Medtronic—SynchroMed Implantable Infusion Pumps: Use with Unapproved Drugs May Lead to Increased Risk of Permanent Motor Stalls and Cessation of Drug Infusion

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​In a November 2012 Urgent Medical Device Safety Notification letter submitted by an ECRI Institute member hospital, Medtronic states that the use of unapproved drugs with the infusion pumps below may result in an increased risk of permanent motor stall and cessation of drug infusion. Data from Medtronic's Implantable Systems Performance Registry (ISPR) shows the overall failure rate of the SynchroMed II pump at 78 months post-implantation to be 2.4% when used to dispense approved drugs, and 7.0% when used to dispense unapproved drugs. The use of unapproved drugs may lead to intermittent or permanent pump motor stalls, which may be reported as a loss of or change in therapy. Therapy changes may result in serious injury and/or death. Medtronic also states that pump motors may stall when pumps are used with either approved or unapproved drugs; however, pump motor stalls have been reported at a significantly lower rate when approved drugs are exclusively used. Medtronic is investigating motor gear corrosion as a primary...