About Medtronic Pain Therapies

If you've tried other treatments but are still suffering from chronic pain, you may be relieved to hear about another option: Medtronic Pain Therapies.

What Are Medtronic Pain Therapies?

Medtronic offers two types of FDA-approved therapies for chronic pain: Spinal Cord Stimulation (also known as Neurostimulation Therapy) and Drug Delivery Therapy.

If you have been in pain for more than 6 months and your current treatment has not provided adequate relief, Medtronic Pain Therapies may be the right choice for you.

Either therapy may help you:

• Manage your pain
  Patients who are successful with Medtronic Pain Therapies typically experience 50% or greater reduction in pain. ^1,2

• Restore your ability to do everyday activities
  With Medtronic Pain Therapies, you may enjoy more freedom and the ability to perform day-to-day activities with less pain.^1,3

• Decrease your need for oral pain medications
  You may be able to reduce or even eliminate the oral medications you take for pain.^3,4

How Can I Find Out if a Medtronic Pain Therapy Is Right for Me?

You can try a therapy during a screening test to find out if it will work for you before making a long-term commitment. Your doctor will determine if the screening test should be for spinal cord stimulation or drug delivery therapy, based on the type of pain you experience, its severity, and your response to pain treatments.

After the screening test ends, you and your doctor will discuss the results and decide together if you should proceed to long-term therapy. With long-term therapy, a spinal cord stimulator or drug pump is placed under the skin during a surgical procedure.

Are Medtronic Pain Therapies Safe and Effective?

Medtronic spinal cord stimulators and intrathecal drug pumps are approved by the United States Food and Drug Administration. The first spinal cord stimulator was approved in 1984 and the first programmable implantable drug pump was approved for the treatment of chronic pain in 1991.

Medtronic was the first company to introduce a spinal cord stimulation system and a programmable implantable drug infusion system. Since Medtronic made these therapies available, more than 400,000 people suffering from chronic pain have chosen a Medtronic Pain Therapy.

What Are the Risks?

Medtronic Pain Therapies are safe and effective when used as directed. The neurostimulation implant 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, lead breaking, and movement of the lead within the epidural space which may require reprogramming or surgical replacement of the lead. These events may result in uncomfortable stimulation or loss of therapy.

The implanted drug 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 drug 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 a more complete list of adverse events that have been associated with the therapies, please refer to the Important Safety Information. Please talk with your doctor to fully understand the risks and benefits.

Next: About Spinal Cord Stimulation

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. Winkelmüller M, Winkelmüller W. Long-term effects of continuous intrathecal opioid treatment of chronic pain of nonmalignant etiology. J Neurosurg. 1996;85:458-467.
3. 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.
4. Ohnmeiss DD, Rashbaum RF, Bogdanffy GM. Prospective outcome evaluation of spinal cord stimulation in patients with intractable leg pain. Spine. 1996;21:1344-1350.