BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2900887 · Received January 2, 2013

    Report

    Report Number
    9710014-2012-00503
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED BECAUSE THE PT'S PARENTS THOUGHT THEY WERE RECEIVING A DEVICE FROM ANOTHER MFR. THEY HAD THE PERCEPTION THAT THE MORE EXPENSIVE DEVICE FROM THE OTHER MFR IS OF HIGHER QUALITY. THE SURGEONS TRIED, BUT COULD NOT CONVINCE THEM THAT THIS WAS NOT THE CASE. THE SURGEON ELECTED TO IMMEDIATELY EXPLANT THE DEVICE AND REPLACE IT WITH THE DESIRED DEVICE FROM THE OTHER MFR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention