BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX ST 53

    MDR report key: 1001006 · Received February 20, 2008

    Report

    Report Number
    1028232-2008-00103
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    October 27, 2008
    Report Date
    January 28, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS RETURNED WITHOUT OOS DOCUMENTATION. PER REP OF BIOTRONIK, THE LEAD BECAME DISLODGED. THE LEAD WAS THEN REMOVED, AND THE PHYSICIAN OPTED TO USE AN ACTIVE FIXATION LEAD. THERE ARE NO COMPLAINTS ASSOCIATED WITH THE LEAD AND THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 53 PACER LEAD DTB BIOTRONIK GMBH AND CO 346366

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization