BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE CHF GENERATOR

    MDR report key: 1042804 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33835
    Date Received
    May 8, 2008
    Report Date
    September 8, 2010
    Product Code
    NIK
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A DECREASED MONITORING VOLTAGE FROM 2.83V TO 2.66 V IN THREE MONTHS. PREMATURE BATTERY DEPLETION WAS QUESTIONED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION. A TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THE MIDDLE OF LIFE 1 (MOL1) PERIOD AND RECOMMENDED TO REVIEW AGAIN IN THREE MONTHS TO DETERMINE IF THE BATTERY LEVELS CHANGED AGAIN. THEY DISCUSSED THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY AND ITS RELATION TO CHARGE TIMES. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS SCHEDULED FOR FOLLOW-UP IN THREE MONTHS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE WAS LATER EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE CHF GENERATOR NIK

    Patients

    Seq Age Sex Outcome Treatment
    1 THE DEVICE 4470/447460 WAS IMPLANTED 14-JAN-2005| THE DEVICE 0186/101198 WAS IMPLANTED 14-JAN-2005| THE DEVICE 4542/103391 WAS IMPLANTED 14-JAN-2005| THE DEVICE LATR WAS USED DURING THE EVENT.