BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3041230 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00977
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    September 11, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING A FURTHER FOLLOW-UP VISIT, REVIEW OF THE ARRHYTHMIA LOG BOOK REVEALED TWO NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. THESE EPISODES WERE NOT TREATED, HOWEVER CAUSED PACING INHIBITION AS THE PATIENT IS PACEMAKER DEPENDENT. THE NOISE PATTERN IS SIMILAR TO MYOPOTENTIALS AND CONSISTENT WITH DIAPHRAGMATIC MYOPOTENTIAL. IT WAS THOUGHT THIS OCCURRED DURING INTENSIVE EXERCISE THAT LED TO MYOPOTENTIAL OVERSENSING, HOWEVER A LEAD INSULATION ISSUE COULD NOT BE EXCLUDED. A DECISION WAS MADE TO FURTHER MONITOR THIS SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. TECHNICAL SERVICES REVIEWED THE DATA AND CONFIRMED PACING INHIBITION GREATER THAN TWO SECONDS COMPATIBLE WITH MYOPOTENTIALS OR DIAPHRAGMATIC SIGNALS. THE DEVICE DETECTED THREE BEATS IN THE VF ZONE AND RECOVERED WITH NORMAL PACING. ANOTHER EPISODE REVEALED NOISE WITH PACING INHIBITION AND THE DEVICE RECORDED FOUR FAST BEATS AND AFTER 1.5 SECONDS, THE DEVICE BEGAN PACING IN DDD MODE AT THE SENSOR RATE LIKELY DUE TO THE PATIENT MOVEMENT OF BENDING TO REMOVE HIS SHOES. FURTHER ANALYSIS WILL BE PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, A REVIEW OF THIS RIGHT VENTRICULAR LEAD AND DEVICE ARRHYTHMIA LOG BOOK REVEALED TWO EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA. THE EPISODES RESULTED IN PACING INHIBITION GREATER THAN TWO SECONDS ASYSTOLE AND HAD NOT BEEN TREATED BY THE DEVICE IN THIS PACEMAKER DEPENDENT PATIENT. THE NOISE COULD BE REPRODUCED. THE DEVICE WAS REPROGRAMMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. DUE TO THE PATIENT'S AGE AND CONDITION, A DECISION HAS BEEN MADE TO FURTHER MONITOR THIS DEVICE AND LEAD BY REMOTE MONITORING. IF FURTHER NOISE EPISODES ARE NOTED IN THE FUTURE; A REVISION PROCEDURE MAY BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142578 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1