BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1944905 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19415
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 1, 2010
    Report Date
    November 6, 2018
    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

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    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. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT 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

    SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT WAS EVALUATED IN THE OFFICE AND THE SHOCK IMPEDANCE MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL LIMITS. NO OUT OF RANGE IMPEDANCE MEASUREMENTS WERE OBSERVED WITH POCKET AND ISOMETRIC MANEUVERS. AS A RESULT, NO COMMANDED OR NON-INVASIVE PACING STIMULATION (NIPS) WILL BE PERFORMED AT THIS TIME. THE PATIENT WILL CONTINUED TO BE MONITORED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS. THE PATIENT WAS TO BE BROUGHT IN FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR N119| 4554| 0180| 4135