BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADWELL ES-16

    MDR report key: 1952249 · Received December 28, 2010

    Report

    Report Number
    1952249
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 15, 2010
    Manufacturer
    IMPULSE MONITORING, INC.
    Product Code
    IKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT TAKEN TO OPERATING ROOM, INTUBATED, AND POSITIONED FOR MICRO LUMBAR SURGERY WITH GRAFT INSTRUMENTATION, TRANSFORAMINAL LUMBAR INTERBODY FUSION L3-S1 WITH PEDICLE SCREWS AND NEURO MONITORING. NEURO MONITORING DEVICE ELECTRODES WERE CONNECTED TO PATIENT AND WAS NOTED TO NOT FUNCTION CORRECTLY. NO SURGICAL INCISIONS WERE MADE. BASE UNIT (B)(4) WAS TESTED PRIOR TO PATIENT BEING BROUGHT INTO ROOM BUT PER COMPANY REP, THERE IS NO WAY TO TEST THE NEURO MONITORING BOX (ELECTRODE BOX) PRIOR TO CONNECTING TO PATIENT. REPORTED TO COMPANY REP AND COMPANY ON SAME DAY OF EVENT. COMPANY REP RETURNED EQUIPMENT TO COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADWELL ES-16 NEURO MONITORING BOX IKN IMPULSE MONITORING, INC. CADWELL ES-16
    2 CADWELL ES-16 NEURO MONITORING BOX IKN IMPULSE MONITORING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other