BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1020483 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00324
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 3, 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

    BSC CRM RECEIVED INFORMATION THAT THIS DEXTRUS ATRIAL LEAD DISLODGED. DURING A REVISION PROCEDURE, THE PHYSICIAN WAS DISSATISFIED WITH THE SUTURE SLEEVE, WHICH WAS NOTED AS LOOSE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT 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 Hospitalization