BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1051844 · Received May 23, 2008

    Report

    Report Number
    1028232-2008-00546
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    March 7, 2008
    Report Date
    April 28, 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 TWO WEEKS POST IMPLANT, A CHEST X-RAY CONFIRMED THAT THIS ATRIAL LEAD BECAME DISLODGED. A REVISION PROCEDURE WAS PERFORMED; THE LEAD WAS REMOVED AND REPLACED. THE LEAD WILL NOT BE RETURNED. NO ADVERSE PT EFFECTS WERE NOTED.

    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