BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3050111 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04426
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WILL CONTINUE TO BE MONITORED FOR FURTHER LOW SHOCK IMPEDANCE MEASUREMENTS. 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) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A SHOCK IMPEDANCE MEASUREMENT OF 0 OHMS. TROUBLESHOOTING REVEALED THE PATIENT WAS UNDERGOING AN ELECTRICAL STIMULATION TREATMENT AT THE TIME THE DAILY MEASUREMENT WAS TAKEN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED ELECTROMAGNETIC INTERFERENCE COULD HAVE CAUSED THE MEASUREMENT OF 0 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154056 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 4543| N119| 4549| 4135| 0184| 0181