Shellie'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 1993, Shellie was 16 years old, a member of a dance and vocal group, a talented artist, and captain of her track team. On July 11 of that year, she went for a drive that changed her life.

While driving down a freshly graveled dirt road with her sister and brother, the car fishtailed and hit a metal bridge. In the backseat, Shellie suffered a head injury.

Shellie's family was there for her in the days and years following the accident. "For 3 days after the accident, she was in a coma and her eyes were closed," says Alison, Shellie's mother. "Then, her eyes opened, but she remained in a coma for the remainder of her one-year hospital stay."

Severe spasticity set in, leaving Shellie's right leg stuck in a tight bend that crossed over her left leg. Her wrists were curled under and her arms were locked tightly to her chest. Her family was determined not to send Shellie to a healthcare facility, and so they brought her home. She remained in a coma for the next 2 years.

"She had physical, occupational, and speech therapy two to three times a week," Alison recalls. "She was so stiff. When my husband and I would turn her over, her head and spine were in perfect alignment. She was unresponsive, not blinking or smiling. She couldn't move at all."

Initial Treatments

Shellie's doctor recommended that the family travel from their Colorado home to Salt Lake City, Utah, for treatment. There, she had 7 inches of bone removed from her right femur to straighten out her leg. Shellie also was placed on oral baclofen. Within a few months she began to move her right arm and to slowly emerge from the coma.

Many surgeries on both arms, both legs and both wrists followed. Despite multiple surgeries, Shellie continued to experience discomfort. Alison remembers a time when she and her husband took Shellie camping. "We pitched a tent and we had our campfire. Shellie knew it was supposed to be fun, but she was suffering and could only cry."

In 1997, Shellie's doctor told her family about the Medtronic baclofen pump (ITB Therapy). Her doctor hoped it would reduce her severe spasticity.

At the screening test, Shellie responded positively to a test dosage of intrathecal baclofen. She went on to have the pump surgically placed. Shellie experienced no complications, other than constipation, which was treated.

Risks of the Procedure

Although Shellie didn't experience any additional complications with her 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.

How ITB Therapy Helped Shellie

The pump has provided Shellie with significant relief of severe spasticity and helped her avoid back surgery. Her muscles have relaxed, and she is able to lift both legs and to kick her left leg. She can use her right arm, although her left arm remains at her chest. She is able to sleep through the night.

"Best of all, she is enjoying her activities and is comfortable and happy," says Alison. ”Student speech therapists at the local college have helped Shellie with her swallowing for the past eight years. Starting in the spring of 2008, she can now swallow a mixture of half Sprite and half water by straw.

"Since receiving the pump, Shellie's tongue is more relaxed, and so she speaks," explains Alison. "She is still gradually working on pronunciation of words. Although she can lip-sync songs and sentences, she is working on volume of sound. The intrathecal baclofen has relaxed her throat and vocal cords more to make this possible. She loves math and can instantly give you the answers to addition, subtraction, and most multiplication problems. Her progress is very slow, but she still continues to improve. Our goal is to get her to a point where she can express her needs."

When Shellie and her family tried camping again, she was relaxed in her wheelchair, able to enjoy the campfire and eating s'mores. "The pump has helped Shellie enjoy life again," says Alison.

Next: Eric'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: 8 Sep 2008