BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2781049 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13306
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 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 THIS DEVICE SYSTEM DETECTED A SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. IN CLINIC TESTING RESULTED IN SHOCK IMPEDANCE MEASUREMENTS WITHIN ACCEPTABLE LIMITS. NO NOISE WAS REPRODUCABLE AS A RESULT OF ISOMETRIC TESTING. THE PATIENT'S PHYSICIAN ELECTED TO CONTINUE TO MONITOR THE DEVICE SYSTEM. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4518| H179| N118| 0185