BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4140485 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17247
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0087-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. REVIEW OF THE DEVICE MEMORY INDICATED THAT A LOW VOLTAGE ALERT, CODE 1003, WAS RECORDED. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED, BUT STILL SUPPORTED FULL DEVICE FUNCTION. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH THE DEVICE'S ABILITY TO DELIVER THERAPY WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH A COMPROMISED LOW VOLTAGE CAPACITOR 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. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE RECENTLY DISPLAYED A LOW VOLTAGE ALERT CODE OF 1003. BOSTON SCIENTIFIC ENGINEERS WERE CONSULTED AND STATED THAT THE CODE 1003 IS DUE TO LOW VOLTAGES BEING DECLARED DUE TO THREE DAILY VOLTAGES BEING BELOW THE THRESHOLD OF 3.025 VOLTS. THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY AND NOT REFLECTING THE DEPLETION CONDITIONS, AND THUS, IS INACCURATE WHICH IS THE REASON FOR THE LOW VOLTAGE ALERT. SINCE THIS DEVICE IS MALFUNCTIONING, IT IS RECOMMENDED TO BE REPLACED IMMEDIATELY. THE DEVICE REMAINS IMPLANTED AT THIS TIME. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619325 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWS GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R 0125| 1851| MISMATCH| N119| T125| 4592