BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1033734 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00432
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 12, 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 (BSC) REC'D INFO THAT THIS ATRIAL LEAD HAD LOSS OF CAPTURE AND HIGH THRESHOLDS. THE DR INDICATED THE LEAD HAD DISLODGED. DURING A PROCEDURE TO REPOSITION THE LEAD, THE DR WAS UNABLE TO EXTEND OR RETRACT THE HELIX. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization