BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3904733 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10031
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0087-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 NOT INCLUDED IN THE AUGUST 29, 2013 ADVISORY POPULATION, BUT WAS ADDED TO THE EXPANDED POPULATION ON SEPTEMBER 17, 2014.

    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 BODY FLUID CONTAMINATION OF THE LEAD BARRELS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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, THIS 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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382176 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R N119| 4086| 0184| 4542