BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3952584 · Received May 15, 2014

    Report

    Report Number
    9710014-2014-00249
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    November 27, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    AUDIOLOGIST
    Health Professional
    Yes

    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 ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 MONTHS AGO, THE PATIENT STARTED TO HEAR WITH INTERMITTENCIES WITH HIS COCHLEAR IMPLANT. THE EXTERNAL COMPONENTS WERE CHECKED AND THE PROBLEM SEEMED TO BE SOLVED. TEN DAYS AGO THE INTERMITTENT SOUND APPEARED AGAIN AND THEN PATIENT LOST ACCESS TO SOUND ON (B)(6) 2014. THIS WAS CONFIRMED WITH 2 DIFFERENT AUDIO PROCESSORS. AN ACCIDENT OR TRAUMA IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291225 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Required Intervention