BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OJEMAN CORTICAL STIMULATOR

    MDR report key: 4905137 · Received July 8, 2015

    Report

    Report Number
    1222895-2015-00031
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    June 11, 2015
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    GYC
    PMA / PMN Number
    K924226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    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.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(4) 2015 . THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: THE COMPLAINT INCIDENT WAS DUPLICATED. THE OCS2 DHR WAS REQUESTED FROM THE MANUFACTURING FACILITY INTEGRA BILLERICA APPENDIX 1. THE DHR WAS REVIEWED FOR OCS2 OJEMAN CORTICAL STIMULATOR SERIAL NUMBER 1131. DATE OF MANUFACTURE: 2008 ¿DEC. NO NON-CONFORMANCE REPORTS WERE RAISED DURING THE MANUFACTURING PROCESS FOR THIS MONITOR. 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. RATE OF OCCURRENCE: DURING THE TIME PERIOD ¿JUN 2014 TO NOV 2015, THE QUANTITY OF COMPLAINTS (B)(4) OVER THE REVIEW PERIOD WITH THE KEY WORD IDENTIFIED IN THE COMPLAINT REVIEW CAN THEREFORE BE CALCULATED AS (B)(4). CONCLUSION: THE ROOT CAUSE OF THE COMPLAINT INCIDENT WAS VERIFIED AS LOOSE BATTERY CLIPS CAUSING AN INTERMITTENT POWER SUPPLY TO THE OCS2 MONITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT PRODUCING ENOUGH. THERE WAS NO PATIENT CONTACT, NO PATIENT PREPPED FOR SURGERY, NO PATIENT INJURY, AND NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444042 OJEMAN CORTICAL STIMULATOR NA GYC INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1