BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 3931257 · Received June 20, 2014

    Report

    Report Number
    2648612-2014-00031
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    February 9, 2012
    Report Date
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MFG AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFO RECEIVED, THE PHYSICIAN DID NOT BELIEVE THE DEATH WAS VALVE RELATED AND THE CAUSE REMAINS UNK.

    Description of Event or Problem · 1

    A PT UNDERWENT MITRAL VALVE REPLACEMENT USING THIS 27MM SJM MASTERS SERIES VALVE. THE PT EXPERIENCED HEART FAILURE AND EXPIRED ON (B)(6) 2012. THE PHYSICIAN DID NOT BELIEVE DEATH WAS DUE TO THE VALVE AND NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364302 SJM MASTERS SERIES MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL 27MJ-501

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| H| R