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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00677-1
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 The SynchroMed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision. Although drug is not intended to be delivered to the cerebrospinal fluid (CSF) during the priming bolus, mixing of the drug and non-drug (sterile water/CSF) fluids occurs at the high infusion rates used during a priming bolus. Mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. Patients will receive unintended drug at a high rate of infusion in the CSF during the priming bolus, and a period of reduced concentration of drug will occur following the priming bolus.
Recall Action Hazard Alert
Recall Action Instructions Through the 'Hazard Alert' letter, Medtronic is advising clinicians regarding ongoing patient management recommendations. Medtronic recommends following published guidance for managing all patients with intrathecal therapy, in addition to the following:
- Continue use of the priming bolus procedure to ensure that therapy is initiated while the patient is under medical supervision.
- Monitor all patients following start or restart of intrathecal therapy. The post-procedure monitoring period will depend upon specific drug, dose administered and patient co-morbidities.

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Contact Information 1800 668 670 - Medtronic Australasia