BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1950770 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22501
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 21, 2010
    Report Date
    October 31, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION WAS COMPLETED TO ASSESS THE RATE OF BATTERY DEPLETION. GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE, THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, DEFIBRILLATION, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED FOR UNKNOWN REASON AND RETURNED FOR ANALYSIS. UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECEIVED INAPPROPRIATE ANTI TACHYCARDIA THERAPY AS WELL AS MULTIPLE INAPPROPRIATE SHOCKS DUE TO A SINUS VENTRICULAR TACHYCARDIA (SVT). EPISODES WERE FORWARDED TO TECHNICAL SERVICES FOR REVIEW. TECHNICAL SERVICE DISCUSSED REPROGRAMMING OPTIONS AND NOTED THAT EVEN THOUGH THE ATP AND SHOCKS WERE CLINICALLY INAPPROPRIATE THE DEVICE FUNCTIONED NORMALLY AS DESIGNED AND PROGRAMMED. 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 P107

    Patients

    Seq Age Sex Outcome Treatment
    1 P106| 0185| 4136| 4543| P107