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 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Patient experienced sp implant site wound breakdown, caused by eyeglass temple trauma, as noted by the physician.The wound dehiscence was repaired by the physician using a u-shaped, l temporoparietal scalp flap.The sp (battery unit) was also replaced as a precautionary measure, as noted by the physician, to help decrease the probability of postoperative infection.Device was programmed and activated.Device has not yet been returned to emc, and the issue is not related to device deficiency (no deficiency is alleged) but rather to use (eyeglass frame trauma).

Event Description

Envoy medical corp.(emc) was notified on (b)(6) 2019 of a sterile wound dehiscence.The physician noted that the leads had eroded through thin postauricular skin due to eyeglass temple trauma (eyeglass frame rubbing through temple skin at sp implant site).No device deficiency or infection was alleged or noted.A revision/battery change occured (b)(6) 2019 to address the issue.The physician successfully corrected the wound dehiscence using a u-shaped l temporoparietal scalp flap.The sp was replaced during the revision as a precautionary measure, as noted by the physician, to help decrease the probability of postoperative infection.Sp was replaced per standard procedure.No infection was found/noted.Patient was successfully programmed and activated following the revision procedure.Patient/clinical history with emc: (b)(6) 2008 - implant, (b)(6) 2008 - device on, (b)(6) 2008 - device activation, (b)(6) 2008 - 2 month check, (b)(6) 2008 - 4 month check, (b)(6) 2011 - battery change, (b)(6) 2014 - fitting, (b)(6) 2015 - battery change, (b)(6) 2015 - fitting, (b)(6) 2017 - fitting, (b)(6) 2019 - battery change ibc, (b)(6) 2019 - revision with sp change.

• 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: 9328491
• MDR Text Key: 185274277
• Report Number: 3004007782-2019-00007
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/30/2019
• Device Model Number: 2001
• Device Catalogue Number: 902001-003
• Device Lot Number: EMC0006322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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): Required Intervention