Programmable Infusion System
Introduction to SynchroMed® Infusion System
The SynchroMed Pump
Clinical Considerations in Selecting 20 mL and 40 mL Pumps

N'Vision® Programmer
Important Safety Information and Risks

Intrathecal Catheters

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.

To see information about Patient Selection. . .

Programmable Infusion System
Introduction to SynchroMed® Infusion System
The SynchroMed Pump
Clinical Considerations in Selecting 20 mL and 40 mL Pumps

N'Vision® Programmer
Important Safety Information and Risks

Intrathecal Catheters