BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3050063 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03761
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    December 18, 2012
    Report Date
    March 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0025-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING ANALYSIS PERFORMED CONFIRMED THE LOW VOLTAGE FAULT. THE FAULT WAS DECLARED ON (B)(6) 2012 DUE TO THREE DAILY VOLTAGES BELOW A THRESHOLD OF 3.025 VOLTS. NO OTHER FAULTS OR RESETS WERE OBSERVED. BASED ON THE CURRENT VOLTAGE OF 2.945 VOLTS, THERAPY DELIVER WAS UNAFFECTED. A LONGEVITY CALCULATION USING THE DEVICE MEMORY DATA CONFIRMED THE DEVICE HARDWARE WAS NOT DETECTING THE LOSS OF BATTERY ENERGY. BECAUSE OF THIS, THE BATTERY STATUS INDICATORS WERE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE THUS CAUSING THE FAULT. A DEVICE REPLACEMENT WAS RECOMMENDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED A LOW VOLTAGE BATTERY FAULT (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED TOOL MARKS ON THE HEADER. AFTER THE TITANIUM CASE WAS OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY WAS THEN REMOVED, SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT USAGE WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO TWO COMPROMISED LOW VOLTAGE CAPACITORS THAT ARE CONNECTED TO THE DEVICE'S BATTERY. THIS TYPE OF COMPONENT MALFUNCTION CAN RESULT IN A HIGH CURRENT DRAIN, WHICH OVER TIME CAN RESULT IN PREMATURE BATTERY DEPLETION, AS WAS OBSERVED IN THIS CASE.

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND REPLACED TWO MONTHS LATER AND RETURNED FOR LABORATORY ANALYSIS. UPON COMPLETION FROM ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A SHOCK FROM THE DEVICE. DURING THE DEVICE CHECK A FAULT CODE WAS OBSERVED INDICATING A BATTERY VOLTAGE DEPLETION ANOMALY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE AT THIS TIME.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149557 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR N119| 4469| 4543| 0174