BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN

    MDR report key: 37904 · Received August 27, 1996

    Report

    Report Number
    37904
    Event Type
    Injury
    Date Received
    August 27, 1996
    Date of Event
    July 22, 1996
    Report Date
    August 27, 1996
    Manufacturer
    MAGSTIM CO LTD (DIST) SMITH & NEPHEW RICHARDS INC
    Product Code
    JXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PARATIODECTOMY. NEUROSURGEON MONITORING DEVICE. DEVICE WAS PLACED ON PT. SURGEONS WERE CONCERNED THAT DEVICE WAS NOT WORKING WELL. DISCONTINUED USE OF MACHINE AND WENT TO A DISPOSABLE NERVE STIMULATOR. MONITOR WAS REMOVED FROM SERVICE AND EVALUATED BY BIOMED DEPARTMENT. BIOMED REPORTED THAT ONE OF THE CHANNELS IN THE CABLE WAS INCONSISTENT AND IF LEAD HAD BEEN BAD THE MONITORING COULD BE INACCURATE. HOWEVER, LEADS WERE FUNCTIONING PROPERLY. MONITOR SENT TO ECRI FOR INDEPENDENT REVIEW. PT DID EXPERIENCE A FACIAL PARALYSIS AS A RESULT OF THIS SURGERY BECAUSE OF THE SUPERIOR BRANCH OF FACIAL NERVE WAS CUT. THIS MACHINE IS USED AS AN AIDE IN SURGERY. 20% SURGEON'S KNOWLEDGE OF ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSIGN NERVE MONITOR JXE MAGSTIM CO LTD (DIST) SMITH & NEPHEW RICHARDS INC 100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention