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

Model Number 2001

Device Problem Premature Discharge of Battery (1057)

Patient Problem Hearing Impairment (1881)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

Test results from device manufacturing were reviewed.Sound processor sn 213578 passed all functional testing in production.A dhr review revealed that the device met all specifications and there were no manufacturing issues.The battery was confirmed to be depleted at the time of explant.

Event Description

Emc was notified of a battery depletion on (b)(6) 2020.The battery was found to be at 2.3v, reflecting a depleted battery.The battery life was found to be 2.34 years.The minimum stated battery life of the eii sp is 2.8 years.Upon functional testing, a low battery was verified, and it was determined the device passes testing and no additional malfunction has occured with the device.Patient usage/environment are possible factors to consider.The patient's profound high frequency loss, max gain settings used and regular exposure to loud environments are possible factors to consider.Patient/clinical history with emc: (b)(6) 2011 implant, (b)(6) 2011 fitting, (b)(6) 2014 fitting, (b)(6) 2014 battery change, (b)(6) 2018 fitting, (b)(6) 2018 battery change, (b)(6) 2020 battery change, (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 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: 10868408
• MDR Text Key: 217452668
• Report Number: 3004007782-2020-00009
• 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: 11/19/2020

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: 01/31/2019
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• 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