BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM REGENT HEART VALVE W/FLEX CUFF

    MDR report key: 1232159 · Received November 14, 2008

    Report

    Report Number
    2648612-2008-00037
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS EXPLANTED AND REPLACED WITH A PERICARDIAL TISSUE VALVE. THE REASON FOR THE EXPLANT IS UNKNOWN. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM REGENT HEART VALVE W/FLEX CUFF REGENT ROTATABLE VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC. (CS) 23AGFN-756

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R