BEUDAMED
    FDA Adverse Event Summary report: N

    DEXTRUS

    MDR report key: 1062011 · Received May 30, 2008

    Report

    Report Number
    1062011
    Date Received
    May 30, 2008
    Date of Event
    November 21, 2007
    Report Date
    April 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTB
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A DUAL CHAMBER PACEMAKER INSERTED LATE LAST YEAR. DURING THAT PROCEDURE THE ARTERIAL LEAD BECAME DISLODGED PRIOR TO THE SKIN BEING COMPLETELY CLOSED. THE PROCEDURE WAS PROLONGED BECAUSE OF THE NEED TO RE-OPEN THE SKIN AND REPOSITION THE LEAD. THE PATIENT WAS DISCHARGED TWO DAYS LATER. THIRTEEN DAYS LATER, THE PATIENT WAS RE-ADMITTED FOR AN UNRELATED PROBLEM (URINARY RETENTION) AND AT THAT TIME IT WAS NOTED THAT THE VENTRICULAR LEAD WAS DISLODGED. THE CARDIOLOGIST REMOVED THE LEAD AND REPLACED IT WITH ANOTHER VENDOR'S LEAD. PATIENT HAD TO UNDER GO ANOTHER PROCEDURE. THERE WAS NO ADVERSE EVENT, BUT THE CARDIOLOGIST WAS CONCERNED THAT THE LEAD MAY PRESENT A FUTURE ADVERSE EVENT IF IT WAS NOT ABLE TO REMAIN IN THE DESIRED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS LEAD, PACEMAKER DTB BOSTON SCIENTIFIC 4136 *

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR