BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2060146 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05828
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION BECAME AVAILABLE THAT THIS DEVICE WAS EXPLANTED AS A RESULT OF THE CLINICAL OBSERVATIONS. THE DEVICE WILL BE RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC¿S POST MARKET QUALITY ASSURANCE LABORATORY CONFIRMED THAT THE DEVICE WAS OPERATING IN FALLBACK MODE. DETAILED ANALYSIS FOUND THAT DEVICE DIAGNOSTICS BUILT INTO THE DEVICE DETECTED UNEXPECTED CHANGES IN CERTAIN LOCATIONS OF DEVICE MEMORY. A DESIGNED PRECAUTIONARY RESPONSE BY THE DEVICE RESULTED IN A CHANGE TO A WELL-DEFINED "SAFE" DEFAULT MODE WHICH OPERATES AS A SINGLE-ZONE ICD WITH LIMITED PROGRAMMABILITY AND SHOCKING CAPABILITY. THE CAUSE OF THE MALFUNCTION WAS CONCLUDED TO BE A RESULT OF SOFTWARE CORRUPTION INDUCED BY RADIATION THERAPY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE INTERROGATION WOULD NOT SHOW DAILY MEASUREMENTS FOLLOWING PATIENT RADIATION SESSIONS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED A MEMORY ANALYSIS BE PERFORMED. THIS ANALYSIS WAS SENT IN FOR ANALYSIS AND IT REVEALED THAT THE DEVICE HAS PERFORMED SEVERAL SYSTEM RESETS WHICH WERE MOST LIKELY DUE TO DETECTED AND CORRECTED MEMORY ERRORS CAUSED BY RADIATION EXPOSURE. ADDITIONALLY FAULTS WERE DETECTED IN BOTH THE INTERVAL DATA HISTORY AND EGRAM DATA HISTORY - THESE FAULTS ARE CONSISTENT WITH MEMORY CORRUPTION DUE TO RADIATION EXPOSURE. SYSTEM ACTIVE PROCESS INDICATES THAT A BATTERY AND SHOCK IMPEDANCE MEASUREMENT ARE ACTIVE. THE SHOCK IMPEDANCE VALUE IS INDICATIVE OF A CONDITION WHICH RENDERS THE DEVICE UNABLE TO PERFORM MANUAL OR DAILY MEASUREMENTS AND PREVENTS TACHY THERAPY. IT IS RECOMMENDED THAT THE DEVICE BE REPLACED AS THERAPY CANNOT BE GUARANTEED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR T167| 5076| 0185| 1853| MISMATCH