Important Safety Information

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Sign up here to receive additional information from Medtronic. Our support program offers several complimentary benefits, including:

  • Updates on ITB Therapy
  • Invitations to online presentations by doctors and patients.

Please sign up below. In order to provide the information most appropriate for you or someone you care for, please take a minute to complete the brief questionnaire. If it is easier, you may respond by calling (800) 856-3823, ext. 101. This questionnaire does not take the place of thorough discussions with your doctor. Only you and your doctor can determine whether a baclofen pump is appropriate to treat your condition.

Please provide all information.

Note: If you are a caregiver, please answer from the perspective of the person with spasticity.

 

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By completing and submitting this form, you are granting Medtronic permission to add your personal information, including your contact information and basic healthcare information, to its patient database, and to share that information with Medtronic representatives and health care providers as appropriate. We may conduct analyses on information collected in order to make improvements to and provide training on our operations, products, services, and customer communications.  Medtronic may de-identify data collected, combining it with data collected from other sources.  Lastly, information provided may be shared with your physician for treatment considerations or other purposes. You also agree to being contacted by Medtronic in the future by mail, telephone or by non-password protected electronic communications, such as emails or text messages. Medtronic may exchange information with you regarding our products or services, inquire about your experience, or determine how Medtronic can support you through your journey.

Medtronic respects the confidentiality of your personal information. If at any time you wish to revoke all or part of this permission, you can email us to rs.neuropatientsupport@medtronic.com or send a request in writing to: Medtronic Patient Support, 7000 Central Ave NE, RCE 230, Minneapolis, MN 55432. This permission will expire 10 years after the date of your signature.*

 *If you live in Maryland, the consent expires automatically in one year. We may contact you then to see if you would like to renew it.

 

 

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.