BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3052736 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05616
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    March 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT CONFIRMED THAT THERE WERE NO FAULT CODES PRESENT AND THAT THE OBSERVED PACING INHIBITION/LOSS OF CAPTURE WAS PRESENT ON THE SURFACE EKG. IF A BOSTON SCIENTIFIC DEFIBRILLATOR DETECTS ENERGY ON THE LEADS FROM AN EXTERNAL SOURCE (E.G., CAUTERY, RADIOFREQUENCY ABLATION, OR EXTERNAL DEFIBRILLATION)OVER A SET THRESHOLD, THE DEVICE IS TEMPORARILY DISCONNECTED FROM THE LEAD SYSTEM VIA HIGH-VOLTAGE CAPABLE SOLID STATE SWITCHES. THIS EFFECTIVELY CLOSES THE CURRENT PATH THROUGH THE LEAD, ELIMINATING THE POSSIBILITY OF HIGH CURRENTS FLOWING THROUGH THE LEAD TIP-TISSUE INTERFACES, AND PREVENTING POTENTIAL DAMAGE TO EITHER THE DEVICE CIRCUITRY OR THE TISSUE ITSELF. ONCE THE EXTERNAL SIGNALS CEASE, THE DEVICE RESUMES NORMAL OPERATION. PER PRODUCT LABELING, THE USE OF EXTERNAL PACING SUPPORT IS RECOMMENDED FOR PACEMAKER-DEPENDENT PATIENTS. THE FIELD REPRESENTATIVE CONFIRMED THERE WAS NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED INHIBITION OF PACING DURING ELECTROCAUTERY MODE FOR A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154807 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 4555| 4592| 4136| 0184| 1882TC| S606| N119