BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2053576 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04155
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 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

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING THE CHANGE OUT PROCEDURE, THE FIELD REPRESENTATIVE INDICATED THEY WERE UNABLE TO USE RADIOFREQUENCY (RF) TELEMETRY. IT WAS NOTED THAT THE DEVICE WAS INTERROGATED BEFORE HAND AND WAS OVER ONE HOUR BEFORE THEY WERE ABLE TO REESTABLISH TELEMETRY AGAIN. TECHNICAL SERVICES (TS) INDICATED THAT RF WAS TURNED OFF AFTER SIXTY HOURS. TS INDICATED THEY COULD HAVE REBOOTED AND PROCEEDED. THE FIELD REPRESENTATIVE PROCEEDED WITH A STERILE WAND. THE FIELD REPRESENTATIVE INDICATED THAT THE PHYSICIAN HAD A DIFFICULT TIME INSERTING THE RIGHT VENTRICULAR (RV) PACE/SENSE TERMINAL PIN INTO THE DEVICE HEADER. MINERAL OIL WAS NOT UTILIZED AND THE POCKET WAS CLOSED. THE FIELD REPRESENTATIVE WAS ABLE TO USE THE WAND TO REINTERROGATE THE DEVICE AND FOUND THAT THE RV PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2000 OHMS. A REVISION PROCEDURE WAS PERFORMED AND THE TERMINAL PIN WAS ABLE TO BE FULLY INSERTED INTO THE DEVICE HEADER. NO ADDITIONAL 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 87 YR Required Intervention T175| 0186| 0185