BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1043297 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33350
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 11, 2008
    Report Date
    November 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TO THIS DATE, ALL PRODUCTS REMAIN IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO OUR COMPANY, THE EVENT WILL BE REOPENED AND UPDATED AS NECESSARY. THE DEVICE WAS RETURNED APPROXIMATELY FIVE YEARS LATER WITH NO PAPERWORK. 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. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE 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. THE HIGH RATE PACING ISSUE WAS LIKELY CAUSED BY INTERACTIONS BETWEEN THE DEVICE AND HOSPITAL MONITORING OR DIAGNOSTIC EQUIPMENT WHEN THE MINUTE VENTILATION FEATURE IS PROGRAMMED ON.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS BSC SALES REPRESENTATIVE (SR) CALLED TECHNICAL SERVICES (TS) REPORTING THIS PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR A SYNCOPAL EVENT. WHILE THE PATIENT WAS IN THE HOSPITAL, THEIR HEART RATE INCREASED TO THE MAXIMUM SENSOR RATE DUE TO A SURFACE TELEMETRY INTERACTION. TS EXPLAINED THAT THIS COULD BE AN INTERACTION OF EQUIPMENT IN THE HOSPITAL WITH MINUTE VENTILATION PACING AND NOTED THIS WAS UNRELATED TO THE SYNCOPE. THE SR NOTED THAT THE PATIENT'S THRESHOLD MEASUREMENTS AND R-WAVES WERE GOOD AND THE PATIENT IS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR DXY GUIDANT CRM CLONMEL IRELAND 1190 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1228 MO Life Threatening| R THE DEVICE 4136/244976 WAS IMPLANTED 03-DEC-2007| THE DEVICE 4136/244976 WAS IMPLANTED (B)(6) 2007