BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR-T

    MDR report key: 1181899 · Received September 25, 2008

    Report

    Report Number
    1028232-2008-01133
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    May 16, 2008
    Report Date
    August 28, 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

    THE VISUAL INSPECTION REVEALED BURN MARKS ON THE PACEMAKER HOUSING, WHICH WERE MOST LIKELY CAUSED BY AN HF-SURGERY TOOL. THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION DURING WHICH THE DEVICE PROMPTED A RE-INITIALIZATION REQUEST, INDICATING THAT THE PACEMAKER IS OPERATING IN BACKUP MODE. WHILE IN THIS MODE THE PACEMAKER ENSURES ANTI-BRADYCARDIAC PACING, WHICH WAS CONFIRMED BY THE MEASUREMENTS OF THE PACEMAKER'S OUTPUT SIGNAL. THE PACEMAKER MEMORY AND STATISTICS WERE INSPECTED, REVEALING AN INCREASED CURRENT CONSUMPTION FROM ELECTRONIC MODULE. THE DEVICE WAS THEREFORE SHIPPED TO THE MANUFACTURER OF THE ELECTRONIC MODULE FOR DESTRUCTIVE ROOT CAUSE ANALYSIS WHICH CONFIRMED THE HIGH CURRENT CONSUMPTION. INCREASED CURRENT CONSUMPTION WOULD RESULT IN A BATTERY DEPLETION WITHIN ELEVEN MONTHS, WHICH CORRELATES TO THE IMPLANTATION DURATION. NEXT, A DAMAGED INTEGRATED CIRCUIT WAS IDENTIFIED. THE DAMAGE RESULTED IN AN INCREASED CURRENT CONSUMPTION, DRAINING THE BATTERY. THE DAMAGE DID NOT, HOWEVER, LIMIT THE DEVICE ABILITY TO DELIVER ANTI-BRADYCARDIAC PACING. AFTER AN EXCHANGE OF THE DAMAGED COMPONENT THE ELECTRONIC MODULE WAS FULLY FUNCTIONAL AND THE CURRENT CONSUMPTION RETURNED TO THE EXPECTED LEVEL. THE QUALITY DOCUMENTS ACCOMPANYING THE PACEMAKER HAVE BEEN RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST OF THIS PACEMAKER. CURRENT CONSUMPTION DURING THE PRODUCTION WAS VERIFIED, AND PROVED TO BE NORMAL.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF APPROX 11 MONTHS, AND EXITBLOCK WAS REPORTED, AND THE PACEMAKER INDICATED ERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS DR-T PACEMAKER DXY BIOTRONIK GMBH AND CO. 349806

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization