BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL, INC

    MDR report key: 412932 · Received August 16, 2002

    Report

    Report Number
    412932
    Event Type
    Death
    Date Received
    August 16, 2002
    Date of Event
    August 2, 2002
    Report Date
    August 14, 2002
    Manufacturer
    ST JUDE MEDICAL, INC
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD OPEN HEART SURGERY IN 2002. PHYSICIAN USED THE "SYMMETRY BYPASS AORTIC CONNECTOR" TO SECURE GRAFT. THE NEXT DAY, PT WENT INTO CARDIAC ARREST AND UNDERWENT EMERGENCY SURGERY. THE "SYMMETRY BYPASS AORTIC CONNECTOR WAS FOUND BY PHYSICIAN TO BE DISENGAGED. PT MADE IT THROUGH SURGERY BUT EXPIRED 12 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL, INC SYMMETRY BYPASS AORTIC CONNECTOR FZP ST JUDE MEDICAL, INC ACN-5055 74854

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death