BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OJEMAN CORTICAL STIMULATOR

    MDR report key: 2012160 · Received February 1, 2011

    Report

    Report Number
    1222895-2011-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 1, 2011
    Manufacturer
    INTEGRA RADIONICS, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OJEMAN CORTICAL STIMULATOR (OCS2) FAILED. THE UNIT WAS NON-RESPONSIVE. THE SCREEN WAS READING 1 WHEN TURNED ON. ALTHOUGH THE BATTERY LEVEL WAS GOOD SINCE THE GREEN INDICATOR LIGHT WAS ON, THERE WAS NO RESPONSE FROM THE UNIT WHEN USING THE CHECK CURRENT. THERE WAS NO OUTPUT. THERE WAS PT CONTACT, BUT NO PT INJURY REPORTED. THE PROCEDURE COULD NOT BE PERFORMED. THE PHYSICIAN WANTED TO DO THIS BRAIN MAPPING PROCEDURE FOR THE PT PRIOR TO THE SCHEDULED SURGERY ON FRIDAY (B)(6) 2011. ANOTHER UNIT FROM A DIFFERENT FACILITY WAS SENT TO THE CUSTOMER AND THE PHYSICIAN WAS ABLE TO DO THE BRAIN MAPPING ON (B)(6) 2010 AND ON THE DAY OF THE SURGERY ON (B)(6) 2011 WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OJEMAN CORTICAL STIMULATOR NA ETN INTEGRA RADIONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1