BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OJEMAN CORTICAL STIMULATOR

    MDR report key: 2413169 · Received January 10, 2012

    Report

    Report Number
    1222895-2011-00039
    Event Type
    Injury
    Date Received
    January 10, 2012
    Report Date
    January 10, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    GYC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DURING SURGERY, THE OJEMAN CORTICAL STIMULATOR (OCS2) STOPPED WORKING. SURGERY HAD TO BE STOPPED. A PART OF THE TUMOR COULD NOT BE "DELITED." ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1