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.

Kaleigh's Story

Kaleigh, living with cerebral palsy

Living with Severe Spasticity Due to Cerebral Palsy

Diagnosed with spasticity and cerebral palsy when she was 15 months old, Kaleigh has a can-do attitude that inspires everyone she meets.

"She has an awesome personality," her mother Julie says. "I've had perfect strangers come up to me and say, 'Your daughter just brightened my day.'"

As Kaleigh grew, her spasticity worsened. She walked arched over on her tiptoes, and her mom occasionally needed to carry her.

To treat her severe spasticity, Kaleigh tried a year of injection therapy and casting, but didn't get the relief she hoped for. Julie began searching for alternative options and decided to ask Kaleigh's clinician about ITB Therapy (a Medtronic baclofen pump).

Starting ITB Therapy

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

Kaleigh first needed a screening test to see if the liquid baclofen would relieve her symptoms. After the screening test, "Kaleigh's muscles were like limp noodles," Julie recalls. "I was excited, but Kaleigh was a little scared. She'd never been able to move that much without feeling pain."

As the medication wore off, Kaleigh experienced cramping in her legs. Several hours later, her muscles were back to the way they were before the screening test. They decided to go forward with the surgical procedure so Kaleigh could receive ITB Therapy.

Kaleigh didn't experience any complications with her 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.

Gaining Independence

Since receiving ITB Therapy, Kaleigh has found that she no longer needs crutches when walking short distances. Her gait and posture have also improved, and she's gained enough dexterity to play the piano.

Julie loves the independence that the pump has given her daughter. Kaleigh no longer needs to be carried and enjoys walking in stride with her friends and family.

"I like being able to jump rope and do other hard stuff," Kaleigh says. "Now I can walk better and I don't need Mommy there to make sure I don't fall!"

Next: Ambassador Program

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