BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2850696 · Received November 20, 2012

    Report

    Report Number
    9710014-2012-00414
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    November 16, 2012
    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 HAS BEEN RETURNED TO (B)(4), WHERE IT WILL BE EVALUATED. 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 INSERTION OF THE ELECTRODE ARRAY INTO THE COCHLEA WAS UNEXPECTEDLY DIFFICULT DURING IMPLANTATION SURGERY, WHICH TOOK PLACE ON (B)(6) 2011. THREE ELECTRODE CONTACTS WERE LEFT OUTSIDE THE COCHLEA AFTER IMPLANTATION. THE PERFORMANCE WITH THE IMPLANT HAD DECREASED OVER TIME. A CT SCAN BEFORE RE-IMPLANTATION SURGERY SHOWED 7 ELECTRODE CONTACTS BEING OUTSIDE OF THE COCHLEA. THE PT WAS RE-IMPLANTED ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention