BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3082434 · Received April 24, 2013

    Report

    Report Number
    9710014-2013-00153
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVAL. 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 PT, IMPLANTED WITH THE CI CONCERNED ON (B)(6) 2007, WAS EXPLANTED OF THIS DEVICE ON (B)(6) 2013, DUE TO INFLAMMATION AND SEROMA. RE-IMPLANTATION IS CONSIDERED AT A LATER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177040 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention