BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2940756 · Received January 29, 2013

    Report

    Report Number
    9710014-2013-00017
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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 EXPLANTED AND RE-IMPLANTED DUE TO POOR PERFORMANCE EXPERIENCED SINCE IMPLANTATION WITH THE DEVICE. THE PATIENT HAD AN INCOMPLETE INSERTION OF THE IMPLANT VIA COCHLEOSTOMY ON (B)(6), 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39298 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention