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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion: based on the received information, a damage to the active electrode due to excessive mechanical stress caused by the reported trauma appears very likely.However, to determine an exact root cause device investigation would be necessary.The concerned device was explanted but has not been received for investigation yet.This is a combinded initial and final report.
Event or Problem Description
The user's parent reported that the user was unable to hear sounds with the device after a head impact.The user has been re-implanted.
Additional Manufacturer Narrative
Conclusion: the cause of the device failure is most likely overload fractures in the active electrode, which are consistent with external mechanical impact.Due to multiple damages in the electrode and the fact that the complete electrode was not preserved, the exact location of the damage cannot be determined.This is a final report.
Event or Problem Description
The user's parent reported that the user was unable to hear sounds with the device after a head impact.The user has been re-implanted.

• 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: 23002000
• Report Number: 9710014-2025-00820
• Device Sequence Number: 8806313
• Product Code: MCM
• UDI-Device Identifier: 09008737062682
• UDI-Public: (01)09008737062682
• 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: 2022
• 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
• Report Date (Section B): 10/28/2025

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 Expiration Date: 06/06/2023
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2021
• 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: 4 YR
• Patient Sex: Male