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

Model Number 2001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

Patient was reported to be experiencing a wound breakdown.Mfr records were reviewed.See attached.No device or procedural issues were identified related to this adverse event.

Event Description

Envoy medical corp.(emc) was notified on (b)(6) 2022, by the surgeon, of a sterile wound breakdown over the esteem ii implant site.The patient also had a previous wound breakdown, reported on emdr 3004007782-2022-00006.The patient and surgeon are discussing future care options.Patient/clinical history with emc: (b)(6) 2013: implant.(b)(6) 2013: fitting.(b)(6) 2013: fitting.(b)(6) 2017: battery replacement.(b)(6) 2022: battery replacement.(b)(6) 2022: explant of sp to promote healing (emdr 3004007782-2022-00006).(b)(6) 2022: implant new sp (sn: (b)(4)).(b)(6) 2022: secondary wound breakdown (emdr 3004007782-2022-00014).

Manufacturer Narrative

Follow-up(1): esteem system explant to promote healing of wound.Patient has history of wound healing issues.Patient was reported to be experiencing a wound breakdown.Mfr records were reviewed.See attached.No device or procedural issues were identified related to this adverse event.

Event Description

Follow-up (1): envoy medical corp.(emc) was notified on (b)(6) 2023 that the surgeon removed the esteem system on(b)(6) 2023, to promote wound healing.No allegations or indications of wound/site infection.Envoy medical corp.(emc) was notified on (b)(6) 2022, by the surgeon, of a sterile wound breakdown over the esteem ii implant site.The patient also had a previous wound breakdown, reported on emdr 3004007782-2022-00006.The patient and surgeon are discussing future care options.Patient/clinical history with emc: (b)(6) 2013 implant.(b)(6) 2013: fitting.(b)(6) 2013: fitting.(b)(6) 2017: battery replacement.(b)(6) 2022: battery replacement.(b)(6) 2022: explant of sp to promote healing (emdr 3004007782-2022-00006).(b)(6) 2022: implant new sp (b)(6).(b)(6) 2022: secondary wound breakdown (emdr 3004007782-2022-00014).

• 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: 16029408
• MDR Text Key: 305980289
• Report Number: 3004007782-2022-00014
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

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: 04/20/2023
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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