MAUDE Adverse Event Report: MED-EL Elektromedizinische Geraete GmbH SONATA; Cochlear Implant

Model Number	Mi1260 SONATA 2
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	09/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user suffers from an implant extruding through the skin.As per new information received, the issue started on august 5th; implant telemetry showed the electrodes were functioning correctly, but calibration was not possible because the processors were broken.No skin damage was observed at that time.On august 25th, the mother reported the wound at the implant site.The mother did report to the audiologist that the child had become more aggressive since he stopped using the processors.The devices were sent for technical inspection, and a failure in the rcb was found in both units.
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.

• 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()577885626
• MDR Report Key: 50895292
• Report Number: 9710014-2026-00902
• Device Sequence Number: 21503931
• Product Code: MCM
• UDI-Device Identifier: 09008737385453
• UDI-Public: (01)09008737385453
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/10/2026
• Device Model Number: Mi1260 SONATA 2
• Was Device Available for Evaluation?: No
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 08/10/2023
• 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
• Patient Age: 11 YR
• Patient Sex: Male