BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3020884 · Received March 19, 2013

    Report

    Report Number
    9710014-2013-00104
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    AUDIOLOGIST

    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, IMPLANTED IN 2001, BEGAN TO HEAR NOISES IN (B)(6) 2013. A COUPLE OF DAYS LATER, THE PT BEGAN TO FEEL PAIN AROUND THE IMPLANT AREA, WITH AND W/O THE AUDIO PROCESSOR. THE PT ALSO FELT PAIN DURING TESTING AND CANNOT WEAR HER PROCESSOR, EVEN WITH A VERY LOW VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114504 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR