BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3954867 · Received July 16, 2014

    Report

    Report Number
    9710014-2014-00346
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    August 7, 2012
    Report Date
    July 2, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THAT DURING IMPLANTATION SURGERY ON (B)(6) 2012, ONLY 2 ELECTRODE CHANNELS WERE INSERTED. THE FIRST FITTING TOOK PLACE ON (B)(6) 2012, AND THE PATIENT WAS NOT ABLE TO HEAR WITH LIVE MODE. THE PATIENT HAD ACCESS TO SOUND ON CHANNELS 1 AND 2 WITH SINGLE CHANNELS STIMULATION. THE PATIENT HAS A NORMAL COCHLEA. IT WAS PLANNED TO REINSERT THE ELECTRODE ARRAY INTO THE COCHLEA. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT'S HEARING PERFORMANCE GRADUALLY IMPROVED, SO THE SURGEON DECIDED AGAINST RE-INSERTION. ON (B)(6) 2014, THE EXPLANTED DEVICE WAS RECEIVED AT MED-EL HEADQUARTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415845 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention