BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1131954 · Received August 21, 2008

    Report

    Report Number
    1028232-2008-00999
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    June 5, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFO THAT THIS PT'S RIGHT VENTRICULAR (RV) LEAD MICRODISLODGED, HOWEVER, THE PT WAS STILL RECEIVING THERAPY. THE PHYSICIAN ELECTED TO REPLACED THE LEAD AND DURING THE PROCEDURE, HE ACCIDENTLY CUT THE INSULATION OF THE RV LEAD HE WAS REPLACING. THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED WITH A NEW RV LEAD. NO ADVERSE PT EFFECTS WERE REPORTED DURING THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358574

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization