BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3213949 · Received July 3, 2013

    Report

    Report Number
    9710014-2013-00273
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    July 1, 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 PATIENT HAD HIT HIS HEAD ON THE IMPLANT SIDE. THE PATIENT WORE THE AUDIO PROCESSOR FOR ABOUT 3 DAYS. AFTER THAT HE FELT PAIN. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306008 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM CONCERTO PIN AND COMPRESSED MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention