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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Device was explanted on (b)(6) 2025."defect" was written as reason for explantation; however, it is also indicated that the device did not contribute to explantation.Additional information received states that the user was reimplanted because hearing with the device was not satisfying.The user was re-implanted with a new device.
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.
Additional Manufacturer Narrative
Conclusion: based on measurements performed on the device whilst it was implanted and during explant investigation, it must be assumed that the explantation was not due to a technical problem.The recipient_s perception was unsatisfactory; however, no technical problem could be detected.Based on the recipient report the reason for the lack of benefit for the recipient seems to be non-device related.This is a final report.
Event or Problem Description
Device was explanted on (b)(6) 2025."defect" was written as reason for explantation; however, it is also indicated that the device did not contribute to explantation.Additional information received states that the user was re-implanted because hearing with the device was not satisfying.The user was 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: 23755915
• Report Number: 9710014-2025-01145
• Device Sequence Number: 9584179
• Product Code: MCM
• UDI-Device Identifier: 09008737062682
• UDI-Public: (01)09008737062682
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 04/01/2026

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 Expiration Date: 07/15/2012
• Device Model Number: MI1000 MED-EL CONCERT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2010
• 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: 72 YR
• Patient Sex: Male