MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA; Cochlear Implant

Model Number	Mi1260 SONATA 2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Head Injury (1879); Insufficient Information (4580)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
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
The device was explanted.The reason for re-implantation is an injury in (b)(6) 2026, after which the user suddenly lost her hearing.
Additional Manufacturer Narrative
Additional information: according to the information received the device was explanted due to a loss of benefit after an injury.However, neither in situ measurements nor further information has been received.A root cause cannot be determined due to lack of information.The explanted device has not been received for investigation yet.
Event or Problem Description
The device was explanted.The reason for re-implantation is an injury in january 2026, after which the user suddenly lost her hearing.
Event or Problem Description
The device was explanted.The reason for re-implantation is an injury in (b)(6) 2026, after which the user suddenly lost her hearing.
Additional Manufacturer Narrative
Conclusion: damage to the reference electrode, likely caused by the repeated external impacts, was determined to be the root cause of device failure.Other mechanical damages found are attributable to the removal surgery.This is a final report.

• 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 ; +43-(577)88
• MDR Report Key: 24555112
• Report Number: 9710014-2026-00237
• Device Sequence Number: 15668616
• Product Code: MCM
• UDI-Device Identifier: 09008737385385
• UDI-Public: (01)09008737385385
• 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: 2024
• Device Explanted Year: 2026
• 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): 07/23/2026

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 Model Number: Mi1260 SONATA 2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/03/2026; 03/03/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/28/2026; 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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: 5 YR
• Patient Sex: Female