BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1954061 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24285
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    March 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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS RETURNED IN SAFETY MODE. A VISUAL INSPECTION OF THE DEVICE NOTED THE CASE APPEARS NORMAL. DETAILED ANALYSIS CONFIRMED 3 OSCILLATOR MISMATCH FAULTS THAT OCCURRED IN LESS THAN 48 HOURS. THE DEVICE RESET TO SAFETY CORE OPERATION PER DESIGN. TECHNICIANS NOTED THAT IN SAFETY CORE MODE, THE DEVICE DOES NOT LOG DATA, THEREFORE THERAPY DELIVERY CANNOT BE CONFIRMED. THE DEVICE WAS THEN TAKEN OUT OF SAFETY CORE AND THE PACING, SENSING AND DEFIBRILLATION THERAPIES WERE VERIFIED. LABORATORY TESTING CONFIRMED THE ALLEGATION THAT THE DEVICE REVERTED TO SAFETY CORE POST CAUTERY, HOWEVER NOTED THAT PATIENT INFECTIONS CANNOT BE REPLICATED IN A LABORATORY SETTING.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. SHOULD THIS DEVICE GET RETURNED OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THIS PROCEDURE TO REMOVE THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATION SYSTEM DUE TO AN INFECTION, THE PHYSICIAN MADE CONTACT WITH THE DEVICE CASING WITH CAUTERY AND THE PATIENT RECEIVED A SHOCK. THE DEVICE WAS THEN INTERROGATED AND FOUND IN SAFETY CORE MODE. TECHNICAL SERVICES DISCUSSED SAFETY CORE PARAMETERS AND REMINDED THE SALES REPRESENTATIVE THAT THE DEVICE USES UNIPOLAR PACING AND NOTED THE DEVICE TURNS ITSELF BACK TO MONITOR PLUS THERAPY.

    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 75 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)