BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER

    MDR report key: 1980206 · Received January 31, 2011

    Report

    Report Number
    MW5019268
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    November 17, 2010
    Report Date
    January 31, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMBOLIZATION OF THE AMPLATZER DUCT OCCLUDER INTO RIGHT PULMONARY ARTERY REQUIRING CARDIAC SURGERY FOR RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER DUCT OCCLUDER MLV AGA MEDICAL CORPORATION 9-PDA-005 1005142808

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Disability