BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2914327 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00804
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    March 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE DEVICE HAD NO TELEMETRY UPON RETURN. THE DEVICE CASE WAS OPENED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGH CURRENT CONDITION WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT TO AN ANOMALY IN AN OXIDE LAYER WITHIN AN INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTED IN REPORTED CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED THREE WEEKS LATER. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL LABORATORY ANALYSIS WAS PERFORMED AND NOTED THAT THE OBSERVED HIGH CURRENT OBSERVED ON THE INTEGRATED CIRCUIT (IC) WAS THE RESULT OF ELECTRICAL OVERSTRESS DAMAGE THAT WAS INDUCED BY THE HIGH ENERGY RESCUE SHOCK THAT WAS USED ON THE PATIENT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD), THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED WITH A PROGRAMMER AS TELEMETRY COULD NOT BE ESTABLISHED. IT WAS REPORTED THAT DURING THE IMPLANT OF THE LVAD, THE PATIENT REQUIRED A 200 JOULE EXTERNAL SHOCK TO CONVERT A RHYTHM. THE PATIENT WAS PACEMAKER DEPENDENT AND WAS RECEIVING PACING FROM A TEMPORARY PACEMAKER. DURING TROUBLESHOOTING, THE DEVICE DID NOT EMIT BEEPING TONES WITH MAGNET PLACEMENT. ADDITIONALLY, THE TEMPORARY PACEMAKER WAS TURNED DOWN AND NO PACING WAS OBSERVED FROM THE DEVICE. TS DISCUSSED THE POSSIBILITY OF THE DEVICE BEING AFFECTED BY THE EXTERNAL SHOCK AND DISCUSSED REPLACING THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21088 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 4047| N119| 4470| 0185