Surgery: What to Expect – Implanting the SynchroMed Infusion System

Surgery for Medtronic ITB Therapy^SM takes approximately 2 to 3 hours from start to finish, depending on individual surgical techniques. Your doctor will be able to answer any questions you may have about the specifics of your procedure.

You can also talk with a patient who receives ITB Therapy and has volunteered to share their experience and answer your questions.

Detail - Intrathecal drug delivery

Before the Procedure

Your surgery to receive the Medtronic SynchroMed^® Programmable Drug Infusion System may require a brief hospital stay, or it may be done on an outpatient basis. Before the procedure, you and your doctor will decide where to position the pump for your comfort.

During the Procedure

Typically, the surgery is performed under general anesthesia, but you may discuss alternatives with your doctor. During surgery, the pump will be placed just under the skin of your lower abdomen.

The pump will be connected to a thin, flexible silicone tube called a catheter. The catheter is threaded beneath the skin into the intrathecal space around the spinal cord, into which it will deliver the medication.

Mary Elizabeth Nelson, a nurse practitioner with 8 years of working with patients who have baclofen pumps, describes the surgery for ITB Therapy.

After the Procedure

After surgery, you’ll feel some discomfort and tenderness at the pump and catheter sites. Your doctor may prescribe medication to relieve any pain caused by surgery and antibiotics to prevent infection. Tell your doctor if you notice any swelling, pain, or redness near your incision.

Depending on your doctor’s preference, the pump may be filled during or after surgery. However, some doctors recommend a short waiting period to allow you to recover from surgery and get adjusted to the pump.

Mary Elizabeth Nelson talks about the recovery period following the surgical procedure.

You’ll begin receiving treatment as soon as the pump is filled with medication and the medication travels through the catheter to the intrathecal space. You may feel effects from the medication soon after delivery, or it may take awhile for you to experience benefits. It may take several weeks to months to reach your optimal dose.

Potential Surgical Complications

ITB Therapy (the baclofen pump) can be helpful to people with severe spasticity.

Potential surgical complications may include:

Infection
Meningitis
Spinal fluid leak
Paralysis
Headache
Swelling
Bleeding
Bruising

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

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

Next: Questions and Answers

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: 9 Aug 2011