BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2860572 · Received December 5, 2012

    Report

    Report Number
    9710014-2012-00444
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    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 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, IMPLANTED ON (B)(6) 1997, UNDERWENT A FITTING APPOINTMENT IN (B)(6) 2012, WHERE IT WAS FOUND THAT THE ELECTRODE CHANNELS WERE FUNCTIONAL, BUT THE GROUND PATH IMPEDANCE WAS INCREASED. ON APPLYING THE AUDIO PROCESSOR, WHICH WAS ATTACHED TO THE DIB, THE PATIENT HEARD AN UNCOMFORTABLE NOISE, ALTHOUGH THE AUDIO PROCESSOR WAS NOT SWITCHED ON. THE SAME HAPPENED WITH THE AUDIO PROCESSOR BEING SWITCHED ON, EVEN WITH A LOW MAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR