BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1033740 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00441
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 27, 2008
    Manufacturer
    BIOTRONIK GMBH & 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 REC'D INFO THAT DIFFICULTY WAS EXPERIENCED PLACING THIS IMPLANTABLE RIGHT VENTRICULAR LEAD. EVENTUALLY THE LEAD WAS SUCCESSFULLY PLACED, HOWEVER, SHORTLY THEREAFTER, THE LEAD WAS DISLODGED LIKELY BY PT ACTIVITY. AN ATTEMPT WAS MADE TO REPOSITION THE LEAD WHICH RESULTED IN THE DISLODGEMENT OF THE IMPLANTABLE ATRIAL LEAD AS WELL. AN ATTEMPT WAS MADE TO COMPLETE A SECOND VEIN STICK AND USE THE ATRIAL LEAD TO GAIN ACCESS IN ORDER TO REPOSITION THE RIGHT VENTRICULAR LEAD, BUT ALL ATTEMPTS WERE UNSUCCESSFUL AND BOTH OF THESE LEADS WERE EXPLANTED, DISCARDED AND REPLACED. NO ADVERSE PT EFFECTS WERE EFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization