BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2161190 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07624
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS 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 DURING A ROUTINE DEVICE CHECK OVERSENSED NOISE WAS OBSERVED ON THE RATE/SENSE CHANNEL OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD. IT WAS REPORTED THAT THE PATIENT IS PACER DEPENDENT AND PACING INHIBITION WAS OBSERVED FOR FIVE SECONDS DUE TO THE NOISE. IT WAS FOUND THAT THE PATIENT WAS UNDERGOING A PROCEDURE AT THE TIME OF THE EPISODE. IT WAS UNKNOWN IF A MAGNET WAS USED TO INHIBIT TACHY THERAPY DURING THE PROCEDURE. ADDITIONALLY, AN ELECTIVE POCKET REVISION PROCEDURE WAS PLANNED. 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 63 YR N119| 4543| 0184| 4592