BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1051890 · Received May 13, 2008

    Report

    Report Number
    9710014-2008-00161
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 13, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD PROBLEMS WITH HEARING SENSATION SINCE IMPLANTATION IN 2004. HE HAS NO LONGER HAD ANY HEARING SENSATION FOR THE PAST SEVERAL MONTHS. TESTING SHOWED GOOD RESULTS. HOWEVER, AN X-RAY EXAMINATION CARRIED OUT IN 2008, SHOWED THAT THE ELECTRODE ARRAY WAS NO LONGER IN THE COCHLEAR.

    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 14 YR