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

Model Number 2001

Device Problem Premature Discharge of Battery (1057)

Patient Problem Hearing Impairment (1881)

Event Date 03/19/2024

Event Type  Injury  

Event Description

Envoy was notified that the patient's battery was totally depleted on (b)(6) 2024.The calculated battery life was found to be 1.65 years (1,015 days).The minimum stated battery life of the esteem ii sp is 2.8 years (1,023 days).Patient has no history of early battery depletion, and did not report any feedback.Patient will require a battery change to resolve the issue, which will be scheduled after they recieve surgical clearance from their cardiologist.Patient/clinical history with emc: (b)(6) 2011 implant, (b)(6) 2012 fitting, (b)(6) 2012 fitting, (b)(6) 2017 battery check, (b)(6) 2017 battery change, (b)(6) 2022 battery change, (b)(6) 2022 post ibc fitting, (b)(6) 2024 follow-up visit with dr.(b)(6), (b)(6) 2024 battery check.

Manufacturer Narrative

Test results from device manufacturing were reviewed.Sound processor sn 214217 passed all functional tesing in production.A dhr review revealed that the device met all specifications and there were no manufacturing issues identified.

• Brand Name: ESTEEM
• 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: 19118195
• MDR Text Key: 340340126
• Report Number: 3004007782-2024-00002
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/12/2024

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 Expiration Date: 04/20/2023
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006925
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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): Other