China NMPA Product Recall - Charger 37751 for implantable neurostimulator (trade name: RestoreSensor) and rechargeable implantable neurostimulator (trade name: Activa RC)

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall, reported to the National Medical Products Administration (NMPA) on November 2, 2016, and published on December 7, 2016. This recall addresses an issue with their 37751 charger, which is a component of charging kits for implantable neurostimulators (RestoreSensor) and rechargeable implantable neurostimulators (Activa RC). The primary concern is an increasing number of customer complaints regarding the 37751 charger entering an unresponsive error state, characterized by a blank display and a continuous beeping sound. This malfunction prevents the charger from adequately charging the neurostimulators, although it can often be resolved by resetting the device. Data indicated that chargers manufactured from November 2014 onwards, identified by specific serial numbers, experienced this issue at a higher rate (approximately 2%) compared to older units (0.2%). In response, Medtronic is implementing several corrective actions. They will issue notification letters to all affected hospitals, providing charging recommendations to mitigate potential problems. For patients who encounter the error after proper use, Medtronic will facilitate charger replacements through their field representatives. The company emphasizes its commitment to maintaining patient treatment continuity and ensuring comprehensive product quality. This recall involves no product returns, focusing instead on user support and replacements for faulty units in China, where 66 chargers for RestoreSensor and 2,478 for Activa RC were affected.