BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1944988 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20532
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    April 2, 2010
    Report Date
    October 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BSC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING, NOISE, HIGH PACING THRESHOLD VALUES AND HAD A PACING IMPEDANCE THAT FLUCTUATED FROM 700 TO 1500 OHMS. BSC TECHNICAL SERVICES (TS) REVIEWED ELECTROGRAMS (EGM'S), AND DISCUSSED THAT THIS PATIENT UNDERGOES A LOT OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. THESE ARE TRUE NON-SUSTAINED VT'S. THE MAJORITY OF THE EGMS HAVE THE RIGHT VENTRICULAR (RV) AND SHOCK CHANNELS CLEAN AND EXEMPTED OF NOISE. HOWEVER, SOME EPISODES CONTAIN MECHANICAL-LIKE NOISE ON THE RV CHANNEL. ALTHOUGH THE INFORMATION REVIEWED CANNOT DEFINITIVELY RULE OUT A LOOSENED HEADER/PG BOND, ONE WOULD EXPECT THAT SHOULD A LOOSENED HEADER BE EVIDENT, NOISE WOULD BE SEEN ON ALL CHANNELS. THIS COULD NOT HAVE BEEN OBSERVED IN ANY AVAILABLE EPISODE. IT WAS ALSO NOTED THAT THE NOISE DID NOT RESULT IN GREATER THAN 2 SECONDS OF ASYSTOLE. BSC TS ADVISED THE PHYSICIAN TO PERFORM SOME ADDITIONAL PROVOCATIVE MANEUVERS IN ORDER TO SEE IF THE NOISE CAN BE REPRODUCED, AND TO CLOSELY FOLLOW THE EVOLUTION OF THE VENTRICULAR PACING IMPEDANCES VALUES AS WELL AS THE VENTRICULAR THRESHOLD VALUES. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 0145| 4244| 1821| 1871| 4592| P107