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 Medtronic SynchroMed® Programmable Drug Infusion 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)
  • Make sure your family and friends know about the programmable pump so they can help in an emergency

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 an "Alarm On" status
  • The importance of checking battery status before and after a refill
  • The difference between Low Battery Alarm "Enabled" and "Alarm On"
  • How to learn what the pump alarm sounds like

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

Side effects associated with ITB Therapy usually are temporary and can be managed by adjusting the dosage of intrathecal baclofen (the drug contained in the pump).

The most common side effects include:

  • Loose muscles
  • Sleepiness
  • Upset stomach
  • Nausea/vomiting
  • Headache
  • Dizziness

Symptoms of Baclofen Withdrawal

Please follow your doctor's instruction closely, as 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 early symptoms of baclofen withdrawal, which include:

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

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

 

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.

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, traumatic 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, respiratory depression (difficulty breathing), 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 Novartis Pharmaceuticals Corporation.

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: 23 Apr 2009

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