Placing the pump system usually takes 1 to 4 hours. The procedure is commonly done under general anesthesia, but there are alternatives if needed.
The surgeon will place the pump under the skin of your abdomen. One end of the catheter is then inserted into the fluid around the spinal cord, while the other end is tunneled under the skin and connected to the baclofen pump, resulting in a fully implanted system.
Depending on your doctor's preference and hospital policy, a brief hospital stay may be recommended.
What happens during the implant procedure and recovery?
Follow your doctor’s instructions on activities, oral baclofen, and incision care.
After the procedure, your incisions may feel tender or uncomfortable. Your doctor may prescribe medication to relieve any pain caused by surgery and antibiotics to prevent infection.
Call your doctor immediately if you get a fever or see redness or swelling around the incision. Once you have healed, your incision site will not need special care.
Your doctor may recommend that you restrict activities for 6 to 8 weeks after the procedure. As you become more active, follow your doctor’s instructions about work, sex, travel, recreation, hobbies, and exercise.
Most people say the pump is not uncomfortable or restrictive, and does not interfere with their movement. You may find loose clothing more comfortable. Depending on your body and the pump placement, the pump may not show at all under your clothes.
Your pump will be filled with intrathecal baclofen during the implant procedure. Treatment begins when medication flows from the implanted pump through the catheter into the fluid surrounding the spinal cord.
Let your doctor know how you feel (too loose? not loose enough?) so dose adjustments can be made. It can take weeks, even months, to identify the dose and program that works best for you. This process (known as dose titration) takes time because ITB Therapy isn't "one size fits all."
After a dose adjustment, you will usually see the effects in 6 to 8 hours and the maximum effect in one or two days. As your dose of intrathecal baclofen increases, your doctor may slowly reduce your oral spasticity medicine.
Potential surgical complications may include:
ITB Therapy drug side effects are usually temporary and may be managed by adjusting dosage.
The most common side effects include:
Please follow your doctor’s instructions closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms), such as:
It’s important to keep your scheduled refill visits so you don’t run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal, which include:
Once the infusion system is implanted, possible device complications may include:
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.