BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2911732 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00606
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    October 22, 2012
    Report Date
    December 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF DEVICE MEMORY REVEALED THE IMPEDANCE MEASUREMENT HAD A VALUE OF 16,832 OHMS, HOWEVER, THIS WAS FOUND TO BE DUE TO A SINGLE BIT MEMORY ERROR. THE TRUE VALUE OF THE IMPEDANCE MEASUREMENT SHOULD BE 448 OHMS. NO RESETS OR OTHER MEMORY ERRORS WERE DETECTED. THE OBSERVED SINGLE BIT MEMORY ERROR IS RELATED TO DIAGNOSTICS AND DOES NOT EFFECT THERAPY AVAILABILITY. 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) DETECTED A HIGH OUT OF RANGE RIGHT VENTRICULAR PACING IMPEDANCE MEASUREMENT, HOWEVER, WAS NOT LISTED ON THE PREVIOUS REMOTE INTERROGATION REPORT. A SAVE TO DISK AND MEMORY DUMP WERE PERFORMED AND WERE FORWARDED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16766 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 4542| T125| N119| 4469| 0184