BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS DR

    MDR report key: 1122228 · Received August 8, 2008

    Report

    Report Number
    1028232-2008-00855
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    March 7, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE ANALYSIS WAS UNABLE TO FIND ANY MANUFACTURING ERRORS OR MATERIAL DEFECTS FOR THE LEAD AS WELL AS THE PACEMAKER. IN REGARD TO THE ELECTRICAL AND MECHANICAL PROPERTIES OF THE LEAD AND THE PACEMAKER, THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT.

    Description of Event or Problem · 1

    OUS MDR. AN INTERMITTENT EXIT BLOCK WAS REPORTED ONE DAY AFTER THE IMPLANTATION. THE INITIAL PACING THRESHOLD DURING THE IMPLANTATION WAS 0.5 V AT 0.4 MS; ON THE FOLLOWING DAY UNDER 4.8 V, EXIT BLOCK THROUGHOUT. ALSO REMOVED: SELOX ST 60, MDR 1028232-2008-00856.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS DR PACEMAKER DXY BIOTRONIK GMBH AND CO 331443

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization