BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2173352 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11145
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED OFF-ELECTROCAUTERY MODE AND RECOMMENDED USING SHORTER BURSTS OF ELECTROCAUTERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, HOWEVER NO FURTHER INFORMATION WAS AVAILABLE. RECORDS INDICATE THIS DEVICE REMAINS 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 THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) UNDERWENT AN ABLATION PROCEDURE. THE DEVICE WAS PROGRAMMED TO OFF-ELECTROCAUTERY MODE, HOWEVER PACING INHIBITION AND LOSS OF CAPTURE WERE OBSERVED WHEN ELECTROCAUTERY WAS USED. 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 N118

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 1273| 1851| 4035| 4513| H175| N118| 4244| 0154