BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 4250049 · Received November 6, 2014

    Report

    Report Number
    9710014-2014-00582
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    April 7, 2014
    Report Date
    October 30, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE RECEIVED INFORMATION, THE OBSERVED SYMPTOMS ARE VERY LIKELY DUE TO AN ELECTRODE MIGRATION OUT OF COCHLEA. THE PATIENT HAS A MONDINI MALFORMATION AND A FULL INSERTION COULD NOT BE ACHIEVED AT IMPLANTATION (TWO ELECTRODE CHANNELS WERE OUT OF COCHLEA). NOW SIX CHANNELS ARE REPORTEDLY OUT OF COCHLEA. A REPOSITIONING SURGERY IS TO BE DISCUSSED WITH THE SURGEON, BUT A DATE FOR REVISION SURGERY HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT CAN ONLY DETECT LOUD SOUNDS. SPEECH SOUNDS ARE NOT RELIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716015 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM SONATA MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention