BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1002737 · Received February 27, 2008

    Report

    Report Number
    9710014-2008-00065
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 26, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 HAS BEEN MAKING EXCELLENT PROGRESS WITH HIS COCHLEAR IMPLANT AND ATTENDS A SCHOOL FOR NORMAL HEARING STUDENTS. HE IS HOWEVER, COMPLETELY DEPENDENT UPON HIS IMPLANT. IN 2007, IT WAS SEEN THAT THE DEVICE WAS SHOWING SIGNS OF MALFUNCTIONING. DURING A CHECK CARRIED OUT IN 2008, THE PT COMPLAINED ABOUT INTERMITTENCY IN HIS HEARING PERCEPTION AND HEARING STRANGE NOISES. THE PT WAS GIVEN NEW EXTERNAL EQUIPMENT, BUT THE PT WAS NOT ABLE TO TOLERATE IT. HE TOTALLY REFUSED TO WEAR HIS NEW AND HIS OLD SPEECH PROCESSORS, STATING THAT THE SOUND HE EXPERIENCED WAS TERRIBLE. TESTING CARRIED OUT WHICH SHOWED THAT THE DEVICE HAS 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 9 YR