BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2173201 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11049
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 13, 2011
    Report Date
    August 26, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CLINICIAN NOTED THE CHARGE TIME ON THE DEVICE WAS 15.6 SECONDS AND CONTACTED TECHNICAL SERVICE (TS) TO DISCUSS. AFTER TS STATED THAT THE CHARGE TIME WAS STILL WITHIN THE NORMAL LIMITS OF THE DEVICE, THE CLINICIAN STATED THAT THE PATIENT EXPERIENCES SYNCOPE WITH TACHYCARDIA ARRYTHMIAS. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE CONTACTED THE CLINIC AND WAS TOLD THAT THERE WAS NO CONCERN OVER DEVICE FUNCTIONALITY AND HAD BEEN OPERATING PER PROGRAMMED VALUES WHILE IMPLANTED IN THE PATIENT. THE DEVICE WAS EXPLANTED SEVEN DAYS LATER FOR NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS ABLE TO OBTAIN FURTHER INFORMATION FROM THE CLINIC THAT THEY WERE UNCERTAIN IF THE PATIENT EVER EXPERIENCED TRUE SYNCOPE. THE CLINIC NOTED THAT THE PATIENT HAD ALWAYS HAD PRE-SYNCOPE SYMPTOMS, SUCH AS DIZZINESS. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening 0158| 4470| T180| 1860