BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESTEEM

    MDR report key: 3022442 · Received March 12, 2013

    Report

    Report Number
    3004007782-2013-00013
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    August 1, 2012
    Report Date
    March 12, 2012
    Manufacturer
    ENVOY MEDICAL
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT REPORTED SOME FORM OF TASTE DISTURBANCE THAT PERSISTED AFTER THE FIRST FITTING AFTER ACTIVATION. NO DEVICE WAS RETURNED FOR ANALYSIS. THE CHORDA TYMPANI IS USUALLY DIVIDED DURING THE IMPLANT PROCEDURE. THE PATIENT 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 FITTING. INITIAL IMPLANT DATE (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104457 ESTEEM OAF ENVOY MEDICAL 2001 EMC0004391

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other