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 02/28/2022

Event Type  Injury  

Event Description

Emc was notified of a battery depletion on (b)(6) 2022.The battery was found to be at 2.14v, reflecting a depleted battery.The battery life was found to be 2.77 years (1,011 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 factors to consider, as the patient's hearing is steadily declining and the previous device depletetion was quicker than average (however, within acceptable timeframe).Patient/clinical history with emc: (b)(6) 2012 implant, (b)(6) 2012 activation, (b)(6) 2012 fitting, (b)(6) 2013 fitting, (b)(6) 2013 fitting, (b)(6) 2015 fitting and remote support note, (b)(6) 2015 fitting, (b)(6) 2016 battery change, (b)(6) 2017 fitting, (b)(6) 2019 battery change, (b)(6) 2020 fitting audio and note, (b)(6) 2021 fitting note and audio, and (b)(6) 2022 battery check - depleted battery confirmed by audiologist.

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.The battery was confirmed to be depleted at the latest battery check.

• 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: 13712020
• MDR Text Key: 286878245
• Report Number: 3004007782-2022-00003
• 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: 03/09/2022

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 Expiration Date: 09/24/2019
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2018
• 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