BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3210825 · Received July 2, 2013

    Report

    Report Number
    9710014-2013-00266
    Event Type
    Other
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 DURING THE FIRST FOLLOW UP APPOINTMENT THE PATIENT WAS NOT ABLE TO UNDERSTAND ANY AUDITORY INFORMATION. THE PATIENT REPORTS OF NO AUDITORY PERCEPT ON ELECTRODE CHANNELS 7-12. THE PATIENT WAS RE-FITTED DURING THIS APPOINTMENT, AND THE CLARITY HAD IMPROVED MUCH AFTER THE MAPPING CHANGES. IN ADDITION TO POOR SOUND PERCEPTION THE PATIENT ALSO COMPLAINS ABOUT DIZZINESS AND IMBALANCE. DIAGNOSTIC IMAGING WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300970 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR