Frequently Asked Questions

What is an Intrathecal Pump Implant ("Spinal Morphine Pump")?

An Intrathecal Pump is a specialized device, which delivers concentrated amounts of medication(s) into spinal cord area via a small catheter (tubing).

Am I a candidate for Intrathecal Pump Implant ("Spinal Morphine Pump")?

Currently at BHI, Intrathecal Pump is offered to patients with

• Chronic and severe pain, who have not adequately responded to other treatment modalities. Some of the examples are failed back syndrome, cancer pain, RSD. These patients receive infusion of painkillers such as Morphine or Dilaudid.
• Spastic disorders such as Multiple Sclerosis, Spinal Cord Injury - associated with muscle spasms. These patients receive infusion of an antispasmodic medication called Baclofen.

What is the purpose of it?

This device delivers concentrated amounts of medication into spinal cord area allowing the patient to decrease or eliminate the need for oral medications. It delivers medication around the clock, thus eliminating or minimizing breakthrough pain and/or other symptoms.

How long does the procedure take?

It is done in two stages. In the first stage, a single injection is made to assess effectiveness and screen for unwanted side effects. If this trial is successful in relieving symptoms, then the permanent device is placed under the skin. The patients have to meet certain other screening criteria before implanting the pump.

Will the procedure hurt?

The procedure involves inserting a needle through skin and deeper tissues (like a "tetanus shot"). So, there is some discomfort involved. However, we numb the skin and deeper tissues with a local anesthetic using a very thin needle prior to inserting the needle. Most of the patients also receive intravenous sedation and analgesia, which makes the procedure easy to tolerate.

Will I be "put out" for this procedure?

The placement of the tubing is done under local anesthesia with patients mildly sedated. The amount of sedation given generally depends upon the patient tolerance.

For the pump placement, patients are given stronger intravenous sedation and analgesia.

How is the procedure performed?

It is done with the patient lying on the side. Sometimes the tubing is placed with the patient sitting up. The patients are monitored with EKG, blood pressure cuff and blood oxygen-monitoring device. The skin is cleaned with antiseptic solution and then the procedure is carried out. X-ray (fluoroscopy) is used to guide the needle for inserting the tubing.

Where is the tubing inserted? Where is the pump placed?

Tubing is inserted in the midline at the lower back. The pump is then placed on the side of the abdomen.

What should I expect after the procedure?

If the procedure is successful, you may feel that your pain may be controlled or quite less. The pump is adjusted electronically to deliver adequate amount of medication.

What should I do after the procedure?

This procedure is normally a day-procedure and patients are kept overnight for observation and pump adjustment.

How long will the pumps last?

The medication contained within the pump will last about 1 to 3 months depending upon the concentration and amount infused. It is then refilled via a tiny needle inserted into the pump chamber. This is done in the office or at your home and it takes only a few minutes.

The batteries in the pump may last 3 to 5 years depending upon the usage. The batteries can not be replaced or recharged. The pump is replaced at that time.

Will the Intrathecal Pump Implant ("Spinal Morphine Pump") help me?

It is very difficult to predict if the procedure will indeed help you or not. For that reason a trial is carried out to determine if a permanent device (pump) will be effective to relieve your pain or not.

What are the risks and side effects?

Generally speaking, this procedure is safe. However, with any procedure there are risks, side effects, and possibility of complications. Please discuss your concerns with your physician.

Who should not have this procedure?

If you are on a blood thinning medication (e.g. Coumadin), or if you have an active infection going on, you should not have the procedure. The patients also have to meet certain other screening criteria before implanting the pump.

Where can I get additional information?

More detailed information is available from the manufacturer of this device. At the time of consultation you will receive a Synchromed Infusion System Patient Education Booklet. Additional information is also available at the Medtronic Web Site

Programmable Infusion System

Clinical Considerations in Selecting 20 mL and 40 mL Pumps

Please refer to the current SynchroMed Pump technical manual for a complete list of indications, contraindications, warnings, precautions and adverse events. Also see Important Safety Information and Risks.

The SynchroMed II Pump is available with a 20 mL or 40 mL reservoir.

The 20mL SynchroMed II Infusion System is available to patients whose body mass is insufficient to accommodate the 40 mL pump. The 20 mL pump is the same diameter as the 40 mL pump, is thinner (19.5 mm vs. 26 mm), weighs 10 grams less, and has a 20 mL reservoir.

The following questions and answers may be helpful in evaluating which size pump should be implanted.

Q: What is the primary reason for choosing a 20 mL pump?

A: The 20 mL pump provides an option for patients whose body mass is too small to accommodate a 40 mL pump. Some body-conscious patients may prefer the thinner profile for cosmetic reasons, but they should be made aware of the trade-off in refill frequency.

Q: What factors should be considered in determining the appropriate pump size for the patient?

A: The key in determining whether a 40 mL pump can be implanted is whether there is sufficient skin and subcutaneous tissue to support the pump. Most, although not all, patients can support a 40 mL pump.

However, a select number of pediatric or cancer patients may require a 20 mL pump due to insufficient anchoring tissue.

Q: Are there differences in implant procedures for the 20 mL pump and 40 mL pump?

A: The only difference at implant between the two pumps is the amount of drug that should be introduced into the reservoir. For the 40 mL pump, maximum fill volume at implant is 40 mL. For the 20 mL pump, maximum fill volume at implant is 20 mL.

Q: Why does the 20 mL pump require refilling nearly twice as frequently as the 40 mL pump?

A: The "usable reservoir volume" for all SynchroMed II pumps is the "reservoir volume" minus the "low reservoir alarm volume." The recommended setting for the low reservoir alarm is at least 1 mL for all SynchroMed II pumps. Patients are expected to return for refill before the alarm sounds. At recommended settings, the "usable reservoir volumes" for the 40 mL and 20 mL pumps are a maximum of 39 mL and 19 mL, respectively.

Q: What are some of the ramifications of more frequent refills?

A: More frequent refills may be a burden to patients who find it difficult to return to the refill center. More frequent refills also increase cost, since there may be an office charge associated with each refill session.

Q: Is there any way to reduce the frequency of refills required?

A: If the patient is receiving a low concentration of the drug, the frequency of refills can be reduced by increasing the drug concentration. Preservative-free morphine sulfate is commercially available in 10 mg/mL and 25 mg/mL concentrations. However, drug concentrations should never be more than 10 times the daily dose, and drug stability requirements should not be exceeded. The drug stability (defined as >90% of the initial concentration) for morphine sulfate is 180 days.

Q: Can I use an electric blanket or heating pad with my implanted device?

A: Please understand that the following recommendations are based on Medtronic's knowledge of the technology rather than on clinical testing. Please follow these guidelines:

If the blanket or heating pad contains a magnet, we recommend that the magnet be kept at least 10 inches away from the implanted drug delivery system.

Medtronic recommends that you discuss with your physician the use of an electric blanket or heating pad before using either product.

Q: What is the difference between "therapeutic" vs. "diagnostic" ultrasound?

A: Therapeutic ultrasound refers to a type of treatment, commonly used by physical therapists or chiropractors, to help with healing of tissue damage. It is also called "deep heat treatment" and is classified under the umbrella titled diathermy.

Diagnostic ultrasound refers to the use of ultrasonic waves for diagnostic purpose, specifically to visualize an internal body structure.

The following compatibility information is based on our knowledge of the technology rather than on clinical testing.

How the therapeutic ultrasound (diathermy) will affect the implanted drug delivery system is unknown. However, the pump can retain heat. If overheated, a pump can over infuse the drug, potentially causing a drug overdose. We are not aware that the implanted drug delivery system has any affect on the outcome of the therapeutic ultrasound.

Diagnostic ultrasound is unlikely to affect the implanted drug delivery system. We are not aware that the implanted drug delivery system has any affect on the outcome of the diagnostic ultrasound.

Please inform your physician about your implanted device right away if therapeutic or diagnostic ultrasound is being discussed as a potential treatment for you.

Q: I have a SynchroMed EL drug delivery pump (model 8626 & 8627). Can I receive the Personal Therapy Manager (PTM)?

A: The Model 8832 Personal Therapy Manager (PTM) is available for pain management. It is an accessory to the SynchroMed II (model 8637) drug delivery system only, not to the SynchroMed EL drug delivery system. When it comes time to replace your pump, you and your physician will decide if this new accessory is right for you. It enables patients to initiate a physician prescribed bolus.

To determine if you could benefit from this product and therapy, discuss this product thoroughly with your physician. Important factors that may affect whether the PTM is a possibility for you also include geographic location, specific hospital, and reimbursement by your medical benefit plan.