BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1033767 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00469
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 27, 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 ATRIAL TRANSVENOUS LEAD BECAME DISLODGED ONE DAY AFTER IMPLANT. INTERROGATION REVEALED THIS LEAD WAS ALSO CAPTURING THE VENTRICLE WHEN IN AAI MODE. A-EVENTS WERE MARKED THE SAME TIME ON THE QRS AS THE V-EVENTS AND P-WAVES MEASURED 14MV WHICH WERE SIMILAR TO THE R-WAVES. THIS LEAD WAS SUCCESSFULLY REPOSITIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization