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

Model Number 2001

Device Problem Intermittent Communication Failure (4038)

Patient Problem Hearing Impairment (1881)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

Envoy medical corp.(emc) quality was notified 09/23/2022 of a patient complaint related to allegations that the device 'stopped working'.It was unclear if this was related to user error or another reason.The patient was scheduled to be seen by an audiologist (b)(6) 2022.The patient was seen by an audiologist (b)(6) 2022.On 10/13/2022 details from the (b)(6) 2022 audiologist visit were provided to emc, stating issues related to communication between the device and the commander fitting software as well as issues related to communication between the device and the patient's personal programmer.Depleted battery was also ruled out by the audiologist during this visit.On 10/17/2022 it was confirmed to emc quality that the patient can not hear out of the affected implanted ear.Note: no surgical or medical intervention has occurred outside of routine troubleshooting.Patient/clinical history with emc: (b)(6) 2008, implant, (b)(6) 2008 turn on, (b)(6) 2008 fitting, (b)(6) 2008 fitting, (b)(6) 2008 fitting, (b)(6) 2009 fitting, (b)(6) 2009 fitting, (b)(6) 2010 fitting, (b)(6) 2014 fitting, (b)(6) 2014 battery replacement, (b)(6) 2021 battery replacement.

• 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: 15651398
• MDR Text Key: 307007342
• Report Number: 3004007782-2022-00013
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2021
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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