Design Enhancement to the SynchroMed II Implantable Infusion Pump to Address Motor Corrosion
In November 2012, Medtronic distributed a communication letter entitled “Urgent Medical Device Safety Notification: Use of Unapproved Drugs with the SynchroMed® Implantable Infusion Pump” to healthcare professionals.
Systematic root cause analysis was performed on representative field returned pumps with confirmed motor stalls vs. field returned pumps that exhibited normal functions.
Root cause investigation of these cases determined the failures were attributed to the corrosion of a motor component due to exposure of the component material to the humid, ionic environment created by the drug solutions in the pump. The component corrosion resulted in insufficient torque transmission to move the mechanical components of the pump, which in turn resulted in cessation of pump therapy.
The design enhancement to address motor corrosion is part of Medtronic’s ongoing activities around monitoring and improving upon SynchroMed II device performance. As of December 2015, all SynchroMed II pumps are being manufactured with the enhanced design.