MAUDE Adverse Event Report: ENVOY MEDICAL CORP. ESTEEM; ESTEEM SENSOR

Model Number 7002

Device Problems Material Puncture/Hole (1504); Output below Specifications (3004)

Patient Problem Partial Hearing Loss (4472)

Event Date 12/04/2023

Event Type  Injury  

Event Description

Envoy medical corporation was notified on 29-sep-2023 that a patient reported a sudden onset of feedback after a flight on (b)(6) 2022.Testing was performed at site 105 on 29-sep-2022, which showed that the max gain had dropped to 5/5 from 40/40 at the patient's last fitting in 2020.Feedback test was out of range at all frequencies and the frequencies presented by the audiometer were not read correctly by the processor when doing the sensor diagnostic.Typanogram was normal, patient has no consistent history of etd.On (b)(6) 2023, surgeon reported that the patient's tympanic membrane was retracted and may be in contact with the driver.The surgeon did a surgery to place a tube in the patient's ear in order to resolve the issue, and recommended a follow-up appointment in a month, either for a fitting, if the patient's symptoms have been resolved, or to discuss next steps if the patient is still experiencing symptoms.On (b)(6) 2023, surgeon reported that the patient was still continuing to experience symptoms and recommended replacing the patient's sp under local and prepare to do a bigger operation if that does not correct his hearing.Patient had a battery change on (b)(6) 2023, performed by surgeon.On (b)(6) 2023, the patient was seen following the battery change by audiologist, testing showed that the max gain and the diagnostic feedback test were unchanged.Clinical spoke with surgeon and is planned to complete an updated case review, which was shared with clinical in a conference call.Surgeon further reported that he was considering a revision to fix the issue.On (b)(6) 2023, the patient had a revision, during which the esteem sp, driver, and sensor were all replaced.On (b)(6) 2023, the surgeon reported that during the revision, the sensor capacitance was measured at 440 and he observed that blood was visible in the lead and that the driver had a visible cut in the head and exposure of bare wire.Patient/clinical history with envoy: on (b)(6) 2011: implant, on (b)(6) 2011: activation, on (b)(6) 2014: fitting, on (b)(6) 2014: battery change, on (b)(6) 2018: battery change, on (b)(6) 2018: fitting, on (b)(6) 2020: battery change, on (b)(6) 2020: fitting, on (b)(6) 2022: case review, on (b)(6) 2022: fitting, on (b)(6) 2023: battery change, on (b)(6) 2023: fitting, on (b)(6) 2023: transmastoid revision.

• Brand Name: ESTEEM
• Type of Device: ESTEEM SENSOR
• 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: 18432469
• MDR Text Key: 331860250
• Report Number: 3004007782-2024-00001
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/02/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2012
• Device Model Number: 7002
• Device Catalogue Number: 907002-002
• Device Lot Number: EMC0003745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2010
• 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