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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Codes	Circuit Failure (1089); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Type of Reportable Event	Malfunction
Event or Problem Description
In (b)(6) 2024, there was a sudden, uncomfortable, painful sensation in the implant area when the audio processor was actively worn and turned on.Reimplantation is considered.
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
On (b)(6) 2024, there was a sudden, uncomfortable, painful sensation in the implant area when the audio processor was worn.Re-implantation is considered, the date has not been scheduled yet.
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
Conclusion: device investigation confirmed that the stimulator electronics is not working according to specifications.The failure of the electronic circuitry was probably caused by humidity ingress at detected micro-leak at the header assembly.Over a certain period of time, humidity will impinge on the electronics and cause damage, potentially leading to complete failure of the circuitry.Other mechanical damages found are attributable to the removal surgery.The problems described in the recipient report appear to match the damage found.This is a final report.
Event or Problem Description
The user experienced a sudden, uncomfortable, painful sensation in the implant area when the audio processor was worn.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: 19773704
• Report Number: 9710014-2024-00639
• Device Sequence Number: 20860723
• 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: 2014
• Device Explanted Year: 2024
• 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): 12/02/2025

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: 08/01/2015
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 07/04/2024; 07/04/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/12/2024; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2013
• 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: 41 YR
• Patient Sex: Male