BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 482235 · Received September 4, 2003

    Report

    Report Number
    1222632-2003-00015
    Event Type
    Injury
    Date Received
    September 4, 2003
    Report Date
    September 4, 2003
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANTING PHYSICIAN REPORTED THAT A DEVICE, IMPLANTED FOR OVER A YEAR, OVER TIME HAD DRIFTING TO THE RIGHT ATRIUM CREATING AN ASD AND SHORTNESS OF BREATH. THE DEVICE WAS SURGICALLY REMOVED AND THE PT IS FINE POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CARDIOSEAL MLV NMT MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention