BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1864035 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15792
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 11, 2010
    Report Date
    August 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 CRT-D REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC 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) DELIVERED AN INAPPROPRIATE SHOCK. PRINTOUTS WERE SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) TO BE ANALYZED. AFTER REVIEWING THE PRINTOUTS, BSC TS DISCUSSED THAT THE CRT-D IS PROGRAMMED TO A 3 ZONE CONFIGURATION WITH A VENTRICULAR TACHYCARDIA-1 (VT-1) ZONE IN MONITOR ONLY (MO). RHYTHM WAS DETECTED IN THE VT-1 ZONE, AND WAS APPROPRIATELY INHIBITED FOR GREATER THAN 2 MINUTES. AFTER 2 MINUTES THE RHYTHM INCREASED UP TO THE VT ZONE. WITH A MO ZONE PROGRAMMED, AFTER INITIAL DETECTION IS SATISFIED, ENHANCEMENTS ARE NO LONGER APPLIED, REGARDLESS IF PROGRAMMED ON IN THE VT ZONE. THIS IS BECAUSE, IN REDETECTION, THE DEVICE DOES NOT APPLY DETECTION ENHANCEMENTS. THE RHYTHM WAS HOVERING AROUND THE VT ZONE CUTOFF FOR THE DURATION OF THE EPISODE, AND THE RHYTHM APPEARS TO BE SINUS DRIVEN. BSC TS SUGGESTED THAT THE MO ZONE BE PROGRAMMED OFF, OR IF THE PHYSICIAN DESIRES TO CONTINUE USING THE MO ZONE, TO ADJUST THE VT ZONE CUTOFF TO BE HIGHER IF CLINICALLY APPROPRIATE. BSC TS NOTED THAT DETECTION ENHANCEMENTS IN THE VT ZONE WILL ONLY BE APPLIED FOR RHYTHMS THAT MEET DETECTION IN THE VT ZONE. 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