MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number MI1250 SYNCHRONY 2

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem Wound Dehiscence (1154)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

The user reported that on (b)(6) 2023 while pulling on his tragus and the external auditory canal (eac), he felt something pop and come out of his ear.Since then the recipient has not been able to hear as well as before with the device.The recipient had canal closure procedure at implantation that has dehisced.Ci electrode is now in eac.User is scheduled for audiological programming soon and revision ci surgery with rotational flap.

Manufacturer Narrative

Conclusion: according to the information received from the field the device was explanted due to an electrode lead extrusion into the external auditory canal leading to the active electrode being pulled out of cochlea.The canal closure dehiscence is reported to have been caused by patient manipulation of the wound.During explantation surgery ten channels were found extra-cochlear.Further, also the implant housing was extruding through the skin.Device investigation additionally showed damage to the active electrode caused by device minute mobility causing fatigue wire breakages.This is a final report.

Event Description

The user reported that on (b)(6)023 while pulling on his tragus and the external auditory canal (eac), he felt something pop and come out of his ear.Since then the recipient has not been able to hear as well as before with the device.The recipient had canal closure procedure at implantation that has dehisced.Ci electrode is now in eac according to note.The surgeon believes that the dehiscence of skin was caused by the user.The user used the device after the electrode lead was in the eac.The user has been explanted.At explantation, it was discovered that the coil and receiver stimulator of the device were extruding from the skin in addition to the ear canal tissue looking unhealthy for immediate re-implantation.Additionally, 10 electrode channels were seen extra cochlear at explantation.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 17893540
• MDR Text Key: 325828386
• Report Number: 9710014-2023-00898
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male