BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2910755 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15844
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THAT THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. 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 DURING AN ABLATION PROCEDURE FOR THIS PACEMAKER DEPENDENT PATIENT, PACING SPIKES WERE OBSERVED WITHOUT CORRESPONDING CAPTURE FOR AN UNSPECIFIED DURATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THIS WAS LIKELY THE RESULT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEFIB DETECT CIRCUIT. IT WAS REPORTED THAT UPON COMPLETION OF THE ABLATION PROCEDURE, APPROPRIATE PACING AND CAPTURE WAS OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18121 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR 4135| 4592| 0181| N119