# China NMPA Product Recall - SynchroMed II Implantable Drug Infusion Pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/11e80469-cc2f-4e8b-8bff-49ce594c9907/
Source feed: China

> China NMPA product recall for SynchroMed II Implantable Drug Infusion Pump by Medtronic Inc. published April 10, 2012. Recall level: . Medtronic Inc., in collaboration with its Chinese subsidiary Medtronic (Shanghai) Management Co., Lt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is recalling the SynchroMed II drug infusion system.
- Company Name: Medtronic Inc.
- Publication Date: 2012-04-10
- Product Name: SynchroMed II Implantable Drug Infusion Pump
- Recall Reason: The “Expected Replacement Pump” date displayed on the programming and printed reports of the N’Vision® Physician Programmer Model 8840 for the Model 8637 SynchroMed II implantable drug infusion pump may be incorrect, potentially causing the pump to reach end of life (EOS) before replacement.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., in collaboration with its Chinese subsidiary Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary recall of specific SynchroMed II implantable drug infusion systems (Model 8637). This action, reported to the National Medical Products Administration (NMPA) on March 30, 2012, addresses a critical software display issue. The primary concern is that the N'Vision® Physician Programmer (Model 8840) may incorrectly display the "Expected Replacement" date for affected pumps. This date might appear as question marks or a date significantly beyond 90 days from the Selective Replacement Indicator (ERI) notification. Although the pump's function and alarms remain unaffected and it continues operation for 90 days after ERI, this display error could potentially lead to the device reaching its end of service before a scheduled replacement. Under the NMPA's regulatory oversight, Medtronic is required to issue an "Urgent: Medical Device Correction" letter to implanters and attending physicians in China. This communication emphasizes confirming receipt and understanding of the correction. Physicians are advised to maintain normal follow-up schedules, monitor for the ERI, and ensure pump replacement within 90 days of the ERI's appearance, consistent with the product manual.

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