BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2173184 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11910
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 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

    UPON RECEIPT, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE DEVICE HAD NO TELEMETRY UPON RETURN. ENGINEERING CALCULATIONS CONFIRMED THE LONGEVITY OF THIS DEVICE WAS NOT AS EXPECTED. THE DEVICE CASE WAS OPENED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGH CURRENT CONDITION WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT TO AN INTEGRATED CIRCUIT (IC). DETAILED ANALYSIS CONFIRMED THAT THE IC ISSUE CREATED THE HIGH CURRENT CONDITION AND THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD EXPERIENCED A FALL. SYSTEM EVALUATION NOTED NO TONES WITH THE USE OF A MAGNET OR A STETHOSCOPE. ADDITIONALLY, INTERROGATION WAS UNSUCCESSFUL AND NO PACING WAS OBSERVED AS THE DEVICE HAD BEEN PROGRAMMED TO A LOWER RATE LIMIT (LRL) OF 80PPM BUT AN INTRINSIC RATE OF 55BPM WAS NOTED. THE DEVICE WAS EXPLANTED AND RETURNED FOR TESTING. 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 81 YR Required Intervention 6949| N119| 0181| V-343