BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2163349 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07165
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 20, 2011
    Report Date
    August 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THERE WERE SOME MARKS ON THE DEVICE HEADER AND CASE DUE TO EXPLANT. MICROSCOPIC VISUAL INSPECTION OF THE HEADER FOUND IT TO BE COMPLETELY INTACT. REVIEW OF THE MEMORY LOG FOUND THAT THE DEVICE RECORDED 4 FAULTS. IT IS KNOWN THAT IF ELECTROCAUTERY IS BEING APPLIED NEAR THE DEVICE SITE DURING SURGERY THIS MAY CAUSE THE OSCILLATOR TO TEMPORARILY NOT FUNCTION PROPERLY WHICH IS KNOWN TO CAUSE FAULTS TO OCCUR, WHICH WILL CAUSE THE DEVICE TO GO INTO SAFETY CORE. THE DEVICE WAS THEN PROGRAMMED OUT OF SAFETY CORE AND INTO NORMAL OPERATION WITH NO ISSUES. THE DEVICE WAS THEN INTERROGATED WITHOUT ANY ISSUES. THE DEVICE WAS THEN PUT THROUGH A SERIES OF AUTOMATED TESTS, WHICH VERIFIED THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT UNDERWENT A MICROVALVE SURGERY, DURING WHICH TIME THE DEVICE WAS PROGRAMMED INTO AN OFF MODE. FOLLOWING THE SURGERY, THE DEVICE WAS IN A SAFETY MODE AND CANNOT BE PROGRAMMED OUT OF THAT MODE. TECHNICAL SERVICES WAS CONSULTED AND STATED THAT YOU CANNOT GET OUT OF THAT MODE AND THAT THE DEVICE NEEDS TO BE REPLACED RIGHT AWAY. AS THE PATIENT IS STILL IN THE HOSPITAL RECOVERING, THEY WILL SCHEDULE THE REPLACEMENT SURGERY RIGHT AWAY. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS AS A RESULT.

    Description of Event or Problem · 1

    NEW INFORMATION BECAME AVAILABLE THAT THIS DEVICE WAS EXPLANTED AS A RESULT OF THE CLINICAL OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening (B)(4)| 4518| 1580| V-340| N118