BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1860266 · Received September 22, 2010

    Report

    Report Number
    9710014-2010-00303
    Event Type
    Injury
    Date Received
    September 22, 2010
    Report Date
    July 14, 2016
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEARING ATTENTION IS CONTINUOUSLY CHANGING ON HIGH FREQUENCIES. SINCE IMPLANTATION, THE HIGH FREQUENCIES HAVE ALWAYS HAD TO BE CORRECTED AT FITTING. THE PATIENT'S PERFORMANCE IS GOOD, BUT A CHANGING COULD HAVE BEEN OBSERVED. TESTING REVEALED THE ELECTRODES 1, 11 AND 12 WITH STATUS HI. NO ACCIDENT WAS REPORTED.

    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 9 YR Female Required Intervention