BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3041268 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03764
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 14, 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

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND RECOMMENDED SYSTEM TESTING. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD BEEN EXHIBITING GRADUALLY RISING SHOCK IMPEDANCE MEASUREMENTS. MOST RECENTLY, A LATITUDE RED ALERT WAS GENERATED DUE TO MEASUREMENTS GREATER THAN 125 OHMS. ALL OTHER LEAD MEASUREMENTS ARE STABLE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143653 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR H215| N118| 0174| 4480| 4520