BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES VALVE EXPANDED CUFF W/ SILZONE

    MDR report key: 3213905 · Received July 3, 2013

    Report

    Report Number
    2648612-2013-00033
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO INC
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUR TO THE PARAVALVULAR LEAK AND WAS REPLACED WITH A MECHANICAL VALVE FROM ANOTHER MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303712 SJM MASTERS SERIES VALVE EXPANDED CUFF W/ SILZONE ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL PUERTO RICO INC 33MECS-602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R