BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 1849402 · Received September 23, 2010

    Report

    Report Number
    1028232-2010-02116
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    June 18, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD BECAME DISLODGED ONE DAY POST IMPLANT. THE PHYSICIAN REPLACED THIS LEAD WITH AN ACTIVE FIXATION, PERFORMED J ST JUDE 1888TC 46, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACER LEAD DTB BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization