BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1142729 · Received August 26, 2008

    Report

    Report Number
    1028232-2008-01017
    Event Type
    Injury
    Date Received
    August 26, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS MICRO-DISLODGED. THIS RESULTED IN INCREASED THRESHOLD MEASUREMENTS AND DECREASED R-WAVES. THE RV LEAD WAS SUCCESSFULLY REPOSITIONED. DURING THE REPOSITIONING PROCEDURE, SLACK WAS INCREASED ON THE RIGHT ATRIAL LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization