BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3213731 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09312
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS THAT WERE DETECTED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM. A REVIEW OF HISTORICAL MEASUREMENTS INDICATED THAT THE SHOCK IMPEDANCE HAD NORMALLY RAN IN THE 50 OHM RANGE BUT HAD SPIKED TO OUT OF RANGE VALUES RECENTLY. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED TROUBLE-SHOOTING OPTIONS WITH THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE INCLUDING DELIVERING A LOW AND HIGH ENERGY SHOCK TO EVALUATE SYSTEM INTEGRITY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312277 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4469| 0184| 4518| 0185| N118