BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL CS-28-QL-VSD

    MDR report key: 380225 · Received March 5, 2002

    Report

    Report Number
    1222632-2002-00004
    Event Type
    Injury
    Date Received
    March 5, 2002
    Date of Event
    January 4, 2002
    Report Date
    March 1, 2002
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE IMPLANTING PHYSICIAN. "PT, THAT RECEIVED IMPLANTATION OF A DEVICE ON 11/2001, IN JANUARY PRESENTED WITH PLEURITIC CHEST PAIN AND WAS FOUND TO HAVE PULMONARY EMBOLISM, WHICH WAS NOT HEMODYNAMICALLY SIGNIFICANT. TEE REVEALED THROMBUS ON THE RIGHT ATRIAL AS WELL AS LEFT ATRIAL SIDE OF THE DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-28-QL-VSD CARDIOSEAL MLV NMT MEDICAL, INC. CS-28-QL-VSD 0110119

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention