BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2212548 · Received August 10, 2011

    Report

    Report Number
    9710014-2011-00239
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    August 4, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO INNSBRUCK WHERE IT WILL BE EVALUATED. 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 DEVICE'S ELECTRODE WAS NOT INSERTED IN THE COCHLEA. IT WAS DECIDED TO REPOSITION THE ELECTRODE IN A REVISION SURGERY. THE SURGERY WAS NOT SUCCESSFUL. THE PATIENT WAS EXPLANTED IN THE SAME SURGERY.

    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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention