BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILOS SR

    MDR report key: 552819 · Received November 2, 2004

    Report

    Report Number
    1028232-2004-00125
    Event Type
    Other
    Date Received
    November 2, 2004
    Date of Event
    September 9, 2004
    Report Date
    October 22, 2004
    Manufacturer
    BIOTRONIK GMBH & CO
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RECEIVED OOS REPORT BUT NO DEVICE. OOS REPORT INDICATED THAT THE DEVICE HAS INTERMITTENT PACING OUTPUT, TOTAL LOSS OF CAPTURE, TOTAL LOSS OF SENSING, LEAD PROBLEM, AND WAS REPLACED WITH PHILOS DR. K

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS SR PACEMAKER DXY BIOTRONIK GMBH & CO 331 446 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization