BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3131187 · Received May 22, 2013

    Report

    Report Number
    9710014-2013-00197
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MED-EL ELEKROMEDIZINISCHE 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 PT VISITED THE CLINIC FOR HIS 3-MONTH EVALUATION OF HIS BILATERAL COCHLEAR IMPLANTS. THE CHILD HAD FALLEN BACK AND HIT HIS HEAD THE EVENING BEFORE THE PROGRAMMING APPOINTMENT, THERE WAS NO REDNESS, SWELLING, SORENESS NOTED OVER THE IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227019 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MED-EL CONCERT +FLEX28 MCM MED-EL ELEKROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO