BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3212596 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08982
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 28, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0025-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THIS DEVICE WAS EXPLANTED AND WAS RETURNED FOR LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS. 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 NO ANOMALIES. INITIAL AUTOMATED TESTING VERIFIED BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE. 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

    ENGINEERING REVIEW OF THE DEVICE DATA CONFIRMED A LOW-VOLTAGE FAULT (FAULT CODE 1003) HAD OCCURRED OVER TWO MONTHS AGO. THERE WERE NO OTHER FAULTS OR RESETS STORED WITHIN DEVICE MEMORY. THE VOLTAGE WAS 2.921 VOLTS, CONFIRMING THERAPY DELIVERY WAS STILL UNAFFECTED. THE DEVICE WAS MALFUNCTIONING SUCH THAT THE BATTERY STATUS INDICATORS WERE NOT REFLECTING THE DEPLETION CONDITION AND WERE THEREFORE INACCURATE. A REVIEW OF THE BATTERY VOLTAGE MEASUREMENT DATA INDICATED THE CURRENT DRAIN WAS CONSISTENT OVER TIME, SO THERE WAS SUFFICIENT RESERVE FOR THE DEVICE TO MAINTAIN NORMAL THERAPY FUNCTIONS FOR APPROXIMATELY 7 DAYS. TECHNICAL SERVICE'S RECOMMENDATION FOR DEVICE REPLACEMENT WAS CONFIRMED BY ENGINEERING'S REVIEW OF THE DEVICE MEMORY. AS OF TODAY, THE DEVICE REMAINS IMPLANTED PENDING A REPLACEMENT PROCEDURE. THIS REPORT WILL BE UPDATED WHEN THE DEVICE IS EXPLANTED, RETURNED, AND ANALYZED.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD BEEN HOSPITALIZED DUE TO AN INFECTION RELATED TO THE IMPLANTED DEVICE. WHILE IN THE HOSPITAL, THE DEVICE WAS INTERROGATED AND A FAULT CODE 1003 WAS DISPLAYED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED DEVICE REPLACEMENT DUE TO THE FAULT CODE, AND REQUESTED A COPY OF THE DEVICE MEMORY BE SAVED TO A DISK AND SUBMITTED FOR ENGINEERING EVALUATION. NO ADDITIONAL 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
    313549 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R