China NMPA Product Recall - Implantable neurostimulation system extension leads, deep brain stimulation extension lead kit

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall for its Implantable Neurostimulation System Extension Leads and Deep Brain Stimulation Extension Lead Kits (models 37085, 37086). This recall was reported to the National Medical Products Administration (NMPA) on April 27, 2015, and officially published on May 15, 2015. The action followed an internal product analysis, conducted between October 1, 2014, and March 2, 2015, which identified a critical issue: a 0.14% occurrence rate of extension leads breaking near the connector. This breakage leads to high impedance and a potential loss of stimulation, which is vital for patients receiving Parkinson's disease or tremor control therapy. While most faulty leads were replaced during initial implantation, some cases necessitated separate revision surgery. Medtronic is currently investigating the root cause of these failures. Under the NMPA's medical device recall protocols, Medtronic is sending notification letters to affected hospitals, emphasizing adherence to corrective action guidelines in the implantation manual, and strongly recommending intraoperative impedance testing to confirm system integrity. Medtronic China reported no specific complaints related to this recall and offers a lifetime warranty for Activa® extension leads in the region.