BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2040684 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00685
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    October 26, 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

    PROGRAMMING INQUIRIES WERE DISCUSSED. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD AN INAPPROPRIATE SHOCK IN THE VT ZONE AFTER BEING DETECTED IN THE VT-1 ZONE WHICH WAS MONITOR ONLY. IT WAS REPORTED THAT THE PATIENT HAD ANTITACHYCARDIA PACING AND THEN WENT INTO VENTRICULAR TACHYCARDIA. 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 56 YR 4470| H177| 4543| 0185| N119| N118