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	06/23/2025
Type of Reportable Event	Malfunction
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 noticed in the last 2 months that when he presses with his finger in the mastoidectomy region, the implant sound becomes louder and clearer and he can hear better.As soon as he stops pressing, the sound degrades.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However, to determine an exact root cause a device investigation of the explanted device is necessary.No information on possible further steps has been received.
Event or Problem Description
The user noticed in the last 2 months that when he presses with his finger in the mastoidectomy region, the implant sound becomes louder and clearer and he can hear better.As soon as he stops pressing, the sound degrades.The user is awaiting another ent appointment.
Event or Problem Description
The user noticed in the last 2 months that when he presses with his finger in the mastoidectomy region, the implant sound becomes louder and clearer and he can hear better.As soon as he stops pressing, the sound degrades.The user has been reimplanted.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.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: 22334660
• Report Number: 9710014-2025-00574
• Device Sequence Number: 9126081
• Product Code: MCM
• UDI-Device Identifier: 09008737062743
• UDI-Public: (01)09008737062743
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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: 08/31/2014
• Device Model Number: MI1000 MED-EL CONCERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 06/24/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/03/2025; 03/02/2026
• Date Device Manufactured: 09/04/2012
• 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: 26 YR
• Patient Sex: Male