BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2925259 · Received January 17, 2013

    Report

    Report Number
    9710014-2013-00011
    Event Type
    Other
    Date Received
    January 17, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 10, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT FROM THE PT'S AUDIOLOGIST, THE PT, PRESENTED TO THE CLINIC WITH RECENT EVENTS OF PAIN, TENDERNESS AT THE IMPLANT SITE AND ABNORMAL SOUND PERCEPTIONS. AN EXPLANATION SURGERY IS PLANNED FOR FEBRUARY THIS YEAR, DESPITE NO TECHNICAL MALFUNCTION OF THE DEVICE COULD BE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26434 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR