BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1873832 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17552
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    May 11, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, TECHNICIANS USED AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION 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 COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF THERAPY DELIVERY, SENSING, 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

    TECHNICAL SERVICES REVIEWED DATA AND ADVISED NORMAL FOLLOW-UPS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION REGARDING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR. THERE WAS EXPRESSED CONCERN OF PREMATURE BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR N119| 0185| 4470| 4543| 4592