It was a six-year struggle for Carol to come back from the effects of a serious stroke. When she first returned home following three months of long-term care in a medical facility, she had a severely drawn up right foot and spasticity in her arm and leg.
Unable to walk because of her foot, Carol relied entirely on the wheelchair for her mobility.
“She couldn’t use her right arm, she couldn’t open her right hand at all,” her husband, Pete, recalls. “We kept trying to get her to do those things and she tried very hard, as much as she could.”
After three years, Pete and Carol met with a physician who suggested that Carol have her right Achilles tendon lengthened so her right foot wouldn’t be drawn up. He also recommended Medtronic ITB Therapy, also known as the baclofen pump, as a way to manage the spasticity on her right side.
Carol had a screening test to see if ITB Therapy would help relieve her spasticity. The test was successful. She went on to have the pump and catheter surgically placed.
Carol’s procedure went well and she did not experience any complications. However, surgical complications, side effects of the drug, or both, can occur with ITB Therapy. 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.
“Once we got the baclofen pump, we started to see some changes,” Pete says. “Her hand started to move. She could open and close her hand. It took a period of time, of course, and her leg started to relax.”
Today, Carol is able to walk and is enthusiastic about her progress. “I walk. And just realize I couldn’t do that before,” she says. “It is such a pleasure to be able to do it.”
Pete is always with Carol, but she is more independent than she was in the past. “I had to help her up almost every stair. I don’t now,” he says. “We walk out and sit on the bench and watch the cars go by and yell at those that go too fast… you know, the things that old folks do!”
The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs 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 know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.
People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.
The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), 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. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. 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. You or your caregiver should 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 0913
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.
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.