China NMPA Product Recall - InterStim Tined Leads Electrode Assembly

Medtronic Inc., in collaboration with its Beijing office, initiated a voluntary global recall of its InterStim Tined Leads Electrode Assemblies (models 3093 and 3889) as announced by the National Medical Products Administration (NMPA) on October 8, 2011. The recall stemmed from reports, totaling 45 by August 2010, of electrode leads breaking during removal procedures. This represented approximately a 1% breakage rate out of 4,482 removed units. The primary concern is that device fragments remain in patients, potentially leading to post-traumatic pain, discomfort, fragment migration, MRI complications, and requiring additional surgical intervention. Medtronic's health hazard analysis concluded that these issues largely arise from not strictly adhering to the implantation manual, particularly concerning lead removal. To address this, Medtronic implemented a corrective action plan involving direct educational briefings for physicians. These briefings, which commenced on May 18, 2011, and were completed by June 10, 2011, aimed to reinforce the correct procedures for lead removal as detailed in the product's implantation manual. The NMPA requested provincial Food and Drug Administrations to enhance supervision of such products. This proactive measure by Medtronic seeks to mitigate patient risks associated with the device's removal.