Getting a Replacement – Baclofen Pump
As someone who has chosen a Medtronic SynchroMed® pump for severe spasticity, you know first-hand the difference it can make. We want to ensure that you continue to benefit from ITB TherapySM.
Battery Life
The Medtronic SynchroMed® II pump uses a battery to keep the drug flowing through the pump and catheter. The pump will last a maximum of 7 years. The automatic shut-down at 7 years is designed to ensure that the pump works correctly to provide ITB Therapy.
The typical battery life of your SynchroMed II pump will range between 5 and 7 years, depending on how much medicine you’re programmed to receive each day. Your doctor will closely monitor the performance and battery levels of your programmable pump at each of your refill appointments.
When to Schedule a Replacement
Before the battery in your SynchroMed pump is depleted, you will need to replace the pump with a new pump. Replacing a pump requires surgery. If you start to show signs of baclofen withdrawal, it could be an indication that your pump isn't working properly and needs to be replaced.
The SynchroMed II pump (most pumps implanted after July 2004) has an elective replacement indicator (ERI) alarm. This alarm sounds when your pump is nearing End of Service (EOS). If the pump is not replaced after the ERI alarm sounds, the pump will continue to operate for a while, but will stop after 90 days. A stopped pump results in a loss of therapy that can lead to serious injury or death.
Like the SynchroMed II, the SynchroMed EL pump (most pumps implanted before July 2004) will sound an alarm when the battery is low. However, it will not automatically shut down. Depending on the rate at which you receive medication, the low battery alarm on most SynchroMed EL pumps will sound after 5 to 8 years of use.
If your pump is a SynchroMed II, it is important to understand that your pump will not last longer than 7 years from the time of implant; Medtronic recommends that you schedule a pump replacement roughly 6 months in advance of the automatic end-of-service at 7 years.
When the ERI alarm on your pump sounds, immediately contact your doctor. However, it is best to contact your doctor before the alarm sounds to schedule a pump replacement so there is no interruption in your therapy.
Early signs of baclofen withdrawl are important to understand and watch out for. They can include an increase or return in spasticity, itching, low blood pressure, lightheadness, or tingling sensation. A sudden stop of intrathecal baclofen therapy can result in serious illness such as high fever, changed mental status, muscle rigidity, and can lead to multiple organ-system failure and, in rare cases, death.
Be sure to tell your doctor right away if you experience any unusual symptoms, side effects, or changes in your condition.
For more information about your pump’s service life, contact your physician.
Catheter Replacement
Your physician will determine at the time of pump replacement if you should also get a new catheter. Often, the catheter can stay in place and be reconnected to the new Medtronic SynchroMed II pump. Talk with your doctor about the new Ascenda™ catheter if you are having your catheter replaced.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call
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.
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