# China NMPA Product Recall - Implantable cardiac pacemaker

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/69954d8f-ee4c-4d04-8af7-1040af786e0e/
Source feed: China

> China NMPA product recall for Implantable cardiac pacemaker by Medtronic Inc. published May 16, 2011. Recall level: . Medtronic Inc. initiated a voluntary recall of specific models of its implantable dual-chamber pacem

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. recalls implantable pacemakers.
- Company Name: Medtronic Inc.
- Publication Date: 2011-05-16
- Product Name: Implantable cardiac pacemaker
- Recall Reason: Approximately 1.8 million dual-chamber pacemakers sold globally may experience a very rare measurement lockout that causes erroneous ERI/RRT (Elective Replacement Indication/Recommended Replacement Time), leading physicians to mistakenly believe the pacemaker is due for replacement. This condition is caused by a random lockout in the measurement system hardware, which may result in a zero battery voltage reading, thus falsely triggering ERI/RRT.
- Discovering Company: Medtronic China Co., Ltd. Beijing Office
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. initiated a voluntary recall of specific models of its implantable dual-chamber pacemakers, including the Kappa 700/900, EnPulse, Adapta, Versa, Sensia, Relia, and Vitatron E/G series. This recall, reported to the National Medical Products Administration (NMPA) / State Food and Drug Administration (SFDA) of China, stems from a rare "measurement lock-up" issue. The problem, first identified in a report dated November 1, 2010, and publicized on May 16, 2011, can cause erroneous Elective Replacement Indication (ERI/RRT) and blank battery voltage readings on programmers. While the pacemaker still provides basic pacing therapy and no patient injuries have been reported, this defect could lead physicians to mistakenly believe a device needs replacement. Approximately 1.8 million affected pacemakers were manufactured globally, with 28,392 sold in China.

In response, Medtronic outlined a series of corrective actions, which commenced on May 3, 2011, with an expected completion by July 31, 2011. These actions include delivering detailed physician notification letters to explain the problem and identification methods. Furthermore, Medtronic technical representatives are dispatched immediately upon notification to reset problematic pacemakers using a specially configured programmer. This reset procedure restores normal function without requiring device removal or impacting battery life. Looking ahead, Medtronic plans a software upgrade by the end of 2011, enabling physicians to automatically reset pacemakers during routine programming to prevent future occurrences of this issue. Detailed records of these corrective activities are being maintained.

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