DESIGN ENHANCEMENT TO THE SYNCHROMED® II IMPLANTABLE INFUSION PUMP TO ADDRESS INTERNAL ELECTRICAL SHORTING
In May 2013, Medtronic distributed a communication letter entitled “Urgent Medical Device Correction: SynchroMed Implantable Infusion Pump Internal Shorting” to healthcare professionals. The letter advised on a device reliability issue where electrical shorting of an internal pump component resulted in the pump failing to delivery therapy. The probability for internal shorting of the SynchroMed II pump was communicated to be 0.69% at 7 years post implant.
In response, Medtronic initiated activities to enhance the robustness of the SynchroMed II design with respect to electrical shorting. Dynamic, interactive problem solving and product development tools within Design for Reliability and Manufacturability (DRM) were utilized to assess the problem, assure capability and repeatability of new manufacturing processes, leverage accelerated testing, and provide objective in vitro evidence of improved device reliability.
The design enhancement to address internal electrical shorting 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.