SynchroMed® EL Infusion System Brief Summary:

Product technical manual must be reviewed prior to use for full disclosure.

Indications:
Chronic intraspinal (intrathecal or epidural) infusion of preservative-free morphine sulfate for treatment of chronic, intractable pain. Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain. Chronic intrathecal infusion of Lioresal^® Intrathecal (baclofen injection) for severe spasticity. Chronic intravascular infusion of floxuridine (FUDR), or methotrexate for the treatment of primary or metastatic cancer.

Contraindications:

When infection is present; when the pump cannot be implanted less than 2.5 cm (one inch) from the surface of the skin; when body size is not sufficient to accept pump bulk and weight; when contraindications exist related to the drug.

Warnings:

Use only with approved drugs. Clinically significant or fatal drug overdose may result from improper use such as overpressurization of the pump reservoir; improper injection of drug through the side catheter access port or into the pump pocket; or failure to account for significant amounts of drug which may reside in the catheter, side catheter access port, pump tubing, and the reservoir.

Precautions:
Only qualified personnel should implant, program, fill and refill the SynchroMed pump or access the catheter access port. Maintain strict aseptic technique during all procedures. Consider use of peri- and postoperative antibiotics for pump implantation and any subsequent surgical procedures. Care must be taken in the pediatric population to select an appropriate anatomical pump site. Initial fill and refill volumes must not exceed levels specified in the technical manuals. Always use a template when accessing the implanted pump's center reservoir fill port or side catheter access port. Do not expose the pump to temperatures above 43 degrees C (110 degrees F) or below 5 degrees C (40 degrees F). Do not implant a pump that has been dropped onto a hard surface or shows signs of damage. Do not steam autoclave or flash autoclave the pump. Magnetic Resonance Imaging (MRI) will temporarily stop the pump motor and suspend drug infusion for the duration of MRI exposure. The pump should resume normal operation upon termination of MRI exposure. During an MRI scan, the patient may experience heating or peripheral nerve stimulation at or near the pump implant site. In the unlikely event that this happens, the MRI scan parameters should be adjusted to reduce Specific Absorption Rate (SAR) for heating or dB/dt for nerve stimulation or both. Before and following completion of an MRI scan, the pump parameters should be confirmed using a SynchroMed^® Programmer. SynchroMed pump performance has not been established in >2.0 T (Tesla) MR scanners, and it is not recommended that patients have MRI scans using these scanners.

Adverse Events:
Include, but not limited to, cessation/change in therapy due to battery depletion or component failure; pocket seroma, hematoma, erosion or infection; complete or partial catheter occlusion, kinking, breakage, leakage or disconnection; catheter dislodgment or migration; bleeding; arachnoiditis; meningitis; spinal headache; drug toxicity and related side effects; and procedural complications.

Rx only.

February 2007

©Medtronic, Inc. 2008                                                   • Contact Medtronic • Privacy Statement • Terms of Use • Site Map