BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM

    MDR report key: 10868408 · Received November 19, 2020

    Report

    Report Number
    3004007782-2020-00009
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 19, 2020
    Manufacturer
    ENVOY MEDICAL CORPORATION
    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

    TEST RESULTS FROM DEVICE MANUFACTURING WERE REVIEWED. SOUND PROCESSOR SN 213578 PASSED ALL FUNCTIONAL TESTING IN PRODUCTION. A DHR REVIEW REVEALED THAT THE DEVICE MET ALL SPECIFICATIONS AND THERE WERE NO MANUFACTURING ISSUES. THE BATTERY WAS CONFIRMED TO BE DEPLETED AT THE TIME OF EXPLANT.

    Description of Event or Problem · 1

    EMC WAS NOTIFIED OF A BATTERY DEPLETION ON (B)(6) 2020. THE BATTERY WAS FOUND TO BE AT 2.3V, REFLECTING A DEPLETED BATTERY. THE BATTERY LIFE WAS FOUND TO BE 2.34 YEARS. THE MINIMUM STATED BATTERY LIFE OF THE EII SP IS 2.8 YEARS. UPON FUNCTIONAL TESTING, A LOW BATTERY WAS VERIFIED, AND IT WAS DETERMINED THE DEVICE PASSES TESTING AND NO ADDITIONAL MALFUNCTION HAS OCCURED WITH THE DEVICE. PATIENT USAGE/ENVIRONMENT ARE POSSIBLE FACTORS TO CONSIDER. THE PATIENT'S PROFOUND HIGH FREQUENCY LOSS, MAX GAIN SETTINGS USED AND REGULAR EXPOSURE TO LOUD ENVIRONMENTS ARE POSSIBLE FACTORS TO CONSIDER. PATIENT/CLINICAL HISTORY WITH EMC: (B)(6) 2011 IMPLANT, (B)(6) 2011 FITTING, (B)(6) 2014 FITTING, (B)(6) 2014 BATTERY CHANGE, (B)(6) 2018 FITTING, (B)(6) 2018 BATTERY CHANGE, (B)(6) 2020 BATTERY CHANGE, (B)(6) 2020 FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335420 ESTEEM ESTEEM II, PRODUCT CODE: OAF OAF ENVOY MEDICAL CORPORATION 2001 EMC0006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other