BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS

    MDR report key: 3012558 · Received March 15, 2013

    Report

    Report Number
    2648612-2013-00012
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS AORTIC VALVE AND A MITRAL SJM MECHANICAL VALVE (MEDWATCH REPORT# 2648612-2013-00011) WERE EXPLANTED DUE TO EXTENSIVE CALCIFIC PANNUS THAT INTERFERED WITH LEAFLET MOTION. BOTH VALVES WERE REPLACED WITH TISSUE VALVES FROM ANOTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110094 SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS STANDARD HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 19AHP - 105

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R