BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1211764 · Received October 24, 2008

    Report

    Report Number
    9710014-2008-00323
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 17, 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 ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUDIOLOGIST REPORTED THE INABILITY TO INCREASE MCLS, DUE TO PAIN SENSATIONS OF THE PATIENT ABOUT 3 MONTHS AFTER ACTIVATION. MCLS ARE VERY LOW AND THE CHILD SHOWS A VERY POOR SPEECH PERFORMANCE AS WELL AS A VERY LOW AUDIOGRAM. ALL EXTERNAL PARTS HAVE BEEN CHECKED. TESTING DID NOT SHOW ANY IMPLANT PROBLEM. THE PATIENT WAS RE-IMPLANTED IN 2008, HOWEVER, MED-EL WAS NOT AWARE OF THE SCHEDULE 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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention