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

Model Number	SONATA
Medical Device Problem Codes	Circuit Failure (1089); Impedance Problem (2950)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user came to the hospital with a report of road traffic accident on (b)(6) 2026.After the incident, there was bleeding from the right ear which was promptly shown to an ent surgeon.There was bleeding from lower and posterior tympanic membrane.Post this incident, the child has not been able to hear anything on the right ear.Further proceedings are currently unknown.
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.
Additional Manufacturer Narrative
Conclusion: based on the information received, a mechanical damage of the stimulator electronics, which is typical for a severe external impact to the housing, appears likely.However, to determine and confirm an exact root cause of failure cause a device investigation of the explanted device is necessary.Further steps are currently unknown.This is a final report.
Event or Problem Description
After a traffic incident, there was bleeding from the right ear and from lower and posterior tympanic membrane.Post this incident, the child has not been able to hear anything on the right ear.Further proceedings are currently unknown.

• 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: 24627006
• Report Number: 9710014-2026-00273
• Device Sequence Number: 12910514
• Product Code: MCM
• UDI-Device Identifier: 09008737049133
• UDI-Public: (01)09008737049133
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 04/22/2026

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: 01/23/2025
• Device Model Number: SONATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/22/2026
• Date Device Manufactured: 01/23/2022
• 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: 7 YR
• Patient Sex: Female