Eric'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 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. Not everyone who receives ITB Therapy will receive the same results as the individual in this story. Talk with your doctor to determine if ITB Therapy is right for you.

Living with Severe Spasticity Due to a Brain Injury

Eric was an athletic 19-year-old. He played hockey and was an excellent swimmer. One day, riding his bicycle a few blocks from his home in Brooklyn, New York, he was hit by a truck.

The impact threw him into a parked car before he hit the ground. "He was comatose at the scene," recalls his mother, Susan.

Though Eric had no broken bones, trauma to his brain resulted in swelling, creating pressure that could only be relieved by multiple surgeries. He was in a coma. A month after the accident, Eric opened his eyes. It took 5 months for him to fully awaken from the coma.

Eric faced many challenges, like relearning how to speak and who his parents were. He also endured intensive physical therapy. He spent a year in a hospital and a trauma center before he returned to his parents' home.

Spasticity made Eric's arms and legs curl up and his wrists curl in. The spasms in his legs made transferring him tricky. Speaking was difficult, and holding his head up was hard for him.

He took oral baclofen to control the severe spasticity, but it made him sleepy. Susan says, "We wanted to give him every chance. We wanted him awake and functioning, so we needed another option."

Starting ITB Therapy

When Eric's neurosurgeon suggested ITB Therapy (a Medtronic baclofen pump), his parents didn't hesitate. ITB 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.

At the test to see if Eric was a good candidate for ITB Therapy, the results were positive. "Before our very eyes," says Susan, "not only did Eric's legs straighten out, but he was able to straighten his arms, too. Within a couple of hours, his wrists were loose."

Before he could have the surgery, Eric first had to have a shunt implanted to combat the remaining hydrocephalus from the accident.

In 1999, several years after his accident, Eric had surgery to place the pump. He stayed in the hospital for 3 weeks while his dosage was adjusted.

Eric didn't experience any complications with his surgery. However, some people do experience surgical complications, side effects of the drug, or both. There are risks associated with ITB Therapy. Some of these risks include pain, 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.

The pump battery lasts an average of 6 to 7 years, and then the pump needs to be replaced. Eric's first pump was replaced in 2004, as the battery's expiration approached.

Eric had one overdose after a doctor's visit that included programming the dosage. "A couple hours after we got home, I noticed he could barely sit up. His wrists were totally straight, he was slurring his words, and he started constantly vomiting," says Susan. She called Medtronic and Eric's neurosurgeon, and the dose was adjusted the following day to alleviate his symptoms.

Finding Independence

The therapy has been a success for Eric. With his severe spasticity managed, Eric was able to continue his progress in physical therapy. "He was able to sit up better and stand with assistance," Susan says. "It was easier to get him in and out of bed. It gave him more freedom with his arms."

Most importantly, the decreased spasticity gave him better control of his movements. "Now he's able to use his arms to hold up his body a little bit," says Susan.

He can hold his own drinking cup, help feed himself, take off his shirt, shoes, and socks. He also expresses his playful personality by pulling his socks off his feet and putting them on his hands as puppets.

Eric was also able to return to swimming and he recently started taking water-exercise classes.

"As cliché as it seems," says Susan, "[thanks to ITB Therapy,] life is fuller for him. Without the pump, we would not have been able to keep him home."

Next: Jason'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.

IMPORTANT SAFETY INFORMATION ON 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, 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, dizziness, respiratory depression (difficulty breathing), hypothermia, 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 Medtronic, Inc.

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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: 20 Feb 2013