# China NMPA Product Recall - Implantable neurostimulation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/92b79fee-14e7-496e-9023-c927b7a482ee/
Source feed: China

> China NMPA product recall for Implantable neurostimulation system by Medtronic Inc. published August 15, 2014. Recall level: . On August 8, 2014, Medtronic (Shanghai) Management Co., Ltd. reported to the National Medical Produc

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. of the United States has issued a recall of its implantable neurostimulation systems.
- Company Name: Medtronic Inc.
- Publication Date: 2014-08-15
- Product Name: Implantable neurostimulation system
- Recall Reason: Medtronic has discovered a problem affecting the L284 integrated circuit (used in MA11703A and M215413A mixed-signal circuits). This integrated circuit is received by Medtronic as a wafer, diced into individual chips, and then these individual chips are picked up by specialized equipment and placed into packages. These packages are then sent to the production line. However, we discovered that a clamp in the equipment detached from the shank, causing the equipment to pick up the chips with a metal shank. The physical contact of the metal shank damaged the L284 chips. This damage caused some affected mixed-signal circuits to fail mixed-signal testing. However, Medtronic also observed instances where damaged chips passed mixed-signal testing.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: On August 8, 2014, Medtronic (Shanghai) Management Co., Ltd. reported to the National Medical Products Administration (NMPA) a voluntary recall by its manufacturer, Medtronic Inc., for an implantable neurostimulation system (Registration Certificate No.: CFDA (Imported) 2013 No. 3210203). The recall stemmed from a critical manufacturing issue affecting the L284 integrated circuit, crucial for the device's I-channel. Investigations revealed that a detached clip in the production equipment caused a metal handle to damage L284 chips during the wafer handling process. A significant concern was that while some damaged chips failed quality tests, others erroneously passed, indicating a potential for defective devices to enter circulation. The affected products, identified by specific serial numbers including NKM724776H, are intended for Parkinson's disease and tremor control therapy. Medtronic confirmed these particular recalled units were not sold or imported into China. The NMPA directed provincial and municipal food and drug administrations to reinforce supervision and management of medical devices, ensuring product safety even without direct market impact within China for this specific recall.

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