BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIKING II

    MDR report key: 20703 · Received March 10, 1995

    Report

    Report Number
    20703
    Event Type
    Injury
    Date Received
    March 10, 1995
    Date of Event
    January 12, 1995
    Report Date
    March 8, 1995
    Manufacturer
    NICOLET BIOMEDICAL, INC.
    Product Code
    GWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EVOKE POTENTIAL MACHINE DID NOT WORK PROPERLY DURING SURGICAL REMOVAL OF ACOUSTIC NEUROMA. EQUIPMENT HAD AN INTERMITTENT SENSITIVITY PROBLEM THAT REQUIRED MFR REPLACEMENT OF A TM101 MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIKING II EVOKE POTENTIAL MACHINE GWJ NICOLET BIOMEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention