BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1062527 · Received June 20, 2008

    Report

    Report Number
    2135147-2008-00050
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    April 25, 2007
    Report Date
    June 20, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM AN ABSTRACT PUBLISHED IN THE AMERICAN JOURNAL OF CARDIOLOGY; REVERSE REMODELING OF THE HEART AFTER TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT IN PATIENT ABOVE MIDDLE AGE:53 PATIENTS UNDERWENT TRANSCATHETER ATRIAL SEPTAL DEFECT CLOSURE WITH THE AMPLATZER SEPTAL OCCLUDER BETWEEN 2003 AND 2005. ATRIAL ARRHYTHMIA WAS PRESENT IN FOUR PATIENTS. FOLLOW-UP ECHOCARDIOGRAPHY AFTER DEVICE CLOSURE REVEALED ATRIAL ARRHYTHMIAS IN FOUR PATIENTS. TWO PATIENTS HAD PAROXYSMAL ATRIAL FIBRILLATION, NO SYMPTOMATIC ATRIAL FIBRILLATION WAS DOCUMENTED DURING THE FOLLOW-UP PERIOD. PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION AND ATRIAL FLUTTER (ONE PATIENT EACH) ARE WAITING FOR CATHETER ABLATION.AGA MEDICAL CONTACTED THE AUTHOR OF THIS ARTICLE AND NO ADDITIONAL INFORMATION WILL BE PROVIDED REGARDING THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention