BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3022638 · Received March 21, 2013

    Report

    Report Number
    9710014-2013-00109
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 2, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OBVIOUS DECLINE IN PT'S HEARING PERFORMANCE WAS NOTICED BY THE GUARDIANS SINCE 2011. PROBLEMS OF THE EXTERNAL DEVICES WERE EXCLUDED. A HISTORY OF A HEAD TRAUMA WAS DENIED BY THE GUARDIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118668 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention