BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS SR

    MDR report key: 1122229 · Received August 8, 2008

    Report

    Report Number
    1028232-2008-00854
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    March 13, 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

    RESULT AND CONCLUSION OF MANUFACTURER'S INVESTIGATION. THE PACEMAKER UNDERWENT A VISUAL INCOMING GOODS CHECK. IT WAS NOTED THAT THERE WERE SLIGHT SCRATCHES ON THE FRONT SIDE OF THE PACEMAKER. THE DEVICE WAS SUBJECTED TO AN ELECTRICAL INCOMING GOODS CHECK. THE INTERROGATION OF THE PACEMAKER WAS POSSIBLE WITHOUT PROBLEMS. THE PACEMAKER WAS PROGRAMMED TO SSI MODE WITH A RATE OF 70 PPM. THE PACING AMPLITUDE WAS PROGRAMMED TO 2.0 V AT 0.2 MS. PACING WAS TESTED. NO PACING LOSS COULD BE OBSERVED, AND THE OUTPUT SIGNAL WAS DELIVERED AS PROGRAMMED. NEXT, A LOAD TEST WAS PERFORMED. THE PACEMAKER WAS MEASURED IN THE TEMPERATURE CYCLE. INTERMITTING PACING LOSSES COULD BE CONFIRMED UNDER THERMAL STRESS. THE PACEMAKER WAS RETURNED TO THE MANUFACTURER OF THE CIRCUIT. DURING THE ANALYSIS AT THE MANUFACTURER, INTERMITTENT OSCILLATOR INTERRUPTIONS COULD BE IDENTIFIED AS CAUSE OF THE INTERRUPTIONS IN PACING. IN SUMMARY, IT CAN BE SAID THAT THIS IS A CASE OF A COMPONENT DEFECT WITHOUT SYSTEMATIC BACKGROUND.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 58 MONTHS, IT WAS NOTED DURING FOLLOW-UP THAT THE PACEMAKER DOES NOT PACE. AN INTERROGATION OF THE PACEMAKER WAS NOT POSSIBLE. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE PACEMAKER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOS SR PACEMAKER DXY BIOTRONIK GMBH AND CO. 338851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization