BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHEAR IMPLANT SYSTEM

    MDR report key: 1915385 · Received November 3, 2010

    Report

    Report Number
    9710014-2010-00353
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 29, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS BEEN EXPERIENCING INTERMITTENT/WEAK SOUND AND HAS TRIED SEVERAL SPEECH PROCESSORS BUT WITH NO IMPROVEMENT IN THE SOUND QUALITY. DURING AN APPOINTMENT TO CHECK THE DEVICE AT THE CLINIC, FIVE SETS OF TESTING WERE CARRIED OUT, OF WHICH ONE WAS NOT OK. THE PT'S AUDIOLOGIST ALSO REPORTS THAT THERE IS MORE DIFFICULTY IN PROGRAMMING AROUND THE PT'S FACIAL NERVE STIMULATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR