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

Model Number 2001

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem Partial Hearing Loss (4472)

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

Patient experienced a backed-out driver lead after a routine battery replacement.This required a follow-up surgery to evaluate and eventually replace the sp.The patient's hearing was restored after the sp was replaced.Mfr records were reviewed 12/10/2021.No issues were identified in the mfr records.

Event Description

Envoy medical corp.(emc) was notified on 10/28/2021 of a patient reporting eii device cutting in and out immediately after a battery change procedure (occurring (b)(6) 2021).A follow-up procedure was completed (b)(6) 2021 and a backed-out driver lead was confirmed.The sp was removed and replaced with a new sp.The system was then found to be operating as expected after the revision procedure.Patient is meeting nal-rp target with excellent wrs.No device or system performance issues are indicated or alleged.Patient/clinical history with emc: (b)(6) 2012 ,105-0123(a0) st-mo implant; (b)(6) 2012, 105-0123(a0) st-mo activation; (b)(6) 2012, 105-0123(a0) st-mo fitting; (b)(6) 2017, 105-0123 stmo fitting; (b)(6) 2017, 105-0123 st-mo battery change; (b)(6) 2021, s1051-105-0123 st-mo ibc (driver lead backed out); (b)(6) 2021, 105-0123 st0mo post ibc fitting; (b)(6) 2021, s1051 105-0123 st-mo ibc to address driver lead backing out; (b)(6) 2021, 105-0123 st-mo post ibc 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 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: 12975733
• MDR Text Key: 289904683
• Report Number: 3004007782-2021-00010
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/10/2021

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: 07/22/2022
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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): Required Intervention