BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM MASTERS SERIES VALVE EXPANDED CUFF W/SILZONE

    MDR report key: 1971432 · Received January 21, 2011

    Report

    Report Number
    2648612-2011-00008
    Event Type
    Death
    Date Received
    January 21, 2011
    Date of Event
    November 11, 2007
    Report Date
    January 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS ADMITTED TO THE HOSPITAL IN (B)(6) 2007 FOR A CEREBRAL HEMATOMA AND ALSO IN (B)(6) 2007 FOR A CEREBRAL HEMATOMA. THE PT WAS TRANSFERRED TO (B)(6) FOR SURGERY AND DIED ON (B)(6) 2007. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MASTERS SERIES VALVE EXPANDED CUFF W/SILZONE ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC. (CS) 25MECS-602

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death