China NMPA Product Recall - SynchroMed II Implantable Drug Infusion Pump

Medtronic Inc., in collaboration with its Chinese subsidiary Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary recall of specific SynchroMed II implantable drug infusion systems (Model 8637). This action, reported to the National Medical Products Administration (NMPA) on March 30, 2012, addresses a critical software display issue. The primary concern is that the N'Vision® Physician Programmer (Model 8840) may incorrectly display the "Expected Replacement" date for affected pumps. This date might appear as question marks or a date significantly beyond 90 days from the Selective Replacement Indicator (ERI) notification. Although the pump's function and alarms remain unaffected and it continues operation for 90 days after ERI, this display error could potentially lead to the device reaching its end of service before a scheduled replacement. Under the NMPA's regulatory oversight, Medtronic is required to issue an "Urgent: Medical Device Correction" letter to implanters and attending physicians in China. This communication emphasizes confirming receipt and understanding of the correction. Physicians are advised to maintain normal follow-up schedules, monitor for the ERI, and ensure pump replacement within 90 days of the ERI's appearance, consistent with the product manual.