neurostimulator implant

It depends on what she does for work. It also depends a lot on her personal medical history & what exactly they are doing for her procedure. Typically, the recommendation for stimulator implants is no lifting of 5 lbs. or more for 6 weeks. Bending & stretching activities may also be limited by the physician for 6 weeks or longer.

Some people are higher risk & require less activity, but most people can handle light activity starting a couple weeks post-op. I can't imagine her being "layed up" for the whole 6 weeks unless there is some complicating factor, but it is entirely possible that she couldn't return to her work or participate in many activities for that time. Running, hiking, swimming, aerobics, etc. are typically all prohibited until the leads have scarred into place. If the person getting the implant resumes regular activities too soon, the leads can move & the person would have to have another surgery to put the leads back into place.

Hope that helps! Well wishes for your friend!
frances

Thank you both for your response I am not sure which surgery she is having but will guess it is percutneous leads since she is having day surgery. She is a waitress but everyone around her works with her so she is not lifting anything over 5 pounds already or bending. She has been in such pain for so long it will be a pleassure to see her get some relief so she can get back to enjoying life and playing with the grandbabies.

Thank you for responding. I hate to see her hurting and I hope this will help her. My heart goes out to all of you having to deal with this. I complain when I get aches and pains and then look at what my friend and others in her situation go through and it makes me feel guilty for whining.

I have had the implant since 1996.  I was told that average time for replacement of the battery is 4 yrs 7 months.  Mine lasted more than 7 years because of the way I use it.  Most people turn it on for a while and then turn it off - several times a day.  I turn mine on in the morning and turn it off at night.

I had not had my implant adjusted and re-set since 2002.  I had it checked yesterday and my battery is doing fine.  They reset the controls and I feel like a new person.  The pain is gone!!!  It is very important to have it checked on a regular basis.

The surgery to replace the battery is out patient and the recovery time is very short.

MsKitty

Hi Brent:

My Medtronic rep. told me that my battery has an average life-span of about 9 years (the RestoreUltra). BionicWoman was told 10 years so it seems it is somewhere around there!

The leads can move and break..just like any equipment but the chance of that happening with the surgical leads is much, much lower. There can be problems with the tunneling cable as well but, again, the chance of any problem is low.

The battery replacement surgery is an out-patient, procedure as others have mentioned. They just open you up and insert a new battery, close you and send you home!

The tunneling to place the leads is not bad at all..you really don't feel that because those are in your spinal canal. "Tunneling" really refers to the connecting cable from the paddle to the battery/generator. I had mine tunneled over my ribs and around my waist and it was pretty painful but nothing unbearable. It's a very tender, bruised feeling. That's the best way I can describe it.

Are you considering a stimulator trial??

Best,
Danimal

Danimal,
Yes, I am considering it, though I find the idea of something with a battery permanently implanted in my body a bit scary (the stuff that makes up batteries is invariably both toxic and corrosive, from what I have been told, and a leak is always possible with any device). I discussed my concerns with my PM doc earlier this week. He feels I am a good candidate for the device, and I am on the verge of making my decision. The doc recommends the Medtronic "ultra" model.
I like the idea of pain relief sans drug side effects like tolerance, sleepiness, etc. In that way it sounds like a wonderful device.
I am concerned about a few things. I asked my doc a ton of questions on Tuesday, but forgot a couple. I will ask him next month about the following, but welcome your comments and experiences as well:
1. Does having the device implanted mean that you will not be a candidate for an artificial disc in the future, or could it simply be removed and disc replacement surgery performed?
2. I have read that if you have a heart attack and get defibrillated, this device poses a problem. What happens in that situation? Do they simply let you die because the device is implanted?
What happens if your disease (in my case lumbar disc problems) progresses and they need to get a picture? I know they cannot do an NMR. Is there an alternative, or do you have to have it removed and re-implanted just for an NMR?
I know these are technical issues, but if you have any knowledge I'd love to hear what you know. Also love to hear any comments on the Medtronic "ultra" or any other model).
Brent

I see Danimal answered with much of the same information, but I wrote all of this earlier and forgot to hit submit. Seems a shame to waste it, so *submit*
The SCS doesn't interfere with fusion hardware, artificial disks, etc. directly. Keep in mind is that the SCS leads are typically placed at a healthy area of your spinal cord, not at the injury site or problem area of your spine. For example, the majority of people that have an SCS implanted for lumbar problems find their leads placed in the thoracic spine - T8 through T12. My issues are mainly L4/L5/S1 and normally, my doctor said he'd place the leads for that area between T10-T12. I have some non-symptomatic disk issues in that area too, so my leads are placed at T7-T8.

The problem with defibrillators is that the leads can pick up the electric charge, transmit it backwards, and damage the impulse generator. The FDA requires the implant manufacturers to advise patients and doctors of any device that can cause damage to the system or that the system make interfere with. As far as defibrillation goes, the stimulator and leads have potential to interfere with the function of the defibrillator and that's the most important reason for the warnings - you must always carry the card so that emergency medical personnel can make any adjustments required to render effective care to you (i.e. turn off the stimulator if you're unable, change settings on their equipment, etc.) As far as letting you die because of the device, Medtronic states clearly in multiple places in their literature (including the patient instruction manual) that preserving the life of the patient is the primary concern, and repairing any damage to the system is secondary.

To answer the first part - if your doctor needs imaging of your spine and you have an SCS, they will most likely turn to the CT scanner.
I'm assuming by NMR, you're referring to magnetic resonance imaging. I recently had a long discussion about this topic with my doctor.
The reason you can't have an MRI with the SCS implant is because of the electromagnetic field created by the scanner; the pulse generator and the lead wires absorb heat during the scanning process and rise to a temperature that literally burns and destroys the tissue around them. Even when doctors explant an SCS system, they rarely remove the lead wires entirely; typically, they remove the IPG, remove the electrode ends of the leads, but they leave the wires along the tunnel intact because removing the wire from the scar tissue would require an incredibly invasive surgery for very little actual benefit. And, unless you've had every single bit of the SCS system removed, the MRI remains off limits because the remaining pieces of the lead wires will still conduct heat.
I asked my doctor specifically what we'd do if he needed another MRI of my spine. He sort of laughed and said that needing an MRI is a very relative thing. His explanation of that was to tell me that the MRI scan is a lot like "one stop shopping" at Walmart. You can get what you need, all in one store, and the price is pretty good when you look at the average cost per item, and you're in and out pretty quick. What people tend to forget is that with a little more effort, you can also get all the same things at several little Mom & Pop shops, but you might pay a little higher cost per item, drive a little farther, and it'll take a bit longer. Either way, when you're done shopping, you have what you need to make dinner. Doctors can run a single MRI and obtain a lot of information (i.e. Walmart), but people fail to realize an MRI isn't the only way we can get that information; it can also be obtained through a combination of other diagnostic tests (i.e. Mom & Pop Shops).

Brent,
It is a fairly involved procedure to implant a SCS. For my procedure, it took 5.5 hours from start to finish. I was wide awake & unsedated for the whole thing & can attest to the fact that it can be quite involved. Yes, the surgeon stands to make quite a profit from the procedure, but God help us if we have more than a rare few doctors who make serious medical decisions based on potential for profit rather than what's truly in the best interests of their patients. There are some doctors who really enjoy performing surgical procedures & limit their practice to only procedures & not to prescribing other types of treatments. From my experience, those doctors are very open about the fact that they only do procedures & that if I hadn't already tried less invasive treatments, that I should find another PM and try those first. As with any surgery, there are real risks involved & though they may be far less than say, a fusion surgery, that doesn't change the fact that surgery should be one of the last treatment options considered in any case, except where there exists the potential for loss of life or limb.

My own PM feels pretty strongly about the SCS as a truly miraculous form of treatment. He does try meds, PT, massage, heat/cold therapy, alternative medicine, etc. prior to recommending surgery, but he has also seen how drastically quality of life changes for the vast majority of his patients who've had one implanted. He hasn't seen those kind of results with any other treatment so whenever he feels that a patient of his qualifies for an SCS implant, he gets really excited. Do remember that the reason why many of these doctors practice in the field of pain medicine is b/c they want to see their patients in less pain & with increased functionality. When I think of it that way it is not hard to understand why my PM gets so excited. Out of the hundreds (nearly 1K now) of patients in whom he's implanted an SCS unit, only 2 have said that they see no real relief from it. 1 of them had the unit explanted & the other is considering that. Honestly, I have seen how distraught he is over those 2 patients. He really empathizes with people & I have occasionally seen him on the verge of tears when a patient of his isn't responding to any treatments at all. He really wants to be successful in treating people & often enough that involves an SCS.

Now, some people just aren't good candidates for an SCS. If you're really concerned that your doc is in it for the money, ask him how he rules people out for an SCS implant. If he doesn't have any criteria, I'd personally run as fast as I could out of that office & never come back. That is sloppy medicine & something is up. As a follow-up, you might ask if he's ever had to turn a patient down for an implant & why. He ought to be able to give at least one example. Beyond that, I think that the SCS is probably just a combination between the latest toy & the closest thing to a "miracle cure" that's available. If you're into that kind of thing, it can be pretty exciting. Obviously, it's less alluring for the patients who worry about how to pay for it, what the side effects might be, how long & difficult the recovery period will be & whether it will really work as well as they say (I think it rarely does, but that's not to say that it wouldn't be a fantastic turn-around in your treatment. Mine has allowed me to be far more active than before. My PM promised I would be 100% better. I think it's probably closer to 60-70% improvement, but that's still a really impressive result). That said, just try to focus on the facts & leave as much of your PM's salesman-like exuberance out of your decision-making. :)


Also,
In regards to the MRI issue:
I had a problem with that. Yes, to an extent, there are other tests that can be run. 18 months ago when I was hospitalized, I found out just what that meant. I have the SCS in my neck. But a couple years ago I developed severe, crippling pain in my low back such that all I could do was scream & moan all day long until I would fall asleep or pass out from the pain. They ran a Lumbar CT, bone scan & some kind of nuclear medicine test. Then they did a discogram/L-CT. We still couldn't get a dx. I had to wait 60 days, have my PM fill out a ton more forms for my insurance to cover more procedures & then go through 2 more discogram/L-CT's. Finally, they found the problem -- a bulged disc, some sort of miniscal tear (not sure I've got that right), and multiple fractures to my vertebrae at L4 & L5.
I was so angry about having to go through all of that, so I started to do some research. Apparently, trying to find previously unidentified problems with a CT is like looking for a needle in a haystack. You have to have both the patient & the equipment positioned just right & they you need the right kind of pictures. It is not easy by any measure. What would have almost certainly otherwise been diagnosed after a single MRI, now took me almost 6 months & exposure to a LOT of radiation to find out what was wrong. If I had it to do all over again, I would get another SCS implanted without batting an eyelash. But, I think that doctors often make it out to be far simpler than it really is to try to get diagnosed without an MRI.
Now, if it really were life-or-death, my PM said he would have signed off on me getting an MRI done. U.S. law allows the implanting surgeon to make that judgment call. There are studies that have been done in Spain with humans that indicate that the leads do not get hot to cause either serious or irreversible tissue damage, but the FDA does not allow any such trials to be completed here in the U.S. So we have to rely on small animal trials & those do not always perfectly translate into what happens in humans. There are leads in development that are supposed to be safe with an MRI, but so far they have only been tested in small animals & primates. The FDA is not allowing human trials yet even of those new "safer" leads. So, we're at a bit of a standstill.
I don't say any of that to necessarily discourage you from getting an SCS. Like I said, I really love mine, but there are real issues to take into consideration & I think everyone should know as much as possible about what they're getting into ahead of time.

best of luck with your decision,
frances

You really don't have anything to lose by going through the trial. At the end of the trial period - whether it's a success or a failure - the entire system is removed, including the leads. When they put the trial leads in, they usually just use a single stitch to hold the wire to your skin on the outside, to give it a little bit of stability. Once the trial is removed (which amounts to the doctor clipping the stitches, grabbing the lead wire, and pulling) your body is in the exact same condition as it was prior to the trial, with the exception of a couple little needle holes in your back.

I think for most people, the trial period gives them the answer to what they're willing to "sacrifice" for the relief it offers - or doesn't offer. For me personally, I worried about a laundry list of things before my trial was placed. By the time my trial was removed, my perspective had completely changed about my laundry list of worries and I knew that if I didn't go forward with the permanent implant, I would be throwing away an amazing opportunity to regain a huge portion of my life, based on a list of "if's" and "mights" that had no certainty to them at all.

Brent,
Some surgeons will remove the leads after the trial no matter what. Others will leave the leads in place & immediately following the trial they will do the permanent implant. A lot of docs won't do the latter since it means scheduling a surgery room without knowing whether or not it will be used.

There is basically no scarring that occurs during the 1 week trial. If you think about any time you've gotten a serious gash or cut, it takes some time for the wound just to heal closed. Then the scar tissue forms over the months following the initial injury. It is the same with the "injuries" caused by implanting the leads -- it takes months for them to scar into place. You should have the leads removed after the trial for sure if you decide not to go further. Some docs do reference tissue damage as the reason why they like to go straight from the trial to the implant. It is not always easy to get the exact same location due to them creating a new tunnel. From my understanding, they cannot reuse the same tunnel so some surgeons prefer to use the original leads. For me, the trial leads went in at C7 & were tunneled up to C1/C2. The leads then connected to an external battery pack that I wore around my waist in a fanny pack. For the permanent implant, the leads went in a T7 & were tunneled up to C2 (then a cord & extension cord went down to the battery pack in my derriere). They could not get the exact same location, but that was due to scar tissue that had formed years prior from a C1 laminectomy.

It would be weird for your surgeon to leave the temporary leads in since they stick out of your body (& then connect to an external battery pack that controls the settings). I can't see how they could leave wires sticking out of your body. Perhaps your doc just didn't explain it quite right. ;)

take care & good luck with your decision,
frances

Wow!  Bionic, you really had to wait quite some time for the permanent implant.  My PM took 2 weeks from the trial to the permanent surgery & that was only b/c it was split by Christmas vacation.  Usually he would only put 1 week in between.  Fortunately, his practice has their own surgical center & so they don't have as many obstacles to face with scheduling the OR.  BS has a lot of reps (at least in my area), so it was no problem to get someone out to the OR.  It wasn't my usual rep, but I figure they're all trained the same anyways.  My PM did pre-cert the trial & implant together with my insurance.  I'm not sure whether that's always possible, but perhaps it is something to look into for those of you who are considering getting this procedure done.  Of course, if you are getting the paddles & have 2 different surgeons doing the trial & implant, that probably isn't possible, but I know for me that was the hardest part knowing that I could get relief from the SCS & then having to go without it for a period of time whilst waiting for the implant surgery.

There are ways to use the permanent leads for the trial, cut off the external part, attach a connector & add on an extension cord (or 2) to run down to the battery pack.  One NS I interviewed did that.  He is one of the first people who ever did neurostimulator implants in the U.S. & trains many of the doctors in the Midwest on the procedure.  He actually trained my PM, but my PM decided to do it differently on the advice of the BS rep.  I'm quite happy with the result, so perhaps there is something to that, but I do think there are certain cases where people have had multiple surgeries when you only have one shot at getting the leads placed right -- in those cases, maybe starting with the permanent leads is the best option -- but I'm with Bionic that I would rather have them removed (miserable as it is to have them re-placed).

btw -- I think the pics that Bionic posted are really fantastic.  I saw the samples of them that the BS rep brought for my decision meeting prior to the trial & had forgotten about the part that the cord that runs from the external battery to the leads actually looks a lot different from the permanent one that runs to the internal battery; I think it's really neat that they put that out on the web.  So cool! :)

I think this is what my doc was saying - I remember him talking about cutting part of it off. So, if the trial failed, I think he intends to cut off the part that sticks out of the skin but leave the rest in there. I don't like that idea. Do you all think that I should have the right to tell him I want it fully removed if the trial is a failure?
BTW, thank you Frances, Bionic Woman, Danimal, everyone! For me the decision to accept an implant of any type is very hard, possibly because I still want to believe I may get better someday and the implant forces me to think that what damage I I have in my back is a permanent defect. Anyway, the more info I get the better, and I know you guys are giving me the straight dope - not manufacturer's propaganda nor worthless scuttlebutt. I am becoming more comfortable with the idea (although the thread about someone regretting their decision to get one for a cervical problem shoved me a bit in the other direction). I know ultimately I will need to to something. I don't want to just be all spaced out on painkillers, my insurance company won't pay for IDET or an artificial disc (my only other covered option is a spinal fusion, and that has such a high incidence of failure to bring relief I can't believe they even suggest it), so the stimulator is all I really have as an option.
Thanks again everybody. The information you have provided for me is wonderful and I truly appreciate that you all took the time & made the effort to do so!
Brent