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

Model Number 2001

Device Problem Premature Discharge of Battery (1057)

Patient Problem Hearing Impairment (1881)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Emc was notified of a battery depletion on (b)(6) 2022.The calculated battery life was found to be 2.78 years (1,015 days).The minimum stated battery life of the eii sp is 2.8 years (1,023 days).The device's manufacturing records were reviewed and no issues related to this event were found.Patient usage is a possible factor to consider.Patient has a history of early battery depletion.Patient/clinical history with emc: (b)(6) implant, (b)(6) activation, (b)(6) fitting, (b)(6) fitting, (b)(6) fitting, (b)(6) analysis, (b)(6) fitting, (b)(6) battery change, (b)(6) fitting and remote support summary, (b)(6) battery check, (b)(6) battery change, (b)(6) fitting, (b)(6) battery change, (b)(6) battery change.

Manufacturer Narrative

Test results from device manufacturing were reviewed.Sound processor sn (b)(4)passed all functional testing in production.A dhr review revealed that the device met all specifications and there were no manufacturing issues.

• 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: 15322402
• MDR Text Key: 298910569
• Report Number: 3004007782-2022-00008
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/30/2022

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 Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• 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