BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2193645 · Received July 22, 2011

    Report

    Report Number
    9710014-2011-00220
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    April 16, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE COMPLAINT HAS BEEN CLOSED OUT AS THERE IS NO INFORMATION ABOUT A POTENTIAL DATE FOR SURGERY THE COMPLAINT WILL BE REOPENED AS AND WHEN THE PATIENT UNDERGOES SURGERY AND THE DEVICE IS RECEIVED FOR INVESTIGATION. CURRENTLY AVAILABLE INFORMATION INDICATES A POSSIBLE PROBLEM WITH THE ACTIVE ELECTRODE. TO DETERMINE AN EXACT ROOT CAUSE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ACCORDING TO CURRENTLY AVAILABLE INFORMATION, DAMAGE TO THE ACTIVE ELECTRODE AS MIGHT BE CAUSED BY AN EXTERNAL MECHANICAL IMPACT APPEARS LIKELY. THIS DAMAGE HAS BEEN ALREADY PRESENT SINCE 2011. REPORTEDLY, THE RECIPIENT HAS BEEN A NON-USER FOR SEVERAL YEARS. A DEVICE INVESTIGATION IS NECESSARY TO DETERMINE A ROOT CAUSE. HOWEVER, NO DATE FOR REVISION SURGERY HAS BEEN STIPULATED YET.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN 2011 THAT THE USER HAS NO MORE HEARING SENSATION WITH THE DEVICE. IN SITU MEASUREMENTS FROM DECEMBER 2010 SHOWED A FUNCTIONAL DEVICE, TESTING FROM JUNE 2011 SHOWED ALL CHANNELS IN STATUS HIGH OR INVOLVED IN SHORT CIRCUITS. A CT SCAN FROM 2011 SHOWED THE ARRAY IN POSITION. AS PER ADDITIONAL INFORMATION FROM 2019, THE USER HADN'T BEEN USING HIS AUDIO PROCESSORS (BILATERAL IMPLANTED) FOR 6 YEARS SINCE THEY WERE LOST. DURING A PROCESSOR UPGRADE HANDOUT IN SITU MEASUREMENTS SHOWED ALL CHANNELS WITH HIGH IMPEDANCE. IN 2010 THE EXTERNAL AND INTERNAL PARTS WERE CHECKED AND WORKING, HOWEVER THE USAGE WAS JUST FOR 6 MONTHS. IN 2011 THE PATIENT HAD SUFFERED CONVULSIONS AND HIGH FEVER. NO TRAUMA HAS BEEN REPORTED. THERE ARE NO REPORTS ON FURTHER STEPS THAT THE CLINIC WILL TAKE, ALTHOUGH RE-IMPLANTATION HAS BEEN SUGGESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NO LONGER HAS NAY ACCESS TO SOUND. THE PATIENT HAD THE FIRST FITTING IN (B)(6) 2010 AND HAD GOOD RESPONSES TO SOUND IN THE LOW AND MIDDLE FREQUENCIES AFTER THE FIRST FITTING, DURING (B)(6) 2011, ACCORDING TO THE FATHER. THE PATIENT WAS UNABLE TO ATTEND FURTHER FITTING IN (B)(6) 2011, DUE TO ILLNESS (VOMITING AND HIGH TEMPERATURE). TESTING OF THE DEVICE ON (B)(6) 2011, SHOWED ONLY 1 ELECTRODE CHANNEL OK, THE REST OF THE ELECTRODE CHANNELS HAD EITHER HI IMPEDANCES OR SHORT CIRCUITS. THE GP IMPEDANCE WAS NOT DETERMINABLE. THERE IS NO REPORT OF AN ACCIDENT OR TRAUMA OCCURRING. THE PATIENT IS BILATERALLY IMPLANTED AND HAS A SIMILAR ISSUE WITH THE CONTRA-LATERAL SIDE, SEE MFR REPORT 9710014-2011-02219.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention