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 Post Operative Wound Infection (2446)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: test results from device manufacturing and dhr were reviewed.All components in question passed all functional testing in production and passed quality inspections.No anomalies associated with sterilization of product.No device failures are alleged.(b)(4).

Event Description

Envoy medical corp.(emc) was notified on (b)(6) 2019 of a patient that experienced perioperative, surgical incision site infection, post battery change.Patient was treated by patient's local ent with a course of antibiotics and the infection was cleared.No device deficiencies are alleged.Patient/clinical history with emc: (b)(6).

Manufacturer Narrative

Device evaluation summary: test results from device manufacturing and dhr were reviewed.All components in question passed all functional testing in production and passed quality inspections.No anomalies associated with sterilization of product.No device failures are alleged.

Event Description

Envoy medical corp.(emc) was notified on 08/22/19 of a patient that experienced perioperative, surgical incision site infection, post battery change.Patient was treated by patient's local ent with a course of antibiotics and the infection was cleared.No device deficiencies are alleged.Patient/clinical history with emc: 130604 - implant, 130807 - activation, 131030 - fitting, 140122 - fitting, 140430 - fitting, 140917 - fitting, 160928 - fitting and remote support, 190719 - battery change, 190822 - emc notified of surgical incision site infection (mdr: 3004007782-2019-00005).Update: patient experiencing returning/continuing infection in the affected area.Physician recommendation is to explant the eii system due to complications of the infection.Explant has not yet occurred due to covid-19 pandemic/concerns.Antibiotic treatment was originally used to clear up the infection, however it seems to have returned.Physician states that diabetes is likely a major contributing factor.

Manufacturer Narrative

Device evaluation summary: test results from device manufacturing and dhr were reviewed.All components in question passed all functional testing in production and passed quality inspections.No anomalies associated with sterilization of product.No device failures are alleged.

Event Description

Envoy medical corp.(emc) was notified on (b)(6) 2019 of a patient that experienced perioperative, surgical incision site infection, post battery change.Patient was treated by patient's local ent with a course of antibiotics and the infection was cleared.No device deficiencies are alleged.Patient/clinical history with emc: (b)(6) - implant.(b)(6) - activation.(b)(6) - fitting.(b)(6) - fitting.(b)(6) - fitting.(b)(6) - fitting.(b)(6) - fitting and remote support.(b)(6) - battery change.(b)(6) - emc notified of surgical incision site infection (mdr: 3004007782-2019-00005).(b)(6) - esteem ii system explant.Update: patient experiencing returning/continuing infection in the affected area.Physician recommendation is to explant the eii system due to complications of the infection.Explant has not yet occurred due to covid-19 pandemic/concerns.Antibiotic treatment was originally used to clear up the infection, however it seems to have returned.Physician states that diabetes is likely a major contributing factor.Update (2): patient has been explanted (b)(6) 2020 as expected (noted in update/follow up mdr #1).

• 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 MN 55110
• MDR Report Key: 8944734
• MDR Text Key: 160998572
• Report Number: 3004007782-2019-00005
• Device Sequence Number: 1
• Product Code: OAF
• Combination Product (y/n): N
• PMA/PMN Number: P090018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2020

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: 09/24/2019
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006353
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/29/2020; 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention