BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESTEEM SYSTEM

    MDR report key: 2912881 · Received December 3, 2012

    Report

    Report Number
    3004007782-2012-00014
    Event Type
    Other
    Date Received
    December 3, 2012
    Date of Event
    August 17, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ENVOY MEDICAL
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACIAL NERVE WEAKNESS A KNOWN COMPLICATION OF MASTOIDECTOMY. ENVOY MEDICAL HAS CONFIRMED WITH IMPLANTING SURGEON THAT THE ISSUE HAD RESOLVED. DEVICE NOT EXPLANTED. NOTE: LATE FILING OF REPORT AS PER DISCUSSION WITH (B)(4) 2012.

    Description of Event or Problem · 1

    FACIAL NERVE WEAKNESS REPORTED AT FIRST FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTEEM SYSTEM OAF ENVOY MEDICAL 2001 EMC0004332

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other