BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 505710 · Received January 8, 2004

    Report

    Report Number
    1222632-2003-00018
    Event Type
    Injury
    Date Received
    January 8, 2004
    Date of Event
    November 5, 2003
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WHO UNDERWENT CLOSURE OF A PFO VIA A CARDIOSEAL IMPLANTATION IN 2002 DEMONSTRATED DURING AN ECHO FOLLOW UP SIGNIFICANT RESIDUAL SHUNTING WITH VALSALVA. THE PT WAS PRESENTED WITH THE OPTION OF MEDICATION THERAPY VS SURGICAL CLOSURE OF THE PFO. THE PT OPTED FOR SURGICAL CLOSURE. THE PROCEDURE WAS PERFORMED IN 2003.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention