BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2042236 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01270
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    August 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS 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.

    Additional Manufacturer Narrative · 1

    ONGOING ALERTS CONTINUE FOR THIS ISSUE AND IT WAS REPORTED THIS ISSUE WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    ANOTHER ALERT PRESENTED FOR THIS SAME ISSUE. THE PHYSICIAN HAD INQUIRED IF THESE MEASUREMENTS COULD BE RELATED TO A SINGLE COIL LEAD AND PATIENT'S BODY POSITION DUE TO SEVERE SCOLIOSIS. TECHNICAL SERVICES DISCUSSED LEAD TESTING COULD PROVIDE FURTHER INFORMATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AND HIGH OUT OF RANGE SHOCK IMPEDANCE. 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 73 YR N119| 4555| S603| 1298| (B)(4)| 0181| (B)(4)| (B)(4)