BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3904599 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09813
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 15, 2014
    Report Date
    July 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REMAINS IN SERVICE AT THIS TIME. THIS REPORT WILL UPDATED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED WHEN THE PATIENT CALLED TO REPORT THEIR DEVICE WAS ALSO EMITTING BEEP TONES AND WAS EXPLANTED EARLY DUE TO PREMATURE DEPLETION. ADDITIONAL TESTING IS BEING PERFORMED BY THE POST MARKET QUALITY ASSURANCE LABORATORY BASED ON THIS NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LABORATORY ENGINEERS NOTED THAT SINCE NO ALERTS WERE FOUND IN THE DEVICE MEMORY, THERE WERE NO OTHER INDICATIONS THAT WOULD HAVE CAUSED THE DEVICE TO EMIT ANY TONES. THE DEVICE DID NOT EMIT ANY IRREGULAR TONES DURING ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE HAS NOT BEEN RETURNED. SHOULD THIS DEVICE GET RETURNED, IT WILL BE THOROUGHLY ANALYZED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT NO LOW VOLTAGE ALERTS (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. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH COMPROMISED LOW VOLTAGE (BYPASS) CAPACITORS 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 NOT A PART OF THE IDENTIFIED POPULATION.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    AS PART OF AN ANALYSIS TO REVIEW THE SAFETY ARCHITECTURE LOW VOLTAGE ALERT (CODE 1003), BATTERY VOLTAGE DATA WAS PULLED FROM THE REMOTE PATIENT MONITORING SYSTEM. DURING OUR ANALYSIS, THE DEVICE WAS IDENTIFIED AS DEMONSTRATING EVIDENCE OF PREMATURE BATTERY DEPLETION THAT COULD POTENTIALLY LEAD TO COMPROMISED THERAPY IF NOT ADDRESSED IN A TIMELY MANNER. BOSTON SCIENTIFIC TECHNICAL SERVICES PROACTIVELY REACHED OUT TO THE FIELD REPRESENTATIVE TO NOTIFY THEM OF THIS FINDING AND RECOMMEND DEVICE REPLACEMENT. AT THIS TIME, THE DEVICE REMAINS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIELD REPRESENTATIVE WILL DISCUSS THE ISSUE FURTHER WITH THE PATIENT'S FOLLOWING CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382447 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWS GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4554| 5386| 1688T| N119| 0158