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.

Diana's Story

Living with Severe Spasticity Due to MS

In 1993, Diana was diagnosed with multiple sclerosis (MS). The first symptoms emerged as pain in her face and left arm. The multiple sclerosis progressed over time and symptoms made it hard for her go about her daily activities.

"I walked with a cane for five years. Some days I could walk fairly well, but most of the time I was much too spastic. It made me feel uneasy to have to walk that way, but then I was glad I could walk at all," Diana recalls.

Her tight, stiff muscles interfered with her independence. She and her husband, Doug, loved to play disc golf and go camping. Having to use a cane made it hard to set up camp and playing disc golf became an "exercise in futility." Even simple things took twice as long to do and tending her garden became very challenging.

Starting ITB Therapy

Diana tried using oral medications to treat her severe spasticity, but they weren’t very effective and made her very drowsy. Diana’s doctor suggested ITB Therapy (a Medtronic baclofen pump).

Before Diana and her doctor made the decision to have the pump placed, she needed to have a screening test to see if the liquid baclofen would relieve her symptoms.

"Four hours after my screening test began, I could swing my leg from my hip," Diana remembers. "I was walking like I had been before I was diagnosed with MS; I could not believe it. The doctors and nurses couldn’t believe the difference."

When Diana attempted to stand up shortly after the test dose, she experienced a headache caused by a spinal fluid leak. Diana’s doctor quickly took measures to resolve the problem.

ITB 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.

Diana had the pump placed in March of 2000. She spent 3 days in the hospital recovering from her surgery and spent another few weeks in physical therapy as an outpatient.

Diana 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.

Life with ITB Therapy

Since receiving ITB Therapy, Diana no longer needs a cane to assist her in walking. She has gotten back to doing the things that she loves, like gardening, camping, and accompanying her husband on disc golf tournaments.

According to Diana, "ITB Therapy has made it a lot easier for my husband as my caregiver. In addition to accompanying Doug on the disc golf course, I have joined the Professional Disc Golf Association (PDGA) and passed my Officials Test. Now I can help run local tournaments and make judgment calls on the course when needed. I still can't play the game but I can contribute to the sport!”

Next: Ed'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