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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00636-1
Product Name/Description SynchroMed II and SynchroMed EL Implanted Infusion Pump

All models and serial numbers affected

ARTG Number: 97770
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 4/07/2013
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Within the SynchroMed pump, feedthroughs are components that provide an electrically insulated path for current to flow from the electronic circuitry to the motor. An electrical short can occur when ions from the drug solution and humidity permeate through the drug pathway tubing inside the pump and interact with the feedthrough over time. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and leads to a loss of or reduction in therapy which may result in the return of underlying symptoms and/or withdrawal symptoms.
Recall Action Hazard Alert
Recall Action Instructions Through the 'Hazard Alert' letter, Medtronic is advising clinicians regarding ongoing patient management recommendations. Medtronic does not recommend prophylactic replacement of SynchroMed II or SynchroMed EL pumps due to the estimated low occurrence rate, the presence of pump alarms, and the risks associated with replacement surgery. However, appropriate consideration should be given to individual patient needs.

If repeated short duration motor stalls, Low Battery Resets (with or without Safe State), or a premature Elective Replacement Indicator occur, replacement surgery should be scheduled for therapy continuation. Alternative medical management should be considered if appropriate.

For more details, please see .
Contact Information 1800 668 670 - Medtronic Australasia