BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2050374 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03053
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INDICATED THAT THEIR COMMUNICATOR DISPLAYED A FAULT CODE. THERE WAS A DISCREPANCY WITH THE ERROR CODE AS THERE WERE TOO MANY DIGITS; HOWEVER, ELIMINATING THE LAST DIGIT WOULD INDICATE A LOW SHOCK IMPEDANCE MEASUREMENT. TECHNICAL SERVICES (TS) INDICATED THAT THE LATEST LATITUDE SEND SHOWED THE SHOCK IMPEDANCE MEASUREMENT HAS BEEN STABLE IN THE 50 OHMS RANGE AND THE LAST SHOCK DELIVERED WAS ON THE DATE OF IMPLANT WITH IMPEDANCE MEASUREMENTS OF 34 OHMS. IT WAS NOTED THAT ALL OTHER LEAD MEASUREMENTS WERE NORMAL AND STABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE INDICATED THAT THE CLINIC THAT FOLLOWS THIS PATIENT CHECKED LATITUDE AND NO ISSUES WERE REPORTED; THEREFORE, THE PHYSICIAN DID NOT BRING THE PATIENT IN FOR FURTHER EVALUATION. SUBSEQUENTLY, A RED ALERT WAS ISSUED FOR LOW SHOCK IMPEDANCE MEASUREMENTS. TS RECOMMENDED BRINGING THE PATIENT IN FOR FURTHER EVALUATION.

    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 78 YR N119| 4518| N118| 4592| 0158