BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3211633 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07650
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    September 6, 2011
    Report Date
    May 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. ON VISUAL INSPECTION, SEVERAL ELECTROCAUTERY MARKS WERE NOTED ON THE PACEMAKER CASE AND ON THE HEADER. THE DEVICE HAD NO TELEMETRY TRANSMISSIONS AND WAS NOT ABLE TO COMMUNICATE WITH SOME OF THE EVALUATION EQUIPMENT. INITIALLY THE PACEMAKER HAD PACING OUTPUTS AT THE RESET-VVI PARAMETERS, BUT THE PACING AMPLITUDE KEPT LOWERING UNTIL THERE WAS NO PACING OUTPUT. THE PACING OUTPUT STOPPED BEFORE THE SENSITIVITY MEASUREMENTS COULD BE TAKEN. THE DEVICE CASE WAS REMOVED AND A PORTION OF THE SENSITIVITY FILTER CIRCUIT CAME LOOSE AND FELL OFF THE INTERNAL CIRCUITRY DURING VISUAL INSPECTION; THIS WAS DUE TO AN OPEN SOLDER JOINT. THIS FINDING COULD CAUSE NOISY SIGNALS AND OVERSENSING AS NOTED IN THE FIELD OBSERVATIONS. THE CAUSE OF THE NO OUTPUT AND NO TELEMETRY WAS ISOLATED TO THE DIGITAL POWER SUPPLY WHICH WAS FOUND TO BE INTERMITTENT WHILE FLEXING THE INTERNAL CIRCUITRY, AND IT WAS DETERMINED THAT THIS WAS INDUCED DAMAGE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND OVERSENSING WHICH LEAD TO FALSE ATRIAL TACHY RESPONSE (ATR) EPISODES BEING DETECTED. THE DEVICE WAS PROGRAMMED AT DDD 40, AND THE ATRIAL LEAD HAD BEEN PROGRAMMED TO UNIPOLAR SENSING. THE PATIENT WAS NEW TO THE CLINIC SO THE HISTORICAL TRENDS OF THE LEAD AND INDICATION FOR THE PROGRAMMING AND SENSING CONFIGURATION WAS NOT KNOWN. THE HEALTH CARE PROFESSIONAL (HCP) CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND PROGRAMMING AND TROUBLESHOOTING OPTIONS WERE DISCUSSED. THE PATIENT HAD REPORTED FEELING LIGHTHEADED AND DIZZY AT TIMES, AND RATES BELOW 40 WERE OCCASIONALLY NOTED DUE TO THE MODIFIED ATRIAL TIMING OF THE EVENTS. ADDITIONAL INFORMATION WAS RECEIVED APPROXIMATELY ONE AND A HALF YEARS AFTER THE PREVIOUS OBSERVATION THAT THE PACEMAKER HAD BEEN EXPLANTED FOR AN UNKNOWN REASON. THERE WERE NO FURTHER ALLEGATIONS OR OBSERVATIONS FROM THE FIELD RELATED TO THE PERFORMANCE OR FUNCTIONALITY OF THIS SYSTEM. THE GENERATOR WAS RETURNED TO BOSTON SCIENTIFIC AND UPON INITIAL EVALUATION THERE APPEARED TO BE A PRODUCT PERFORMANCE ISSUE, AND ADDITIONAL TESTING WAS GOING TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310394 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR 4469| 4470| 1298| 4471