BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 1033999 · Received April 25, 2008

    Report

    Report Number
    2648612-2008-00014
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 14, 2007
    Report Date
    April 25, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS EXPLANTED DUE TO AN IMPEDED LEAFLET RESULTING IN LEAKAGE AND ELEVATED GRADIENT. THE VALVE WAS REPLACED WITH A TISSUE VALVE. ADDITIONAL INFO 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, B.V. 25AJ-501

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R