BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 471126 · Received July 9, 2003

    Report

    Report Number
    1222632-2003-00012
    Event Type
    Injury
    Date Received
    July 9, 2003
    Report Date
    July 9, 2003
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "A PATIENT WITH A CARDIOSEAL IMPLANT WAS SEEN PRESENTING WITH SIGNS OF A TIA. PATIENT REFUSED TEE. AN ECHO WAS PERFORMED REVEALING A THROMBUS ON THE LEFT ATRIUM. ADDITIONAL TESTING HAS BEEN SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN