BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 3231360 · Received July 17, 2013

    Report

    Report Number
    2135147-2013-00069
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS, PRIOR TO SHIPMENT. NO PRODUCT WAS RETURNED.  REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A 22MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SUCCESSFULLY IMPLANTED; HOWEVER, A FEW HOURS LATER THE PATIENT STARTED TO EXPERIENCE JUNCTIONAL TACHYCARDIA THAT WOULD NOT RESPOND TO MEDICATION. LATER THAT DAY, THE ASO WAS PERCUTANEOUSLY RETRIEVED AND SINUS RHYTHM WAS RESTORED. THE PATIENT'S DEFECT WAS SURGICALLY REPAIRED THE NEXT DAY. ACCORDING TO THE PHYSICIAN, THERE WAS NO ASO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332380 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-022 11112064712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention