BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 1020713 · Received March 24, 2008

    Report

    Report Number
    1028232-2008-00273
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    January 5, 2008
    Report Date
    February 28, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS RIGHT VENTRICULAR (RV) LEAD ONE DAY POST-IMPLANT DEMONSTRATED LOSS OF CAPTURE (LOC), NO SENSING, AND NO IMPEDANCE MEASUREMENTS. IT WAS DISCOVERED THAT THE LEAD HAD BECOME DISLODGED AND WAS SUCCESSFULLY REPOSITIONED. TO DATE, NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEADS DTB BIOTRONIK GMBH AND CO 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization