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, 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.

Jenny’s Story

Living with Spasticity

Jenny had been a competitive gymnast since she was three years old. She was 16, tumbling outside on wet grass, when she injured her spinal cord.

After her injury, Jenny had spasticity. She took oral medications to control her spasticity, but they made it hard for her to stay awake. “I was in college and falling asleep,” she says.

She could sit in hour-long classes at college and be fine as long as she didn’t move. “But after the first time I moved,” she says, “my legs would spasm, my back would spasm. Thankfully I was never tossed out of the chair.”

When the drugs that made her so groggy still didn’t control the severe spasticity, her doctor told her about a Medtronic baclofen pump (ITB Therapy).

How ITB Therapy Helped Jenny

ITB Therapy (Intrathecal Baclofen 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.

In 1992, Jenny had a screening test to see if she would be a good candidate for a Medtronic baclofen pump. The results were positive and the next day she had the pump surgically placed.

Risks of the Procedure

After the surgery, Jenny had a spinal headache, which subsided after she lay flat for several days.

Jenny didn’t experience any additional complications with her surgery. However, some people do 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.

Jenny recently had her fourth pump implanted, and has now had a pump continuously for 16 years. The pump battery lasts an average of 6 to 7 years, so the pump needs to be replaced periodically. The life of the battery is affected by how much medication the pump is programmed to deliver. Jenny’s first two pumps each lasted 5 years, while the third pump was replaced at 6 years. While the battery was okay, she explained that she didn’t want to risk the battery dying while she was overseas.

Jenny has learned the importance of maintaining regular refill appointments. Twice she has run out of baclofen a few days before her scheduled refill. The resulting withdrawals caused a return of her severe spasticity, causing convulsions, fever, and short-term memory loss. These symptoms were relieved by an immediate refill, and her alarm date for future refills was moved up.

“One of the Best Things I Ever Did”

Life with a pump has meant Jenny has stopped taking all oral medications, except valium at night to help her back. She has a minor amount of spasticity that she says doesn’t get in the way of daily activities.

“I can easily say ITB Therapy is one of the best things I ever did,” Jenny says. “By managing my spasticity, it’s allowed me to be independent. I live on my own; I can get dressed; I can do transfers. I’m able to travel internationally.”

Next: Mary N.'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.

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.

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: 3 Aug 2008