BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1082325 · Received July 29, 2008

    Report

    Report Number
    9710014-2008-00237
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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'S AUDIOLOGIST CONTACTED MED-EL BECAUSE DURING A ROUTINE APPOINTMENT, IMPEDANCE MEASUREMENTS WERE FOUND TO BE HIGHER THAN NORMAL. THREE ELECTRODE CHANNELS HAD HI IMPEDANCES, 2 ELECTRODE CHANNELS WERE SHOWING SHORT CIRCUITS AND 4 ELECTRODE CHANNELS SHOWING HIGHER THAN NORMAL IMPEDANCES. THE GROUND PATH IMPEDANCE HAS ALSO INCREASED. THE PATIENT DESCRIBED HEARING A 'SHHHH' SOUND THROUGH HER RIGHT SPEECH PROCESSOR. THE PATIENT IS BILATERALLY IMPLANTED. INTEGRITY TESTING IS CURRENTLY BEING SCHEDULED BY MED-EL CORP WITH THE PATIENT AND THE CLINIC.

    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 5 YR