This story recounts the experience of one individual who is receiving ITB TherapySM (Intrathecal Baclofen Therapy) for the treatment of severe spasticity. Medtronic invited this person to share her story candidly. The experiences noted here are specific to this particular person. 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 benefits as the individual in this story. Talk with your doctor to determine if ITB Therapy is right for you.
Frank's first symptom was difficulty walking. Over time, his mobility became increasingly compromised. It wasn't long before he was diagnosed with multiple sclerosis.
For about 10 years, Frank took oral medications four times a day to control his MS-related severe spasticity, but his symptoms continued to worsen. His ankles and feet would often flex out and his calves would tighten when he was sitting at work or watching TV. He also experienced unpleasant side effects from his medications, including fatigue, lethargy, and disorientation. In addition, he would often forget to take his pills, which would make matters worse.
Frank's doctors worked with him to find the right treatment, and ultimately recommended that he try a baclofen pump. To determine if the therapy was right for him, Frank first had the screening test. It was successful, and he went on to have the pump and catheter placed.
Frank's procedure went well and he did not experience any complications. After the surgery, in 2009, while at an appointment to have his pump dose adjusted, a blood clot was found in his leg. His doctors were not sure if it was related to his recent surgery. Blood thinners resolved the situation.
Surgical complications, side effects of the drug, or both, can occur with treatment with a baclofen pump. There are risks associated with treatment with a baclofen pump. 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.
Since having the baclofen pump placed, Frank no longer has to deal with the burden of taking oral medications four times every day, and his calves don't tighten up as much. Today, he is able to maintain his focus, allowing him to be more productive in his career as an engineering project manager.
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.
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.