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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user has no hearing sensation with the device.Re-implantation is considered.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a technical implant failure seems likely.However to determine an exact root cause device investigation would be necessary.Re-implantation is considered but no date has been scheduled yet.
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it 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
The user has no hearing sensation with the device.Re-implantation is considered.
Event or Problem Description
The user has no hearing sensation with the device.The user has been re-implanted.
Additional Manufacturer Narrative
Conclusion: the device investigation revealed a defective welding joint between feed-through pin and the implant coil.Other mechanical damages found during investigation are very likely related to the removal surgery.The investigation results appear to match the problems mentioned in the user report.This is a final 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 ; 57788
• MDR Report Key: 21362779
• Report Number: 9710014-2025-00129
• Device Sequence Number: 8577022
• Product Code: MCM
• UDI-Device Identifier: 09008737062675
• UDI-Public: (01)09008737062675
• 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: 2023
• 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): 07/29/2025

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: 10/05/2025
• Device Model Number: MI1000 MED-EL CONCERT PIN
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 02/10/2025; 02/10/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 02/19/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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: Female