Answers to Common Questions

Following are some common questions about Medtronic spinal cord stimulation (also known as neurostimulation therapy) and drug delivery therapy for chronic pain. Don’t see your question here? Ask your doctor, find a pain management specialist in your area who can answer your questions, or see doctors' answers to common questions.

Questions About Medtronic Pain Therapies

Is it dangerous to have a foreign object in my body?

Medtronic performs routine testing to ensure devices are safe to be implanted in your body. Millions of people around the world have implanted medical devices such as pacemakers and implantable cardioverter defibrillators (ICDs).

Is there a risk of infection?

As with any surgical procedure, there is a risk of infection. Follow directions given by your doctor to avoid infection. Contact your doctor with questions or concerns.

Is the drug pump or spinal cord stimulator a new device?

No. The U.S. Food and Drug Administration approved the Medtronic programmable implantable drug pump as safe and effective for the treatment of intractable chronic pain in 1991. Spinal cord stimulation was developed by Medtronic and approved in 1984.

Will my insurance company cover the costs?

Many insurance companies will pay for Medtronic Pain Therapies. However, as with many pain treatments, your doctor will have to get approval from your insurance company before you can receive treatment. Your out-of-pocket costs will vary according to your insurance plan. Consult your doctor or insurance carrier for more specific information.

Are the screening test and long-term therapy procedure covered by Medicare?

Medtronic Pain Therapies are approved for coverage by Medicare. Medicare will pay 80% of the cost as long as the procedure is determined to be medically necessary. Talk to your doctor about the Medicare Conditions of Coverage.

How will I know if it will work for me?

Talk to your doctor to determine the kinds of pain treatments that may work for you. The choice of treatment depends on the type of pain, its severity, and your response to your pain treatment. If your doctor thinks you are a good candidate for spinal cord stimulation or drug delivery therapy, you can complete a screening test to see if the therapy will provide adequate pain relief.

How does neurostimulation feel?

The sensation felt from spinal cord stimulation varies from person to person, but most people report a mild tingling sensation in the area of their pain.

Will neurostimulation therapy completely eliminate my chronic pain?

Typically, people who find the treatment helpful experience significant and sustained reduction in chronic pain.¹ However, spinal cord stimulation does not eliminate the source of pain, so the amount of pain reduction varies from person to person. Neurostimulation therapy is not a cure for chronic pain, but rather a therapy to help you manage your pain.

Why would my doctor and I choose a neurostimulator that offers adaptive stimulation?

As you change positions, your spinal cord may move closer to or further from the electrodes that send out the mild electrical pulses. A therapy level that blocks your pain well when you're standing may cause discomfort when you're lying down.

Depending on the neurostimulator you and your doctor choose, you can either adjust the stimulation manually by using your programmer, or your neurostimulator will automatically adjust it for you, using a technology called AdaptiveStim^®. AdaptiveStim is available only from Medtronic, with RestoreSensor^®. Adaptive stimulation reduces the need to manually adjust your stimulation level when you change positions.

Will drug delivery therapy completely eliminate my pain?

Many people experience significant improvement in their pain symptoms and quality of life after receiving Medtronic drug delivery therapy. However, realistic expectations are essential to satisfaction with any pain treatment. Drug delivery therapy does not eliminate the source of the pain, so the amount of pain relief varies from person to person. Drug delivery therapy is not a cure for chronic pain, but rather a therapy to help you manage your pain.

Will Medtronic Pain Therapies eliminate other sources of pain?

Your spinal cord stimulation or drug delivery system will not provide relief from other types of pain such as headaches, stomach aches, fractures, etc.

Questions About the Screening Test for Spinal Cord Stimulation

How long does the screening test take?

The procedure to get the screening test takes approximately 30 to 90 minutes. The screening test period lasts approximately 3 to 7 days.

Will the procedure hurt?

You will have local anesthesia when the leads (thin, insulated medical wires) are placed. There may be some occasional discomfort during the procedure, and you may have pain at the incision site once the anesthesia wears off. This should resolve after a day or so. You should not have pain or discomfort during the rest of the screening test period.

What are the risks of the screening test?

Complications can occur with the screening test and may include infection and movement of the lead within the epidural space. Please discuss the benefits and risks with your doctor.

Can I have pain medication during the screening test?

Your doctor may reduce or withdraw your oral medication 1 to 2 weeks prior to the test. During the neurostimulation screening test, oral medication may be given for breakthrough pain. Never stop taking your prescribed pain medication without first consulting your doctor.

Will I receive the same relief that I get during the screening test when I receive my long-term spinal cord stimulation?

Your pain relief may differ slightly. For most people the stimulation they feel at implant is similar to that at the screening test. Your doctor can adjust your neurostimulator so it delivers the best pain relief possible. Be sure to tell your doctor about the way you feel, so that changes can be made to optimize your therapy.

After the screening test, how long will it be until the long-term neurostimulation system is implanted?

If the screening test is successful, you and your doctor will discuss when the system should be implanted. There is typically a waiting period between the screening test and the implant procedure. This will give the incision in your back time to heal and allow time for your insurance provider to be notified and for the surgery to be scheduled.

Questions About the Screening Test for Drug Delivery Therapy

How long does the screening test take? Do I have to stay in the hospital?

This will vary depending on the type of screening test your doctor believes will be best for you. The test could take as little as a day, and up to 4 days. Depending on the type of screening test, you may undergo a procedure that takes approximately 1 to 2 hours and then need to stay in the hospital to be monitored after the procedure. Talk with your doctor to understand the details of the type of screening test that your doctor thinks would be best for you.

What are the risks of the screening test?

Complications can occur with the screening test, including bleeding, infection, and drug side effects. The catheter may need to be replaced. You should not undergo a screening test if you have an active infection at the time of the test, have a body size too small to accommodate an implanted pump, or if you are allergic to the screening medication.

Can I have pain medication during the screening test?

It depends on your pain level and your doctor. Your doctor may withdraw oral pain medications 1 or 2 weeks prior to the screening test. However, you may be given oral medication during the screening test for breakthrough pain. Never change the way you take your prescribed pain medication without first consulting your doctor.

If the screening test is successful, will an implantable drug delivery system provide the same pain relief?

Your pain relief may differ slightly. During the recovery period your doctor will slowly adjust the medication dose so you receive the best pain relief possible. This is because the medication dose may be different than the dose used during the screening test. Be sure to tell your doctor about the way you feel, so changes can be made to optimize your therapy. It may take some time to find the dose that works well to manage your pain – this is called “titrating” the dose.

How long after the screening test is the drug delivery system implanted?

If the screening test is successful, you and your doctor will discuss when the system should be implanted. There is typically a waiting period between the screening test and the implant procedure. This will give time for your insurance provider to be notified and your surgery to be scheduled.

Questions About Long-term Spinal Cord Stimulation

What are the benefits of spinal cord stimulation?

What are the risks?

What is the procedure like?

The procedure to implant the neurostimulation system takes approximately 1 to 3 hours and may require a brief hospital stay.

What type of anesthesia is used during the implant?

Typically, the implant of the neurostimulation system is performed under general anesthesia. However, you may wish to talk with your doctor about other options.

What is the average length of the hospital stay?

Depending on your doctor’s preference and hospital policy, a hospital stay may be recommended. However, the procedure may be performed on an outpatient basis, which means no overnight stay is required.

How big is a spinal cord stimulator?

The device is about the size of a stopwatch.

Will I hear or feel the neurostimulation system inside me and will people notice it?

The spinal cord stimulator does not make any noise. The device does not normally show through your clothes. It is often implanted in the lower abdomen, where it is most comfortable and least visible. It may be felt as a small bulge under your skin.

How do I control the stimulation?

You control the spinal cord stimulation with a handheld programmer that works like a remote control to adjust your stimulation within the settings your doctor has selected.

How often will I need to see my doctor?

A typical follow-up schedule is once every 6 months, although initially the neurostimulation system may require more frequent adjustments to provide the best pain relief possible.

Can the spinal cord stimulator be removed?

Yes, it can be turned off or surgically removed.

Will there be any restrictions on my activities?

After you have healed from the implant procedure, you may be able to get back to the activities you once enjoyed. There are some activity restrictions, such as activities that put undue stress on the implanted components of your neurostimulation system or that include sudden, excessive, or repetitive bending, twisting, bouncing, stretching, or lifting. Please discuss specific activities with your doctor.

What if I need an MRI?

Questions About Long-term Drug Delivery Therapy

What is long-term drug delivery therapy?

In long-term therapy, the drug delivery system is placed under your skin during a surgical procedure.

What are the benefits of drug delivery therapy?

What are the risks?

On average, how long does the implant procedure take?

On average, the procedure takes about 1 to 3 hours from start to finish. Talk with your doctor about the specifics and duration of your procedure.

What type of anesthesia is used during the implant?

Typically, the implant is performed under general anesthesia. However, you may wish to talk with your doctor about other options.

What is the average length of the hospital stay?

Depending on your doctor’s preference and hospital policy, a 1- to 2-night hospital stay may be recommended.

Can a previous abdominal incision be used to implant the drug pump?

Usually not. The incision needs to be made where the pump will be implanted to help properly anchor the pump. Proper anchoring helps keep the drug pump in place. This may help minimize your discomfort and speed recovery.

Between which vertebrae is the catheter placed?

That depends on your specific condition(s) and the results you received from the trial. Your doctor will advise you of the recommended catheter location.

Are there other side effects associated with placing the catheter in the intrathecal space?

In some cases, you may experience a spinal headache as a result of a needle or catheter being placed in the intrathecal space. A spinal headache is caused when cerebrospinal fluid (the fluid that surrounds the spinal cord) leaks out of the intrathecal space. This headache may correct itself, or the doctor may treat it.

How long will it take before I start receiving benefit from my drug pump?

You will begin receiving treatment as soon as your drug pump is filled with medication and the medication is delivered through the catheter to the specific site. However, depending on your medication, it may take several days to weeks before you experience benefits from your medication. During this transition period, your doctor may reduce or eliminate your other medication.

How often will the drug pump need to be refilled?

The medication in your pump needs to be refilled every 6 to 26 weeks, depending on your dosage. It is refilled by a needle injection in your doctor’s office. During these appointments your doctor can adjust your dose of medication to address your pain relief needs.

What if my pain changes? Can my doctor increase or decrease my dosage?

Yes. After implantation, your doctor can make changes in dosage requirements.

What if I have no improvement after the drug pump is implanted?

Let your doctor know if you are not receiving adequate relief from your symptoms. The doctor may be able to reprogram the pump to adjust the amount of medication it delivers.

What if I need an MRI?

The Medtronic programmable drug delivery system allows full-body MRI scans under specific conditions. Your drug pump does not need to be emptied prior to MRI exposure. It is important to know that the magnetic field of the MRI scanner will temporarily stop your pump motor and stop drug infusion until the MRI exposure is complete. Your pump should then resume its normal operation. Your doctor will make sure your normal infusion has resumed after the MRI procedure.

Can the pump be removed?

Yes. The screening test is designed to determine whether the pump will help manage your pain. However, your doctor can fill the pump with sterile saline or surgically remove the system.

How big is a drug delivery pump?

The SynchroMed II drug pump is 3.4" wide and less than an inch thick.

Will people be able to see that I have a pump?

Because your pump is placed near the surface of your skin for refill access, on occasion someone might notice a slight bump if you are wearing fitted clothes. However, depending on your size and shape, where the pump is implanted, and the size of your pump, it may not show under your clothes at all.

What do I need to know about opioids (pain medication) used in my pump?

Some doctors choose to use an opioid medication in the drug pump. There are risks associated with the use of any opioid pain medication. For more details, see opioid pain medication questions and answers.

Next: When to Consider Medtronic Pain Therapies

References

1. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized controlled trial in patients with failed back surgery syndrome. Pain. 2007;132:179-188.
2. Ohnmeiss DD, Rashbaum RF, Bogdanffy GM. Prospective outcome evaluation of spinal cord stimulation in patients with intractable leg pain. Spine. 1996;21:1344-1350.
3. IMV MRI market benchmark report 2007.
4. Doleys DM, Brown JL, Ness T. Multidimensional outcomes analysis of intrathecal, oral opioid and behavioral functional restoration therapy for failed back surgery syndrome: a retrospective study with 4 years’ follow-up. Neuromodulation. 2006;9:270-283.
5. Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5:6-13.
6. Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic non-cancer pain. Eur J Pain. 2001;5:353-361.
7. Brogan SE. Intrathecal therapy for the management of cancer pain. Curr Pain Headache Rep. 2006;10:254-259.
8. Gerber HR. Intrathecal morphine for chronic benign pain. Best Pract Res Clin Anaesthesiol. 2003;17:429-442.
9. Nance P, Meythaler J. Intrathecal drug therapy. Phys Med Rehabil Clin N Am. 1999;10:385-401, viii-ix.
10. Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10:357-366.
11. Smith TJ, Swainey C, Coyne PJ. Pain management, including intrathecal pumps. Curr Pain Headache Rep. 2005;9:243-248.
12. Winkelmüller M, Winkelmüller W. Long-term effects of continuous intrathecal opioid treatment of chronic pain 6. of nonmalignant etiology. J Neurosurg. 1996;85:458-467.