BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2823596 · Received October 30, 2012

    Report

    Report Number
    9710014-2012-00389
    Event Type
    Other
    Date Received
    October 30, 2012
    Date of Event
    June 1, 2011
    Report Date
    October 25, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS TO BE EXPLANTED AND RE-IMPLANTED ON (B)(6) 2012, DUE TO LACK OF BENEFIT WITH THE IMPLANT. THE PT'S AUDIOLOGIST REPORTS THAT THE PT IS NOT PERFORMING AS WELL AND HAS NEVER PERFORMED WELL. PT WAS ACTIVATED IN (B)(6) 2010 AND REPORTS LITTLE BENEFIT FROM THE DEVICE. SHE HAS AUDIBILITY OF SOUND, BUT REPORTS DIFFICULTY UNDERSTANDING SPEECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR