BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 4859415 · Received June 16, 2015

    Report

    Report Number
    9710014-2015-00439
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT LOST ACCESS TO SOUND WHILE PLAYING HOWEVER, NO TECHNICAL FAILURE COULD BE DETECTED. TELEMETRY SHOWS AN IMPLANT WORKING WITHIN SPECIFICATION. THE DIAGNOSTIC IMAGE SHOWS THE ELECTRODE POSITION UNCHANGED AND. ACCORDING TO MOST RECENT INFORMATION, THE PATIENT IS HEARING AGAIN. AN EXPLANATION FOR THE INITIALLY REPORTED PROBLEM CANNOT BE DETERMINED, BUT THE REASONS SEEM TO BE DEVICE UNRELATED. NO PROBLEM PERSISTS WITH THE DEVICE, WHICH REMAINS IMPLANTED AND IN USE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT SUDDENLY LOST ACCESS TO SOUND WHILE PLAYING. THE DIAGNOSTIC IMAGE SHOWS THE ELECTRODE POSITION UNCHANGED.

    Description of Event or Problem · 1

    THE PATIENT SUDDENLY LOST ACCESS TO SOUND WHILE PLAYING. THE DIAGNOSTIC IMAGE SHOWS THE ELECTRODE POSITION UNCHANGED. INFORMATION RECEIVED ON JULY 24, 2015 STATES THAT THEE PATIENT HAS AGAIN ACCESS TO SOUND WITH CL. THERE IS NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392644 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR