BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 2183012 · Received July 28, 2011

    Report

    Report Number
    2135147-2011-00087
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    May 22, 2011
    Report Date
    July 28, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, SUBJECT DEVELOPED MIGRAINE HEADACHES 2-3 DAYS POST DEVICE PLACEMENT. THESE HAVE OCCURRED ABOUT ONCE A WEEK AND ARE ACCOMPANIED BY NAUSEA AND THE NEED TO LAY DOWN AND REST. NO OTHER SYMPTOMS NOTED. THERE IS A FAMILY HISTORY OF MIGRAINE HEADACHE IN SUBJECT'S MOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-011 1005112594

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention