Medical Device Safety and Recalls: Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Due to Failure of Priming Bolus – Update Related to May 2013 Recall

Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death. On October 7, 2016 Medtronic initiated an update recall to communications issued on May 14, 2013. Medtronic made a software change to the Synchromed II application contained on the Model 8870 software application card. This change will correct the priming volume associated with the priming bolus function. They also updated the labeling related to the software change and priming bolus function.