BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2062438 · Received April 19, 2011

    Report

    Report Number
    2124215-2011-06771
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    May 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    A COPY OF DEVICE MEMORY WAS PRESERVED AND SUBMITTED FOR ANALYSIS. TECHNICAL SERVICES REVIEW OF THE ELECTROCARDIOGRAM STRIPS CONFIRMED THE CLINICAL OBSERVATION OF LOSS OF CAPTURE. ANALYSIS OF THE PATIENT DATA DISK FOUND ONE RECORDED FAULT INDICATING LEAD LEAKAGE. NO OTHER FAULTS WERE RECORDED AND NO DEVICE RESETS HAD OCCURRED. INTRINSIC AMPLITUDES, THRESHOLDS, AND ALL IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE LEAD LEAKAGE FAULT ISSUED BY THIS DEVICE INDICATES THAT AN ELECTRICAL ENERGY/STIMULUS WAS BEING APPLIED NEAR THE LEAD SYSTEM. SUCH STIMULUS MAY TEMPORARILY POLARIZE THE LEAD SYSTEM AND CAN POTENTIALLY CAUSE LOSS OF SENSITIVITY AND CAPTURE. ALL BOSTON SCIENTIFIC CRM DEVICES INCLUDE NOISE DETECTION AND SAFETY RESPONSE FEATURES AS AN INTEGRAL PART OF THEIR DESIGN TO PROTECT CIRCUITRY AND THERAPY DELIVERY WHEN IN THE PRESENCE OF EXTERNAL ENERGY THAT THEY CAN ENCOUNTER. ONE SUCH FEATURE IS AN EXTERNAL DEFIBRILLATION DETECTION CIRCUIT. THIS IS DESIGNED TO PROTECT THE DEVICE IN THE EVENT THAT THE PATIENT MUST UNDERGO A TREATMENT INVOLVING EXTERNAL HIGH ENERGY ON THE DEVICE/LEAD SYSTEM (I.E., AN EXTERNAL DEFIBRILLATION).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT PLACED INTO ELECTROCAUTERY MODE PRIOR TO THE PATIENT'S ATRIAL FLUTTER ABLATION PROCEDURE. OCCASIONAL LOSS OF CAPTURE (LOC) WAS OBSERVED. ELECTROCAUTERY MODE WAS SUBSEQUENTLY PLACED TO ON, AND EVEN THEN OCCASIONAL LOC WAS NOTED TO HAVE OCCURRED. THE LOCAL AREA SALES REPRESENTATIVE DIRECTED THE PHYSICIAN TO ELECTRICALLY RE-PROGRAM THE DEVICE TO RV ONLY AT MAXIMUM OUTPUTS, WITH THE SAME RESULT. THERE WERE NO OBSERVED PATIENT SYMPTOMS; HOWEVER, A REVIEW OF ELECTROCARDIOGRAMS MAY BE DONE TO REVIEW FOR POTENTIAL ISSUES. THE LOCAL AREA SALES REPRESENTATIVE SUBSEQUENTLY CONFIRMED THAT 3 SECONDS DURATION OF ASYSTOLE HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other 4518| H175| 4087| 4088| 0158| N118| 1298