BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1033768 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00468
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 27, 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 IMPLANTABLE RV LEAD BECAME DISLODGED A FEW MONTHS POST-IMPLANT. THE PT HAD A TORTUOUS SUPERIOR-VENA-CAVA, AND IT WAS THOUGHT BY THE BSC REP THAT DUE TO THIS, THE LEAD DID NOT HAVE ADDITIONAL SLACK AS USUAL. IT WAS REPORTED THAT THE LEADS WERE BEING REPOSITIONED AROUND THE TIME OF THE BSC REP'S CALL TO TECHNICAL SERVICES. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization