MAUDE Adverse Event Report: ENVOY MEDICAL CORPORATION ESTEEM; ESTEEM II, PRODUCT CODE: OAF

Model Number 2001

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem Partial Hearing Loss (4472)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Patient experienced a backed-out driver lead after a routine battery replacement.This required an immediate follow-up surgery to re-insert the lead.The patient's hearing was restored after the driver lead was re-inserted.Following the re-insertion revision procedure, the system stopped operating once again.This required an additional revision procedure, where the driver was confirmed backed-out.The sp was replaced.The system is operating as expected.Mfr records were reviewed (b)(6) 2021.No issues were identified in the mfr records.The returned sound processor was visually and functionally evaluated (b)(6) 2021, using standard visual inspection, test lead insertion and final functional electrical testing processes.No visual issues/concerns were found.Lead insertion was confirmed to be successful.Device passed functional testing.

Event Description

Envoy medical corp.(emc) was notified on (b)(6) 2021 of a patient whose driver test results was outside of confidence intervals immediately after a battery change procedure (occurring (b)(6) 2021).A backed-out driver transducer lead was suspected, requiring a follow-up procedure.The follow-up procedure was completed immediately after the battery change procedure ((b)(6) 2021) and a backed-out driver lead was confirmed.The backed-out driver lead was re-inserted to its proper position and the patient's hearing was then found to be restored.The sp was not removed/replaced.On (b)(6) 2021, envoy audiologist reported that the patient called again indicating the system was once again not operating as expected.On (b)(6) 2021, a revision procedure occurred and driver lead was confirmed to have backed-out.The sound processor was replaced.The system was then found to be operating as expected.The explanted sound processor was returned to emc and arrived on (b)(6) 2021.Returned product evaluation was conducted on (b)(6) 2021, per standard visual and final functional testing.No issues or concerns were identified during visual inspection.Test lead insertion was confirmed to be successful.Final functional test results were passing.Based on returned product evaluation results, there were no device issues identified.Patient/clinical history with emc: (b)(6) 2012: implant, (b)(6) 2014: fitting, (b)(6) 2016: battery change, (b)(6) 2021: battery change, (b)(6) 2021: transmastoid revision (re-insertion of driver lead), (b)(6) 2021: transmastoid revision (replacement of sound processor).

• Brand Name: ESTEEM
• Type of Device: ESTEEM II, PRODUCT CODE: OAF
• Manufacturer (Section D): ENVOY MEDICAL CORPORATION; 4875 white bear parkway; white bear lake MN 55110
• Manufacturer (Section G): ENVOY MEDICAL CORPORATION; 4875 white bear parkway; white bear lake MN 55110 8057
• Manufacturer Contact: maksim trofimovich ; 4875 white bear parkway; white bear lake, MN 55110-8057 ; 6513618029
• MDR Report Key: 12469218
• MDR Text Key: 271535547
• Report Number: 3004007782-2021-00007
• 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: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/14/2021

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: 03/15/2022
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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