SynchroMed II Drug Infusion System for Chronic Pain

Implant Procedure & Techniques

Screening Test

Before implantation, a screening test of the intrathecal or epidural drug is necessary to assess the patient's response to the medication.

Refer to the drug package insert for procedure and dosing recommendations and a complete listing of indications, safety & warnings.

In general, there are 3 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 intake1,2

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 Trial

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) opiod intake. The dose is increased every 12 to 24 hours until pain relief is reported3,4
  • The typical morphine dose conversion is as follows:
  • Oral to Intravenous = 3:1
  • Intravenous to Epidural = 10:1
  • Epidural to Intrathecal = 10:1

References

  1. Hassenbusch SJ, Pillay PK, Magdinec M, et al. Constant infusion of morphine for intractable cancer pain using implanted pump. J Neurosurg, 1990; 73: 405-409
  2. Onofrio B, Yaksh T. Long-term relief produced by intrathecal morphine infusion in 53 patients. J Neurosurg, 1990; 72:200-209
  3. Penn R., Paice J. Chronic intrathecal morphine for intractable pain. J Neurosurg,1987; 67:182-187
  4. Onofrio B, Yaksh T. Long-term relief produced by intrathecal morphine infusion in 53 patients. J Neurosurg,1990;72:200-209

Implant Procedure

The Medtronic SynchroMed® II Programmable Infusion System (including a Medtronic 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.

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 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 the Indications, Safety & Warnings.

System Implantation

There are a number of tasks that need to be completed in preparation for the implant procedure. Some of the major pre-operative responsibilities include obtaining informed consent, identifying and controlling infections, marking the pump pocket site, and proper patient positioning, and draping.

The pump pocket site is determined preoperatively. The amount of supportive tissue, skin integrity, patient activity, clothing and belt lines, and other surgical/radiation therapies—such as gastrostomy—likely to be performed in the future should be considered.

The sterile surgical implant procedure generally takes 1 to 3 hours. Implantation of the catheter and pump is usually done under general anesthesia, but can be done under local or spinal anesthesia with monitored anesthesia care if the physician desires or the patient's condition warrants.

The pump is implanted subcutaneously in the abdomen. This area has sufficient skin and subcutaneous tissue to support the implanted system.

A brief overview of the implant procedure is provided below. For a complete description of the intended use, indications, contraindications, warnings, and precautions, refer to the current manuals that accompany the product. Additional education and training materials are also available from your Medtronic Representative.

Related Manuals & Technical Resources

> View all related Manuals and Technical Resources

Procedure Videos

This short video contains an overview of the bridge bolus programming procedure.

This video gives an overview of pump preparation prior to implant including supplies, pump package contents, confirming pump status, sterile field, emptying the pump and more.

This video shows how to connect the syringe and empty the pump prior to a refill.

This video shows how to prepare and assemble the syringe and illustrates a pump refill.

This video shows how to rinse the SynchroMed II pump.

This video provides in-depth information on the refill procedure for the SynchroMed II pump and SynchroMed EL Infusion Systems.