BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR-T

    MDR report key: 3092018 · Received May 3, 2013

    Report

    Report Number
    1028232-2013-01301
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    November 20, 2012
    Report Date
    April 22, 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

    DURING THE PACEMAKER ANALYSIS, FIRST THE CONNECTION SYSTEM WAS EXAMINED MECHANICALLY. THE SCREWS AND THE SPRING ELEMENTS OF THE LEAD CONNECTIONS WERE OK. LEADS INSERTED IN A TEST COULD EASILY AND RELIABLY MAKE CONTACT WITH LOW-OHM VALUES. THE DRILL HOLE DIMENSIONS WERE ALL WITHIN THE DIMENSIONS PROSCRIBED BY (B)(4). THE PACEMAKER THEN UNDERWENT AN ELECTRICAL INCOMING GOODS CONTROL. THE PACEMAKER WAS INTERROGATED AND THE MEMORY CONTENT ANALYZED. THE ANALYSIS OF THE MEMORY CONTENT SHOWED PROPER DEVICE BEHAVIOR. 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 A BEHAVIOR ACCORDING TO SPECIFICATIONS IN REGARD TO ITS DEVICE FUNCTIONS. BASED ON THE COMPLAINT DESCRIPTION, THE IMPEDANCE MEASUREMENT FUNCTIONS OF THE PACEMAKER WERE TESTED. THERE WERE NO ANOMALIES THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. IN SUMMARY, BOTH THE LEAD AND THE PACEMAKER UNDERWENT A DETAILED ANALYSIS. IN PARTICULAR THE CONNECTION SYSTEM AND THE IMPEDANCE MEASUREMENT FUNCTIONS OF THE PACEMAKER PROVED TO BE OK. THE ANALYSIS DID NOT FIND ANY DEVIATIONS FROM THE SPECIFICATION THAT COULD BE CONNECTED TO THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 2 MONTHS, IMPEDANCE VALUES OF GREATER THAN 1500 OHM WERE REPORTED. THE EXACT DATE OF IMPLANT WAS NOT PROVIDED, ONLY THAT IT HAD BEEN IMPLANTED IN 2010. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194025 CYLOS DR-T PACEMAKER DXY BIOTRONIK SE & CO. KG 349806

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization