BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7159511 · Received January 3, 2018

    Report

    Report Number
    9710014-2018-00005
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    December 8, 2017
    Report Date
    April 13, 2018
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015033). 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 · 0

    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH AND VIBRANT MED-EL SUBMIT MDR REPORTS ON BEHALF OF MED-EL CORPORATION (EXEMPTION NUMBER E2015033). CONCLUSION: THE INVESTIGATION RESULTS CONFIRMED THAT THE DEVICE HAS FAILED DUE TO AN EXTERNAL IMPACT TO THE ACTIVE ELECTRODE. ALL THE PROBLEMS GIVEN IN THE RECIPIENT REPORT APPEAR TO MATCH WELL WITH THIS FINDING. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    THE USER HAS NO HEARING SENSATIONS WITH THE DEVICE SINCE HE HIT HIS HEAD AT THE PLAYGROUND. EXTERNAL PARTS HAVE BEEN CHECKED WITHOUT IMPROVEMENT. RE-IMPLANTATION IS CONSIDERED.

    Description of Event or Problem · 0

    THE USER NO LONGER HAD ANY HEARING SENSATIONS WITH THE DEVICE AFTER HE HIT HIS HEAD IN THE PLAYGROUND. THE RECIPIENT WAS RE-IMPLANTED ON (B)(6), 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6692 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 4 YR Required Intervention