BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1954056 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24283
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    July 12, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO IN A HALF YEARS LATER, THIS DEVICE WAS RETURNED. SINCE THIS EVENT OCCURRENCE, THERE HAVE BEEN NO FURTHER ALLEGATIONS OR COMPLAINTS AGAINST THE PERFORMANCE OF THIS PRODUCT. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. SEAL RING MARKS OBSERVED INDICATE GOOD LEAD INSERTION DEPTH FOR ALL PACING LEADS. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED A POTENTIAL CONNECTION ISSUE DUE THE RECENT IMPLANT OR A POSSIBLE INTERMITTENT CONDUCTOR PROBLEM. THE PHYSICIAN IS PLANNING ON PERFORMING A REVISION PROCEDURE IN THE NEXT FEW DAYS. AT THIS TIME, THERE IS NO FURTHER INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE HOSPITAL ONE MONTH POST THE DEVICE CHANGEOUT FOR A FOLLOW UP. THE PRESENTING ELECTROGRAM SHOWED NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. A SURFACE ELECTROCARDIOGRAM WAS THEN REVIEWED WHICH SHOWED LEFT VENTRICULAR (LV) PACING ONLY. THE RV PACE/SENSE LEAD IMPEDANCES WERE SHOWING, HIGH OUT OF RANGE MEASUREMENTS. A REVIEW OF THE DAILY MEASUREMENTS SHOWED THE RV LEAD IMPEDANCES HAD BEEN WITHIN NORMAL RANGE, BUT THEN JUST TODAY WENT OUT OF RANGE. PATIENT WAS NOT ADVERSELY SYMPTOMATIC DUE TO THE LOSS OF RV PACING, HOWEVER HAD BEEN FEELING A LITTLE SLUGGISH OVER THE PAST FEW WEEKS. THE SALES REPRESENTATIVE (SR) DID SOME MORE LEAD TESTING AND NOTED NO CAPTURE AT 5V. WHEN TESTING THE LEAD IN TEMP MODE THERE WAS CAPTURE AND IMPEDANCES DROPPED TO NORMAL RANGE AND NO NOISE WAS NOTED. THEN GOING BACK TO NORMAL TESTING, SAME ISSUES WERE OCCURRING. THE PATIENT INDICATED THAT HE DID NOT LIKE THE PULSATING FEELING WHEN BI-V PACING SO THE SR REDUCED THE RV OUTPUTS TO LOSE CAPTURE AND LV PACE ONLY, WHICH MADE THE PATIENT FEEL BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR H177| 4542| N119| 0158| 4470