BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3122097 · Received May 16, 2013

    Report

    Report Number
    9710014-2013-00188
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    May 7, 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 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 PT WAS RE-IMPLANTED ON (B)(6) 2013 FOLLOWING A REINFORCED ELECTRODE LEAD EXTRUSION THROUGH THE SKIN NOT ALLOWING CLOSURE OF THE SURGICAL WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216739 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MED-EL CONCERT + FLEX28 MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention