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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
There was a decline in hearing with the device in early (b)(6) 2025.After about two months' attempt of head bandage, there was no change in the situation.Therefore, the user was re-implanted.
Event or Problem Description
The user's hearing performance with the device is affected.The user was re-implanted.
Additional Manufacturer Narrative
Conclusion: based on the received information from the field, a technical failure at the reference electrode seems likely.However, as the device has been received damaged an exact location cannot be determined.Further damage to the active electrode caused by device minute mobility was found.Other mechanical damages are attributable to the removal surgery.This is a final report.
Event or Problem Description
There was a decline in hearing with the device in early (b)(6) 2025.After about two months' attempt of head bandage, there was no change in the situation.Therefore, the user was re-implanted.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, a technical failure of the reference electrode seems likely.However, to determine an exact root cause, a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.

• 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: 23141189
• Report Number: 9710014-2025-00893
• Device Sequence Number: 8944023
• 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: 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): 12/10/2025

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: 10/19/2022
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 09/23/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/04/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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
• Patient Age: 5 YR
• Patient Sex: Male