# China NMPA Product Recall - Rechargeable implantable spinal cord stimulator; Rechargeable implantable deep brain stimulation pulse generator kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/6470bbbe-1964-44ff-bed3-4e2803f87e9b/
Source feed: China

> China NMPA product recall for Rechargeable implantable spinal cord stimulator; Rechargeable implantable deep brain stimulation pulse generator kit by Medtronic (Shanghai) Management Co., Ltd. published November 25, 2020. Recall level: Level 3 Recall. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall on November 25, 202

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. is proactively recalling its rechargeable implantable spinal cord stimulator and rechargeable implantable deep brain stimulation pulse generator kit.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2020-11-25
- Product Name: Rechargeable implantable spinal cord stimulator; Rechargeable implantable deep brain stimulation pulse generator kit
- Recall Level: Level 3 Recall
- Recall Reason: The design change to resolve the unresponsive error state of the 37751 charger has been completed and therefore customer notification is required.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall on November 25, 2020, for its rechargeable implantable spinal cord nerve stimulators and rechargeable implantable deep brain stimulation pulse generator kits. The recall was prompted by a design change implemented to resolve an unresponsive error in the 37751 charger. This issue potentially affected the functionality of the device charging, although the specific impact on patient safety is not detailed in the provided information beyond the Class III designation. The regulatory framework overseeing this action is the National Medical Products Administration (NMPA) in China, specifically referencing a report from the State Drug Administration (Shanghai) Co., Ltd. The company proactively addressed the technical malfunction by implementing a design modification to ensure product reliability. Affected product models, specifications, and batch numbers are detailed in an accompanying "Medical Device Recall Event Report Form" for stakeholders. This action demonstrates Medtronic's commitment to product quality and patient safety, operating under NMPA guidelines for medical device oversight.

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2/