BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    MDR report key: 274752 · Received April 7, 2000

    Report

    Report Number
    274752
    Event Type
    Injury
    Date Received
    April 7, 2000
    Date of Event
    December 1, 1999
    Report Date
    April 7, 2000
    Manufacturer
    MEDTRONIC CARDIAC SURGERY
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S HEART VALVE HAD A PARAVALVULAR LEAK WITH VALVE DEHISCENCE. LEAK WAS NOTICED IN DEC OF 1999. SURGERY TO REMOVE LEAKY VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC HALL PROSTHETIC HEART VALVE 31MM MEDTRONIC HALL VALVE LWQ MEDTRONIC CARDIAC SURGERY M7700131 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization