BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3043147 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01961
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 13, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0025-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ENGINEERING REVIEW OF THE DEVICE DATA CONFIRMED A LOW-VOLTAGE FAULT (FAULT CODE 1003) HAD OCCURRED. THERE WERE NO OTHER FAULTS OR RESETS STORED WITHIN DEVICE MEMORY. THE VOLTAGE WAS 3.014 VOLTS, CONFIRMING THERAPY DELIVERY WAS 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 TWO WEEKS' TIME. 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

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REPORTED HEARING TONES FROM THE DEVICE. UPON INTERROGATION, FAULT CODE 1003 WAS DISPLAYED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT WAS CONTACTED AND RECOMMENDED IMMEDIATE DEVICE REPLACEMENT. A COPY OF THE DEVICE MEMORY WAS SAVED TO A DISK AND SUBMITTED TO BOSTON SCIENTIFIC FOR ENGINEERING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146371 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1