BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSEAL

    MDR report key: 1031724 · Received March 28, 2008

    Report

    Report Number
    1031724
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 28, 2008
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NMT CARDIOSEAL DEVICE WAS PLACED INTO THE PATIENT'S BODY, BUT WOULD NOT DEPLOY. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL SEPTAL OCCLUDER MLV NMT MEDICAL, INC. * 0711098
    2 CARDIOSEAL SEPTAL OCCLUDER MLV NMT MEDICAL, INC. * 0710074

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR