Products and Procedures

Medtronic provides clinicians with a straightforward and effective screening test for determining if a patient is a candidate for the SynchroMed^® II programmable infusion system for intrathecal drug delivery.

During the screening test, intraspinal morphine is administered via a lumbar puncture or percutaneous catheter and continuous intrathecal/epidural delivery. Patients receiving a significant reduction in pain during the screening test may be considered for implantation with the SynchroMed II infusion system. Refer to the drug package insert for procedure and dosing recommendations and a complete listing of Indications, Safety and Warnings.

In general, there are three approaches to the screening test:

Single Injection

• The patient is injected with a single bolus injection of intrathecal morphine, via a lumbar puncture.
• The dose is typically 0.2 to 1.0 mg per day, or the intrathecal equivalent of the patient's daily (systemic) opioid intake^3,4

Multiple Bolus Injections

• The patient is given a series of injections, either intrathecally or epidurally.
• For epidural administration, administer injections via an epidural catheter inserted under fluoroscopy to ensure proper placement
• Patients may receive a placebo to compare symptom relief

Continuous Infusion

A catheter is placed either intrathecally or epidurally and connected to an external infusion pump.

• Morphine therapy is tested over a period of days. The initial dose is typically 0.2 mg/hour or the epidural equivalent of the patient's daily (systemic) opioid intake. The dose is increased every 12 to 24 hours until pain relief is reported^4,5
• The typical morphine dose conversion is as follows:
• Oral to Intravenous = 3:1
• Intravenous to Epidural = 10:1
• Epidural to Intrathecal = 10:1

Resources

• Intrathecal Morphine for Pain Management Chapter of the SynchroMed II Clinical Reference Guide

  This chapter of the SynchroMed II Programmable Infusion System Clinical Reference Guide provides information about conducting the screening test.

The SynchroMed II programmable infusion system, which includes the pump and an intrathecal catheter, is implanted in a sterile surgical procedure performed under general or regional anesthesia.

The pump is implanted in the lower abdomen just beneath the skin. One end of the catheter is inserted into the intrathecal space of the spine. The other end of the catheter is then tunneled under the skin and connected to the pump.

Before implantation, a screening test of the intrathecal or epidural drug is necessary. This procedure will help assess if the patient responds appropriately to the medication. Refer to the drug package insert for procedure and dosing recommendations and a complete listing of warnings, precautions, and contraindications.

For a complete description of the intended use, indications, contraindications, warnings, and precautions, refer to the current implant manuals that accompany the products.

For detailed information on intrathecal drug delivery implant procedures, including information on the prevention and management of surgical complications, refer to: SynchroMed II Clinical Reference Guide – Surgical Procedures

Contraindications for Pump Implant

Implantation of the programmable pump is contraindicated:

• When infection is present
• When the pump cannot be implanted 2.5 cm or less from the surface of the skin
• When body size is not sufficient to accept pump bulk and weight
• When contraindications exist relating to the drug; drugs with preservatives

Do not use the myPTM^® personal therapy manager accessory to administer opioid to opioid-naïve patients or to administer ziconotide. Blood sampling through the catheter access port is contraindicated.

Contraindications relating to the use of the prescribed drug must be observed. For more information, see Indications, Safety, and Warnings.

Resources

• Surgical Procedures Chapter of the SynchroMed II Clinical Reference Guide

  This chapter of the SynchroMed II Clinical Reference Guide provides information regarding pump implant, replacement, and removal.

  Low Complication Catheter Implant Technique

  This guide describes a low-complication catheter implant procedure for the 8709C and 8731C catheters. These instructions are not intended to address all of the surgical options, potential complications, or individual patient requirements. However, the technique presented in the guide may result in fewer catheter complications than other techniques.

The SynchroMed II infusion system has an expected longevity of 4 to 7 years, depending on the flow rate. Some pumps with flow rates above 0.9 mL/day may reach their end of service prior to the 7-year maximum battery life. However, the majority of SynchroMed II pumps are programmed to have a flow rate below 0.9 mL/day and are expected to last up to 7 years.

When a SynchroMed II infusion system reaches end of service at 7 years, it is designed to automatically shut off. This automatic shutoff helps ensure safe therapy transition by avoiding unpredictable failures that could occur as the pump's mechanical components age.

The SynchroMed II pump was launched in the U.S. in June 2004. As expected, the first pumps implanted will reach normal end of service in the coming months and will begin automatically shutting off.

View details about the Elective Replacement Indicator (ERI) and End of Service (EOS).

For more information on the indications, contraindications, warnings, and precautions for the SynchroMed programmable infusion systems, please review Important Safety Information.

Resources

• Surgical Procedures Chapter of the SynchroMed II Clinical Reference Guide

  This chapter of the SynchroMed II Clinical Reference Guide provides information regarding the pump replacement procedure.