BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3082589 · Received April 24, 2013

    Report

    Report Number
    9710014-2013-00150
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    August 2, 2012
    Report Date
    April 19, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO INNSBRUCK WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6), 2012, THAT THE PATIENT HAS NOT BEEN ABLE TO HEAR AS WELL AS PREVIOUSLY. THE PATIENT IS A BILATERAL IMPLANT RECIPIENT. THE LEFT IMPLANT APPEARS TO BE MOVING. THE PATIENT IS AWARE OF A CLICKING SENSATION OCCASIONALLY WHEN CHEWING. AFTER SEVERAL REPROGRAMMING SESSIONS THE SOUND WAS REPORTEDLY IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176200 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MED-EL CONCERT+MEDIUM MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention