BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2911322 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16067
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 27, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THIS CRT-D WAS CARRIED OUT. VISUAL INSPECTION IDENTIFIED NO ANOMALIES. ELECTRICAL TESTS, INCLUDING IMPEDANCE MEASUREMENTS, WERE PERFORMED AND NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED HIGH, OUT OF RANGE PACE IMPEDANCE MEASUREMENTS ON THE RIGHT ATRIAL CHANNEL. THE IMPEDANCE WAS TRENDING AROUND 500 OHMS AND THEN SPIKED TO GREATER THAN 2000 OHMS ON THREE SEPARATE OCCASIONS. THE OUT OF RANGE MEASUREMENTS WERE NOT ABLE TO BE REPRODUCED. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATED THAT NO FURTHER TROUBLE SHOOTING WAS PERFORMED AND THAT THE PATIENT WOULD CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED FOLLOWING PATIENT DEATH. NO FURTHER ALLEGATIONS WERE REPORTED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18151 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4046| N119| T165| 0158| 5076