BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1952517 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23442
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    May 26, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LATITUDE DETECTED AN ALERT FOR A HIGH SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. TECHNICAL SERVICES DISCUSSED RECOMMENDATIONS AND THE BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS TO FOLLOW UP WITH THE PATIENT'S PHYSICIAN FOR POSSIBLE REPROGRAMMING. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS REPROGRAMMED TO A VALUE OTHER THAN MONITOR PLUS THERAPY, AS A RESULT OF THE INCREASED SHOCK IMPEDANCE MEASUREMENTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE LOCAL AREA BOSTON SCIENTIFIC SALES REPRESENTATIVE REPORTED THAT DURING THE PREVIOUS CHANGE OUT PROCEDURE, A KINK WAS OBSERVED IN THE PROXIMAL COIL OF THE RIGHT VENTRICULAR (RV) LEAD NEAR THE DEFIBRILLATION PIN. THE DEVICE WAS PROGRAMMED TO RV TO CAN AT THAT TIME. THE DEVICE HAD BEEN REPROGRAMMED TO TRIAD, RESULTING IN THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE DEVICE WAS REPROGRAMMED TO RV TO CAN AND THE MEASUREMENT WAS WITHIN ACCEPTABLE LIMITS. A SECOND OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS OBSERVED IN THIS CONFIGURATION. TECHNICAL SERVICES DISCUSSED TESTING RECOMMENDATIONS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 4518| 5076| H219| 0157| N118| (B)(4)| 4076| H125