BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM

    MDR report key: 9296756 · Received November 8, 2019

    Report

    Report Number
    3004007782-2019-00006
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 28, 2019
    Report Date
    November 8, 2019
    Manufacturer
    ENVOY MEDICAL CORPORATION
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS EXPERIENCING FEEDBACK THAT IS CONSISTENT WITH ELECTRICAL FEEDBACK. THE DEVICE WAS DEMONSTRATING FEEDBACK SIMILAR TO OTHER CONFIRMED CASES OF ELECTRICAL FEEDBACK AND THERE IS NO REASON TO BELIEVE THAT FEED BACK WAS MECHANICAL IN NATURE. BASED ON AVAILABLE TEST AND DIAGNOSTIC DATA, THE SOURCE OF THE FEED BACK CANNOT BE CONCLUSIVELY IDENTIFIED AS THERE IS NO VISUAL EVIDENCE OF THE PREVIOUSLY ALLEGED HEADER ABRASION ISSUE, KNOWN TO CAUSE ELECTRICAL FEEDBACK IN SIMILAR CASES. THEREFORE NO ROOT CAUSE COULD BE IDENTIFIED FOR THIS CASE.

    Description of Event or Problem · 1

    ENVOY MEDICAL CORP. (EMC) WAS NOTIFIED ON 05/29/2019 THAT A PATIENT WAS EXPERIENCING LOW FREQUENCY FEED BACK, WITH A FEEDBACK TEST ABNORMAL AT 250-500 HZ. THIS LOW FREQ FEEDBACK PREVENTED PROPER PROGRAMMING. TEST RESULTS WERE CONSISTENT WITH ELECTRICAL FEEDBACK. THE ALLEGED ISSUE COULD NOT BE CONFIRMED UNTIL A BATTERY REPLACEMENT PROCEDURE COULD BE PERFORMED AND THE APPROPRIATE TESTING COULD BE PERFORMED TO CONFIRM EFFICACY OF THE DEVICE. FOLLOWING THE BATTERY CHANGE PROCEDURE, THE PATIENT'S ESTEEM DIAGNOSTICS WERE WITHIN RANGE. PATIENT NO LONGER EXPERIENCES GAIN / FEED BACK LIMITATIONS AND IS MEETING NAL/RP TARGETS AND WRS IS CONSISTENT WITH BASELINE. RETURNED DEVICE EVALUATION WAS RUN SUCCESSFULLY AND VISUAL INSPECTION SHOWS NO EVIDENCE OF PREVIOUSLY ALLEGED HEADER ABRASION. ROOT CAUSE COULD NOT BE DETERMINED UTILIZING AVAILABLE ANALYSIS/TEST METHODS. PATIENT/CLINICAL HISTORY WITH EMC: (B)(6) 2014- IMPLANT. (B)(6) 2014- ACTIVATION. (B)(6) 2015- FITTING. (B)(6) 2015- FITTING. (B)(6) 2019- CLINICAL REVIEW. (B)(6) 2019- FITTING. (B)(6) 2019- BATTERY CHANGE. (B)(6) 2019- POST BATTERY CHANGE FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094550 ESTEEM ESTEEM II, PRODUCT CODE: OAF OAF ENVOY MEDICAL CORPORATION 2001 EMC0005473

    Patients

    Seq Age Sex Outcome Treatment
    1