China NMPA Product Recall - Implantable Deep Brain Neurostimulator

Medtronic Inc. has initiated a voluntary recall for specific models and batches of its Implantable Deep Brain Neurostimulator, specifically the Percept PC, under the regulatory guidance of the National Medical Products Administration (NMPA) of China. This recall, formally documented as NMPA Index No. JGXX-2022-10292 and publicized on December 16, 2022, addresses a critical functionality issue identified in these devices. The primary concern is that while the Percept PC neurostimulators continue to deliver therapeutic treatment to patients, they are unable to establish communication with either the patient's personal programmer or the clinician's programming interface. This communication failure, reported by Medtronic (Shanghai) Management Co., Ltd., poses a significant challenge for monitoring device status, adjusting therapy settings, or troubleshooting, even though the core treatment remains active. The voluntary recall encompasses devices identified by Registration Certificate No.: 20223120364, with comprehensive details regarding the affected models, specifications, and batch numbers provided in the accompanying Medical Device Recall Event Report Form. Medtronic's proactive measure highlights its commitment to product quality, patient safety, and compliance with national medical device regulations, ensuring that all affected devices are appropriately managed to mitigate potential risks associated with the communication malfunction.