BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 622285 · Received July 22, 2005

    Report

    Report Number
    9710014-2005-00183
    Event Type
    Injury
    Date Received
    July 22, 2005
    Date of Event
    July 14, 2005
    Report Date
    July 21, 2005
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT THE PATIENT COMPLAINED ABOUT INTERMITTENT AND WEAK SOUNDS AND THAT PATIENT HEARD NOTHING AT ALL IN 06/2005. TELEMETRY TESTING REVEALED "POOR COUPLING", THE IMPLANT HAD MALFUNCTIONED. THE PATIENT WAS REIMPLANTED ABOUT TWO WEEKS LATER.

    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 16 YR Required Intervention