BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2052111 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04017
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 22, 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

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR RECEIVED INAPPROPRIATE SHOCK THERAPY. TECHNICAL SERVICES (TS) INDICATED THAT THE PATIENT'S RHYTHM WAS DETECTED IN THE VT-1 ZONE AND THEN CROSSED OVER TO THE VT ZONE. TS INDICATED THAT ONCE THE DEVICE CROSSES OVER FROM THE VT-1 ZONE TO THE VT ZONE, PROGRAMMED DETECTION ENHANCEMENTS DO NOT CONTINUED TO BE APPLIED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.

    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 42 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)