BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1020534 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00296
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 11, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    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 OEM RIGHT ATRIAL (RA) LEAD MAY HAVE BEEN SENSING NOISE. ALL LEAD MEASUREMENTS WERE NORMAL. TECHNICAL SERVICES REVIEWED ELECTROGRAM STRIPS AND ADVISED THAT IT WAS IMPOSSIBLE TO DISTINGUISH WHETHER NOISE WAS BEING OVERSENSED OR IF THIS WAS SIMPLY ATRIAL FIBRILLATION (AF). SUBSEQUENTLY, THE PT ADMITTED HIMSELF TO THE EMERGENCY ROOM, WHERE HE PRESENTED WITH PALPITATIONS AND WAS IN AF. THE PEM RA LEAD HAD DISLODGED AND WAS REPOSITIONED. AT A FOLLOWING CHECK, THE LEAD WAS NOTED TO HAVE DISLODGED AGAIN.

    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