BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1212064 · Received October 24, 2008

    Report

    Report Number
    9710014-2008-00336
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PERFORMANCE PROGRESSIVELY DECREASED OVER THE PAST YEAR, WITHOUT ANY REASON. THE PATIENT NO LONGER HAD ANY BENEFIT FROM HIS IMPLANT. THE PATIENT WAS RE-IMPLANTED IN 2008, HOWEVER, MED-EL WAS NOT INFORMED ABOUT THE SCHEDULED RE-IMPLANTATION.

    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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention