BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3040693 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00688
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 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

    RECORDS INDICATE THIS DEVICE AND LEAD REMAIN IN SERVICE. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE PATIENT WAS BROUGHT INTO CLINIC FOR FOLLOW-UP AND ALL MEASUREMENTS TAKEN IN CLINIC WERE WITHIN RANGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THIS LEAD RUNS A HIGHER IMPEDANCE AND REMOTE MONITORING WILL SEND ANOTHER ALERT IF ANOTHER HIGH OUT OF RANGE IMPEDANCE MEASUREMENT IS DETECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143650 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 4135| 4592| 4046| 4543| N119| 0180