BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTOS DR/CLS

    MDR report key: 1071013 · Received July 2, 2008

    Report

    Report Number
    1028232-2008-00707
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 5, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE. THIS DEVICE LOST CAPTURE FOR NO APPARENT REASON. THIS DEVICE WAS REPLACED WITH A CYLOS DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOS DR/CLS PACEMAKER DXY BIOTRONIK GMBH AND CO., 122300

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization