BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2514494 · Received March 28, 2012

    Report

    Report Number
    9710014-2012-00085
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 16, 2012
    Report Date
    March 23, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 IS STILL USING AND BENEFITTING FROM HER CI, HOWEVER, SINCE THREE MONTHS AGO, THE PT REPORTS A DECREASE IN LOUDNESS. THE PT'S MOTHER REPORTED THAT THE PT USED TO PERFORMED NEUROFEEDBACK (NFB) THERAPY. TESTING CARRIED OUT ON (B)(6) 2012 SHOWS 7 ELECTRODE CHANNELS IN STATUS HI.

    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