BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3954866 · Received July 16, 2014

    Report

    Report Number
    9710014-2014-00355
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER 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 HAS AN OBSTRUCTED EAR CANAL WALL AND THAT THE ELECTRODE ARRAY WAS FOUND IN THE EAR CANAL FOLLOWED BY RE-IMPLANTATION WITH A NEW DEVICE FOR PROPHYLACTIC REASONS. DURING RE-IMPLANTATION CHOLESTEATOMA AND INFECTION WERE OBSERVED. IT WAS ALSO REPORTED THAT THE DEVICE WAS WORKING PROPERLY AND THAT NO DEVICE QUALITY PROBLEM WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415881 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA +FLEX28 MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention