BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2052633 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04089
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A POST OPERATIVE CHECK OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THERE WAS AN INHIBITION OF PACING DUE TO OVERSENSING ATRIAL ACTIVITY ON A NON-BOSTON SCIENTIFIC LEAD. THIS WAS BASED ON THE ELECTROGRAM ALONE. THE THRESHOLD OF THIS RIGHT VENTRICULAR LEAD WAS REPORTED HIGH WITH LOW AMPLITUDES. WITH DECREASING THE SENSITIVITY INHIBITION WAS THEN ONLY EVERY OTHER BEAT. OTHER PROGRAMMING OPTIONS WERE DISCUSSED WITH TECHNICAL SERVICES. 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