BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1934667 · Received November 26, 2010

    Report

    Report Number
    9710014-2010-00381
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    March 21, 2007
    Report Date
    November 24, 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 F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUARDIANS HAVE NOTICED A DECLINE IN THE CHILD'S AUDITORY AND SPEECH PERFORMANCE SINCE 2007. PROBLEMS OF OUTER DEVICE HAVE BEEN EXCLUDED AND HISTORY OF HEAD TRAUMA HAS BEEN DENIED BY THE GUARDIANS. LATEST TESTING SHOWED THE CHANNELS 1,5, AND 6 IN STATUS HI. THE IMPEDANCES OF CHANNEL 3, 4, 8, 9, 10 AND 11 ARE NOTED BY >, BUT THE PT STILL HAS AUDITORY SENSATION OF THESE CHANNELS. A TEMPORAL CT SCAN WAS PERFORMED, WHICH SHOWS NOTHING SIGNIFICANTLY ABNORMAL IN THE COCHLEAR.

    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 8 YR