BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM REGENT HEART VALVE

    MDR report key: 2013211 · Received March 8, 2011

    Report

    Report Number
    2648612-2011-00023
    Event Type
    Death
    Date Received
    March 8, 2011
    Date of Event
    January 22, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, AFTER THE VALVE WAS PLACED, THERE WAS A PROBLEM WITH THE LEAFLETS OPENING AND CLOSING, SO THE VALVE WAS REMOVED AND REPLACED WITH A SMALLER 21 MM REGENT VALVE (MEDWATCH REPORT# 2648612-2011-00024). THE PT EXPIRED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM REGENT HEART VALVE REGENT ROTATABLE VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 23AGN-751

    Patients

    Seq Age Sex Outcome Treatment
    1 Death