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 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Patient experienced a backed-out sensor lead after a routine battery replacement.This required an immediate follow-up surgery to re-insert the lead.No device deficiency was alleged or found.Issue was related to the procedure vs.The device.The patient's hearing was restored after the sensor lead was re-inserted.Mfr records were reviewed on 11/02/2020.No issues were identified related to this adverse event.

Event Description

Envoy medical corp.(emc) was notified on 10/23/2020 of a patient whose sensor testing had no output immediately after a battery change procedure.A backed-out transducer lead was assumed, requiring a follow-up procedure.The follow-up procedure was completed immediately after the battery change procedure and a backed-out lead was confirmed.The backed-out lead was re-inserted to its proper position, and the patient's hearing was then found to be restored.The sp was not removed/replaced.No device deficiencies are alleged because the system was found to be functioning properly intraoperatively, and the issue is related to the lead backing-out.Patient/clinical history with emc: (b)(6).

• 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: 10771004
• MDR Text Key: 214797685
• Report Number: 3004007782-2020-00008
• 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: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/02/2020

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: 10/28/2020
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• 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): Required Intervention