BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4232469 · Received October 15, 2014

    Report

    Report Number
    9710014-2014-00576
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    October 9, 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

    NOT AVAILABLE. 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 THE PATIENT WAS PERFORMING WELL WITH HER IMPLANT UNTIL AN IMPACT HAPPENED ON THE IMPLANT SITE IN (B)(6) 2014. SINCE THEN IN SITU MEASUREMENTS SHOW 5 ELECTRODE CHANNELS IN STATUS HI AND OTHER 2 CHANNELS INVOLVED IN A SHORT CIRCUIT. RE-IMPLANTATION IS BEING CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652695 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR