The Main Complaint About Spinal Cord Stimulators

Bones, joints and muscles
1

I’ve had a Nevro spinal cord stimulator in me permanently since June 2018. I did a trial version of it for ten days about 3 months prior to the permanent implantation. I have what is called the “paddle” version of the stimulator, which means the leads that go up my spine are connected at the top to a paddle that looks somewhat like a flattened end of a spoon. And of course at the other end the two leads are connected to my battery. The battery is implanted in my right butt cheek.

I’ve been reading this message board since shortly after I got my stimulator implanted permanently. While there haven’t been a large number of comments about spinal cord stimulators on here (maybe a dozen or so), but I’ve noticed a distinct pattern in all of the comments about these stimulators. Virtually everyone who complains about their stimulator is not technically complaining about the stimulator itself, their complaints seem more centered on the implantation itself. That seems to be the main complaint - that some aspect of how the doctor placed it inside their body was somehow wrong, or was done in a way that left them vulnerable to feeling pain, or to having the stimulator shift, or the leads detach, or some other malady related to implantation. I don’t think I’ve read almost any comments about the functionality of the stimulator itself, meaning whether or not it actually relieves their pain. Everyone seems focused on some aspect as to how it was placed in their body.

That’s not to diminish their sense of pain or discomfort, but those comments are not about how well the stimulator itself works as designed, it is about the unique pain of potentially bad implantation. Hasn’t anyone had a successful implantation, who can then answer whether the device did the job as it was intended or not?

For those people whose primary complaint was about implantation, I would ask two questions: first, what part of your body was the device placed in? Mine was placed in my buttocks and has caused no problems. Seems like everyone else had theirs put in their ribcage, which seems to be related to their implantation pain. And the second question would be: what type of medical professional implanted it? Was it a full-time surgeon, or was it your pain management specialist? Mine was done by an actual back surgeon, mainly because the implantation of the “paddle” type of stimulator requires it (they have to break open the vertebrae to place the paddle). Most pain management doctors, however, may not be trained surgeons, and that could be a factor in why folks complain of implantation problems.

I’d be interested to hear the answers to these two questions from those who have had stimulators implanted, especially those who have had implantation complaints. It could be helpful to those who are thinking about getting a stimulator (i.e. ask whether you can have an actual surgeon put in the device, and ask where it will be placed).

2

My device consists of a paddle and battery. The paddle was inserted mid back just as yours was. The battery is located on my lower hip. Each surgery was performed by a neurosurgeon, not my pain management doctor.

3

mine is implanted above my right butt cheek, and i have the leads that are anchored mid back. i had it implanted june of 2015, and my pain management dr put it in. my trial was only 3 days because the programming device malfunctioned, but my dr determined that i had a successful trial and went ahead with the implant.
i had significant pain relief for the first year, but then it started dropping down till i was no longer getting any pain relief. i believe it is now malfunctioning. when i try to charge it…i have the paddle that you place over the battery…it tells me that it cannot locate the ipg to charge it. i havent even turned it in for a few months, and thought i could just leave it in, and not use it, as i do not want to go thru another surgery, nor do i want a replacement put in. right now, along with the pain, i have constant vibrating/buzzing that goes from my lower back, down both legs. my pcp dr did an xray, and everything is still in place, so now i am going to have to have it removed.
one thing i have noticed from a lot of people commenting here, and other support groups i’m in, is that a lot if people had the trial with the leads, then when it came time for the implant to go in, they are putting the paddle in, without telling patients before hand, that that is what was being done. it seems more people have problems with the paddle than the leads.
don’t know if that answers your questions, but that is my experience. i do know, that if i would have done more research before hand, i would not have had it done.

4

And how has the stimulator been for you, in terms of effectiveness of pain relief?

5

Thanks for that detailed reply. In terms of the problems with the paddle version, my doctor was pretty clear with me in advance that a paddle was going in - he said they tended to recommend the use of a paddle for folks who are likely to be active after the surgery, and who could deal better with the surgery itself (since implantation of the paddle is a more rigorous operation than the alternative, the so-called “percutaneous” method where they just implant the leads but no paddle). Indeed I’m surprised folks wouldn’t be aware they were getting the paddle version, it’s a much different surgery (implanting the paddle is an actual back surgery requiring general anesthesia and a laminectomy of the spine).

What is your view on why the paddle version causes more problems? I was told that - aside from having to undergo a more aggressive surgery - that the paddle version would lead to fewer problems once it was operational. Since the leads are anchored to the paddle in your thoracic section of the spine, there is no possibility of downward migration as there is with the percutaneous version of the implantation. And it is the potential for downward migration of the leads, typically through simple gravity, that throws off the stimulator because it changes the spinal location of where the stimulator is stimulating.

The only downside I could see from the paddle version is that it might cause pulling at the other end (being so secure at the thoracic end) that it might lead to the wires pulling away from the battery pack. Although no doctor or medical professional said that to me, that’s just my conjecture. What have you heard as being the cause of more problems with the paddle version?

6

I am waiting for an scs with leads trial, I also am interested in other peoples experiences. Seafarer123, how has it helped with your pain? Have you had good relief and would you have it done, if you knew what you know now.

7

It has worked wonderfully except for this episode. My pain dropped at least 70%.

8

Hi Laura,
Bottom line is, I would have it done again, but I do wish someone had told me more about what to expect from the experience. I’ve experienced anywhere from 20% pain relief to 90% pain relief, depending on certain things I’ll discuss below.
While I am satisfied overall with the stimulator and would do it again, there are three things I wish I had understood better about the stimulator experience:
(1) Understand that once the stimulator is implanted, Nevro (and to a certain extent your doctor) have made their money off of you. Nevro in particular has no further possibility of making money off of you after implantation - and the service shows. Yes they will help you because they don’t want people going around saying their stimulators fail, but the service level is vastly diminished. For example, my Nevro tech was answering my texts about 2-3 times a day during my trial period; after it was implanted, the tech was much harder to get in touch with, and seemed annoyed to have to deal with me. I assume they are paid on commission, and hence time spent with patients after implantation doesn’t put money in his pocket, and it showed. He does his job, but his level of helpfulness and support is vastly diminished. Just be aware of that.
(2) My relief level of 90% which occurred immediately was at my then-existing medication level. The goal, of course, is to not only reduce your pain but to also get you down (or off of) the pain meds. For the last year we have tried to lower my pain meds but there are SO MANY settings they can program into the Nevro, and they really don’t seem to know which ones to try, so it is trial and error. And some of them don’t work, so that when you lower your pain meds and they try to adjust for it, you can spend a lot of time in pain during that experimentation period. I’m about ready to give up, after a year, and just say “let’s go back to my original pain med dosage, at least the stimulator, coupled with that pain med level, left me virtually pain free.”
(3) Finally the MOST IMPORTANT thing I wish I knew - and they DON’T seem to tell you about this - is something they call “over-stimulation.” I call it “phantom pain,” but I’m sure their lawyers don’t let them refer to the phenomenon with any term that suggests their product can actually CAUSE pain. What happens in this case is that if you turn up the stimulator sometimes, hoping to get stronger pain relief (more is better, right?), the higher energy level can “over-stimulate” your nerves. What that actually means is that the stimulator can CAUSE PAIN, often in areas of your body that were never causing you pain in the first place. It can also aggravate pain in your usual pain areas (lumbar, sciatica, etc). This over-stimulation pain can actually be quite draining and can, in some cases, be fairly severe. The good news is that it goes away in about 30-60 minutes if you lower the power level on the stimulator. The bad news is that you can’t always tell that the pain is due to over-stimulation - you just think “hey, maybe I overdid it today. Maybe I strained a muscle, or slept wrong, or inflamed my usual pain area.” It’s hard to tell.
*
I know those three items I listed above sound severe, but in reality if you stay on top of it (including staying on top of your Nevro tech), you can control these issues and make the stimulator work for you. But severe pain can be depressing as it is, and I suspect a lot of people, when faced with these hassles of the stimulator (that nobody tells you about in advance), get depressed and want to give up on the stimulator. But it CAN work, you just have to really involve yourself in the process, it doesn’t just turn on, relieve your pain and allow you to throw the pain meds in the trash can. It takes a lot of work, and patience, often in the face of frustration and re-occurrence of pain.
Hope that helps.

9

my stimulator implant was first implanted by my pain management doctor. He put in my right side of my buttocks and within a few hours the battery slipped about three inches and pulled the lead wires completely out of the spinal chord. Because of this I had to seek another doctor that knew what he was doing. the first doctor was worthless and should of never pretended he knew what he was doing. He wanted the kick back he received from the manufacturer of NEVRO F10.
My second surgeon did the paddle system which was a great surgery but the Nevro F10 just didn’t work. All it did was create more pain…battery stopped working, infection and the battery pack slipped causing pain sitting or lying on the bed. I called the doctor and told him I wanted the piece of crap out of my body. Once he removed it I felt so much better. The surgeon said because the way the pain management doctor was not qualified to do the implant he created scar tissue among other complications.

10

i guess i cant really give you an honest view of the problems with the paddle, as i dont have that one. the main thing i was hearing from others is that the wires were breaking off, and the fact that many were unaware that that was the one that was being implanted. i dont know how /why a dr would chose to put the paddle in without the patient being aware of it, and without their consent. i would think with your description of paddle insertion being an actual back surgery, by law, they would be required to inform the patient of this, as it would entail a longer recovery period.

You are quite lucky if your dr is willing to bring you back up to the dosage of pain meds you were on previously (i think you stated it in one of your comments to another)
i also dont know what previous surgeries you had before you decided to go with a SCS. i have kind of a unique and different situation. i had a disc replacement with a titanium cage above at L4-5 S1 in 2006, which was not successful. But, the dr that performed my surgery lost his medical license. he was involved in a scheme where they were putting in fake screws that were made in a job shop in California, and taking kickbacks from them. The name of the company is Spinal Solutions, and was also featured on an edition of Crime Watch Daily with Chris Hanson. if you google it, you will find the story. what is happening, because they are not hospital grade titanium screws, they are breaking in half in people. the only way you know if you have these screws in, is to get your records from the hospital and see what is listed as being used in your surgery, or, if they open you up to see for sure, which they are not recommending. not everyone was able to obtain their records, as the hospital is also involved in a lawsuit, and i heard the dr took some patients records with him when they shut down his practice. i was not able to get mine, so i dont know if ive got a ticking time bomb in me or not. i guess this is some of my hesitation in not wanting to have another surgery, and having my SCS taken out, but i dont think i have a choice.

11

Thankyou so much for your comprehensive reply, it’s very useful to know all this. The med part of it doesn’t really worry me as I’ve not found anything that really helps with the pain, been taking gabapentin, but weaning myself off it. Any pain relief would be good, also I heard the nevro reps aren’t all that good with communication after implantation.
The escalation of pain, or maybe pain caused in other areas is concerning, thankyou for explaining this, it’s something to watch out for.
The waiting list is quite long where I am, it’s a few months since I was put forward, and still waiting for assessment, then a few months for the trial.
Wish me luck!

12

Ouch - what a horror story. I’m so glad I had a true surgeon do the paddle approach on me. I’ve had no slippage of the battery pack, no detachment of the leads, no surgical problems whatsoever.
I’ve had the problem with the unit causing its own form of neurological pain, but as I mentioned elsewhere in this thread, I was able to work around that, mainly by powering it down and having the tech try different settings (one important setting change they can make is the “pulsing” setting - they can change the amount of time the power is on vs. off. That made a big difference for me.
But your issues were big - both an incompetent placement of the device and then the device simply didn’t work for you once implanted correctly. Sorry to hear you suffered so much with it…

13

For me the first implant was done by my pain management doctor. Bad idea…

My second surgery done by a neurosurgeon who did a great job putting in the paddles, but I think if the first doctor hadn’t screwed things up how would the Nevro F10 worked.

14

I had a spinal cord stimulator put in 2 years ago, never worked for the get go. Battery stopped working about 6 months in and could never get it to charge. The Medtronic rep had the jump start it and it didi start but would not hold a charge, due to the fact that the device is to stay upright and mine is sideways. I am still fighting to get it removed, and it is beginning to be so painful. I just don’t know where to turn next. Any advice would be so very helpful.

Thank,
Beth

15

I had a spinal cord stimulator put in 2 years ago, never worked for the get go. Battery stopped working about 6 months in and could never get it to charge. The Medtronic rep had the jump start it and it didi start but would not hold a charge, due to the fact that the device is to stay upright and mine is sideways. I am still fighting to get it removed, and it is beginning to be so painful. I just don’t know where to turn next. Any advice would be so very helpful.

Thank,
Beth

16

Beth,
So very sorry to hear that. The batteries should be good for at least 5 or 7 years, at which point it is pretty common that the doctor goes in to replace it. I don’t see why, if the battery has demonstrably stopped working, that they won’t just swap out for a unit with a working battery.
Two questions though:
(1) Who exactly is saying no to you regarding a removal/replacement? Is Medtronic refusing to give you a replacement stimulator? Is the doctor who implanted it refusing to do the replacement/removal? Is an insurance company (or NHS if you are British) refusing to cover the cost of the replacement/removal? To get the situation resolved you would first and most importantly want to know who actually is the roadblock.
(2) Second question, a little unrelated. You say that the pain from the stimulator is getting really bad. Generally speaking, stimulators shouldn’t cause any problems when they are essentially turned off. Where is your stimulator implanted? Are you sure the pain you are feeling is from the stimulator?
*
But aside from that, I would say once you find out who exactly is refusing to help you (and what their reasoning is), the best way to get action (particularly if you are in the US) is to go speak with a personal injury lawyer. A botched procedure like yours is something they would find very attractive as a case. They might at least be able to rattle cages with a threatening letter, to at least get the doctor to remove the device. Best case scenario, they could get you some money for your pain and suffering. Also, it is very likely that Medtronics has made payments to your doctor for his support of their product. You can find those payments on openpaymentsdata.cms.gov, simply by typing in your doctor’s name. If you do find such payments, that would make the case even more appealing to an attorney.
Good luck!

17

My Spinal Cord Stimulator has been in my body since 2018. It was implanted in my right upper butt cheek. Now it is just under my right kidney. I had told the surgeon not to put it on that side because I have a “Dumbbell” tumor on top of my sciatic nerve. My stimulator was sitting on top of the tumor for quite some time. Now it has migrated north just above the tumor. I am concerned about my kidney since I have Stage 3 Kidney Disease due to Lupus.
Should I contact another surgeon since I am no longer in the same state? What should I do? I am 65 years old and very concerned about my health.

18

There are numerous articles, investigations & other doctors & clinics that have documented the problems, injuries & worse of spinal stimulators. There are also recalls & class action lawsuits on spinal stimulators & it’s got nothing to do with the placement of the devices. My pain specialist has told me, in no uncertain terms, that I either get a spinal stimulator or he stops my opioids. I am not a good candidate for a stimulator because of all the conditions I have as well as the depression & anxiety I have. I’ve done all the injections that are available & nothing has worked except for opioids & they only do so much. I refuse to get a stimulator & I’m sure that I’ll be looking for a new pain specialist but they are few & far between for me because I am on high doses because of all my problems & because I have been suffering them for over 20 years. I no longer am comfortable with anyone trying to implant anything in me that’s not my original equipment because of the failure of the cervical fusion done in 1999. If I could, I wouldn’t see another doctor for anything because they do not know enough about the spinal cord to be doing anything with it. If a stimulator works for you, congratulations! but it doesn’t work for everyone & it causes too many injuries to people to be considered for a worthwhile alternative to opioids.

19

i have had mine only a few months and ive had problems with mine from the get go. i am a heavy woman and i have to twist like a pretzel to even get it to work , and the thing aint did nothing but cause me more pain they have charged the settings 3 time and it still aint right, and the battery dies quick , and when it is charged it feels like its burning my skin, i am finally going to get it out this month . after trying to get them to take it out 3 times and they didnt want to , till now

20

Hi folks,
I’ve had the Nevro Spine Stimulator since Feb-2018. It is paddle installation mid back with battery in right side abdominal. I’ve had 7 back surgeries including 2 laminectomies, a charite artificial disc (L5/S1), Fusion cage L4 to S1 and then removal of the fusion hardware due to bad installation. Finally in 2018 I had the Spine Stimulator installed.

Prior to my charite disc I was in a wheelchair and that allowed me to walk. Similarly prior to the SCS I was in a wheelchair for about 4 months and it allowed me to walk again so I have to say it was very successful.

Unfortunately according to my doctors my spine is continuing to degrade so we are planning for another return to the “chair” in the next couple of years.

To that point, the SCS (after about 4 years) is no longer providing relief. I believe it’s probably time for it to be removed however I now live in a country that the Nevro device is not sold or licensed in (Philippines). I’ve reached out to my old surgeon as well as Nevro (3 times each) unsuccessfully to find out what should be removed.

Do any of you know?

  1. Can just the battery be removed so I don’t have to worry about it being damaged?
  2. Do I have to remove the paddle leads from the spine along with the wires?
  3. Can I just leave all the hardware alone and not use it any longer?

Thanks so much for any thoughts or experiences you have. Great forum. It is wonderful to see all the information and I wish you all well.

Thanks,
Tony