MAUDE Adverse Event Report: MED-EL Elektromedizinische Geraete GmbH CONCERTO; Cochlear Implant

Model Number	Mi1000 MED-EL CONCERT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
In (b)(6) 2025, the user developed edema and swelling at the right cochlear implant incision site.The user was explanted.
Additional Manufacturer Narrative
The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

• 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 ; +43()577885626
• MDR Report Key: 50767291
• Report Number: 9710014-2026-00862
• Device Sequence Number: 9195653
• Product Code: MCM
• UDI-Device Identifier: 09008737083632
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/24/2025
• Device Model Number: Mi1000 MED-EL CONCERT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 10/24/2023
• 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: 3 YR
• Patient Sex: Male