BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3043222 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03340
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER WHO STATED THE PATIENT WILL BE IN FOR A FOLLOW UP AT THE END OF THE MONTH. THE CONSULTANT SUGGESTED SYSTEM EVALUATION INCLUDING AN X-RAY AND ISOMETRICS. EFFORTS TO OBTAIN ADDITIONAL EVENT DETAILS WERE UNSUCCESSFUL. THE SYSTEM REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED FROM THIS SYSTEM DUE TO SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145167 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4136| 4554| S602| 0180| N119| 4457