BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIKING SELECT

    MDR report key: 4996032 · Received August 12, 2015

    Report

    Report Number
    3010611950-2015-00013
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 14, 2015
    Manufacturer
    NATUS NEUROLOGY, INCORPORATED
    Product Code
    IKN
    PMA / PMN Number
    K890495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REGISTERED INTERNALLY AS A COMPLAINT (B)(4) FOR FURTHER INVESTIGATION BY MANUFACTURER. COMPLAINANT DID NOT SUPPLY SPECIFIC DETAILS REGARDING ALL OF PATIENT ATTRIBUTES. (PATIENT AGE AT TIME OF EVENT) AND (PATIENT WEIGHT) SET EQUAL TO "0" (ZERO) IN ORDER TO PROVIDE DATA ENTRY REQUIRED BY ESUBMITTER SOFTWARE. DEVICE EVALUATED BY MANUFACTURER: COMPLAINANT EVALUATED THE VIKING SELECT SYSTEM ON SITE, CHECKED THE SYSTEM OUTPUTS, EVALUATED SEVERAL ITEMS, AND CONCLUDED THE VIKING SELECT SYSTEM IS NOT THE CAUSE OF THE BURNS. A SEPARATE MDR HAS BEEN CREATED AND SUBMITTED FOR THE ELECTRODES USED, P/N 019-409000, L/N 509329 (REF MDR 3010611950-2015-00008). ELECTRO-CAUTERY EQUIPMENT WAS IN USE BY THE COMPLAINANT AT THE SAME TIME AS THE NATUS DEVICE IN QUESTION. THERE ARE KNOWN RISKS ASSOCIATED WITH SUCH DEVICE TO DEVICE COMBINATIONS WHERE ELECTRODES CAN INTERCEPT STRAY RADIO FREQUENCY ENERGY AND RESULT IN THERMAL HEATING. NATUS SAFETY INFORMATION SUPPLIED TO END USERS STATES SUCH INTERACTIONS EXIST AND WARNS END USERS THAT ELECTRODE DISCONNECTION MAY BE NEEDED TO AVOID SUCH INTERACTIONS (REF NATUS SAFETY REFERENCE GUIDE, LABEL #269-594705).

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE USING NATUS VIKING SELECT EMG SYSTEM P/N 982A0403, THE CUSTOMER HAS REPORTED BURNS TO THE PATIENT AT THE ELECTRODE SITE WHILE PERFORMING EMG STIMULATION AND MONITORING. THE BURNS OCCURRED WHEN USING MONOPOLAR ELECTROCAUTERY EQUIPMENT (NOT A NATUS DEVICE) FOR THE SURGICAL INCISIONS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531516 VIKING SELECT ELECTROMYGRAPH IKN NATUS NEUROLOGY, INCORPORATED 982A0403

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other