BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2910889 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15931
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    January 7, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE PATIENT'S SYMPTOMS AND HER CONCERNS REGARDING DEVICE LONGEVITY. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SUBSEQUENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION AND WAS RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED WHEN DEVICE EVALUATION IS COMPLETE.

    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. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT STATED SHE HAS HAD MANY PROBLEMS WITH THIS DEVICE SINCE IMPLANTATION. SHE STATED THAT A LASER WAS USED TO REMOVE AN OLD LEAD AND AFTER THE PROCEDURE, SHE DEVELOPED BLOOD CLOTS IN HER NECK AND ARM WHICH ARE STILL AN ISSUE. SHE ALSO REPORTED FEELING EXTREME PRESSURE IN HER HEAD WHEN SHE BENDS OVER AND OFTEN EXPERIENCES HIGH RATES WHICH CAUSE HER TO SWEAT PROFUSELY. THE PATIENT FEELS HER PREVIOUS PHYSICIAN WAS ABLE TO PROGRAM HER DEVICE TO REMEDY HER ISSUES. HOWEVER, HER CURRENT PHYSICIAN ONLY PRESCRIBES MEDICATIONS WHICH THE PATIENT HAS FOUND DO NOT WORK WELL FOR HER. DURING HER VISIT TODAY, SHE WAS INFORMED THAT HER DEVICE IS EXPECTED TO ONLY LAST ANOTHER TWO YEARS WHICH WOULD ONLY BE FOUR YEARS FROM THE IMPLANT DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16848 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR N119| 1273| 4269| 1284| 0950| 4054| 0185| H170| 4542