BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM

    MDR report key: 13712583 · Received March 9, 2022

    Report

    Report Number
    3004007782-2022-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 9, 2022
    Manufacturer
    ENVOY MEDICAL CORPORATION
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT EXPERIENCED A BACKED-OUT DRIVER LEAD AFTER A ROUTINE BATTERY REPLACEMENT. THIS WILL REQUIRE A FOLLOW-UP SURGERY TO REMEDY THE SITUATION. MFR RECORDS WERE REVIEWED. NO ISSUES WERE IDENTIFIED IN THE MFR RECORDS.

    Description of Event or Problem · 0

    ENVOY MEDICAL CORP. (EMC) WAS NOTIFIED ON (B)(6) 2022 OF A PATIENT EXPERIENCING WHAT APPEARS TO BE SOUND INTERMITTENCY ("ON/OFF"). GENTLE PHYSICAL MANIPULATION AROUND THE IMPLANT SITE SEEMS TO AFFECT THE INTERMITTENCY. ON (B)(6)2022 EMC RECEIVED CONFIRMATION OF A BACKED-OUT TRANSDUER LEAD, DRIVER. CONFIRMATION WAS MADE VIA LATERAL SKULL FILM. THE RESULTING FILM APPEARS TO SHOW A BACKED-OUT LEAD. THE PATIENT'S LAST PROCEDURE WAS A BATTERY CHANGE OCCURING (B)(6)2022. PATIENT/CLINICAL HISTORY WITH EMC: 110714 111-0073(A0) WI-ST IMPLANT, 110907 111-0073(A0) WI-ST ACTIVATION, 110929 111-0073(A0) WI-ST FITTING, 111025 111-0073(A0) WI-ST EXPLANT, 120315 111-0073(C0) WI-ST IMPLANT, 120430 111-0073(C0) WI-ST ACTIVATION, 120606 111-0073(C0) WI-ST FITTING, 130130 111-0073 WI-ST FITTING, 131218 111-0073 WI_ST FITTING, 140814 111-0073 WI-ST FITTING, 170614 111-0073 WI-ST BATTERY CHANGE, 170614 111-0073 WI-ST POST BATTERY CHANGE FITTING AND AUDIOGRAM, 220204 111-0073 WI-ST BATTERY CHANGE, 220204 111-0073 WI-ST POST BATTERY CHANGE FITTING,AND 220215 111-0073 WIST INTERMITTENCY COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2759682 ESTEEM ESTEEM II, PRODUCT CODE: OAF OAF ENVOY MEDICAL CORPORATION 2001 EMC0006839

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention