BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2040910 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00908
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    October 13, 2010
    Report Date
    January 11, 2011
    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

    TECHNICAL SERVICES DISCUSSED THAT INITIAL DETECTION WAS MET IN THE VENTRICULAR TACHYCARDIA (VT) 1 ZONE WHICH WAS SET TO MONITOR ONLY. THE RHYTHM WAS THEN REDETECTED IN THE VT ZONE. DETECTION ENHANCEMENTS WOULD NOT BE APPLIED SINCE THE EPISODE WAS IN REDETECTION. TECHNICAL SERVICES DISCUSSED DETECTION ENHANCEMENTS AND MONITOR ONLY ZONE PROGRAMMING. THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR SUPRAVENTRICULAR TACHYCARDIA (SVT). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 51 YR 4543| 4470| N119| 4195| 0185