BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSEAL OCL-040

    MDR report key: 283491 · Received June 22, 2000

    Report

    Report Number
    9612007-2000-00016
    Event Type
    Malfunction
    Date Received
    June 22, 2000
    Date of Event
    October 14, 1999
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO NMT MEDICAL: NO PROBLEM IN LOADING THE OCCLUDER IN THE DELIVERY SYSTEM. NORMAL OPENING OF THE DISTAL SECTION IN THE ATRIUM. FAILURE IN OPENING THE PROXIMAL SECTION IN THE RIGHT ATRIUM. AFTER 14 DAYS, ELECTIVE SURGERY WAS PERFORMED TO REMOVE THE OCCLUDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL OCL-040 CARDIOSEAL MGB NMT NEUROSCIENCES IMPLANTS OCL-40 981056

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention