BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3053092 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04594
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    September 24, 2012
    Report Date
    March 20, 2013
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND NON-BSC RIGHT VENTRICULAR (RV) LEAD DISPLAYED GRADUALLY INCREASING, HOWEVER, WITHIN ACCEPTABLE LIMITS, SHOCK IMPEDANCE MEASUREMENTS. THE PHYSICIAN ELECTED TO PERFORM A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) AND DEFIBRILLATION THRESHOLD (DFT) TEST, RESULTING IN A WITHIN ACCEPTABLE LIMITS SHOCK IMPEDANCE MEASUREMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SHOCK IMPEDANCE MEASUREMENT WAS GREATER THAN 125 OHMS. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN HAS ELECTED TO CONTINUE TO MONITOR THE DEVICE SYSTEM. NO DEVICE ALLEGATIONS AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155941 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 4543| 1688T| 7122| (B)(4)| N119