# China NMPA Product Recall - Implantable neurostimulator

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/7759c2f6-9b98-44f4-8d84-0cd02d6098a0/
Source feed: China

> China NMPA product recall for Implantable neurostimulator by Medtronic Inc. published July 06, 2016. Recall level: Level II. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall for specific batches

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. initiates voluntary recall of implantable neurostimulators
- Company Name: Medtronic Inc.
- Publication Date: 2016-07-06
- Product Name: Implantable neurostimulator
- Recall Level: Level II
- Recall Reason: The company confirmed four cases of incomplete product charging. It was confirmed that during battery charging, insufficient coupling between the implantable neurostimulator and the charger prevented the device from receiving enough power to sustain treatment, leading to accelerated battery depletion and subsequent over-discharge within one to two days.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall for specific batches of its implantable neurostimulators, as reported to the National Medical Products Administration (NMPA) on July 6, 2016, with an internal report date of May 17, 2016. The recall addresses an issue with incomplete charging of the RestoreSensor implantable neurostimulator.
The primary concern stems from insufficient coupling between the neurostimulator and its charger, preventing the device from receiving adequate power to sustain treatment. This defect can lead to accelerated battery depletion, causing the device to over-discharge within one to two days, significantly shorter than its typical 30-day operational period. Medtronic confirmed four such incidents globally, representing a small fraction (0.007%) of devices sold, with no reported cases in China at the time of the report.
Under the NMPA framework for medical device recalls, Medtronic's required actions involve issuing a global safety alert. This entails distributing a customer letter to all implanting hospitals, informing them of the potential charging issue. The company emphasized that this corrective action does not include product returns, focusing instead on proactive communication to ensure patient safety and proper device management.

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