BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2053319 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03889
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    November 30, 2010
    Report Date
    May 31, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION AND WAS RETURNED FOR TESTING. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED ANALYSIS FOUND THAT BUILT-IN DEVICE SELF-DIAGNOSTICS DETECTED UNEXPECTED CHANGES IN CERTAIN LOCATIONS OF DEVICE MEMORY THAT CONTROL EPISODE DATA. IN RESPONSE TO THIS, THE DEVICE INITIATED A WARM RESET IN AN ATTEMPT TO CORRECT THIS PROBLEM. THE PROCESSING PERFORMED DURING THIS WARM RESET WAS APPROPRIATELY EXECUTED; HOWEVER, A FIRMWARE DESIGN ISSUE PREVENTED THE DEVICE FROM INITIALIZING SPECIFIC DATA VARIABLES USED TO CONTROL EPISODE DATA. THIS FINDING WOULD NOT LIKELY HAVE IMPACTED THIS DEVICE'S ABILITY TO SENSE AND DELIVER THERAPY GIVEN THIS PATIENT'S EPISODE HISTORY. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE'S STORED MEMORY WAS REVIEWED AND EVALUATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. DETAILED ANALYSIS FOUND THAT BUILT-IN DEVICE SELF-DIAGNOSTICS DETECTED UNEXPECTED CHANGES IN CERTAIN LOCATIONS OF DEVICE MEMORY THAT CONTROLS EPISODE DATA. IN RESPONSE TO THIS, THE DEVICE INITIATED A WARM RESET IN AN ATTEMPT TO CORRECT THIS PROBLEM. THE PROCESSING PERFORMED DURING THIS WARM RESET WAS APPROPRIATELY EXECUTED, HOWEVER, A FIRMWARE DESIGN ISSUE PREVENTED THE DEVICE FROM INITIALIZING SPECIFIC DATA VARIABLES USED TO CONTROL EPISODE DATA. BOSTON SCIENTIFIC SOFTWARE ENGINEERS RECOMMENDED REPROGRAMMING THE EPISODE DATA STORAGE SETTINGS TO PREVENT THE INTERVAL INFORMATION MISMATCH FROM CAUSING FUTURE WARM RE-SETS. THE REPROGRAMMING WAS CONDUCTED AND DEVICE DATA WAS SUBMITTED FOR REVIEW; THE SOFTWARE ENGINEERS CONFIRMED THAT THE PROGRAMMING CHANGES HAD CORRECTED THE ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ASSOCIATED WITH A REMOTE MONITORING REPORT THAT INDICATED NEGATIVE VALUES FOR COUNTERS SINCE THE LAST REMOTE FOLLOW-UP FOR THE NUMBER OF ATR MODE SWITCHES, PVC AND RATE SMOOTHING EVENTS. IT ALSO WAS OBSERVED THAT THE REPORTED DEVICE TOTALS FOR SOME EVENT TYPES WERE LIKELY INCORRECT, AS THE LABELED NUMBER OF ATR EPISODES EXCEEDED THE REPORTED DEVICE TOTAL. THERE WAS NO EVIDENCE OR HISTORY OF DEVICE EXPOSURE TO RADIATION THERAPIES. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED CONDUCTING A DEVICE CHECK AND DOWNLOADING THE STORED DATA FOR AN ENGINEERING ANALYSIS. THE PATIENT WAS SEEN CLINICALLY, AND DEVICE INTERROGATION SHOWED NO OPERATIONAL ANOMALIES. A COPY OF DEVICE DATA WAS SUBMITTED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T127

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 0155| T127| 4016