BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4140506 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17565
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 22, 2014
    Report Date
    November 7, 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). 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 DEVICE PERFORMANCE 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).

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS IDENTIFIED TO BE INCLUDED IN THE LOW VOLTAGE CAPACITOR 2014 PRODUCT ADVISORY, WHICH WAS INITIALLY COMMUNICATED ON (B)(6) 2014. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED DEVICE REPLACEMENT. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618138 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 4086| 4592| N119| 0185