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

Model Number	SONATA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the recipient never had experienced hearing benefit from the device.Demonstrating only sound detection for loud impact noises.However, this information was never communicated to the med-el clinical support team.In recent years, the recipient had discontinued follow-up appointments.He developed a significant middle ear infection, and the family decided to proceed with explantation.The recipient has been explanted.To be confirmed.
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
Reportedly, the recipient never had experienced hearing benefit from the device.Demonstrating only sound detection for loud impact noises; however, this information was never communicated to the med-el clinical support team.In recent years, the recipient had discontinued follow-up appointments.He developed a significant middle ear infection, and the family decided to proceed with explantation.The recipient has been explanted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to a middle ear infection.Review of the device_s sterilization records show that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of the reported issue.Further it was reported that the recipient never had satisfactory hearing benefit with the device.However, the lack of hearing benefit seems to be device unrelated.In situ measurements show two channels involved in a short circuit.The remaining channels should provide sufficient hearing benefit.The explanted device has not been received for investigation yet.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the device was explanted due to a middle ear infection.Review of the device_s sterilization records show that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of the reported issue.Further it was reported that the recipient never had satisfactory hearing benefit with the device.However the lack of hearing benefit seems to be device unrelated.Device investigation revealed damage to the active electrode caused by device minute mobility.In situ measurements before explantation only showed two channels involved in a short circuit.The remaining channels should have provided sufficient hearing benefit.Apart from the wire breakages the device works within specification.This is a final report.
Event or Problem Description
Reportedly, the recipient never had experienced hearing benefit from the device.Demonstrating only sound detection for loud impact noises; however, this information was never communicated to the med-el clinical support team.In recent years, the recipient had discontinued follow-up appointments.He developed a significant middle ear infection, and the family decided to proceed with explantation.The recipient has been explanted.

• Brand Name: SONATA
• 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: 22156777
• Report Number: 9710014-2025-00515
• Device Sequence Number: 8906978
• Product Code: MCM
• UDI-Device Identifier: 09008737049171
• UDI-Public: (01)09008737049171
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SONATA
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 06/02/2025; 06/02/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/16/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 32 YR
• Patient Sex: Male