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.

Tim’s Story

Living with Spasticity

Tim was a foreman at an electric company. While working one day in 1998, he was electrocuted. “It went down my spine,” he recalls. “It burned out all the way through.”

For nine weeks, Tim was in a coma. When he woke up it was early 1999. “Initially, my leg was spasming and jumping up and down,” he says. "I thought I was going to be able to walk.” But he did not regain the use of his legs.

Initial Treatments

Tim tried several oral medications to manage his severe spasticity. Some helped him sleep better at night; some offered short-term relief from spasms. But the spasticity was so severe that it interfered with physical therapy.

“My legs want to clamp together all the time,” he says. “They don’t want to bend. During physical therapy, my legs wanted to fight me and the person who was doing physical therapy with me.”

A couple of weeks after he awoke from his coma, Tim’s doctor suggested a Medtronic baclofen pump (ITB Therapy).

How ITB Therapy Helped Tim

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.

Tim took a screening test to see if he was a good candidate for a baclofen pump. “I was a little apprehensive,” says Tim, “but I had been through quite a bit, so whatever the doctor told me, that’s what I was going to get.” Two weeks later, he had the pump surgically placed.

Risks of the Procedure

Tim had no complications with the trial or his initial pump placement. 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.

Proud Papa

Once Tim’s dosage was regulated, his spasticity management became consistent. He is now able to do more in physical therapy since his legs are loosened.

Before the pump, Tim had severe spasms in his legs, stomach, and back. Now, he’s able to go to the mall in his wheelchair, and do other mobile activities. But his most memorable moment was taking his daughter down the aisle at her wedding.

Tim’s advice for people considering a Medtronic baclofen pump? “Look at the things you can do with the pump as far as getting more medication during the night or the day depending on the situation. Those are big advantages of the pump.”

Tim notes that it’s important to work with your doctor to manage dosage amounts and program the pump to provide different drug amounts throughout the day. Once you find the right dose, Tim says, “You can do what you want to do in your lifestyle.”

The pump battery lasts an average of 6 to 7 years, and then the pump needs to be replaced. Tim has had several replacements. Two months after his third pump was surgically placed, he developed an infection, which prompted a subsequent replacement.

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: 19 Nov 2009