BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4131497 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14270
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. 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 THE DEVICE¿S ABILITY TO DELIVER THERAPY WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. REVIEW OF THE DEVICE MEMORY INDICATED THAT A VOLTAGE ALERT WAS RECORDED. 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. ON AUGUST 29, 2013, BOSTON SCIENTIFIC DISTRIBUTED A LETTER TO PHYSICIANS CONCERNING THIS ISSUE. THIS LETTER INFORMED PHYSICIANS THAT, IN A SUBSET OF DEVICES, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS DEVICE IS PART OF THE IDENTIFIED POPULATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS RECENTLY EMITTING TONES AND DISPLAYED A LOW VOLTAGE ALERT CODE OF 1003. BOSTON SCIENTIFIC ENGINEERS WERE CONSULTED AND STATED THAT THE CODE 1003 IS DUE TO LOW VOLTAGES BEING DECLARED DUE TO THREE DAILY VOLTAGES BEING BELOW THE THRESHOLD OF 3.025 VOLTS. THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY AND NOT REFLECTING THE DEPLETION CONDITIONS, AND THUS, IS INACCURATE WHICH IS THE REASON FOR THE LOW VOLTAGE ALERT. SINCE THIS DEVICE IS MALFUNCTIONING, IT IS RECOMMENDED TO BE REPLACED IMMEDIATELY. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS WONDERING WHY THIS ALERT WAS NOT DISPLAYED PRIOR TO THE IN OFFICE VISIT, AND BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) LOOKED AND STATED IT WAS INITIALLY DISPLAYED ONE MONTH PRIOR, BUT DISMISSED BY THE PHYSICIAN AT THAT TIME. THEN DURING THE NEXT INTERROGATION IT WAS DISPLAYED AGAIN. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611856 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWS GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 0185| N119| 4136| 4592