MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH CONCERTO; COCHLEAR IMPLANT

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Infectious Otitis Media (4815)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the device was explanted due to multiple device unrelated infections in the middle ear (chronic suppurative otitis media), which did not spread to the implant site.Additionally, the recipient was reportedly a non-user.A review of the device's sterilization records shows that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of the infection.Further device investigation of the received parts revealed damage to the reference electrode, likely caused by repeated external impact on the implant site and damage to the active electrode, likely caused by device minute mobility.Other mechanical damages found are attributable to the removal surgery.This is a combined initial and final report.
Event or Problem Description
According to the doctor, the user experienced multiple infections in the middle ear, and there were concerns regarding the potential for meningitis.No meningitis occurred and the infection did not spread to the implant site.The device has been explanted.

• Brand Name: CONCERTO
• Common Device Name: 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: 24255945
• Report Number: 9710014-2026-00106
• Device Sequence Number: 20914702
• Product Code: MCM
• UDI-Device Identifier: 09008737062705
• UDI-Public: (01)09008737062705
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MI1000 MED-EL CONCERT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR
• Patient Sex: Female