BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2170251 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10038
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 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

    THE FIELD REPRESENTATIVE REPORTED THAT THIS PATIENT WAS NOT FOLLOWED BY LISTED PHYSICIAN AND HAD NO FURTHER INFORMATION TO PROVIDE. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF AN ADVISORY AND WAS MALFUNCTIONING. THERE WAS INQUIRY AS TO WHAT ADVISORY AND TECHNICAL SERVICES DISCUSSED. IN ADDITION, THERE WAS AN ALERT TO CHECK THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL AND LEFT VENTRICULAR LEADS. THE HEALTH CARE PROVIDER WAS TO FURTHER DISCUSS THIS CASE WITH THE PHYSICIAN. 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 85 YR 0157| 350 973| MISMATCH| 4542| 350 974| N119