BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3951047 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-12070
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    November 7, 2011
    Report Date
    November 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) SYSTEM EXHIBITED A HIGH SHOCK IMPEDANCE MEASUREMENT. DURING THE NEXT READING, THE SHOCK IMPEDANCE WAS NORMAL. ALL OTHER PARAMETERS WERE NORMAL AS WELL. THIS DEVICE REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THIS SYSTEM AGAIN EXHIBITED SUBSEQUENT HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS THROUGH THE PATIENT'S HOME MONITORING SYSTEM. ATTEMPTS TO OBTAIN FURTHER INFORMATION WERE MADE, HOWEVER, NO FURTHER DETAILS WERE MADE AVAILABLE. THE DEVICE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428409 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 P107