BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASD

    MDR report key: 1040879 · Received May 9, 2008

    Report

    Report Number
    MW5006799
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 9, 2008
    Manufacturer
    AGA MEDICAL CORP
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AN ASD DEVICE PLACED TO CLOSE UP A HOLE IN THE SEPTUM OF THE HEART. PATIENT EXPIRED 12 HOURS LATER. PATIENT WITH MULTIPLE HEALTH PROBLEMS AND WE ARE NOT CERTAIN THAT THE PROCEDURE OR, THE DEVICE IS WHAT CAUSED THE DEATH. DIAGNOSIS OR REASON FOR USE: CLOSE A HOLE IN THE SEPTUM OF THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASD ASA DEVICE MLV AGA MEDICAL CORP 9-ASD-022 M07 L06 - 22

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death