BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 7984561 · Received October 19, 2018

    Report

    Report Number
    2124215-2018-18488
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    August 28, 2018
    Report Date
    September 21, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. THE STYLET TEST CONFIRMED BLOCKAGE AT TERMINAL CONNECTOR AREA OF LEAD DUE TO FOREIGN MATERIAL (FM). A VISUAL OF THE FM SHOWS THAT IT IS LIKELY AN AGGLOMERATE OF BLOOD/BODY FLUID AND POLYMER FROM THE LEAD/GUIDEWIRE INTERACTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT, IT WAS ATTEMPTED TO PASS GUIDEWIRE, IT WAS STARTED AT TERMINAL PIN, ATTEMPTING TO BACK LOAD/FRONT LOAD RIGHT AT TERMINAL PIN. NOT SURE IF IT WAS FLUSHED SOMETHING IN THEM. THE LEAD WAS NEVER IN THE PATIENT'S BODY. THE LEAD WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826101 ACUITY IMPLANTABLE LEAD LWP CPI - DEL CARIBE 4674

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 0292| 4674| 7741| E140| G148