# China NMPA Product Recall - Implantable neurostimulation electrodes

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/4df74b98-a489-4024-81b1-5ddc0fbb46de/
Source feed: China

> China NMPA product recall for Implantable neurostimulation electrodes by Medtronic Inc. published July 30, 2013. Recall level: . Medtronic Inc., through its Chinese unit Medtronic (Shanghai) Management Co., Ltd., initiated a volu

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. recalls implantable neurostimulation electrodes.
- Company Name: Medtronic Inc.
- Publication Date: 2013-07-30
- Product Name: Implantable neurostimulation electrodes
- Recall Reason: The DBS electrode was damaged at the electrode connector end.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., through its Chinese unit Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary recall of implantable neurostimulation electrodes (Registration Nos. 械（进）字2012第3213291, 国食药监械（进）字2012第3213292). This action, reported to the National Medical Products Administration (NMPA) on June 17, 2013, was prompted by reports of damage to the electrode connector end when an electrode cap is used. Specifically, tightening or loosening a retaining screw could twist the connector block, potentially harming the proximal electrode connection, often at contact #3. Although no permanent patient injuries or fatalities have been reported, and multi-stage procedures involving the cap are uncommon in China, the potential for device damage necessitated a recall.

Under NMPA oversight, Medtronic implemented corrective actions. The company issued a "Notification Letter to Healthcare Professionals - Emergency Medical Correction," advising against using DBS electrode caps unless medically essential. Medtronic also relocated its product manufacturing and updated production lines to prevent recurrence; all neurostimulation electrodes currently imported into China incorporate these improvements. Company representatives personally informed implanting physicians, obtaining signed acknowledgments of the safety notification. Medtronic is further collecting data from Chinese doctors to emphasize the infrequent use of staged DBS procedures in the region.

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