Ronald's Story

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.

Living with Spasticity

In November 2004, while on active duty in Kandahar, Afghanistan, Ronald was in the midst of a 6-mile run as part of his physical training when he collapsed and stopped breathing. His two comrades stopped a passing truck, and he was transported to the nearest medical facility. Ronald was without oxygen for 17 minutes before doctors were able to revive him.

He was sent to Germany where his condition stabilized, and then to Walter Reed Army Medical Center in Washington, D.C. for 6 weeks before being transferred to a nursing home in Lexington, Ky., where he stayed for 8 months.

Initial Treatments

"The doctors told me Ronald was in a vegetative state," recalls his wife, Maud. "He couldn't communicate, talk or eat. He just sat."

Ronald received therapy for 3 months, making progress with eating and talking. But his severe spasticity increased dramatically. Maud could barely move Ronald because he was so stiff, prompting him to moan in pain. To control the spasticity, oral medications were increased.

"The medications made him so sleepy that he couldn't participate in speech, occupational or physical therapy so the services were ultimately cancelled," says Maud.

Ronald's doctor told Maud about the Medtronic baclofen pump (ITB Therapy) and its potential to help control Ronald's severe spasticity without excessive drowsiness. To determine if he was a candidate for the therapy, he underwent a screening test during which a dose of baclofen was administered.

"We saw an incredible difference at the screening test," Maud remembers. "His legs and feet were loose and he could bend them. It was like night and day."

While she was excited about ITB Therapy (Intrathecal Baclofen Therapy), Maud was concerned about the surgery. She had been transferring him with the help of a Hoyer lift and worried how that might affect his incision.

How ITB Therapy Helped Ronald

When Ronald had a Medtronic baclofen pump surgically placed in November 2007, he experienced no complications. He spent a night in the hospital and went home the following day.

"To my great relief, the wound healed perfectly," says Maud.

Risks of the Procedure

Although Ronald didn't experience any complications with his surgery, they can occur. 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.

Life with a Baclofen Pump

"Ronald used to sleep continuously; now he takes an occasional nap but is awake most of the day. He's responsive and smiles when I say his name. I think he feels better and it isn't painful for him when I dress or bathe him because the spasticity-related pain is gone. Everything is easier for me because the spasticity is controlled."

Since the Medtronic baclofen pump was placed, three of Ronald's six oral medications have been eliminated. The doctors have reduced two more and are working to reduce the other one.

"It was helpful for me to talk to patients who had ITB Therapy before we decided on it. For others who are considering it, I'd recommend contacting the Medtronic Ambassador Program so you can decide if it's right for you. My husband is doing great – it’s a change of day and night since the pump implant," says Maud.

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: 8 Sep 2008