BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2910125 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15406
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THROUGH A REMOTE MONITORING SYSTEM THAT THIS DEVICE DETECTED AN OUT OF RANGE PACING IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. WHEN LATITUDE WAS CHECKED, THERE WERE NO OUT OF RANGE MEASUREMENTS. A 1840 OHMS WAS THE HIGHEST PACING IMPEDANCE MEASUREMENT FOR THE DATE THE OUT OF RANGE MEASUREMENT WAS DETECTED. AS A RESULT, THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17905 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1