BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYS

    MDR report key: 4180419 · Received October 15, 2014

    Report

    Report Number
    9710014-2014-00532
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    October 8, 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 MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT

    Description of Event or Problem · 1

    IN (B)(6) 2013, THE PT HAD ONLY 2 ELECTRODES (E1 AND E9) WITH HIGH IMPEDANCES. CURRENT IN SITU MEASUREMENTS SHOWS 6 CHANNELS IN STATUS HIGH AND 2 IN SHORT CIRCUITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655958 MED-EL MAESTRO COCHLEAR IMPLANT SYS MED-EL CONCERT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR