This story reflects the experience of one individual who is receiving Medtronic ITB Therapy^SM (Intrathecal Baclofen Therapy) for the treatment of severe spasticity. Medtronic, Inc. invited this person to share this story candidly. As you read it, please bear in mind that the experiences are specific to this particular individual. Results vary; not every response is the same.

Joey’s Story

Living with Spasticity

Joey, living with spinal cord injury

In 2000, Joey was driving down the highway. “A semi truck got in the way and my car flipped into the median,” he recalls. The accident caused a spinal cord injury. Much of Joey’s body was paralyzed.

When he was first injured, Joey had no spasticity because his body was in spinal shock. About a month later, he started to get feeling in his body and more movement in his arms. Spasticity soon followed.

Before his accident, Joey had developed a muscular body as a speed skater. “All the muscles I had built up started working against me,” he says. “They would kick me out of my chair. The nurses hadn’t seen spasticity like mine before.”

He took oral medications to control his severe spasticity, but he got tired of how they made him feel “loopy” and he wasn’t satisfied with how well they worked. His neurologist suggested a Medtronic baclofen pump (ITB Therapy).

How ITB Therapy Helped Joey

ITB Therapy (Intrathecal Baclofen Therapy) relieves severe spasticity by using a programmable pump placed just under the skin of the abdomen. The pump is connected to a thin, flexible catheter that delivers a liquid form of baclofen directly into the area where fluid flows around the spinal cord, called the intrathecal space.

Joey had a screening test to see if he was a good candidate for a Medtronic baclofen pump. As a result of the test, “I was completely loose and my legs were calm,” he says. “I was pretty convinced that I needed a pump.”

Risks of the Procedure

Joey, living with spinal cord injury

Joey had a spinal headache for a week or so after his screening test. After his doctors did a blood patch (blood is injected where the spinal tap was performed), it cleared up.

Joey didn’t experience any additional complications with his initial procedure to have the pump surgically placed. However, some people do experience surgical complications, other side effects of the drug, or both. As with any surgical procedure, there are risks associated with ITB Therapy. Some of these risks include meningitis, spinal fluid leak, infection, paralysis, headache, swelling, bleeding, and bruising. Drug-related side effects may include loose muscles, drowsiness, nausea/vomiting, headache, and dizziness.

Back to the Grind

Joey says, without the pump, he couldn’t do many of the things he does now. “I drive. I get in and out of bed by myself. I work full time. I don’t think I’d be able to do that without it.”

He is happy to say he no longer takes oral medications to counter spasticity. “I was so sleepy, I wasn’t able to concentrate on anything,” he says. “After I got the pump, my mom told me she was happy to have her Joey back. Having all those medications in me changed my personality.”

After 7 years, Joey received a new pump in October 2007. The average battery life for a pump is 6 to 7 years, and then the pump needs to be replaced.

A few months after receiving his new pump, Joey was at a wedding away from his home state. His spasticity began to worsen. A hole in the catheter was preventing the drug from being delivered into the space around his spine.

A surgery to replace his catheter fixed the problem until he returned home and again began experiencing spasms. Joey’s physician replaced his catheter again to ensure medication was being delivered to the right place, and his symptoms immediately subsided.

Since then, Joey’s spasticity has been under control. He’s recommended ITB Therapy to others. He says, “It changed my life a lot for the better.”

Next: Jenny's Story

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Safety Information – ITB Therapy

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, traumatic brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait 1 year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.

The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, respiratory depression (difficulty breathing), seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced or if there is a problem with the pump. Always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.

For more information, please read the Lioresal^® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.

This therapy is not for everyone. Please contact your doctor. A prescription is required.

Lioresal^® is a registered trademark of Novartis Pharmaceuticals Corporation.

This story reflects one person's experience. Not every person will receive the same results. Talk to your doctor about your treatment options.

Last updated: 3 Aug 2008