Questions and Answers – Living With ITB Therapy
How do you set my dose?
Mary Elizabeth Nelson, a nurse practitioner with 8 years of working with patients who have baclofen pumps, explains how the pump is programmed and the therapy is adjusted.
What if the pump runs out of medication?
Your programmable pump needs to be refilled with medication periodically using an external procedure performed in your doctor's office.
More: After Surgery
Can I stop taking other medications for severe spasticity once I have ITB TherapySM?
Your doctor will determine if you still need to take other medications.
How will alcohol or other medications affect me?
The drowsy effect of Lioresal® Intrathecal (baclofen injection) may add to the effect of alcohol or other depressants. Drowsiness has been reported in people receiving Lioresal Intrathecal. You should be careful driving, operating dangerous machinery, or taking part in activities that may be dangerous if you are not alert.
Does ITB Therapy affect sexual function?
There have been reports of people who have been affected. This effect isn't usually permanent and may be helped by changing the dose of Lioresal Intrathecal.
Does ITB Therapy interact with metal detectors, theft detectors, and security devices?
Your pump may set off metal theft detectors, or security devices. Don't linger near or lean on security screening devices. If you set off a device, show your ID card to security personnel.
Can I have a diagnostic ultrasound?
Electromagnetic interference (EMI) from diagnostic ultrasound (for example, carotid scan, Doppler studies) is unlikely to affect your SynchroMed pump. Note: To minimize potential image distortion, the transducer must be kept 15 centimeters (6 inches) away from the infusion system.
Can I use a cell phone?
Your programmable pump is protected from the low-powered stray electromagnetic interference (EMI) present in a typical cellular phone. However, if your phone is near your programmable pump (1 meter), be sure to turn your phone off prior to any telemetry on your pump to help prevent EMI. Some cellular phones contain a tiny magnet.
Will a microwave oven affect my pump?
Under normal conditions, the household appliances you use in your daily activities will not affect the programmable pump. If you suspect interference with your programmable pump, move away from or turn off the electrical device. The programmable pump will not be permanently affected.
Can I undergo magnetic resonance imaging (MRI) testing?
Contact your doctor before having magnetic resonance imaging (MRI) performed. Programmable pump performance has not been established for Magnetic Resonance Imaging (MRI) scanners at fields greater than 3.0 T (Tesla) scanners. People with a pump should not have an MRI using greater than 3.0 T scanners.
The MRI will cause your pump to temporarily stop and suspend drug delivery during the MRI. The MRI may also cause your pump to temporarily sound an alarm. The pump should resume normal operation after the MRI is complete. Your doctor will check your pump after an MRI to confirm it is still working properly.
What kind of activities should I avoid?
Avoid activities that put undue stress on the implanted components of your infusion system. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching can damage the components or cause the catheter to dislodge. This can require surgery to repair or replace the components. The catheter could also become kinked or blocked, preventing drug delivery and resulting in a loss of or change in therapy that can lead to serious injury or death.
Do I need to take special precautions for long airline flights or high-altitude activities, such as skiing or hiking in the mountains?
Before engaging in activities at high altitudes (such as airline flights, skiing, or hiking in the mountains), discuss the effects of low pressure with your doctor. Patients who live or travel at high altitudes are exposed to lower air pressures. With continued exposure to lower pressure, the flow rate of the pump may increase and then stay at the higher rate. If your doctor determines that such an increase in flow rate might pose an undue risk to you, your doctor can adjust your infusion prescription to offset this higher flow rate.
In rare cases, exposure to the lower pressures can cause the flow rate of the SynchroMed II pump to exceed the programmed flow rate by more than 14.5% while the patient is exposed to the lower pressure. The infusion prescription in SynchroMed pumps can be changed for patients who will be exposed to lower pressures.
Can I go scuba diving or use hyperbaric chambers?
Do not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA). Pressures below 10 meters (33 feet) of water (or above 2.0 ATA) could damage the pump, requiring surgery to replace the pump. To minimize damage to the pump when hyperbaric treatment is required, your doctor should fill the pump to capacity using the appropriate refill kit and maintain the current infusion prescription prior to exposure to hyperbaric conditions. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with your doctor. As pressure increases, pump flow decreases. Continuing to increase the pressure will eventually lead to serious injury or death.
Can I use hot tubs, steam rooms, saunas, and tanning beds?
If the temperature of a hot tub, steam room, sauna, or tanning bed is greater than 39˚C (102˚F), you should not use it. The flow rate of the pump will vary with body temperature. The flow rate increases as the temperature increases. If the increase is significant, the pump can deliver too much medication. This may lead to serious injury or death.
What should I plan for regarding my ITB Therapy before traveling this summer?
Dr. Stephen Koelbel says: “There are a few very important things you must consider before heading out of town. First, find out when your pump is due to be refilled and make sure this date doesn’t overlap with your trip. If the dates do coincide, then make arrangements to have the pump refilled prior to your trip.
Next, find out if there is a doctor who offers ITB Therapy in the area you’re visiting. You shouldn’t have a problem if you are near a major metropolitan area. In fact, I was once contacted by a patient from Arizona who was visiting every major ballpark in the country. They were given my name as a physician in the Boston area. I was very happy to help this patient with a refill, and I got to hear some great ballpark stories in the process!
Your doctor may be able to help you find a doctor in the area, or you can use the online directory.
Finally, be sure to carry your Medtronic medical ID card with you, particularly if you will be using an airline. This card may help you pass through security with fewer questions. It also serves as an emergency card if something happens while traveling. Happy travels!”
Stephen Koelbel, MD, practices physical medicine and rehabilitation at South Shore Physiatry and Spasticity Management, in affiliation with Braintree Rehabilitation Hospital, in Braintree, Mass.
Is depression a concern among caregivers?
Dr. Alison Krawiecki says: “Caregiving itself does not cause depression, but it is not unusual for caregivers to experience strong emotions including sadness and anxiety. Often caregivers overlook their own physical or emotional needs in order to prioritize the needs of their loved ones. Over time, this can lead to feelings of anger, sadness, resentment, and exhaustion. These emotions are normal, but when they become more intense it may indicate depression.
Common signs that may point to depression include:
- Loss of interest in and satisfaction from previously enjoyed activities.
- Feeling sad, down, hopeless, or worthless.
- Unintentional change in eating habits, weight gain, or weight loss.
- Decreased attention to or interest in personal hygiene or dress.
- A change in sleeping patterns (sleeping too much or too little).
- Crying spells for no clear reason or just being more tearful than usual.
- Becoming easily irritated, restless, or angry.
- Feeling your actions don’t measure up.
- Thoughts of death or suicide.
- Loss of interest in sex.
- Increased use of alcohol, tobacco, or other substances.
- Physical symptoms that do not respond to treatment.
Talking with a primary care doctor or trained mental health professional early on may prevent the depression from becoming more serious.”
Alison Krawiecki, Psy.D., is a clinical neuropsychologist and health psychologist in private practice in Englewood, CO. She is a member of the Colorado Neurological Institute.
How important is a support network for those receiving ITB Therapy?
Dr. Michael Saulino says: “It is important for my patients who have ITB Therapy to have two strong networks of support—medical and emotional. Often, there are other issues that interrelate with severe spasticity that may need attention after a SynchroMed pump is placed. For example, a wheelchair that requires adjusting, the need for a new brace, or an adverse event. If you are at a reputable medical center that offers comprehensive services, these issues will likely be handled competently and you will find navigating them is easier because you have access to the necessary resources.
It’s also crucial to have an emotional support network. There is tremendous value in having a relationship with someone who has experienced the same symptoms you are feeling. Overall, I find that my patients who have a connection to others with their same condition—often through a support group—have a higher level of understanding and ask more substantive questions about their health. They move through the healthcare system with greater ease and skill.”
Michael Saulino, M.D., is board-certified in physical medicine and rehabilitation, spinal cord injury medicine, and pain management. He is Clinical Director, Intrathecal Therapy Services at MossRehab in Philadelphia, PA.
Why should I choose a Medtronic device over another option?
When choosing a device to manage your severe spasticity symptoms, look to a healthcare company that understands your condition and has extensive experience offering safe and effective therapies.
Here are some important facts for you to consider:
- More than 60,000 Medtronic SynchroMed® pumps have been implanted worldwide for Medtronic ITB Therapy.
- For more than 15 years Medtronic has collaborated with numerous advocacy groups to help raise awareness of spasticity and the conditions that can cause it.
- Medtronic is the only company to track product performance, including more than 17,000 neurological devices and more than 6,100 patients.
- The quality, reliability, and strength of the new Medtronic Ascenda™ catheter may reduce complications caused by kinks, breaks, and leaks – even during active daily living.
- Your Medtronic infusion system can be programmed and refilled in clinics across the United States and around the world
- Medtronic has more intrathecal therapy experience than any other company.
- Medtronic ITB Therapy is the only intrathecal therapy backed by 20 years of severe spasticity management experience.
- Explore the proven benefits of Medtronic ITB Therapy.
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 www.fda.gov/medwatch, or call 1-800-FDA-1088.
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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