BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2161534 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-11735
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE STATUS OF THE DEVICE IS UNKNOWN. IT HAS NOT BEEN RETURNED TO BSC CRM FOR ANALYSIS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT LOSS OF CAPTURE WAS OBSERVED DURING A RADIO FREQUENCY (RF) VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WHILE THIS DEVICE WAS PROGRAMMED TO CAUTERY MODE. VENTRICULAR PACE MARKERS AND PACING SPIKES WERE OBSERVED ON THE SURFACE ELECTROGRAM (EGM) BUT THERE WAS NO CAPTURE. THE LOSS OF CAPTURE PERSISTED FOLLOWING DEVICE REPROGRAMMING TO MAXIMUM OUTPUTS. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONSULTED FOR TROUBLESHOOTING ADVICE. THERE WAS NO PATIENT INJURY REPORTED. THREE DAYS AFTER THE ABLATION PROCEDURE, DEFIBRILLATION THRESHOLD TESTING WAS COMPLETED AND THE DEVICE WAS LEFT IMPLANTED. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THAT THE PATIENT PASSED AWAY APPROXIMATELY SIX WEEKS AFTER THE ABLATION PROCEDURE. THERE WERE NO ADDITIONAL ALLEGATIONS AGAINST DEVICE FUNCTION OR PERFORMANCE AND NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME.

    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 77 YR 4469| 4592| 0180| 4470| N119| S602