Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall
MedSun: Newsletter #58, March 2011

FDA MedWatch Safety Alert

Pocket fills (the unintended injection of drugs or fluids into the patient's subcutaneous tissue at the pump pocket site instead of the pump) may result in patient harm, serious injury, and/or death due to drug overdose or underdose. Medtronic reminded healthcare professionals to check needle placement within the pump septum during the drug refill procedure. According to Medtronic, it is essential that the needle be inserted through the refill septum until it has reached the needle stop in the pump reservoir.

Additional Information:

FDA MedWatch Safety Alert. Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall. February 16, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243686.htm


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