BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1863694 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15838
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 18, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, IT WAS REPORTED THAT THE PHYSICIAN WAS GOING TO CONSULT ANOTHER PHYSICIAN AND POSSIBLY CONTACT THE PATIENT TO DO FURTHER EVALUATIONS. THE PATIENT IS BEING FOLLOWED VIA LATITUDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. INFORMATION NOTES BOTH PRODUCTS REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION NOTES THIS MEASUREMENT CONTINUES. TECHNICAL SERVICES DISCUSSED PROGRAMMING AND POSSIBLE CAUSES. THIS ISSUE WAS STILL BEING INVESTIGATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) > 125 OHMS WAS MEASURED ON THIS CHRONIC DEFIBRILLATION LEAD. RESOLUTION WAS REQUESTED FROM THE FIELD. IT WAS THEN REPORTED THAT THE PHYSICIAN RECONNECTED THE DEVICE AND LEADS. THE MEASUREMENTS WERE ALSO TESTED THROUGH THE PROGRAMMER IN ALL CONFIGURATIONS RESULTING IN THE SAME MEASUREMENTS.

    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 50 YR