# China NMPA Product Recall - Charger 37751 for implantable neurostimulator (trade name: RestoreSensor) and rechargeable implantable neurostimulator (trade name: Activa RC)

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/658eb7e8-8a49-4ab9-a8ab-00248d794086/
Source feed: China

> China NMPA product recall for Charger 37751 for implantable neurostimulator (trade name: RestoreSensor) and rechargeable implantable neurostimulator (trade name: Activa RC) by Medtronic Inc. published December 07, 2016. Recall level: Class II Recall. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall, reported to the Nat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. has initiated a voluntary recall of implantable neurostimulators and rechargeable implantable neurostimulators.
- Company Name: Medtronic Inc.
- Publication Date: 2016-12-07
- Product Name: Charger 37751 for implantable neurostimulator (trade name: RestoreSensor) and rechargeable implantable neurostimulator (trade name: Activa RC)
- Recall Level: Class II Recall
- Recall Reason: The 37751 charger is in a no-response error state and cannot work properly, accompanied by a blank display and beeping sounds, preventing the charger from charging the neurostimulator.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall, reported to the National Medical Products Administration (NMPA) on November 2, 2016, and published on December 7, 2016. This recall addresses an issue with their 37751 charger, which is a component of charging kits for implantable neurostimulators (RestoreSensor) and rechargeable implantable neurostimulators (Activa RC). The primary concern is an increasing number of customer complaints regarding the 37751 charger entering an unresponsive error state, characterized by a blank display and a continuous beeping sound. This malfunction prevents the charger from adequately charging the neurostimulators, although it can often be resolved by resetting the device. Data indicated that chargers manufactured from November 2014 onwards, identified by specific serial numbers, experienced this issue at a higher rate (approximately 2%) compared to older units (0.2%). In response, Medtronic is implementing several corrective actions. They will issue notification letters to all affected hospitals, providing charging recommendations to mitigate potential problems. For patients who encounter the error after proper use, Medtronic will facilitate charger replacements through their field representatives. The company emphasizes its commitment to maintaining patient treatment continuity and ensuring comprehensive product quality. This recall involves no product returns, focusing instead on user support and replacements for faulty units in China, where 66 chargers for RestoreSensor and 2,478 for Activa RC were affected.

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