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

Model Number 2001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Hearing Impairment (1881)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Patient is experiencing feedback that is consistent with electrical feedback, similar to that seen in previous instances of header abrasion.Device in question has not been replaced/explanted at the time of this report.Explant is planned but not yet scheduled.Emc will submit follow up to this initial report once the device is available for evaluation and final root cause determination.

Event Description

Envoy medical corp.(emc) quality was notified on 07/29/2020 of a suspected header abrasion (abnormal feedback scan).Although electrical feedback is an indication of possible header abrasion, due to related fluid ingress, this will not be confirmed until after the device is explanted and evaluated at emc.Due to reporting agreements/guidelines and the currently available information indicating possibility of header abrasion, emc is filing this mdr.Note: returned product analysis (visual inspection) has not yet been completed as the device has not yet been removed/explanted.Patient/clinical history with emc: (b)(6) 2012: implant.(b)(6) 2012: activation.(b)(6) 2012: fitting.(b)(6) 2017: battery check.(b)(6) 2017: battery change.(b)(6) 2017: fitting.(b)(6) 2018: fitting.(b)(6) 2019: fitting.(b)(6) 2020: fitting.

• 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
• Manufacturer (Section G): ENVOY MEDICAL CORPORATION; 4875 white bear parkway; white bear lake, mn
• Manufacturer Contact: maksim trofimovich ; 4875 white bear parkway; white bear lake, mn ; 3618029
• MDR Report Key: 10358901
• MDR Text Key: 205314400
• Report Number: 3004007782-2020-00005
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2017
• Device Model Number: 2001
• Device Catalogue Number: 902001-002
• Device Lot Number: EMC0005991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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