BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 1012559 · Received March 15, 2008

    Report

    Report Number
    2135147-2008-00019
    Event Type
    Injury
    Date Received
    March 15, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN HAS BEEN REQUESTED, BUT THE DEVICE HAS NOT ARRIVED. FURTHER MEDICAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED ON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    WHILE PREPARING TO IMPLANT DEVICE PATIENT DEVELOPED ARRHYTHMIAS REQUIRING DRUG INTERVENTION. IT WAS DECIDED PATIENT WAS NOT SUFFICIENTLY STABLE TO CONTINUE WITH PROCEDURE. THE PHYSICIAN PLANNED TO SURGICALLY REPAIR VSD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-VSD-MUSC-006 M07K17-59

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention