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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Tears (2516); Ear infection (4813)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the user presented a significant case of infection in the right ear, and there was also extrusion of the electrode array.
Additional Manufacturer Narrative
The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient had an infection in the ear, leading to formation of mastoiditis and extrusion of the electrode array.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No available information points to the implant being the source of infection.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user had an infection in the right ear, and the electrode array had extruded.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage.This finding was expected, because according to the information received from the field the recipient had an infection in the ear, leading to formation of mastoiditis and extrusion of the electrode array.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No available information points to the implant being the source of infection.This is a final report.
Event or Problem Description
The user had an infection in the right ear, and the electrode array had extruded.The user was hospitalized to treat the infection, and was explanted a few days later.The user has been reimplanted.

• 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: 22506722
• Report Number: 9710014-2025-00638
• Device Sequence Number: 9264867
• Product Code: MCM
• UDI-Device Identifier: 09008737366155
• UDI-Public: (01)09008737366155
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/07/2023
• Device Model Number: MI1000 MED-EL CONCERT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 07/07/2025; 07/07/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/26/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• 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; Hospitalization
• Patient Age: 11 YR
• Patient Sex: Female