BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7171395 · Received January 8, 2018

    Report

    Report Number
    9710014-2017-001117
    Event Type
    Injury
    Date Received
    January 8, 2018
    Date of Event
    December 8, 2017
    Report Date
    June 15, 2020
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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

    THE PATIENTS HEARING WITH THE DEVICE IS AFFECTED. NO TRAUMA HAS BEEN REPORTED. THE PATIENT HAS BEEN EXPLANTED ON (B)(6) 2017.

    Description of Event or Problem · 1

    THIS IS A CORRECTION OF THE PREVIOUSLY SUBMITTED FU#1 REPORT TO MATCH THE INITIAL REPORT. FU#1 WAS SUBMITTED ON FEBRUARY 21, 2018 WITH INCORRECT MFR REPORT NUMBER: 9710014-2017-1117. INITIAL WAS SUBMITTED ON JANUARY 05, 2018 WITH MFR REPORT NUMBER: 9710014-2017-001117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16198 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO Required Intervention