BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1871211 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18719
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. ANALYSIS DETERMINED THAT THIS DEVICE ENTERED SAFETY CORE, AS DESIGNED, AFTER EXPERIENCING THREE FAULTS DUE TO A MEMORY ERROR, IN A SHORT AMOUNT OF TIME. THE BEEP TONES NOTED IN THE FIELD WERE A RESULT OF THE DEVICE OPERATING IN SAFETY CORE. ANALYSIS FOUND THE DEVICE ENTERED SAFETY CORE DUE TO MEMORY CORRUPTION, MOST LIKELY AS A RESULT OF RADIATION EXPOSURE, WHICH COULD NOT BE CORRECTED BY THE DEVICE'S MEMORY ERROR CORRECTION ROUTINE. WHEN IN SAFETY CORE, THE DEVICE EMITS TONES AND BI-VENTRICULAR OUTPUTS INCREASE TO 5V @ 1 MSEC. THOSE ARE THE MOST LIKELY CAUSES FOR THE REPORTED CLINICAL OBSERVATIONS. THE DEVICE WAS REMOVED FROM SAFETY CORE STATUS BY CORRECTING THE MEMORY ERROR AND A COMPREHENSIVE SERIES OF AUTOMATED DIAGNOSTIC TESTS WERE CONDUCTED TO VERIFY THE PERFORMANCE OF DEVICE MEMORY, PACING, DEFIBRILLATION AND RECORDING FUNCTIONS. THE DEVICE PERFORMED AS EXPECTED FOR EACH TEST. OF NOTE, COGNIS DEVICES HAVE BEEN SPECIFICALLY DESIGNED SUCH THAT IF THREE SYSTEM RESETS OCCUR WITHIN A TIMEFRAME OF APPROXIMATELY 48 HOURS, THE DEVICE WILL ENTER SAFETY CORE. MEMORY ERRORS SUCH AS THAT IDENTIFIED WITHIN THIS DEVICE MAY BE CAUSED BY EXPOSURE TO RADIATION; HOWEVER, THE ROOT CAUSE OF THE SPECIFIC ERROR IN THIS DEVICE COULD NOT BE DEFINITIVELY CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR HEARD BEEPING TONES COMING FROM HIS DEVICE STARTING IN (B)(6), 2010. UPON INTERROGATION OF THE DEVICE IN (B)(6), 2010 A RED WARNING SCREEN WAS NOTED. THE DEVICE WAS IN SAFETY MODE WITH THE NOTIFACTION THAT 'DEVICE FUNCTION IS LIMITED TO V-TACHY 1 ZONE AND VVI PACING'. THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R