BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE DEVICE E110/ WAS IMPLANTED

    MDR report key: 1253990 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40842
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 23, 2008
    Report Date
    January 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P960040/S155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    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. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT 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

    IT WAS REPORTED THAT THIS DEVICE WAS LATER EXPLANTED AND REPLACED FOR REPORTED NORMAL BATTERY DEPLETION SEVERAL YEARS LATER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE DEVICE E110/ WAS IMPLANTED IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION E110 000099

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| O THE DEVICE 0154/356381 WAS IMPLANTED 18-JUL-2002| THE DEVICE E110/ WAS IMPLANTED| THE DEVICE 4472/303838 WAS IMPLANTED 18-JUL-2002