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ITB Therapy Ambassador Program

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 Therapy^SM 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.

Talk With Someone Who Understands

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:

• What was the screening test like?
• What was the implant procedure like?
• Are you happy with the treatment?
• How does ITB Therapy feel?

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.

• For medical questions, please consult your doctor
• If you have a Medtronic product and need technical support, please call 1-800-510-6735

Participation Is Easy

There are two ways to request time with an ambassador:

• Sign up online. You'll be able to view profiles of our ambassadors, choose the ambassadsor you'd like to talk to, and schedule a time that is convenient for you.

 

• Call 1-800-503-4110 between 7:00 am and 6:00 pm CT Monday through Friday

What Ambassadors Say

Here's what a few of our ITB Therapy Ambassadors say about the Ambassador Program.

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.

We reserve the right to end the Ambassador Program at any time. You may request literature about Medtronic ITB Therapy from your healthcare provider. We also encourage you to carefully review the information on the website and to discuss therapy options with your doctor.

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.

Important Safety Information – ITB Therapy

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure 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 understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait 1 year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.

The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, 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. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia, seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. 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. 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 0911

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