Product Support – SynchroMed Programmable Drug Infusion System

Taking proper care of your Medtronic SynchroMed^® pump (baclofen pump) is important to the successful treatment of your severe spasticity. Your doctor can help teach you and your family caregiver what you need to know about your SynchroMed System.

Always remember to:

Tell your doctor if you don't feel well or if you are having problems with the programmable pump
Immediately notify your doctor if you hear a pump alarm
Learn the programmable pump name (SynchroMed) and model number and the name of the medication used in the pump—Lioresal^® Intrathecal (baclofen injection).
Make sure your family and friends know about the programmable pump so they can help in an emergency

Refills
Troubleshooting
Pump Alarms
Potential Device Complications
Drug Side Effects
Symptoms of Baclofen Withdrawal
Sources of Ongoing Support
Patient Guide
Out of Town Doctors
Patient Identification Card

Refills

It's extremely important to attend all of your refill appointments to maintain the level of medication you need for continuous and effective treatment. During a typical refill appointment, the programmable pump will be emptied and refilled by a needle inserted through your skin. This is a relatively short and painless procedure.

At each follow-up visit, your doctor will also check the pump to ensure it's working properly. He or she will prescribe and adjust the amount of medication to best meet your needs.

Troubleshooting

The pump has an alarm that will beep softly when it should be checked. If you hear the alarm, call your doctor to determine the cause and make the necessary adjustments.

Take some time to talk to your doctor about the following:

Which three conditions cause the alarm to sound
The importance of checking battery status before and after a refill
What the pump alarm sounds like

Pump Alarms

Pumps have two different alarms: a 3-second dual-tone alarm and a 1-second single-tone alarm. The alarms sound when:

The pump needs to be refilled.
The pump needs to be replaced.
There is a problem with the pump.

After your implant, ask your doctor to temporarily program your pump to sound the alarm in his or her office so you will recognize the sound if an alarm goes off in the future.

Here are the SynchroMed II pump alarms:

Please note that the volume of the alarm on your computer may be louder than the volume of the alarm heard from the implanted pump.

Potential Device Complications

Once the infusion system is implanted, possible device complications may include:

Catheter or pump moving within the body or eroding through the skin
Leakage, tearing, kinking, or disconnection of the catheter resulting in underdose or no baclofen infusion
Pump failure leading to overdose or underdose of intrathecal baclofen

Pump failure may cause an overdose or underdose of intrathecal baclofen. The signs and symptoms of an overdose include:

Drowsiness
Lightheadedness
Difficulty breathing
Seizures
Loss of consciousness or coma

The signs and symptoms of an underdose include:

Increase or return of spasticity
Itching
Low blood pressure
Lightheadedness
Tingling sensation

It is important to call your doctor immediately if you experience any of these symptoms.

Drug Side Effects

ITB Therapy drug side effects are usually temporary and may be managed by adjusting dosage. The most common side effects include:

Loose muscles
Sleepiness
Upset stomach and vomiting
Headaches
Dizziness

Symptoms of Baclofen Withdrawal

Please follow your doctor's instructions 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
Multiple organ-system failure and death (in rare cases)

It's important to keep your scheduled refill visits so you don't run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal, which include:

Increase or return in spasticity
Itching
Low blood pressure
Lightheadedness
Tingling sensation

Call your doctor immediately if you experience any of the above symptoms.

Sources of Ongoing Support

In most cases, your doctor and his or her staff should be your first point of contact, but Medtronic also offers ongoing support. The information below will help you determine who to contact when you have questions.

Your Doctor

Please direct all medical, medication, and therapy questions to your doctor's office. Your doctor has access to your medical records and history and can best diagnose any change in symptoms. Ask your doctor how to reach the on-call doctor for any medical concerns that arise after hours or on weekends.

Medtronic Patient Services

Call Medtronic Patient Services if you have questions regarding your ITB Therapy infusion system. Note that as a medical device manufacturer, Medtronic can offer technical assistance when you have questions about or problems with your ITB Therapy infusion system; however, Medtronic is not able to comment on your medical condition.

To reach Medtronic Patient Services, call toll-free: (800) 510-6735
Monday-Friday, 8 a.m. to 5 p.m. Central Time

Patient Guide

Your doctor will give you the manual you need to use your SynchroMed system. For your convenience, it is also available for download.

SynchroMed II Programmable Infusion System Patient Manual

Out of Town Doctors, for When You Travel

Medtronic has a presence in 120 countries worldwide. So no matter where life takes you, there will likely be a physician familiar with Medtronic products.

If you experience problems with your Medtronic SynchroMed system or need a refill while you're traveling within the U.S., use our “Find a Doctor” locator. Just enter the zip code of your travel location and the locator will list all nearby doctors who can help you. We suggest that you plan ahead and print this information prior to your departure. Consider carrying a copy in your purse or wallet during vacation so you have it handy, should an emergency arise.

Find a Doctor

Patient Identification Card

Carry your patient ID with you in your wallet or purse. It shows that you have an implanted medical device in case of an emergency, and you will need it when going through security at airports.

If you move, change doctors, or lose your ID card, there are two ways to update your information or request a replacement card.

Complete an online form.
Call Medtronic Patient Registration Services at (800) 551-5544, Monday through Friday, 7 a.m. to 6 p.m., Central Time.

Next: Getting a Replacement

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

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.

Last updated: 20 Feb 2013