BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2181349 · Received July 8, 2011

    Report

    Report Number
    9710014-2011-00197
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 20, 2011
    Report Date
    February 16, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 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 USED TO BE AN EXPERIENCED CI USER FOR OVER 3 YEARS. HE WAS DOING WELL, BUT REPORTED OF UNPLEASANT NON-AUDITORY SENSATION WHEN THE SPEECH PROCESSOR WAS SWITCHED ON. TESTING CARRIED OUT ON (B)(6) 2011, SHOWS 11 ELECTRODE CHANNELS IN INCREASED IMPEDANCE, AS WELL AS THE MEASUREMENTS OF THE REMAINING 1 CHANNEL IN STATUS OK BEING INCONSISTENT.

    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 9 YR Male Required Intervention