BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 3211691 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08285
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    July 31, 2009
    Report Date
    February 14, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, 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. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN 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, SEVERAL YEARS AGO, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED NOISE ON ALL THREE CHANNELS. THE PATIENT HAD SOME NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EVENTS DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT WAS CONTACTED REGARDING THIS ISSUE AND DISCUSSED THAT THIS NOISE APPEARS TO BE EXTERNAL NOISE. THE FIELD REPRESENTATIVE ATTEMPTED TO RECREATE THE NOISE; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. TS DISCUSSED THAT SINCE THIS WAS AN ISOLATED EVENT AND ALL OF THE MEASUREMENTS ARE WITHIN NORMAL LIMITS, THEN THEY MAY CONSIDER MONITORING THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS RELATED TO THIS EPISODE OF NOISE. A FEW WEEKS AGO, THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. AGAIN, THERE WAS NOISE PRESENT WHICH APPEARED TO BE ELECTROMAGNETIC INTERFERENCE (EMI). ALL MEASUREMENTS REMAIN WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE EVENT IN THE LOGBOOK DID NOT OCCUR AT THE SAME TIME AS THE PATIENT'S SYNCOPAL EPISODE; THEREFORE, THEY CANNOT CONCLUDE ANYTHING ABOUT THE NOISE AT THIS POINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NO INTERVENTION HAS BEEN PERFORMED AND NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308623 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening 4470| 1290| 0185| 4457| T180