China NMPA Product Recall - Nerve stimulation system, nerve stimulator

Medtronic (Shanghai) Management Co., Ltd., on behalf of manufacturer Medtronic Inc., initiated a voluntary Class II recall of its neurostimulation systems and neurostimulators, including models 3023, 3058, and 7425. This recall was reported to the National Medical Products Administration (NMPA) with a report date of January 12, 2015, and published on January 27, 2015.The primary issues identified relate to the device's battery performance and display accuracy. Specifically, while product labeling suggests cyclic stimulation extends battery life, certain parameter settings can, in fact, shorten it. Furthermore, when cyclic stimulation is active, the N'Vision® programmable controller used by clinicians may display an inaccurate estimated battery lifespan. It's important to note that these issues do not impact treatment delivery or the system's ability to notify users of low or depleted battery levels.In response to these findings, Medtronic is undertaking corrective actions. The company will issue notification letters to all affected distributors and hospitals globally, providing guidance on methods to optimize and extend stimulator battery life when utilizing the cyclic stimulation function. This action aims to ensure appropriate device management and patient safety under the regulatory oversight of the NMPA.