BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1853439 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14705
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    February 23, 2010
    Report Date
    December 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE 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.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED THIS SINGLE COIL LEAD AND HOW IMPEDANCES CAN RUN HIGHER. HOWEVER, IT IS THE PHYSICIAN DISCRETION ON WHETHER TO CONTINUE TO MONITOR OR REVISE THE LEAD. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. RESOLUTION WAS REQUESTED FROM THE FIELD REPRESENTATIVE HOWEVER, NOTHING FURTHER HAS BEEN PROVIDED. INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ONGOING ALERTS CONTINUE FOR HIGH SHOCK IMPEDANCES.

    Additional Manufacturer Narrative · 1

    THE REPRESENTATIVE FURTHER PROVIDED THAT THIS PATIENT IS NOT IN CLOSE PROXIMITY TO THEIR FOLLOWING HEART CLINIC. A CLINICIAN IS TRYING TO CONTACT THIS PATIENT IN ORDER FOR THE PATIENT TO BE FURTHER EVALUATED.

    Additional Manufacturer Narrative · 1

    IT WAS FURTHER REPORTED THAT THIS PATIENT IS SCHEDULED FOR A LEAD REVISION.

    Description of Event or Problem · 1

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED CHANGES IN SHOCKING IMPEDANCES ON THIS DEFIBRILLATION LEAD. SHOCK LEAD IMPEDANCE TESTING (SLIT) CHANGED FROM 94 TO 104 OHMS AND RECENT SHOCKS HAD IMPEDANCES OF 110-114 OHMS. IT WAS LATER DETECTED VIA LATITUDE THAT THESE SHOCK IMPEDANCES WERE > 125 OHMS. THERE WAS NO NOISE ON THE LEAD AND OTHER LEAD DIAGNOSTICS WERE FINE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 4592| 0185| H210| 4543| 4471| 4469| 0180| 4047| N119