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 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. Not everyone who receives ITB Therapy will receive the same results as the individual in this story. Talk with your doctor to determine if ITB Therapy is right for you.

Jason’s Story

Living with Severe Spasticity Due to a Spinal Cord Injury

At 17 years old, Jason was quickly moving up the ranks in the world of motocross racing. But while practicing on a jagged road, Jason slammed the front tire of his dirt bike into a hidden rock. He was hurled headfirst over his handlebars to the ground, severing his spinal cord at the T5/T6-level. Jason became paralyzed below the chest.

Even after his injury, Jason was determined to live life in the fast lane. He started racing again, this time in his wheelchair. But it wasn’t long before Jason suffered an onset of severe spasticity in his legs and back. “The spasms were so bad they would throw me backward out of my chair,” he recalls.

Jason’s spasms made even day-to-day activities challenging. He had difficulty staying in his racing chair, transferring, and dressing without having an attack. Jason tried oral baclofen, but it left him feeling weak and groggy. His doctor suggested ITB Therapy (a Medtronic baclofen pump).

Starting ITB Therapy

ITB Therapy relieves severe spasticity 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 body’s intrathecal space, where fluid flows around the spinal cord.

Jason underwent a successful screening test and had the pump surgically placed the next day. Jason’s leg and back muscles relaxed. Activities like transferring, dressing, and racing became easier.

Jason didn’t experience any complications with his initial surgery. However, some people do experience surgical complications, side effects of the drug, or both. There are risks associated with ITB Therapy. Some of these risks include pain, 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.

When Jason went in after 5 years for his first routine pump replacement, he developed an infection. His doctor removed the pump until the infection could heal completely.

“My spasms were horrible without the pump,” he says. “But as soon as the infection healed, I had the pump replaced and got them back under control.” Since that time, Jason has had a subsequent pump replacement without any complications.

Nothing Is Impossible

With his spasticity under control, Jason enrolled at the University of Illinois, where he joined the wheelchair racing team. He completed his degree at Northeastern University in Boston, and went on to earn his master’s degree in business administration at Boston University.

Jason continues to excel, both on the job and on the road. To date, he has completed over 140 road races, 28 marathons.

“ITB Therapy helps me prove that nothing is impossible,” says Jason.

Next: Kaleigh'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.

IMPORTANT SAFETY INFORMATION ON 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, 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, dizziness, respiratory depression (difficulty breathing), hypothermia, 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 Medtronic, Inc.

USA Rx Only Rev 0911

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: 20 Feb 2013