BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 708960 · Received May 4, 2006

    Report

    Report Number
    2135147-2006-00031
    Event Type
    Injury
    Date Received
    May 4, 2006
    Date of Event
    April 17, 2006
    Report Date
    May 4, 2006
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUSPECTED CASE OF EROSION. THE CASE WAS AN ASD AND THE DEVICE IMPLANTED WAS 9-ASD-026. THE DEVICE WAS SURGICALLY EXPLANTED YESTERDAY (4-17-2006) AND PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORP. 9-ASD-026 M05J14-34

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention