BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2173226 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10859
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 13, 2011
    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 AN OUT OF RANGE LOW SHOCKING IMPEDANCE MEASUREMENT OF LESS THAN 20 OHMS WAS DETECTED AND THE PATIENT WAS BROUGHT INTO THE CLINIC FOR A DEVICE INTERROGATION. UPON EVALUATION, THE SHOCK LEAD IMPEDANCE TEST REVEALED AN IMPEDANCE MEASUREMENT OF 60 OHMS IN A TRIAD CONFIGURATION. THE CLINICIAN WAS UNABLE TO REPRODUCE THE OUT OF RANGE LOW IMPEDANCE MEASUREMENT WITH ISOMETRICS OR POCKET MANIPULATION. REVIEW OF THE ARRHYTHMIA LOGBOOK SHOWED TWO NON-SUSTAINED EPISODES THAT WERE APPROPRIATE AND TRENDING NOTED THAT THE SHOCK LEAD IMPEDANCE HAS BEEN STABLE. TWO COMMANDED SHOCKS WERE ALSO PERFORMED, BOTH YIELDED IMPEDANCE MEASUREMENTS WITHIN RANGE. THE PATIENT WILL CONTINUE TO BE MONITORED AND THE DEVICE AND LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 4543| 1888TC| 0185| N119