BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4180417 · Received October 15, 2014

    Report

    Report Number
    9710014-2014-00530
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 27, 2014
    Report Date
    April 20, 2016
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER
    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 MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DECREASE IN PT'S HEARING PERFORMANCE WAS OBSERVED. NO ACCIDENT OR TRAUMA HAS BEEN REPORTED. RE-IMPLANTATION HAS BEEN SUGGESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655400 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention