BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLTEK EP16

    MDR report key: 454708 · Received April 10, 2003

    Report

    Report Number
    9612330-2003-00002
    Event Type
    Malfunction
    Date Received
    April 10, 2003
    Date of Event
    March 13, 2003
    Manufacturer
    EXCEL TECH LTD.
    Product Code
    GWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE STOPPED FUNCTIONING DURING LUMBAR FUSION SURGERY. THE SURGEON WENT WITHOUT EVOKED POTENTIAL DEVICE FOR ONE HOUR WHILE A REPLACEMENT EVOKED POTENTIAL MACHINE WAS LOCATED. ACCORDING TO THE EVOKED POTENTIAL TECHNOLOGIST, NO PARALYSIS OR SENSORY LOSS OCCURRED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XLTEK EP16 EVOKED RESPONSE ELECTRICAL STIMULATOR GWF EXCEL TECH LTD. EP16 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other