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Thank you for your interest in treatment options for severe spasticity.

To help us provide the information most appropriate for you or someone you care for, please take a moment to complete the brief questionnaire below. If it is easier, you may respond by calling 1-800-856-3823, ext. 101. This questionnaire does not take the place of thorough discussions with your doctor. Only you and your doctor can diagnose and decide whether ITB Therapy^SM is appropriate to treat your condition.

* Required questions must be answered

First Name *
Last Name *
Address *
City *
State *
-- Select One -- AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY Zip *
Phone
Email *

1. Which of the following best describes you? * (Please select all that apply.)

I have spasticity (tight, stiff muscles)
I am a family caregiver
I am currently receiving ITB Therapy
Other (please specify)

2. Due to spasticity,how difficult is it for the person affected to perform everyday activities such as moving comfortably, eating, walking, dressing, or sleeping? *

Not Difficult
Somewhat Difficult
Difficult
Very Difficult

3. Please note the level of satisfaction with the current spasticity treatments. *
Very Satisfied
Satisfied
Dissatisfied
Very Dissatisfied

4. Have you discussed ITB Therapy with your doctor? If so, what steps have you taken? (Please check all that apply.)

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

I have not yet discussed this treatment with my doctor
I have talked with my doctor about ITB Therapy and she/he believes I am a candidate
I am just starting to learn about this treatment
I am scheduled for a screening test
I have undergone the screening test (test dose of the medication) and had a successful response
I have undergone the screening test (test dose of the medication) and DID NOT have a successful response
My doctor does not believe I am a candidate
I am actively considering ITB Therapy

5. What is the name of the physician who manages the spasticity?

6. The origin of the spasticity is most closely related to: *
Cerebral palsy
Brain injury
Stroke
Multiple sclerosis
Spinal cord injury
I am unsure

7. Please tell us if the individual living with severe spasticity is: *
An adult (18 or older)
A child (Under 18)

Name of parent or guardian granting permission is required: *

 

By submitting this form you are granting Medtronic permission to add your contact information to its database for Severe Spasticity and consent to receiving information and communications related to Medtronic products and therapies. You may revoke this permission at any time by emailing spasticity@medtronic.com or sending a request in writing to: Medtronic ITB Therapy 7000 Central Avenue NE, RCE 240, Minneapolis, MN 55432-3576.

Medtronic respects the confidentiality of personal information. We assure you we will not share your personal information, except as otherwise noted in our privacy policy.

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 ON 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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