This story recounts the experience of one individual who is receiving ITB Therapy.SM Medtronic invited him to share his story candidly. Please bear in mind that the experience is specific to this particular person. Not everyone who receives ITB Therapy will receive the same results as the patient in this story. Talk with your doctor to determine if ITB Therapy is right for you.
Diagnosed with cerebral palsy and spastic quadriplegia as an infant, Kyle has experienced the effects of spasticity his entire life.
He began taking oral medications for spasticity three times a day when he was 11 months old. Early on, his parents knew the medications would be a short-term solution. The medications would have a positive effect shortly after they were taken, but would wear off, leaving him in severe pain and discomfort. Kyle's parents worried about the long-term effects of a lifetime of high daily doses of oral medication.
As he grew, lights and sounds regularly triggered Kyle's spasticity and caused him to get upset, sweat, and forcefully push against his wheelchair.
Life with ITB Therapy
Kyle's family worked with a team of professionals to find the right treatment. When he was 12 years old, they decided to try Medtronic ITB Therapy, also known as the baclofen pump. 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.
To determine if the therapy was right for him, Kyle first underwent a screening test. It was successful, and he went on to have the pump and catheter surgically placed.
Up until the time he had the pump placed in 2009, Kyle was taking oral baclofen. After the surgery, his oral dosage was reduced and his intrathecal dosage was increased in order to get him off the oral drug. During this process, Kyle experienced withdrawal from his oral medication. His health care team increased the intrathecal dosage to correct the problem.
Kyle did not experience any other complications or side effects from ITB Therapy. 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 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.
To manage the spasticity in his upper limbs, Kyle continues to take oral medications for his spasticity, but at about half the dose he was taking prior to receiving the pump. His medical professionals and family hope to eventually taper him off of all oral spasticity medications.
Today, Kyle doesn't have to fight spasticity in his muscles in order to comfortably sit in a chair for long periods of time. He has more control over his lower extremities. And ITB Therapy is helping release Kyle's potential. Eight months after receiving the pump, he went skiing for the first time. An adapted bi-ski with a small chair provided Kyle with one of the most memorable experiences of his life...so far.
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Important Safety Information – ITB Therapy
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.
IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen 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 www.fda.gov/medwatch, or call 1-800-FDA-1088.