BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2961221 · Received January 29, 2013

    Report

    Report Number
    9710014-2013-00024
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 21, 2013
    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 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 PARENTS STATED THAT THE CHILD REMOVED HIS RIGHT PROCESSOR ON SATURDAY, (B)(6), REPORTING THAT IT WAS UNCOMFORTABLE AND THAT IT SOUNDED LIKE STATIC. THE PATIENT WAS SEEN FOR AN APPOINTMENT ON (B)(6) AND TROUBLESHOOTING ATTEMPTED TO ALLEVIATE THE STATIC SOUND BY USING BACK-UP EQUIPMENT AND MODIFYING THE PROGRAMMING. THIS WAS NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39541 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR