BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1002738 · Received February 27, 2008

    Report

    Report Number
    9710014-2008-00061
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 25, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 THE PATIENT HEARD BUZZING NOISES AND EXPERIENCED FLUCTUATIONS IN HIS HEARING PERCEPTION. THE IMPEDANCE OF CHANNEL 1 FELL FROM 6 TO 0.5 AND SHOWED ZEROS IN THE APPROPRIATE COLUMN OF THE VOLTAGE MATRIX. AFTER THE SPEECH PROCESSOR AND THE COIL CABLE HAD BEEN EXCHANGED, IT SEEMED THAT THE BUZZING SOUND WAS NO LONGER THERE. ON FEBRUARY 19, 2008, THE POSSIBILITY OF FURTHER ACTIONS WERE DISCUSSED WITH THE CLINIC OF AN IMPLANT CHECK HAS BEEN SCHEDULED FOR THE FOLLOWING MONTH.

    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 16 YR