS and I was told, “NO”… Yet, it happened.

    I personally sent in information to the FDA regarding my case with the SCS(s), my Neurosurgeon wrote up a case study on me (with my permission), my Neurologist submitted a report to the FDA regarding my issues with both Medtronic and Boston Scientific and we all tried to do our part to get the information out there.

    As a patient, if you have issues like this happen to you, you need to be willing to report it so that others can be aware of it. Otherwise the DME companies (i.e. Medtronic, Boston Scientific, etc…) will not release the information unless they are pressured.

    One final note… After my SCS was removed at 3 weeks post-op I flew to Frankfurt, Germany for treatment of my CRPS. I was treated in Germany off and on until 2013. Then in late 2013 I was treated in the US with a form of Complementary medicine that was the final push to get me into remission. I have been pain free since then. : )

    • Nancy Sajben MD Says:

      Thank you Traci.

      Doctors routinely see scarring at any site where surgery or a procedure has been done, be it in abdomen, pelvis, spine or other. That is how the body heals, first by forming an inflammatory response that leads to scarring. Some of us scar far more than others, but a foreign body such as electrode leads or battery pack now become a constant source of inflammation, not just one surgery that triggers one response that heals.

      With CRPS, surgery is done sparingly as it may lead to spread of the pain to the new site. I have seen patients in whom the surgical area, or area of the battery pack, then becomes the site of #1 worst pain.

      I am delighted to hear you are in remission. I am sure many of us would love to hear what was most beneficial for you. I know I would. It may help so many others.

  2. Whrndi S. Roberts Says:

    Hello….My name is Whendi. I have had four spine aurgeries including a two level fusion and most recently removal of the hardware. I continued in alot of pain in my lowet back and legs and tried Radiofrequency Ablation and Scar tissues removal and around seven or eight steriod injections in the last year..Im eas at my wits end with pain and am not a big fan of pain pills. I still have major low back and leg pain. I had a meeting last week with a phychiatrist for a medical evaluation for a spine cord stimulator. Ive been pushing for it for several months now. I got the insurance clearance and my pain management Doctor is hesitant but willing to do it….however after readi.g there horror stories of paralysis and seriouse complications im rethinking the whole thing and might just opt for injections and pills. Im not trying to get paralyzed and one in a hundred get complcations….Thats high ……Thats alot of problems. I dont know what would be best for me anymore. Maybe juat injections and pills. Now i understand why my pain management Doctor doesnt want to do it on. He thinks it couldwreck my life even more

    • Danielle Smith Says:

      My name is Danielle and I am the wife and VA caregiver for my husband who was injured while on active duty. After years of low back pain and physical therapy, traction, and other non surgical things he was seen by a doctor that talked to him about “cortisone” shots into his spine. (also called facet injections). He had these done and the pain got so bad that he stopped. The last shot was given in the doctors office without fluoroscope. At the time it didn’t seem odd. Within minutes of getting that last shot he knew something was very wrong. That was the last time he saw that doctor and was sent to a hospital in Biloxi MS. He was seen by the head of neurology and to our surprise he was told that he had a rare, incurable disease called Arachnoiditis. From what we can figure out it was from the shot that he was given in the doctors office. Looking into what the “cortisone” really was – Depomedrol – it seems that this is what caused the disease. It is easier for me to tell you to look up the disease than it would be for me to explain what it is. He has been suffering for the past 17 years and it has turned our life into a living hell. Doctors don’t understand the disease, and pain management has become a bad word. The ONLY thing that comes close to helping my husband it the medication that gives him some kind of relief. Now that would be ok but doctors are under fire for prescribing pain medication for long term. It is the only thing that can be done as there is no cure for this disease. PLEASE don’t let any doctor give you any shot in or around your spine. I hope you find something that helps you with your pain, but shots are not the answer.

      • Nancy Sajben MD Says:

        Strong words – never is a big word. Get a couple opinions. Looks up the exact drug planned. Read, study. Then decide.

        I don’t do shots but I see people with intractable pain, sometimes from interventions or injuries or spontaneous.

        I have seen only one patient with adhesive arachnoiditis in recent years since changing the choice of treatments. She responded remarkably despite paraplegia and disabling pain, she is now able to work full time as an international attorney and runs 5 k’s.

        She is not pain free, but has the medications to control the pain fairly well including the occasional spikes in pain.

        In moderate remission.

        I wish you both well. Chronic pain kills. It affects everyone in the family.

  3. Nancy Sajben MD Says:

    This was posted after link to RSDS at top banner, but belongs under this subject, thus being moved below by admin. I do not recommend these, partly because I see devastating sequellae and there is no long term data for 5 years. I also know a prominent nationwide anesthesiology pain specialist who never recommends spinal cord stimulators. Never.
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    Jon Wheeler Says:
    01/10/2015 at 7:26 am
    I went the spinal cord stimulator route recently for chronic lumbar pain from stenosis, multiple fractures, and degenerative disk disorder. Take your time considering your options there. That stimulator will cause as much inconvenience and pain as your condition you are trying to treat. The stimulator may not even help your pain. The trial is an option to give you an idea BUT, the trial is not the real thing and has different results as the permanent implant (it also cost almost $40,000). I’m not saying don’t do it, just understand it isn’t a miracle fix for your pain. At best it masks it with a little tingling.
    There are other ways of fixing this condition if we can find the right doctors and support staff to follow through with the treatment.
    A small injection once or twice a week intramuscular route may do more to resolve your pains than a major spine surgery and months recovery (not to mention $60,000 to $130,000 in medical costs). Your insurer WILL fight you every step of the way on that cost.

  4. javier Says:

    Hi my name is javier.l am presently being pressured by my pain management Dr , to have a scs lmplanted on a trail bases.even though I am presently taking pain meds,which I believe are giving me satisfactory pain relieve at the present time. I have had numerous back surgeries (five). With every surgery I was led to believe I would be alright after that surgery. The only surgery that did some what helped was my last one, where they fused my lower back L4 and L5. Afraid that letting the doctor in plant the scs will reverse all my gains over the years.Been dealing with my situation for over 20 years now. Like to know what your thoughts are about my situation.

  5. Whendi Says:

    Ive beed in living hell now for about three months since I got it. I am slowly getting more paralyzed every second of everyday. Please dont get it. Im a mess and now have to get it take out. I am dying. My muscles all over my body hurt so much…I am dying and will die i stay like this. God help me.

    • Bonnie Oldham Says:

      I am in the same situation. Can’t afford to get the scs removed. I have given the FDA the model and serial numbers that are on my scs card. Am losing sensation in my fingers and toes. This ia an outrage!

      • Nancy Sajben MD Says:

        Other conditions may cause loss of sensation, e.g. diabetes can cause neuropathy, so can B6 toxicity, and other metabolic conditions.

        Be sure to see a neurologist. The SCS can be turned off, even if not removed.

        Best wishes!

  6. patti miller Says:

    Oh Whendi , I’m so sorry to here your pain ! I just recently had the spinal cord stim implant about 7 weeks ago, I have never been in so much pain in my life! 2 weeks after my implants they turned on the stim to a 10 for 3 weeks. I felt like I was being fried from the inside out, I felt like someone was taking a Taser gun to my back . Now my legs and back are burning in pain and my legs are turning numb. I’m so scared. Patti 2/21/2017

    • Nancy Sajben MD Says:

      I hope you get help urgently.

      • Anthony Says:

        Had l5s1 fused 4 an 3 decompressed 5 months I was good than scar tissue grabbed some nerves work light one day flat on my back 2 days ,sugery 2,27,2014 chronic pain legs pounding feet numb,back pain from 5 disc was gone bone to bone Pain fused helped but still can not work,work will cause back pain,I considered a stimulator ,trial on 2/9/2017 after reading this ther is enough scar tissue in my epidural space now ,I do not want wires that can not be removed,I am 57 years of age heavy work took te tole ,thanks for info ,I stick to the Medication ,I can not be knocked off my feet,thanks Anthony

        • Nancy Sajben MD Says:

          Many are predisposed to developing more than usual scar tissue. In some cases, it may not even be possible to add a stimulator. Very sorry to hear your spine problems. I hope you will be able to get relief.

        • Anthony Says:

          Hi I just posted this is anthony error in date of stimulator trial is 5/9/2017 this Tuesday if I did not read this I would of mest up I heard bad things about the stimulators ,I have went to at least 8 pain management doctors push the stim,no one told me this,I was going to on 5/5/2017 to ask about the wires sticking in my epidural space,there is not a lot of room in there now ,thanks god bless,keep the faith,Anthony

          • Nancy Sajben MD Says:

            Scar tissue is common, but some people grow an overabundance of scar. The leads are place higher than where you had surgery so it may be ok. But they begin by doing a trial and if that helps, then they implant the permanent device and leads.

  7. freda Says:

    WOW! now I’m scared! I’m suppose to get the spinal stimulator implanted March 28, 2017 – the trail one. After reading about the pain that the previous SCS patients are and have gone thru, I having second thoughts. I am in considerable pain, but I can manage. I don’t want to be paralyzed, I don’t want to have the feeling that I am being “tasered” in my back and I don’t want to go through what you all have gone through. My doctors says that he has preformed “hundreds” of the SCS, but won’t give me a name of one person to speak to about the pros and cons of the procedure. I think I’d be better off just continue taking my “gabby pills” and bite the bullet. I can see myself paralyzed without an car accident. Not if I have a say so in it. May God bless you all, you’ll be in my prayers.

  8. Donna Brown Says:

    Hi, I had an SCS inserted on 12/27/16 and after 3 mpnths of adjustments per Boston Scientic repz stillstill had zero coverage in my lower back, ( I had lumbar spinal fusion of 3 vertebra in 2015 after which was found that the neurosurgeon fractured a vertebra below the fusion).& I was in even worse pain than before the fusion. I turned to the SCS unit as last hope of relief. I just had the unit repositioned,(my 2nd surgery for the SCS) and have been iinn agony with excruciating pain in the area on my spine where the paddle with the electrodes was implanted. I wish I had never had it done, & want it removed. I understand how the pain mgmt specialists make a great amt of $ for these surgeies without even long-term studies proving safeth and long-term success rates. Someone needs to be held accountable for the excessive pain, suffering and misery they mete out on unsuspecting patients that come to them mistly as last desperate attempts to help.

    • Lynn Says:

      Hi I just had my schedule put in on Fri the 28th of April 2017,an the pain in my back where the leads where put in an my bottom area where the battery is. That’s some horrible pain

  9. robert dicristi Says:

    Hi, I feel all your pain. I was dx’d with rsd of my left foot several years ago secondary to a liz franc fracture with compartment syndrome. Unfortunately my foot dr, who did the surgery couldn’t figure out the pain and started to think I was just a drug seeker so he told me to see a pain specialist. Well being a paramedic as soon as he said that I figured he was right and it was in my head. So for the next 3 years I dealt with varying degrees of pain in my foot, up my leg and into my hip. It wasn’t until I stumbled onto an article about RSD that my light bulb went off.
    I went to see the pain management doc and he confirmed it was RSD. So we started with acupuncture, gabapentin and percocet. The acupuncture wasn’t helping at all so we stopped that. After a year and several med changes he talks me into a SCS. So off I go to speak to a neurosurgeon. He boasts about how its helping so many people and tallks me into a trial. Well the trial went really well. I was shocked, I had more then 80% relief. So that sealed it I would get the SCS in an outpatient setting and be out the same day. HA HA HA, 4 days later they have to kick me out of the hospital even though I didn’t think I was ready to leave. I was having horrible pain in my back, I couldn’t move, roll, and it was even hurting to take a deep breath. I constantly had to argue with the pain people because they had me on the same amount as I was on before the surgery and they felt it was enough. It wasn’t until I threatened to call a lawyer that they increased my dose (their excuse was they didn’t know I hadn’t been able to use the SCS as of yet.
    When I got home it was rough going. I couldn’t walk more then a few feet. I spent almost 2 weeks in my recliner and another 8 weeks in pain. After multiple resets and programming they finally got it and I was getting good pain relief. For the 1’st time in many years I felt almost normal. I was back to work (not as a medic anymore) but some pain would be there after too long on my feet. It was that way for almost a year. Then it just stopped working. Only problem is my doc keeps insisting on this new SCS and I am not having more surgery. My doc wont increase my meds at all and I am still in so much pain. Today I can barely walk. Welcome to NY, where the doctors are afraid to treat their patients because the government has them scared.

    • Nancy Sajben MD Says:

      It’s not fear of increasing the dose. It’s reality. Opioids cause inflammation in the brain that causes more pain. They increase pro-inflammatory cytokines. They destroy the balance of inflammation in the innate immune system.

      I feel the same way you do. I’d do anything to help if I had pain, but how can we help without the right tools? We have a few partial answers, and millions are in the same dilemma including young children who will be bedridden for decades of unbearable pain.

      A perfect storm – the more we increase opioids, the more pain we create. NIH does not care; even worse what research are the companies doing that make spinal cord stimulators? What warnings in particular do they give to persons with CRPS who are considering them? What are the true risk of complications? Where are the 5 year studies? Billions in income. Where’s the research?

      People who do not have pain do not understand until they experience persistent pain.

  10. dvaden1117 Says:

    Medtronic updated its product label in February to note “that scar tissue can form around device electrodes and cause nerve damage, including progressive quadriparesis, or gradual weakening of all four limbs.” Wish I would have known this! You know there is soo much more…

    • Nancy Sajben MD Says:

      Medtronic does not seem to list these problems. Can you give exact reference?

      See link at end for the following data from the Medtronic 2015 product report that combines SCS’s with many other devices Medtronic sells.

      “Approximately 82% of spinal cord stimulator (SCS)-implanted patients are expected to need at least 1 MRI within 5 years of implant.”

      As you know, MRI’s cannot be done with metal electrodes sitting on top of your spinal cord.

      Medtronic lists CRPS as an indication for SCS.

      Medtronic has a product registry for all products, expanded in April 2010. Page 76 begins SCS’s, only ****1701 patients with non-product performance events of total 3797 enrolled as of July 31, 2015, following 4,176 spinal cord stimulators in the registry, some patients had more than one SCS.

      “Of the 3,797 total spinal cord stimulation patients enrolled, 44.8% were implanted for the treatment of other pain indications, 43.4% were implanted for the treatment of failed back pain, ****10.8% were implanted for the treatment of complex regional pain syndrome (CRPS), and 1.0% were implanted for indications that were not specified in the database.”

      That seems like a very low total enrollment. Thousands of pain specialists offer them. Companies are well known to represent heavily culled information.

      They list a low number of non-product related events since 2010, i.e. not due to broken leads, dead batteries, antennae cable breakage, etc:

      Muscle spasm in 6 events, paresthesias (tingling, numb) in 19 events, other neurological = 13 events described as ” Composed of event codes with fewer than 5 events each.”

      Difficult to believe. This is not research. I’ve seen almost as many in my own practice.

      Registries are voluntary and doctors do not like to fill them out. A prospective 5 year research study is needed but clearly billions of dollars in income will not buy it.

      http://professional.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@neuro/documents/documents/mdt_product_performance_2015.pdf

  11. Nancy Sajben MD Says:

    Medtronic lists

    “Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, and surgical risks.”

    http://professional.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@neuro/documents/documents/ppr-exec-summary-fy15-scs.pdf

    It’s hard to parse what paralysis means without case reports.


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