BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER DUCT OCCLUDER II

    MDR report key: 7148185 · Received December 27, 2017

    Report

    Report Number
    2135147-2017-00189
    Event Type
    Death
    Date Received
    December 27, 2017
    Date of Event
    May 16, 2017
    Report Date
    December 27, 2017
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024/S037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH ABBOTT PATIENT DEVICE TRACKING (PDT). PER THE PDT FORM, ON (B)(6) 2017, THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926573 AMPLATZER DUCT OCCLUDER II CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA2-06-04 5702177

    Patients

    Seq Age Sex Outcome Treatment
    1 Death