BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2161620 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-10052
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    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, DETAILED TESTING OF THE INTERNAL CIRCUITRY WAS UNDERTAKEN. INTERROGATION FOUND THE DEVICE IN FALL BACK MODE AS THE RESULT OF EXPOSURE TO RADIATION. A REVIEW OF THE DEVICE MEMORY NOTED FOUR FAULTS AND 764 MEMORY CORRECTIONS. MANUAL ELECTRICAL MEASUREMENTS NOTED NORMAL FALLBACK MODE SENSING, PACEMAKER, AND DEFIBRILLATION FUNCTIONS. CODE WAS RELOADED INTO THE DEVICE MEMORY AND STARTED. THE DEVICE WAS THEN FULLY PROGRAMMABLE. THE DEVICE PASSED ALL ELECTRICAL TESTING. NO FURTHER ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE HAD RADIATION EXPOSURE LEADING TO THE MEMORY CORRUPTION FAULT CODE THAT OCCURRED. THERE WAS NO REPORT OF ADVERSE PATIENT SYMPTOM ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention T165| 1688T| 0184| MISMATCH