BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2113809 · Received May 13, 2011

    Report

    Report Number
    9710014-2011-00158
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 10, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 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 PATIENT STOPPED BEING ABLE TO HEAR APPROXIMATELY 15 DAYS AGO. HE SHOWS NO RESPONSE TO STIMULATION OR WITH HIS SPEECH PROCESSOR. ADDITIONAL EXTERNAL EQUIPMENT WAS TRIED BUT THERE WAS STILL NO RESPONSE TO SOUND. THERE IS NO REPORT OF ANY ACCIDENT OR TRAUMA.

    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 10 YR