PATIENT SUPPORT ITB Therapy for Severe Spasticity

MANUAL, PATIENT ID, AND EMERGENCY CARD

PATIENT MANUAL

The patient manual covers your pump system and treatment. You will receive a copy after your implant procedure.

IDENTIFICATION CARD

Always carry a card that identifies you as having an implanted device.

Your doctor’s office will send Medtronic the information necessary for you to receive your patient identification card. This information is also used to track your implanted device, which is an FDA requirement. If your address, phone, or physician changes, you are responsible for updating your information on file.

EMERGENCY MEDICAL INFORMATION CARD

Always carry your blue Emergency Medical Information card from Medtronic. The card includes warning signs and emergency contact information. Ask your doctor for the card, which is ordered from a Medtronic representative. The card looks like this: Emergency Medical Information Card.


MEDTRONIC PATIENT SERVICES

Your doctor’s office is usually the first place to call if you have questions or need help with your treatment. You can also contact Medtronic directly if you have questions or problems related to your ITB TherapySM with Lioresal® Intrathecal (baclofen injection).

WHEN TO CALL YOUR DOCTOR

Call your doctor if you experience any of the symptoms of overdose or withdrawal as soon as you notice them.

Please direct all medical, medication and therapy questions to your physician’s office. Your physician has access to your medical records and history and can best diagnose any change in symptoms. Ask your physician how to reach the on-call physician for any medical concerns that arise after hours or on the weekend. Please contact your physician as soon as possible if you have a medical emergency, experience symptom changes, or hear your pump alarm.

CONTACTING MEDTRONIC PATIENT SERVICES

Medtronic can offer technical assistance when you have questions about your pump. Medtronic is not able to comment on your medical condition.

To reach Medtronic Patient Services, call toll-free 1-800-510-6735 Monday-Friday, 8:00 a.m. to 5:00 p.m. CST.

EMERGENCY TECHNICAL SUPPORT

A doctor or emergency department can call for help at any time with possible withdrawal, overdose, or pump issues. The Medtronic Technical Support number is 800-707-0933. Help is available 24 hours a day, every day.

The phone number is on your Emergency Medical Information card. Always carry your card, which also has the warning signs of overdose and withdrawal. Your doctor can order a copy for you from a Medtronic representative.

REPORTING DRUG SIDE EFFECTS

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.accessdata.fda.gov/scripts/medwatch, or call 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.


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 http://www.fda.gov/medwatch, or call 1-800-FDA-1088.