BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2843781 · Received November 19, 2012

    Report

    Report Number
    9710014-2012-00416
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Report Date
    November 12, 2012
    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. IT IS 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 FELL DOWN AND THE PARENTS REPORTED A HEAD TRAUMA. THE PATIENT IS BILATERALLY IMPLANTED AND IS NOT ABLE TO HEAR WITH THE RIGHT DEVICE (CONCERNED ONE). THE CONTRALATERAL DEVICE IS FUNCTIONING NORMALLY AND THE PATIENT IS HEARING WELL WITH IT. THE PARENTS COULDN'T INDICATE ACCURATELY WHEN THE ACCIDENT HAPPENED. THEY ESTIMATE IT OCCURRED DURING THE HALF OF (B)(6), 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR