BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OJEMAN CORTICAL STIMULATOR

    MDR report key: 8285283 · Received January 29, 2019

    Report

    Report Number
    1222895-2019-00001
    Event Type
    Injury
    Date Received
    January 29, 2019
    Report Date
    January 4, 2019
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    GYC
    PMA / PMN Number
    K924226
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION OF THE RETURNED OCS2 OJEMAN STIMULATOR AND PROBE FOUND NO VISIBLE, PHYSICAL DAMAGE OBSERVED. INSPECTION OF THE INNER ASSEMBLIES FOUND NO EVIDENT PHYSICAL DAMAGED OR BURNT COMPONENTS. FUNCTIONAL TEST: THE UNIT WAS POWERED "ON" AND THE LOW CURRENT ADJUSTED TO 1.0MA. THE OUTPUT CURRENT SCREEN DISPLAYED 0.64MA. (OUT OF SPECIFICATION). THE DHR REVIEW VERIFIED ALL THE FUNCTIONALITY TESTS WERE CARRIED OUT ACCORDINGLY AND ALL RESULTS OF THE TESTS WERE RECORDED AS WITHIN SPECIFICATION PRIOR TO THE OCS2 BEEN RELEASED. SERVICE HISTORY: NONE. THE REPORTED COMPLAINT WAS CONFIRMED. THE UNDERLYING ROOT CAUSE FOR THE REPORTED EVENT WAS UNDETERMINED. (B)(4).

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THERE WAS AN ISSUE WITH THE OCS2 OJEMAN CORTICAL STIMULATOR ON AN UNSPECIFIED DATE. COMPLEMENTARY INFORMATION WAS RECEIVED ON 15JAN2019 INDICATING THAT THE PRODUCT WAS IN CONTACT WITH THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS INJURED (NEGATIVE MAPPING AT 3MA ON PRIMARY MOTOR CORTEX PROCEDURE ABANDONED). THE EVENT DID NOT INCREASE SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80633 OJEMAN CORTICAL STIMULATOR N/A GYC INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1