BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1861017 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15214
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A TS REPRESENTATIVE REVIEWED THE DATA AND CONFIRMED THAT THE NOISE OBSERVED IN THE ELECTROCARDIOGRAMS WAS FROM A STRONG EMI SOURCE, INDICATED BY IT AFFECTING BOTH CHANNELS AND HAVING BOTH A CONSTANT AND VERY HIGH FREQUENCY SIGNAL. FURTHER ANALYSIS OF THE DATA DID NOT FIND ANY CHANGES IN THE TACHY MODE OF THE DEVICE BUT DID CONFIRM THAT THE DEVICE WAS IN MONITOR ONLY WHEN THESE EPISODES WERE RECORDED. IT IS POSSIBLE THAT THE EMI WAS SO STRONG THAT IT MAY HAVE CLOSED THE REED SWITCH OF THE DEVICE OR THAT A MAGNET HAD BEEN APPLIED OVER THE DEVICE. BOTH SCENARIOS WOULD HAVE INHIBITED TACHY THERAPY. AT THIS TIME, THIS ICD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, IT WAS NOTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED FIVE EPISODES OF VENTRICULAR FIBRILLATION (VF) BACK IN (B)(6) 2009, DUE TO NOISE CAUSED BY EMI. IT WAS ALSO NOTED THAT THE STATEMENT "NO THERAPY PROGRAMMED" WAS VISIBLE IN THESE EPISODES. THE DEVICE'S TACHY MODE WAS CHECKED AND STILL INDICATED THAT IT WAS PROGRAMMED TO MONITOR + THERAPY. ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. ATTEMPTS TO RECREATE THE NOISE WITH PATIENT MOVEMENTS WERE UNSUCCESSFUL. AN X-RAY WAS ALSO PERFORMED AND NO ANOMALIES WERE NOTED. THE PATIENT DOES NOT REMEMBER ANYTHING THAT HAPPENED THAT DAY TO HAVE AFFECTED THE DEVICE NOR DID THEY REMEMBER EXPERIENCING ANY SYMPTOMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A SAVE TO DISK WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1