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Pump management TDD 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 the prescribed medication. The best way to ensure this is to attend all your refill appointments.

Keep all your appointments

The pump must be refilled on time to avoid loss of therapy, causing a potentially life threatening emergency. You need to have enough prescribed medication 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 the prescribed medication. 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 TDD therapy leads to prescribed medication withdrawal and a medical emergency, so act quickly.

Critical Alarm

Recognizing the alarms

The pump’s alarms may be quieter 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 prescribed medication 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.

Patient important safety information

When receiving TDD Therapy make sure you follow your clinician’s instructions closely. A sudden stop in therapy can result in serious medication withdrawal symptoms, such as high fever, changed mental status, muscle stiffness, and in rare cases, may result in the loss of function of many vital organs and death.

It is critical that your clinician be called right away if you experience any of these symptoms. Make sure you keep your scheduled refill visits so you don’t run out of medication. You should also know the early symptoms of prescribed medication withdrawal. Some people are at more risk than others for medicine withdrawal; speak with your clinician about this.

 

Q: What is severe spasticity?

A: Severe spasticity is a condition that results from an injury to or disease of the brain or spinal cord. Spasticity may make your muscles feel tight, stiff and difficult to move. With severe spasticity, you can experience stiffening of the muscles that makes your muscles feel like they are locked, or even jerk uncontrollably when you try to use them.

Q: What is TDD Therapy?

A: Targeted drug delivery is a treatment using prescribed medication that is delivered into the fluid around your spinal cord (intrathecal) to help manage severe spasticity. For long term treatment, the drug is placed into a pump that is surgically placed under the skin of your abdomen. The pump delivers prescribed medication through a small tube (catheter) into your spinal fluid. Your doctor can program the pump to deliver the appropriate daily dose for you. Before you can be considered for long term treatment, you must have a test dose to see how you respond to the drug when it is delivered in this way. After the test dose is done, your doctor will discuss the results with you and determine if you are an appropriate candidate for the therapy.

Q: Who is a candidate for TDD Therapy?

A: People who have severe spasticity resulting from conditions of the brain or spinal cord (such as multiple sclerosis, cerebral palsy, stroke, brain injury or spinal cord injury) may be candidates for TDD Therapy. If your spasticity is due to spinal cord injury or multiple sclerosis and is not controlled with medication taken by mouth or you have side effects that are not acceptable from oral medication taken to treat your spasticity, you may be a candidate. If you have had a brain injury due to trauma, you should wait for one year after your injury to be considered for TDD Therapy. Safety and efficacy in patients under the age of 4 has not been established.

Q: Who is not a candidate for TDD Therapy or a screening test dose?

A: If you are hypersensitive to prescribed medication, you should not use it. If you have an active infection, you should not have a screening test or implant until the infection has resolved. You should not receive TDD Therapy if you have a body size that is too small to hold the implantable pump.

Q: What do I need to know if I am using targeted drug delivery?

A: All patients and caregivers should receive information on the risks of the treatment. Your doctor should give you information of the signs and symptoms of receiving too much or too little medication (overdose or withdrawal) and what to do if you notice those symptoms.

Q: What can I do to prevent medication withdrawal or abrupt interruption of medication?

A: It is very important that you not miss refill appointments. If you plan to travel let your doctor know so that your refill can be scheduled so that you don’t run out of medication. If you are hospitalized for any reason near the time of your refill, you or your caregiver should let your doctor know before the refill date so that arrangements can be made to refill your pump. Not all hospitals have doctors that can refill pumps, so let your doctor know as soon as possible if it is near your refill date. You should be aware of what your pump alarms sound like. If you hear an alarm, contact your doctor immediately.

Q: What are the potential pump and catheter implant procedure complications?

A: The implanted pump and catheter are placed under the skin of the abdomen during a surgery. Some complications that you may experience with the implant surgery include infection, meningitis (infection of the lining of the brain and central nervous system), spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

Q: What are the potential pump and catheter complications that can occur after implant?

A: Once the infusion system (the pump and the catheter) is implanted, device complications may occur that may require surgery to remove or replace the pump, catheter or catheter fragment. Some of these device complications may impact the flow of medication delivered, which may cause symptoms of overdose or withdrawal of prescribed medication.

Possible complications include an internal component failure which may result in a loss of therapy, or an inability to program the pump. The pump, catheter or catheter fragment could migrate within the body or erode through the skin. Tissue or an inflammatory mass may form at the tip of the catheter in the intrathecal space and may cause a loss of therapy or neurological impairment including paralysis. The catheter could leak, tear or become disconnected resulting in delivery of medication into the area under the skin where the pump is implanted and/or along the catheter path. The catheter could kink or become blocked resulting in no delivery of medication. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. Errors in locating the pump during the refill procedure can result in symptoms of overdose that may be serious or life-threatening.

Q: Can I undergo Magnetic Resonance Imaging (MRI) testing?

A: Under certain conditions, an MRI can be conducted with the pump. Always inform your doctor that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy. Please ask your doctor to determine if the MRI scan can be used with the pump. The MRI will cause your pump to temporarily stop, which will suspend drug delivery during the MRI. The pump should resume normal operation and drug delivery after the MRI is complete. Your pump may also temporarily sound an alarm during the scan; the alarm should stop at the conclusion of the scan. Following your MRI, your doctor should check your pump to confirm that it is working properly.