BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2042415 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01482
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 25, 2012
    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

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE HAD LESS THAN ONE YEAR PREDICTED LONGEVITY AND HAD BEEN IMPLANTED FOR LESS THAN 2 MONTHS. THE CAUSE OF THE SHORTENED LONGEVITY WAS DUE TO A HIGH CURRENT DRAIN THAT WAS ISOLATED TO THE LV PACING CIRCUITRY. ANALYSIS CONFIRMED THAT CRITICAL THERAPY WAS AVAILABLE. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REVEALED THE BATTERY WAS FUNCTIONING AT 460% OF USAGE FOR NOMINAL'S AND THE LONGEVITY WAS ONE YEAR. TECHNICAL SERVICES (TS) REQUESTED A MEMORY DUMP AND SAVE ALL TO DISK BE SUBMITTED FOR REVIEW. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 50 YR Required Intervention 4543| 0185| N119| 4555| 4470