BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOSEAL OCL-023

    MDR report key: 284643 · Received June 30, 2000

    Report

    Report Number
    1222632-2000-00004
    Event Type
    Other
    Date Received
    June 30, 2000
    Date of Event
    May 10, 2000
    Report Date
    June 30, 2000
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT, WHO UNDERWENT IMPLANTATION OF A 23 MM CARDIOSEAL DEVICE IN 2000 WAS FOUND - ON A TRANSESOPHAGEAL ECHOCARDIOGRAM - TO HAVE A THROMBUS IN THE LEFT ATRIUM CONTIGUOUS WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL OCL-023 CARDIOSEAL MLV NMT MEDICAL, INC. OCL-023 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization