BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2960483 · Received February 11, 2013

    Report

    Report Number
    9710014-2013-00052
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    August 17, 2012
    Report Date
    February 6, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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 THERE WAS A DECLINE IN PATIENT'S HEARING PERFORMANCE, WHICH WAS NOTICED BY THE PATIENT'S GUARDIANS IN (B)(6) 2012. HISTORY OF HEAD TRAUMA HAS BEEN DENIED BY THE GUARDIANS AND PROBLEMS WITH THE EXTERNAL DEVICES WERE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59937 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention