BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM

    MDR report key: 12975733 · Received December 10, 2021

    Report

    Report Number
    3004007782-2021-00010
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 12, 2021
    Report Date
    December 10, 2021
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT EXPERIENCED A BACKED-OUT DRIVER LEAD AFTER A ROUTINE BATTERY REPLACEMENT. THIS REQUIRED A FOLLOW-UP SURGERY TO EVALUATE AND EVENTUALLY REPLACE THE SP. THE PATIENT'S HEARING WAS RESTORED AFTER THE SP WAS REPLACED. MFR RECORDS WERE REVIEWED 12/10/2021. NO ISSUES WERE IDENTIFIED IN THE MFR RECORDS.

    Description of Event or Problem · 0

    ENVOY MEDICAL CORP. (EMC) WAS NOTIFIED ON 10/28/2021 OF A PATIENT REPORTING EII DEVICE CUTTING IN AND OUT IMMEDIATELY AFTER A BATTERY CHANGE PROCEDURE (OCCURRING (B)(6) 2021). A FOLLOW-UP PROCEDURE WAS COMPLETED (B)(6) 2021 AND A BACKED-OUT DRIVER LEAD WAS CONFIRMED. THE SP WAS REMOVED AND REPLACED WITH A NEW SP. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS EXPECTED AFTER THE REVISION PROCEDURE. PATIENT IS MEETING NAL-RP TARGET WITH EXCELLENT WRS. NO DEVICE OR SYSTEM PERFORMANCE ISSUES ARE INDICATED OR ALLEGED. PATIENT/CLINICAL HISTORY WITH EMC: (B)(6) 2012 ,105-0123(A0) ST-MO IMPLANT; (B)(6) 2012, 105-0123(A0) ST-MO ACTIVATION; (B)(6) 2012, 105-0123(A0) ST-MO FITTING; (B)(6) 2017, 105-0123 STMO FITTING; (B)(6) 2017, 105-0123 ST-MO BATTERY CHANGE; (B)(6) 2021, S1051-105-0123 ST-MO IBC (DRIVER LEAD BACKED OUT); (B)(6) 2021, 105-0123 ST0MO POST IBC FITTING; (B)(6) 2021, S1051 105-0123 ST-MO IBC TO ADDRESS DRIVER LEAD BACKING OUT; (B)(6) 2021, 105-0123 ST-MO POST IBC FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877683 ESTEEM ESTEEM II, PRODUCT CODE: OAF OAF ENVOY MEDICAL CORPORATION 2001 EMC0006764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention