BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATUS DISPOSABLE DISC ELECTRODES

    MDR report key: 4996120 · Received August 12, 2015

    Report

    Report Number
    3010611950-2015-00011
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 14, 2015
    Manufacturer
    NATUS NEUROLOGY, INCORPORTAED
    Product Code
    GXY
    PMA / PMN Number
    K850108
    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. THE ELECTRODES DESCRIBED ARE MANUFACTURED FOR NATUS NEUROLOGY INC. BY A CONTRACT MANUFACTURER. THE ELECTRODES ARE SUPPLIED TO NATUS BY A CONTRACT MANUFACTURER. THE CONTRACT MANUFACTURER REVIEWED THE MANUFACTURING AND TEST RECORDS FOR THE LOT OF ELECTRODES IDENTIFIED AND FOUND THE MANUFACTURING PARAMETERS WERE ALL WITHIN SPECIFICATION. A SEPARATE MDR HAS BEEN CREATED AND SUBMITTED FOR THE EQUIPMENT USED, VIKING SELECT EMG SYSTEM P/N 982A0365 S/N (B)(4) (REF MDR 3010611950-2015-00016). 6) 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 POSTIERIOR LUMBAR INTERBODY FUSION PROCEDURE USING NATUS DISPOSABLE ELECTRODES PN 019-409000, 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
    531950 NATUS DISPOSABLE DISC ELECTRODES ELECTROMYGRAPH GXY NATUS NEUROLOGY, INCORPORTAED 019-409000 509329

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other