BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1172729 · Received September 25, 2008

    Report

    Report Number
    2135147-2008-00081
    Event Type
    Injury
    Date Received
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM THE PATIENT VIA TELEPHONE CONVERSATION ON SEPTEMBER 23, 2008. A SUCCESSFUL CLOSURE OF AN ATRIAL SEPTAL DEFECT (ASD) WITH A 22MM AMPLATZER SEPTAL OCCLUDER WAS PERFORMED IN 2004. FOLLOW UP ECHOCARDIOGRAMS SHOWED THE DEVICE IN GOOD POSITION. THE PATIENT CLAIMED TO HAVE DEVELOPED ATRIAL TACHYCARDIA ONE WEEK AFTER THE PROCEDURE. IN 2006, SHE CLAIMED TO HAVE MORE ARRHYTHMIAS AS WELL AS EXERCISE AND HEAT INTOLERANCE. SHE DID NOT HAVE ANY PRE EXISTING CONDITIONS BEFORE THE PROCEDURE AND ONLY HAD MILD PALPITATIONS. THE PATIENT DOES NOT HAVE A DEFIBRILLATOR AND HAS HAD NO OTHER CARDIAC PROCEDURES OTHER THAN THE DEVICE IMPLANT. SHE HAS REPORTED TO HAVE BEEN DIAGNOSED WITH POSTURAL ORTHOSTATIC TACHYCARDIA. A RECENT BLOOD TEST ALSO CONFIRMED THE PRESENCE OF NICKEL IN THE BLOODSTREAM BUT NO REACTION HAS BEEN SEEN. THE PATIENT DOES NOT KNOW IF SHE IS ALLERGIC TO NICKEL NOR HAS SHE EVER BEEN TESTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER AMPLATZER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-022 M03G18-16

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention