BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1864245 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16188
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    June 20, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RE-PROGRAMMING WAS DONE TO MITIGATE THE ISSUE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE SHOCK THERAPY IN VT-1 ZONE PROGRAMMED MONITOR ONLY (MO). THE PATIENT WAS NOTED TO HAVE VENTRICULAR FIBRILLATION AT 210 BEATS PER MINUTE. THE DEVICE BEGAN TO CHARGE, WHILE VT ZONE DETECTION HAD SLOWED BACK DOWN TO MO. THE BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT DISCUSSED DETECTION CRITERIA AND HOW ONCE THE DEVICE STARTS TO CHARGE, FAST IS CONSIDERED FAST EVEN IF IT WAS ONLY IN THE MO ZONE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    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 39 YR 4470| 0147| 4543| H210| H217| N119| 4538| 5071