# 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

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/b4b30530-2e3c-4184-a88b-7fe5db708ff6/
Source feed: China

> China NMPA product recall for 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 by Medtronic Inc. published August 29, 2016. Recall level: Level II. Medtronic (Shanghai) Management Co., Ltd. initiated a Class II voluntary recall for several implanta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. is proactively recalling implantable neurostimulation systems, implantable neurostimulation devices, rechargeable implantable neurostimulators, and deep brain stimulation extension lead kits.
- Company Name: Medtronic Inc.
- Publication Date: 2016-08-29
- Product Name: 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
- Recall Level: Level II
- Recall Reason: The company received two complaints: first, patients lost their ability to swim (coordination disorder) after receiving deep brain stimulation (DBS) treatment; and second, patients suffered injury during DBS stimulation of the surgical tunnel preparation area. The company believes these issues are subsequent consequences of the treatment process, necessitating the addition of relevant warnings, and has decided to update the product instructions to clarify potential adverse reactions.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/