BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2936222 · Received January 30, 2013

    Report

    Report Number
    2124215-2013-02089
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THIS 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PERMANENTLY PROGRAMMED TO VVI 30, HOWEVER, WAS PROGRAMMED TO VOO 80 BIVENTRICULAR PACE FOR AN ATRIOVENTRICULAR NODE ABLATION. DURING THE ABLATION RIGHT VENTRICULAR PACE AND LEFT VENTRICULAR PACE MARKERS WERE OBSERVED, HOWEVER WERE NOT CAPTURING. WHEN THE ABLATING WAS STOPPED PACING RETURNED TO NORMAL. THE DEVICE WAS THEN PROGRAMMED TO VOO 80 RIGHT VENTRICULAR PACE ONLY AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED DEVICE FEATURES RELATED TO NOISE OR ELECTRICAL SIGNALS OBSERVED BY THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40352 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 0147| 4086| 4517| N118