BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1020718 · Received March 24, 2008

    Report

    Report Number
    1028232-2008-00122
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    December 13, 2007
    Report Date
    January 29, 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 PT IS SEVERLY DEMENTED AND MOVED A GREAT DEAL AFTER THE IMPLANT PROCEDURE. IT WAS LATER REPORTED THAT THIS LEAD WAS REPOSITIONED SUCCESSFULLY. HOWEVER, THE LEAD WAS EXPLANTED A FEW DAYS LATER DUE TO UNACCEPTABLY HIGH THRESHOLD MEASUREMENTS. A NEW LEAD WAS IMPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization