BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 2850584 · Received November 16, 2012

    Report

    Report Number
    2648612-2012-00060
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED THE PT WITH A HISTORY OF RHEUMATIC HEART DISEASE UNDERWENT MITRAL VALVE REPLACEMENT. THE IMPLANT SURGEON INDICATED THAT THE IMPLANT PROCEDURE WAS DIFFICULT. FOUR DAYS POST OPERATIVELY IT WAS DETERMINED THAT THE LEAFLET WAS NOT MOVING PROPERLY AND THE VALVE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MASTERS SERIES MECHANICAL HEART VALVE ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 25MJ-501

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R