BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPLORER 360

    MDR report key: 2173078 · Received July 8, 2011

    Report

    Report Number
    2173078
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 8, 2011
    Manufacturer
    STERILMED, INC
    Product Code
    NLH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AFTER PLACING THE CATHETER IN RIGHT ATRIUM, NOTICED NOISE AND UNABLE TO PACE ELECTRICALLY. THE DEVICE IS A REPROCESSED PRODUCT BY STERILMED, INC. AND MANUFACTURED BY EP TECHNOLOGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPLORER 360 CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STERILMED, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR