Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its SynchroMed II Implantable Drug Infusion Pump [Model numbers: 8637-20 and 8637-40].
The manufacturer has received approval to implement a design change to the SynchroMed II implantable drug infusion pump that reduces the likelihood for non-recoverable motor stall, which can cause loss of therapy. For pumps manufactured prior to this design change, analysis of the post-market data estimates the pump survivability specific to non-recoverable motor stall at six years post-implant to be 97.3% for pumps exposed to on-label drugs and 91.1% for pumps exposed to off-label drugs.
The most common contributing factor to motor stall is shaft wear and this is observed in 59% of SynchroMed II pumps returned and analyzed for motor stall. Engineering testing estimates that the new design change addresses over 99% of shaft wear and will decrease the occurrence of motor stall.
The manufacturer recommends the SynchroMed II infusion system be used according to approved product labeling. Reliability for SynchroMed II pumps used with off-label drugs will still be lower than pumps used with on-label drugs, regardless of indication.
According to the manufacturer, all SynchroMed II pumps are now manufactured with the new design change, although there are limited quantities of these new devices in initial production. To ensure the patients have access to uninterrupted therapy, pumps manufactured prior to this latest change will remain available. Once there is sufficient inventory of the pumps with the new design, the manufacturer will no longer distribute pumps manufactured prior to this change.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 September 2017