Long-term Medtronic Pain Therapies

If your screening test is successful, you and your doctor can discuss long-term therapy. In long-term therapy, the neurostimulation (also known as spinal cord stimulation) system or drug delivery system is placed under your skin during a surgical procedure.

Medtronic Pain Therapies are FDA-approved treatments that have been shown to be safe and effective for people who have not had success with other chronic pain treatments.

What to Expect During the Procedure for a Neurostimulation System Implant

If you and your doctor decide to use neurostimulation therapy to treat your chronic pain, the system will be implanted during a surgical procedure. This procedure is most often performed in a hospital or surgery center on an outpatient basis. You may even be able to return home on the same day as your procedure. However, some people stay overnight.

During your procedure:

• You will be placed on an operating room table, probably on your stomach
• The medication you are given may make you drowsy
• Your doctor makes a small incision (about 2 to 4 inches long) on your back and uses a needle to place the leads (medical wires) that deliver the stimulation into the epidural space of your spinal cord
• A second incision (also about 2 to 4 inches long) is made where your doctor forms a pocket under the skin that is large enough to hold the neurostimulator
• Your doctor connects the leads to the neurostimulator
• Once the leads and neurostimulator are in position, the doctor closes the incisions and completes the surgery
• The procedure takes approximately 1 to 3 hours
• The length of your hospital stay will vary depending on your doctor’s preference and hospital procedures

Risks of Neurostimulation Therapy

The spinal cord stimulation system is surgically placed under the skin. Surgical complications are possible and may include infection, pain at the site of surgery, and bleeding into the epidural space. Once the neurostimulation system is implanted, device complications may occur and include corrective surgery, jolting, leads breaking, and movement of the leads within the epidural space which may require reprogramming or surgical replacement of the leads. These events may result in uncomfortable stimulation or loss of therapy.

For additional safety information, please refer to Important Safety Information. Always discuss the potential risks and benefits of the therapy with your doctor.

What to Expect During the Procedure for a Drug Delivery Pump

If you and your doctor decide to use a drug pump as part of your pain management plan, the system will be implanted during a surgical procedure. This procedure is most often performed in a hospital or surgery center on an outpatient basis.

The SynchroMed^® II pump is available in two sizes – 20 ml and 40 ml – to meet your size preference and refill schedule. Your doctor will decide which size is right for you.

Before the procedure, you and your doctor will decide where in your abdomen to position the drug pump for your comfort.

During your procedure:

• You will be placed on an operating room table, probably on your side
• Typically, the implant is performed under general anesthesia
• Your doctor makes an incision (about 6 inches long) in your abdomen. This is where the pump is placed
• Your doctor will form a pocket under the skin that is large enough to hold the pump. This pocket is in the abdomen
• A second incision (about 2-3 inches long) is made on your back. This incision is used to place one end of the catheter into the intrathecal space
• The other end of the catheter is tunneled under the skin and connected to the pump, resulting in a fully implanted system
• Once the drug pump and catheter are in place, the doctor closes the incisions and completes the surgery
• The procedure takes approximately 1 to 3 hours
• The length of your hospital stay will vary depending on your doctor’s preference and hospital procedures

Risks of Drug Delivery Therapy

The implanted pain pump and catheter are surgically placed under the skin. Surgical complications are possible and include infection, spinal fluid leak, and headache. You should not undergo the implant procedure if you have an active infection at the time scheduled for implant.

Once the infusion system is implanted, device complications may occur which may require surgery to resolve. Drug overdose or underdose can result because of these complications and have serious and even life-threatening adverse effects. Possible complications include the catheter or pump moving within the body or wearing through the skin. The catheter could leak, tear, kink, or become disconnected. The pump could stop because the battery has run out or because of failure of another part of the infusion system. Additionally, inflammatory mass has been reported at the tip of the catheter which may lead to complications, including paralysis.

For additional safety information, please refer to Important Safety Information. Always discuss the potential risks and benefits of the therapy with your doctor.

What to Expect the First Weeks of Recovery

The recovery time after getting the therapy is usually short, about 6-8 weeks. You may experience some initial discomfort and limits on movements. Be sure to listen to your body and follow your doctor's instructions.

After a few weeks, it's a good idea to try some activities you enjoy, such as going for a walk, riding your bike, going to a movie, or watching a ball game. Then, set some goals for other activities you'd like to try or tasks you'd like to accomplish.

Medtronic Pain Therapy Adjustments

As you rejoin your life, you may find that you experience pain when you do a particular activity or at certain times of the day. Or your pain may be unpredictable and have no pattern. You can respond to changes in your pain symptoms by adjusting your therapy, using your programmer or therapy manager. This hand-held device is like a remote control that controls your implanted device. It gives you a safe and easy way to take an active role in managing your pain.

Your doctor will use a computer-like programmer in his or her office to program your implanted device settings. Depending on the type of pain therapy you are receiving, you will use one of the hand-held devices below to manage your pain.

What to Expect During Daily Life with a Medtronic Pain Therapy

Realistic expectations are key to satisfaction with any pain treatment. It is important to remember that your drug delivery therapy or neurostimulation therapy will not eliminate the source of your pain or cure any underlying disease, but can help you manage the pain.

Talk with your doctor about activities you can do and when you should be a little more careful. Call your doctor right away if you:

• Experience additional or unusual pain
• Notice changes in the effect your therapy is having on your pain
• Think you need to increase the intensity of your therapy

If you currently have a Medtronic drug pump or neurostimulator and need product support, please visit our website for people receiving a Medtronic pain therapy.

Next: Answers to Common Questions