BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESTEEM

    MDR report key: 2930955 · Received January 11, 2013

    Report

    Report Number
    3004007782-2013-00006
    Event Type
    Other
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 11, 2013
    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

    THIS PT REPORTED SOME FORM OF TASTE DISTURBANCE THAT PERSISTED AFTER THE FIRST FITTING AFTER ACTIVATION. PT DID STATE THE TASTE DISTURBANCE SEEMS TO BE IMPROVING. NO DEVICE WAS RETURNED FOR ANALYSIS. THE CHORDA TYMPANI IS USUALLY DIVIDED DURING THE IMPLANT PROCEDURE. THE PT IS SPECIFICALLY ADVISED OF THIS PRIOR TO THE PROCEDURE. THE PRESENCE OF A TASTE DISTURBANCE IS FREQUENT AND TYPICALLY RESOLVES OVER TIME.

    Description of Event or Problem · 1

    TASTE DISTURBANCE REPORTED AFTER FIRST FITTING. INITIAL IMPLANT (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16897 ESTEEM OAF ENVOY MEDICAL 2001 EMC0004477

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other