BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4473532 · Received January 27, 2015

    Report

    Report Number
    9710014-2015-00045
    Event Type
    Injury
    Date Received
    January 27, 2015
    Report Date
    January 20, 2015
    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

    (B)(4). CONCLUSION: DEVICE INVESTIGATIONS DID NOT REVEAL ANY DEVICE DEFECT OR PROBLEM WHICH IS EXPECTED TO HAVE BEEN PRESENT WHILST IMPLANTED. ACCORDING TO THE PATIENT REPORT THE DEVICE WAS EXPLANTED DUE TO THE EXTRUSION OF THE ACTIVE ELECTRODE INTO THE MIDDLE EAR. THE INVESTIGATION RESULTS APPEAR TO MATCH THE PROBLEMS MENTIONED IN THE PATIENT REPORT. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EXPLANTED AND RETURNED TO MED-EL HEADQUARTERS, WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RE-IMPLANTED. PER DEVICE EXPLANTATION REPORT, THE REASON WAS AN EXTRUDED ELECTRODE INTO THE MIDDLE EAR RESULTING IN NO BENEFIT. THE DEVICE AND ELECTRODE WERE REPORTEDLY NOT ADDITIONALLY FIXATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RE-IMPLANTED. PER DEVICE EXPLANATION REPORT, THE REASON WAS AN EXTRUDED ELECTRODE INTO THE MIDDLE EAR RESULTING IN NO BENEFIT. THE EXPLANTED DEVICE WAS NOT IMMOBILISED. THE ELECTRODE WAS IN A CHANNEL IN BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63167 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MED-EL CONCERT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention