BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1001873 · Received February 25, 2008

    Report

    Report Number
    9710014-2008-00059
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    December 1, 2007
    Report Date
    February 22, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    IT WAS REPORTED THAT IN 2007, THERE WERE CHANGES IN THE LOUDNESS OF THE PATIENT'S CI SYSTEM. IN 2008, SHE REPORTED THAT SHE COULD NO LONGER HEAR THROUGH HER CI SYSTEM. THE COMPLETE EXTERNAL EQUIPMENT WAS EXCHANGED TWICE BY POST. THE PATIENT ATTENDED THE CLINIC ABOUT 9 DAYS LATER. ON THIS OCCASION, ALL OF HER EXTERNAL EQUIPMENT WAS CHECKED AND DEEMED TO BE FUNCTIONING WITHIN SPECIFICATION. TESTING, HOWEVER, CONFIRMED THAT THE INTERNAL DEVICE HAD MALFUNCTIONED.

    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 23 YR