Medtronic SynchroMed Implantable Infusion System Devices: Class I Recall
MedSun: Newsletter #86, July 2013

FDA MedWatch Safety Alert

The SynchroMed Implantable Infusion Pumps are being recalled because of the unintended delivery of drugs during the priming bolus procedure. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid (CSF) followed by a period of reduced drug delivery after the priming bolus.

Additional Information:

Medtronic SynchroMed Implantable Infusion System Devices: Class I Recall. FDA MedWatch Safety Alert. June 28, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm359118.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun