BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3043307 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02611
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVALUATION WAS PERFORMED AT THIS TIME. THE PHYSICIAN WILL CONTINUE TO MONITOR THE SYSTEM THROUGH REMOTE MONITORING AND REGULAR FOLLOW-UP APPOINTMENTS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), IMPLANTED WITH ANOTHER MANUFACTURER'S DEFIBRILLATION LEAD, EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE PATIENT WAS BROUGHT INTO CLINIC AND MANUAL TESTING REVEALED SHOCK IMPEDANCE MEASUREMENTS OF 88 OHMS AND 85 OHMS. ISOMETRICS WAS PERFORMED WITH NO CHANGES IN IMPEDANCE MEASUREMENTS OBSERVED OR NOISE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED DELIVERING A 1.1 JOULE AND A MAXIMUM ENERGY SHOCK TO FURTHER EVALUATE THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146043 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4194| N119| 5076| (B)(4)| 6931