Your Healthcare Team

You'll work with a variety of healthcare professionals as you pursue Medtronic ITB Therapy^SM (the baclofen pump). They'll thoroughly evaluate your condition to find the most appropriate treatment options. To get the best results, it's important to actively participate in discussions and decision-making related to your care.

Your healthcare team for severe spasticity treatment with ITB Therapy may be a combination of the following:

Individual and Family Caregivers

Goal setting
Treatment decisions

Neurologist, Physiatrist (Physical Medicine and Rehabilitation [PM&R] Doctor), or Primary Care Physician

Referrals for a spasticity evaluation
Goal setting
Treatment decisions
Post-surgery monitoring
Coordination of spasticity management with other aspects of care
May be involved in assessment and management of ITB Therapy

Neurosurgeon or Orthopedic Surgeon

Surgically places the pump
May be involved in assessment and management of ITB Therapy

Physical and Occupational Therapist

Functional assessment
Post-surgery rehabilitation

Nurses

Clinical management
Ongoing assessment

Advice from an Ambassador

Jean, who has been receiving ITB Therapy since 2003, volunteers for the Ambassador Program through which people considering ITB Therapy can talk with a current patient. She often shares advice on finding a doctor and treatment plan, based on her own experiences.

“I’ve had to advocate for myself in finding the right doctors to treat my multiple sclerosis and spasticity since my symptoms started in 1992. My doctor at that time was reluctant to diagnose it. After my twin boys were born in 1994, I was diagnosed with MS. That doctor didn't treat the disease, but wanted to watch it instead. I found a new neurologist and started on an injection to slow the disease’s progression.

“In 1996, I had my daughter and started having more spasticity in my lower extremities. My doctor thought it was due to me having three children under the age of two. I disagreed. He didn't listen. My MS got worse and I was in a wheelchair for over three years. The medication wasn't working. I was hospitalized and my internal medicine doctor referred me to a different neurologist. When the spasticity medications didn't work, she recommended ITB Therapy. I am no longer wheelchair bound!

“When I'm talking to people through the Ambassador Program, I've suggested:

Use word of mouth and keep looking until you find the doctor that’s right for you.
Find a doctor who specializes in your condition.
Choose a doctor who listens to you and hears your goals and concerns.
Manage your emotions, no matter how frustrated you are.
Bring a friend or family member to your appointments for support.
Never give up! Some of us are born with this drive and others have to work to find it. Surround yourself with support and when you feel you can't go any further, allow your friend or family members to help you.”

Sign up to talk with an Ambassador

This story reflects the experience of one individual who is receiving Medtronic ITB 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.

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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.

USA Rx Only Rev 0911

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 20 Feb 2013