BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6013684 · Received October 10, 2016

    Report

    Report Number
    9710014-2016-00672
    Event Type
    Injury
    Date Received
    October 10, 2016
    Date of Event
    June 1, 2016
    Report Date
    March 13, 2017
    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
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    DAMAGE TO THE ACTIVE ELECTRODE, AS MIGHT BE CAUSED BY AN EXTERNAL MECHANICAL IMPACT, WAS DETERMINED TO BE THE ROOT CAUSE OF DEVICE FAILURE. A HEAD TRAUMA WAS REPORTED AND THEREFORE, PROBLEMS GIVEN IN THE PATIENT REPORT APPEAR TO MATCH THE DAMAGE FOUND. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    OBVIOUS DECLINE IN PATIENTS HEARING PERFORMANCE AFTER HEAD TRAUMA WAS NOTICED. THE PATIENT HAS BEEN RE-IMPLANTED ON (B)(6) 2016.

    Description of Event or Problem · 1

    OBVIOUS DECLINE IN PATIENTS HEARING PERFORMANCE AFTER HEAD TRAUMA WAS NOTICED. THE PATIENT HAS BEEN RE-IMPLANTED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666378 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Required Intervention