BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1060968 · Received June 17, 2008

    Report

    Report Number
    9710014-2008-00195
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Report Date
    June 5, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, THE PT WENT TO THE CLINIC FOR FITTING. THE AUDIOLOGIST CARRIED OUT TESTING, WHICH CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED, HOWEVER, THE PATIENT WAS STILL ABLE TO HEAR WITH HER DEVICE. THE FOLLOWING MONTH, THE PATIENT CAME TO THE CLINIC AGAIN AND REPORTED THAT SHE IS NO LONGER ABLE TO HEAR WITH HER DEVICE. TESTING WAS CARRIED OUT AGAIN, WHICH CONFIRMED PREVIOUS RESULTS. ALL EXTERNAL PARTS WERE EXCHANGED, BUT WITHOUT SUCCESS.

    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 C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR