BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1172530 · Received September 23, 2008

    Report

    Report Number
    9710014-2008-00303
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Report Date
    September 15, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    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

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

    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 C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR