BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4131687 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15152
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    September 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. REVIEW OF THE DEVICE MEMORY INDICATED THAT A LOW VOLTAGE ALERT, CODE 1003, WAS RECORDED. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED, BUT STILL SUPPORTED FULL DEVICE FUNCTION. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH DEVICE PERFORMANCE WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH A COMPROMISED LOW VOLTAGE CAPACITOR CONNECTED TO THE DEVICE'S BATTERY. LOW VOLTAGE CAPACITORS ARE USED IN THE DEVICE'S HIGH VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE'S BATTERY FASTER THAN NORMAL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED A LONGEVITY REMAINING OF 3.5 YEARS AND THREE MONTHS LATER, AN EXPLANT INDICATOR HAD BEEN REACHED AND THE REMOTE MONITORING SYSTEM NOTED AN ALERT TO EXPLANT THE DEVICE. A DOWNLOAD OF THE DEVICE DATA WAS PROCESSED AND REVIEWED BY A BOSTON SCIENTIFIC ENGINEER. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612611 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWS GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L N119| 0158| T135| T177| 4046| 4470| 4592| 4555