BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3813395 · Received March 31, 2014

    Report

    Report Number
    9710014-2014-00157
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 24, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 MANUFACTURER FOR EVALUATION. 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 PATIENT WAS SUFFERING FROM REOCCURRING DERMATITIS AND THAT A PART OF THE ACTIVE ELECTRODE LEAD WAS OBSERVED PROTRUDING THROUGH THE SKIN, SO A REVISION SURGERY WAS PERFORMED TO ADDRESS THIS PROTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190066 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR