PUMP MANAGEMENT ITB Therapy for Severe Spasticity

PUMP REFILLS

One of your most important responsibilities during treatment is to make sure your pump does not run out of Lioresal® Intrathecal (baclofen injection). The best way to ensure this is to attend all your refill appointments.

KEEP ALL YOUR APPOINTMENTS

The pump must be refilled on time. You need to have enough Lioresal® Intrathecal for continuous, effective treatment.

Missing a refill appointment could result in:

  • A loss or change in your treatment that could cause serious injury
  • Too little medication, which could lead to withdrawal symptoms
  • Damage to the pump, which could require a pump replacement surgery

A REFILL APPOINTMENT

A trained medical professional will empty any remaining medicine from the pump and refill it using a needle inserted through your skin. This is a relatively short procedure.

The pump’s performance and programming are checked.

HOW OFTEN?

The pump needs to be refilled every few months. Your doctor’s office will schedule the next refill based on calculations with the programming device. If transportation issues or bad weather may make it difficult for you to get to your appointment, ask whether it can be scheduled a week earlier just in case. If you will be traveling, call and see if you should have a refill before you go.


PUMP ALARMS

Your pump will sound an alarm if there is a problem, it needs to be replaced, or it needs to be filled with Lioresal® Intrathecal (baclofen injection). There are two different alarms. Learn what each one means, and what to do if you hear it.

SINGLE BEEP: NON-CRITICAL ALARM

A single beep, repeating about once every hour, sounds when the amount of medication in the pump is getting low. Call your doctor right away to schedule a refill appointment.

The single beep will also sound if your pump needs to be replaced within 90 days. Call your doctor.

Non-Critical Alarm

TWO-TONE ALARM: CRITICAL ALARM

If you hear a two-tone alarm, call your doctor immediately.

This alarm sounds when the medication is no longer flowing. The pump may be empty, need replacement, or have another problem. A sudden stopping of ITB Therapy with Lioresal® Intrathecal leads to baclofen withdrawal and a medical emergency, so act quickly.

Critical Alarm


Recognizing the Alarms

The pump’s alarms may be softer than the sample on your computer.

At a refill visit, ask the clinician to temporarily program your pump to sound the alarm so you will know what it sounds like.

If you have hearing loss, ask family members to monitor for alarms, and let your doctor’s office know you may have trouble hearing alarms.

If an alarm does go off, it will sound periodically until silenced by your doctor’s programming device.


PUMP REPLACEMENT

The SynchroMed™ II pump can last up to 7 years, depending on how much medicine the pump delivers each day. Your doctor will monitor the performance and battery level of your pump at each refill appointment.

PUMP ALARMS FOR REPLACEMENT

When your pump is nearing the end of service, a single beep will start sounding. Contact your doctor to schedule a pump replacement.

If the pump is not replaced after the single beep alarm sounds, it will continue to operate for up to 90 days. A critical alarm (two tones) will then sound, and the pump will stop. A stopped pump results in loss of therapy, which can cause dangerous symptoms of baclofen withdrawal.

CATHETER REPLACEMENT

Your doctor will determine at the time of pump replacement if you should also get a new catheter. Sometimes the catheter can stay in place and be connected to the new pump.


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.