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.

Ed’s Story

Living with Severe Spasticity Due to Stroke

Ed, stroke survivor receiving ITB Therapy.

In 2000, Ed experienced a hemorrhagic stroke caused by bleeding into the brain from arteriovenous malformations (AVM), which are masses of abnormal blood vessels. The condition had been treated, and he was recovering well — until one morning in January 2003, when a blood clot traveled from his heart to his brain, causing an ischemic stroke and severe weakness on his left side. Ed found it difficult to get dressed and knew he needed help immediately.

After a month in the hospital, Ed was transferred to a rehabilitation facility where he underwent intensive physical and occupational therapy before returning home.

"The spasticity remained and it was extremely painful," recalls Ed. "It was like having a constant charley horse. I was able to walk, but the spasticity affected my gait."

Ed had been given injection therapy for spasticity in his upper arm, but the effect would diminish in 90 to 120 days. When Ed's doctor suggested ITB Therapy (a Medtronic baclofen pump), Ed was receptive.

Starting ITB Therapy

ITB Therapy uses 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.

Before getting the pump, Ed needed to have a screening test to see if the liquid baclofen would relieve his symptoms.

"During the screening test, my left foot made full contact with the floor for the first time since the stroke," says Ed. "Because I had more foot surface on the floor, I could put more weight on my leg and so I was sturdier. The change in my gait — for the better — was noticeable." Ed had the pump surgically placed in December 2004.

Ed didn't experience any complications with his 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.

“His Movements Are Freer with the Pump.”

While Ed still has spasticity, it has been significantly reduced. He feels steadier on his feet. He is confident about spending time unsupervised while his wife and family caregiver, Andrea, works.

"Ed has more energy and his movements are freer with the pump," says Andrea. "I feel better going to work knowing he's comfortable staying home alone."

Ed also attributes his increased productivity in physical therapy to ITB Therapy. "Because ITB Therapy has reduced my spasticity, I stretch better and am developing more range of motion. I look forward to getting more ability as time goes by."

Next: Eric'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