BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4102131 · Received September 15, 2014

    Report

    Report Number
    9710014-2014-00469
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN SITU TESTING HAS SHOWN AN INCREASING NUMBER OF ACTIVE ELECTRODE CHANNELS WITH STATUS HI SINCE (B)(6) 2011. THE PATIENT CAN NO LONGER BENEFIT FROM THE DEVICE. AN X-RAY SHOWED THE ELECTRODE TO BE IN THE COCHLEA. NO ACCIDENT OR TRAUMA IS KNOWN. THE PATIENT WILL BE RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570326 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR