BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR

    MDR report key: 3183023 · Received June 21, 2013

    Report

    Report Number
    1028232-2013-01663
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER IT WAS RECEIVED, THE PACEMAKER UNDERWENT AN ELECTRICAL INCOMING GOODS INSPECTION. THE PACEMAKER WAS INTERROGATED. THE BATTERY STATUS "OK" IS TO BE EXPECTED AFTER AN IMPLANTATION TIME OF 47 MONTHS. THE MEMORY CONTENT OF THE IMPLANT WAS ANALYZED. THE ANALYSIS OF THE MEMORY CONTENT DOCUMENTED THE RE-INITIALIZATION DESCRIBED IN THE COMPLAINT. THE CAUSE FOR THE RE-INITIALIZATION COULD NOT BE CLARIFIED BASED ON THE AVAILABLE DATA BECAUSE THE MEMORY OF THE IMPLANT WAS READ AFTER THE RE-INITIALIZATION. DURING THE ANALYSIS, THE FOLLOW-UP DATA WERE THOROUGHLY ANALYZED, ESPECIALLY THE ECGS MENTIONED IN THE COMPLAINT. THE CLINICAL COMPLAINT COULD BE CONFIRMED. HOWEVER, THE ANALYSIS OF THE MEMORY EXCERPT FROM THE PROGRAMMER SHOWED THAT THESE ECGS WERE RECORDED DURING A TEST PROCEDURE. THERE WERE NO INDICATIONS OF A DYSFUNCTION OF THE PACEMAKER. THE PACEMAKER'S CAPABILITY TO PROVIDE THERAPY WAS TESTED. THE ANTIBRADYCARDIC OUTPUT SIGNAL MATCHED THE PROGRAMMED VALUES, AND THE SIGNAL SENSING OF THE DEVICE WAS NORMAL. THE PACEMAKER SHOWED BEHAVIOR CONFORMING TO THE SPECIFICATION IN REGARD TO ITS DEVICE FUNCTIONS. IN SUMMARY, THE CAUSE FOR THE RE-INITIALIZATION COULD NOT BE CLARIFIED. IT CAN, HOWEVER, NOT BE RULED OUT THAT EXTERNAL INFLUENCES HAVE CONTRIBUTED TO THIS CLINICAL OBSERVATION. AFTER RE-INITIALIZATION, THE DEVICE BEHAVED PROPERLY. THERE WERE NO INDICATIONS OF A MATERIAL DEFECT OR MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR - UPON INTERROGATION, REINITIALIZATION WAS REQUIRED. AFTER THIS, THE PROGRAMMED PACING PATTERNS DID NOT MATCH THE ACTUAL PACING PATTERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283196 CYLOS DR PACEMAKER DXY BIOTRONIK SE & CO. KG 349799

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization