BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1851903 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14329
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO AN INFECTION. A TEMPORARY WIRE WAS PLACED AS THE PATIENT IS DEPENDENT AND A NEW SYSTEM WILL BE IMPLANTED IN A FEW DAYS. THE LOCAL FIELD REPRESENTATIVE (FR) INQUIRED ABOUT NOISE RESPONSE. THE FR INDICATED THAT BOVEE CAUTERY WAS BEING USED AND THE DEVICE WAS PROGRAMMED TO DUAL CHAMBER PACING, SENSING AND RESPONSE WITH A LOWER RATE LIMIT (LRL) OF 75. THERE WAS A SHORT PERIOD OF ASYSTOLE DURING THE EXTRACTION. TECHNICAL SERVICES (TS) INDICATED THAT IN ORDER FOR NOISE RESPONSE TO ENGAGE, THE NOISE WINDOW WOULD HAVE HAD TO BE CONTINUOUSLY RETRIGGERED FOR THE ENTIRE LRL (800 MILLISECONDS) FOR THE DEVICE TO PACE DUE TO NOISE RESPONSE. THE FR ALSO INDICATED THAT DURING THE PROCEDURE, HE CAME BACK AND RECEIVED A MESSAGE THAT THE ELECTROGRAM'S (EGM) WERE TURNED OFF AND HE WAS UNABLE TO RE-ESTABLISH TELEMETRY. TS DISCUSSED THE 3 TIMES THAT ARE APPLICABLE WHEN THE RADIOFREQUENCY IS ACTIVE AND OUT OF STORAGE: 2 MINUTES IS A PATIENT CONFIRMATION, 15 MINUTES REAL-TIME EGM'S ARE TURNED OFF; HOWEVER, THEY CAN BE RE-ESTABLISHED BY HITTING THE CONFIRM BUTTON, AND THE 60 MINUTE DISABLE RF.

    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 73 YR Required Intervention 6947| H170| N119| 4542| 1861| 5076