BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6517769 · Received April 25, 2017

    Report

    Report Number
    9710014-2017-00336
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    April 7, 2017
    Report Date
    August 16, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE INVESTIGATION REVEALED MECHANICAL DAMAGE TO THE COIL PIN THAT IS TYPICAL FOR SEVERE EXTERNAL IMPACT TO IMPLANT SITE. EVEN THOUGH NO SUCH EVENT, LIKE AN ACCIDENT, IS MENTIONED IN THE PATIENT REPORT.

    Description of Event or Problem · 1

    IT IS NOT POSSIBLE TO CONNECT THE PATIENT TO THE FITTING SOFTWARE CAUSE AN ERROR MESSAGE SHOWS THAT THE SERIAL NUMBER OF THE DEVICE COULD NOT READ. A GENERAL PROBLEM WITH THE SOFTWARE WAS RULED OUT. THE PATIENT HAD SUDDENLY NO SOUND PERCEPTION WITH THE DEVICE.

    Description of Event or Problem · 1

    THE USER HAD SUDDENLY NO SOUND PERCEPTION WITH THE DEVICE. FAMILY REPORTS NO INCIDENT OF ACCIDENT OR TRAUMA. USER WAS RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302470 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 3 YR Required Intervention