BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1020528 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00283
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 28, 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 DEXTRUS ATRIAL LEAD DISLODGED AND THE HELIX APPEARED TO BE RETRACTED. IN A REVISION PROCEDURE, THE LEAD COULD NOT BE REPOSITIONED DUE TO HELIX DIFFICULTIES. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A NEW LEAD. NO ADVERSE PT EFFECTS WERE REPORTED.

    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 UNK Hospitalization