China NMPA Product Recall - Implantable neurostimulation system (trade name: Soletra), Implantable neurostimulation system (trade name: Kinetra), Implantable neurostimulation system (trade name: Activa PC), Implantable neurostimulator (trade name: Activa SC), Rechargeable implantable neurostimulator (trade name: Activa RC), Deep brain stimulation extension lead kit

Medtronic (Shanghai) Management Co., Ltd. initiated a Class II voluntary recall for several implantable neurostimulation systems, neurostimulators, and deep brain stimulation lead kits. This action, reported to the National Medical Products Administration (NMPA) on June 8, 2016, and published on August 29, 2016, addresses two primary concerns based on overseas user reports. The first issue involves patients experiencing coordination disorders, such as a loss of swimming ability, after deep brain stimulation (DBS) treatment. The second relates to patient injuries sustained during DBS preparation surgery. While Medtronic asserts these incidents are related to the treatment process rather than device malfunction, the company recognizes the need for clearer warnings.

Under the NMPA regulatory framework, Medtronic's required actions include updating product instructions to detail these potential adverse reactions and delivering informational notification letters to all implanting hospitals. This corrective measure specifically excludes any product returns. The recall affects all batch numbers of models like Soletra, Kinetra, Activa PC, Activa SC, Activa RC, and Deep Brain Stimulation Extension Lead Kits manufactured before the instruction manual update.