BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECA PREMIERE 4ME

    MDR report key: 85789 · Received April 19, 1997

    Report

    Report Number
    85789
    Event Type
    Injury
    Date Received
    April 19, 1997
    Date of Event
    February 4, 1997
    Report Date
    April 17, 1997
    Manufacturer
    MEDELEC LTD.
    Product Code
    IKN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR POST SPINAL INSTRUMENT AND FUSION T2-L5 WITH CELL SAVER AND EVOKED POTENTIAL MONITORING. EVOKED POTENTIAL MONITORING CHANGED FROM PRESENCE OF SIGNAL TO AN UNDETECTABLE SIGNAL DUE TO "NOISE" OF UNEXPLAINED ORIGIN. WHEN NOISE CLEARED, UNEXPECTED EP SIGNAL NOT PRESENT. VERIFIED LOSS OF SIGNAL WITH ANOTHER DIFFERENT UNIT. PROCEDURE ABORTED. PT RESULT IS PARAPLEGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECA PREMIERE 4ME 4 CHANNEL EMG, NCV, & EP IKN MEDELEC LTD. PREMIERE 4ME NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Disability