BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 1901547 · Received November 12, 2010

    Report

    Report Number
    2648612-2010-00065
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS IMPLANTED WITH DIFFICULTY. INTRAOPERATIVELY THE SURGEON OBSERVED INSUFFICIENCY IN THE PATIENT'S LEFT VENTRICLE. THE VALVE WAS REMOVED AND ONE LEAFLET WAS MISSING FROM THE ORIFICE. A SMALLER VALVE WAS IMPLANTED. POSTOPERATIVELY FOLLOW-UP EXAMS WERE PERFORMED, ONE OF WHICH REVEALED A FOREIGN BODY IN THE PATIENT. THE PATIENT UNDERWENT SURGERY TO REMOVE THE FOREIGN BODY WHICH WAS IDENTIFIED AS THE DISLODGED VALVE LEAFLET. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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) 29MJ-501

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R