This story reflects the experience of one individual who is receiving Medtronic ITB TherapySM (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.

Ricky’s Story

Living with Spasticity

While at work one afternoon in April 1998 at the gas station he owns, Ricky called his wife and told her his equilibrium was off. She noticed Ricky's language was slurred, and then the telephone fell to the floor. A stroke sent Ricky into an unconscious state for the next 5 weeks.

When he finally regained consciousness, his mind was fuzzy and he could not talk. He had no control over his right side and could not walk.

Initial Treatments

Intensive speech, occupational, and physical therapy followed for the next 5 months. Ricky regained much of what he had lost and again was able to speak and walk. However, severe spasticity emerged in his right leg.

Ricky eventually began receiving injection therapy to ease his spasticity. But the shots provided only temporary relief until the spasticity returned.

At the suggestion of his doctor, Ricky underwent a preliminary screening test for a Medtronic baclofen pump (ITB Therapy) in February 2001 to determine if the therapy could control his spasticity. The test was successful, and Ricky began receiving ITB Therapy that same month.

How ITB Therapy Helped Ricky

ITB Therapy (Intrathecal Baclofen Therapy) involves the surgical placement of a programmable pump implanted under the skin of the abdomen. The pump is connected to a catheter that delivers a liquid form of baclofen directly to the body's intrathecal space, where fluid flows around the spinal cord. Because the drug is delivered directly to the spinal fluid, it relieves spasticity with small amounts of medication.

"At first I thought ITB Therapy was going to do something for me. Then I realized it allowed me to do things for myself," recalls Ricky. "Helping customers fill up with gas, cleaning their windshields, checking air pressures and oil… all of it was possible with the help of the pump."

Risks of the Procedure

Ricky's surgery was successful and only minor side effects followed. Immediately after the surgery he had difficulty with his bladder. A simple adjustment of the baclofen dosage resolved the problem. When he returned home, a persistent headache emerged. At a follow-up visit the dosage was again adjusted and the headache disappeared.

Although Ricky didn't experience any additional complications, they may occur. Some people experience surgical complications, 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.

More Control, More Freedom

ITB Therapy has given Ricky more control over his right arm and leg, more than he ever thought possible. "When I cook, I can open jars and hold ingredients in my right hand. I can walk up stairs to my second-floor apartment. I can work part time at the gas station," he says.

Although Ricky continues to use injection therapy in his arm, he now has more independence and a better outlook. "I have come so far," he says. "And with this freedom, I have a better frame of mind."

In April 2007, Ricky’s pump was replaced during a one-day procedure. "It went well," he says. "I had no problem at all." The SynchroMed® II pump battery lasts an average of 6 to 7 years, and then the pump needs to be replaced. The life of the battery is affected by how much medication the pump is programmed to deliver.

While ITB Therapy is helping Ricky do things for himself, it also is helping him do things for others. "If my story prompts just one person to have their blood pressure checked, then my experience with stroke and spasticity has been worth it."

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.

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 3 Aug 2008

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