BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2051992 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03406
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    November 17, 2010
    Report Date
    February 23, 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

    UPON RECEIPT AT OUR (B)(4) LABORATORY, THIS CRT-D WAS THOROUGHLY INSPECTED AND ANALYZED. PIN GAUGE TESTING CONFIRMED THAT ALL PORT DIAMETERS WERE WITHIN DESIGN SPECIFICATION RANGE; HOWEVER, THE DIAMETER OF THE RA SPRING CONTACT COMPONENT WAS FOUND TO BE OUT-OF-SPECIFICATION. THIS MAY HAVE RESULTED IN A SUBOPTIMAL CONNECTION WITH THE LEAD TERMINAL.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED HIGH PACING IMPEDANCE MEASUREMENTS AND NOISE ON THE COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD. THE NOISE RESULTED IN INAPPROPRIATE THERAPY. IT WAS NOTED THAT THE COMPETITOR'S LEAD WAS FRACTURED. A REVISION PROCEDURE WAS PERFORMED AND THIS DEVICE WAS ELECTIVELY REPLACED. THE COMPETITOR'S RV LEAD WAS ALSO EXPLANTED. 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 64 YR Required Intervention 4194| 4076| 6949| 7303| N119