BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2925143 · Received January 17, 2013

    Report

    Report Number
    9710014-2013-00009
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 14, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    THIS COCHLEAR IMPLANT WAS SUCCESSFULLY INSERTED, BUT MONOPOLAR DIATHERMY WAS USED FOR 10 SECONDS DURING THE SIMULTANEOUS BILATERAL SURGERY ON THE RIGHT (OPPOSITE) EAR. THE SURGEON DECIDED TO EXPLANT THE DEVICE, AS HE WAS UNSURE IF IT HAD BEEN DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25775 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MED-EL CONCERT +FLEX28 MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention