BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2841429 · Received December 1, 2009

    Report

    Report Number
    2841429
    Event Type
    Injury
    Date Received
    December 1, 2009
    Date of Event
    October 9, 2009
    Report Date
    October 16, 2009
    Manufacturer
    AGA MEDICAL
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CARDIOLOGIST WAS ATTEMPTING TO IMPLANT AMPLATZER DEVICE TO CLOSE HOLE IN ATRIAL SEPTUM. THE DEVICE WAS DELIVERED BUT THEN BECAME DISLODGED AND ATTEMPTS TO RETRIEVE IT WERE UNSUCCESSFUL. SURGEON PERFORMED OPEN HEART SURGERY AND SURGICALLY REPAIRED HOLE IN SEPTUM AND RETRIEVED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER SEPTAL OCCLUDER DEVICE MLV AGA MEDICAL 9-ASD-034 M07A22-44

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention