MAUDE Adverse Event Report: ENVOY MEDICAL CORP. ESTEEM II; ESTEEM II SP

Model Number 2001

Device Problem Insufficient Information (3190)

Patient Problem Hearing Impairment (1881)

Event Date 05/11/2023

Event Type  Injury  

Event Description

Envoy medical corp.Was notified on (b)(6) 2023 of a patient whose device had allegedly stopped working immediately after falling on their head.The patient was seen by an audiologist, who successfully turned the device back on and performed a complete adjustment, but upon dis-connecting the remote from the computer, it did not successfully communicate with the esteem.The audiologist reported that the device powered off on it's own again a few hours after the appointment and that no further trouble-shooting or adjustments were successful in resolving the issue.An mdr assessment was done on 10jan2023, where it was determined that the event was not reportable, because there was not enough evidence to determine definitively whether device malfunction had occurred.On (b)(6) 2023, emc was notified that the patient had a revision surgery that day to attempt to correct the issue.No visible signs of header damage and no fluid was observed during the surgery.The battery was replaced, and will be activated after 4 weeks to allow full healing of the middle ear before activation.A follow up mdr will be filed to report whether the revision has resolved the issue.Patient/clinical history with emc: (b)(6) 2008 - implant.(b)(6) 2008 - activation.(b)(6) 2008 - fitting.(b)(6) 2008 - fitting.(b)(6) 2008 - fitting.(b)(6) 2009 - fitting.(b)(6) 2009 - fitting.(b)(6) 2010 - fitting.(b)(6) 2014 - fitting.(b)(6) 2014 - battery replacement.(b)(6) 2021 - battery replacement.(b)(6) 2023 - revision.

• Brand Name: ESTEEM II
• Type of Device: ESTEEM II SP
• Manufacturer (Section D): ENVOY MEDICAL CORP.; 4875 white bear parkway; white bear lake MN 55110
• Manufacturer (Section G): ENVOY MEDICAL CORP.; 4875 white bear parkway; white bear lake MN 55110
• Manufacturer Contact: bonnie miller ; 4875 white bear parkway; white bear lake, MN 55110 ; 6513618000
• MDR Report Key: 16967393
• MDR Text Key: 315645248
• Report Number: 3004007782-2023-00006
• Device Sequence Number: 1
• Product Code: OAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2021
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention