When you have an important decision to make, it often helps to talk with someone who has had an experience similar to your own. The ITB TherapySM Ambassador Program gives you the opportunity to talk with someone who is receiving ITB Therapy and has volunteered to share his or her experience with the therapy.
Talking with someone who is receiving ITB Therapy can sometimes provide the perspective and information you need to make a decision. You may have questions that can be answered best by someone who has had a similar experience.
During your one-on-one conversation with an ITB Therapy Ambassador, you can ask questions such as:
Please keep in mind that ambassadors' comments about ITB Therapy relate to their experiences only. As with any treatment, individual results will vary. Talk to your doctor about the therapy or whether it may be right for you.
ITB Therapy Ambassadors are people who have volunteered to talk to you about their personal experiences with ITB Therapy. They are not Medtronic employees, and they do not offer medical advice or technical support.
There are two ways to set up a call with an ambassador. You can call (800) 503-4110. You can also sign up online, which allows you to view profiles of the ambassadors, choose the one you’d like to talk to, and schedule a time convenient for you.
Medtronic does not monitor or control an ambassador's statements, and cannot be responsible for their remarks. Ambassadors are instructed not to disclose your personal information to others but we cannot guarantee this will not happen. Therefore, we encourage you to refrain from sharing your personal information with the ambassador unless you wish to do so.
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.