China NMPA Product Recall - Implantable neurostimulator

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall for specific batches of its implantable neurostimulators, as reported to the National Medical Products Administration (NMPA) on July 6, 2016, with an internal report date of May 17, 2016. The recall addresses an issue with incomplete charging of the RestoreSensor implantable neurostimulator. The primary concern stems from insufficient coupling between the neurostimulator and its charger, preventing the device from receiving adequate power to sustain treatment. This defect can lead to accelerated battery depletion, causing the device to over-discharge within one to two days, significantly shorter than its typical 30-day operational period. Medtronic confirmed four such incidents globally, representing a small fraction (0.007%) of devices sold, with no reported cases in China at the time of the report. Under the NMPA framework for medical device recalls, Medtronic's required actions involve issuing a global safety alert. This entails distributing a customer letter to all implanting hospitals, informing them of the potential charging issue. The company emphasized that this corrective action does not include product returns, focusing instead on proactive communication to ensure patient safety and proper device management.