BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1881187 · Received October 5, 2010

    Report

    Report Number
    9710014-2010-00319
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 12, 2010
    Report Date
    October 4, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 THE GUARDIANS OF THE PT NOTICED AN OBVIOUS DECLINE IN AUDITORY PERFORMANCE ON (B)(6), 2010. PROBLEMS WITH THE EXTERNAL EQUIPMENT HAVE BEEN EXCLUDED AND A HISTORY OF HEAD TRAUMA HAS BEEN DENIED BY THE GUARDIANS. TESTING CONFIRMS THAT THE DEVICE HAS MALFUNCTIONED.

    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 23 MO