BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2072520 · Received April 29, 2011

    Report

    Report Number
    2124215-2011-07578
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS IN VENTRICULAR TACHYCARDIA AND THE DEVICE DETECTION ENHANCEMENTS DID NOT PREVENT 2.5 SECONDS OF PAUSE THAT OCCURRED. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THAT IT APPEARED THE POST-VENTRICULAR CONTRACTIONS (PVCS) THAT WERE ALSO PRESENT WERE BELOW THE RATE CUT OFF. THE PATIENT WAS SYMPTOMATIC AND WAS IN THE HOSPITAL. ELECTRICAL RE-PROGRAMMING TO MITIGATE THE ISSUE WAS DISCUSSED.

    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 65 YR Required Intervention 0148| 4473| T125| T180| 4543| N119