BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 60

    MDR report key: 1243039 · Received November 20, 2008

    Report

    Report Number
    1028232-2008-01488
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM REP. PER OOS, THIS LEAD HAD A TOTAL LOSS OF SENSING AND TOTAL LOSS OF CAPTURE WITH BIPOLAR SETTINGS. THIS LEAD WAS ABLE TO CAPTURE AT UNIPOLAR SETTINGS. THIS LEAD WAS REPLACED WITH ANOTHER SETROX S 60.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 60 NONE DTB BIOTRONIK GMBH AND CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization