BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2040720 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01497
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    July 1, 2010
    Report Date
    January 10, 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

    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) DISPLAYED HIGH RIGHT ATRIAL (RA) PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS ON THE COMPETITOR'S RA LEAD. A REVISION PROCEDURE WAS PERFORMED. WHEN THE PHYSICIAN TUGGED ON THE RA LEAD, IT CAME OUT OF THE RA PORT. THE LEAD WAS TESTED USING A PACING SYSTEM ANALYZER (PSA) AND THE PACING IMPEDANCES WERE WITHIN NORMAL LIMITS. THE DEVICE REMAINS IMPLANTED AT THIS TIME. 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 55 YR Required Intervention MISMATCH| N119| 5076| 0180