# China NMPA Product Recall - EnRhythm P1501DR Implantable Cardiac Pacemaker

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/2de225b0-7606-4c73-b5bb-405d9c52a4bf/
Source feed: China

> China NMPA product recall for EnRhythm P1501DR Implantable Cardiac Pacemaker by Medtronic Inc. published November 16, 2011. Recall level: . Medtronic Inc., in collaboration with its Beijing office, initiated a product recall for specific mo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. recalls implantable pacemakers
- Company Name: Medtronic Inc.
- Publication Date: 2011-11-16
- Product Name: EnRhythm P1501DR Implantable Cardiac Pacemaker
- Recall Reason: Two battery-related issues with the pacemaker have been addressed through a software update. This recall aims to provide physicians with updated pacemaker performance data and offer patient management advice.
- Discovering Company: Medtronic China Co., Ltd. Beijing Office
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., in collaboration with its Beijing office, initiated a product recall for specific models of its EnRhythm P1501DR implantable pacemakers. This recall, published by the National Medical Products Administration (NMPA) on November 16, 2011, addresses significant performance concerns arising from battery-related issues identified in 2010. The primary issues include an increased rate of lithium depletion, leading to a faster-than-expected battery voltage drop, and higher-than-anticipated battery impedance. A subsequent software update in late 2010, designed to improve battery monitoring, inadvertently led to earlier triggering of the Elective Replacement Indicator (ERI) for some devices. While this early ERI still allows for at least one year of operation, it reduces the overall expected pacemaker lifespan by 10-15% from initial estimates. No reports of treatment loss have been identified. Operating under the NMPA's regulatory oversight, Medtronic is implementing a comprehensive corrective action plan. This involves direct communication with physicians through in-person notifications, scheduled from November 14, 2011, to February 28, 2012. The plan details patient management recommendations, including assisting physicians in scheduling urgent patient follow-ups and advising immediate pacemaker replacement upon any ERI or End-of-Life (EOL) indication to ensure complete patient safety. Physicians are also guided on post-update follow-up protocols.

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