BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2061524 · Received March 16, 2011

    Report

    Report Number
    9710014-2011-00091
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    July 1, 2010
    Report Date
    March 14, 2011
    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
    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 FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS INVOLVED IN A TRAUMA IN (B)(6) 2010. SINCE THEN THE PT HAS HAD UNPLEASANT SENSATIONS. X-RAYS WERE PERFORMED BUT EVERYTHING APPEARED NORMAL. IMPEDANCE VALUES HAVE CHANGED SINCE THIS EVENT BUT THE PT'S PERFORMANCE WAS OK. ON (B)(6) 2011, TWO ADDITIONAL ELECTRODE CHANNELS WERE TURNED OFF AND THE PT'S AUDITORY SKILLS HAVE NOW DETERIORATED.

    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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR