BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1875107 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19929
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITINAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A LOCAL FIELD REPRESENTATIVE (FR) THAT THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) POSSIBLY UNDERSENSED VENTRICULAR FIBRILLATION (VF). THE FR SENT IN THE ELECTROGRAMS (EGM) FOR A TECHNICAL SERVICES (TS) CONSULTANT TO ANALYZE. THE TS CONSULTANT REVIEWED THE EGM'S AND BELIEVED THAT THE DEVICE WAS OPERATING AS PROGRAMMED. THE VENTRICULAR TACHYCARDIA (VT) ZONE WAS PROGRAMMED TO 180 BEATS PER MINUTE AND THE EPISODE IN QUESTION HAD INTERVALS THAT FELL OUT OF THE VT ZONE. THE EVENT EVENTUALLY ENDED BUT THEN STARTED UP AGAIN IN THE VF ZONE WHERE ANTI-TACHYCARDIA PACING (ATP)WAS DELIVERED FOLLOWED BY THE CHARGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE.

    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 64 YR Life Threatening 0184| 4136| N119