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

Model Number	MI1260 SONATA 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	03/24/2025
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
About 6 months ago the recipient started experiencing a lack of hearing with the device.The recipient's family reported that the recipient had a trauma in the implant region.The recipient has been re-implanted with a new device.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to a migration of the active electrode out of the cochlea.Reportedly the recipient suffered from a head trauma, which might have contributed to the reported migration.The concerned device was not received for investigation yet.
Event or Problem Description
About 6 months ago the recipient started experiencing a lack of hearing with the device.The recipient's family reported that the recipient had a trauma in the implant region.The recipient has been re-implanted with a new device.
Event or Problem Description
The recipient started experiencing a lack of hearing with the device.The recipient had a trauma in the implant region.The recipient has been re-implanted with a new device.
Additional Manufacturer Narrative
Conclusion: device investigation of the received parts did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found are attributable to the removal surgery.According to the information received from the field the device was explanted due to a migration of the active electrode out of the cochlea.Reportedly, the recipient suffered from a head trauma, which might have contributed to the reported migration.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 ; 57788
• MDR Report Key: 21879373
• Report Number: 9710014-2025-00332
• Device Sequence Number: 7865463
• Product Code: MCM
• UDI-Device Identifier: 09008737385439
• UDI-Public: (01)09008737385439
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/21/2025

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: 05/19/2024
• Device Model Number: MI1260 SONATA 2
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 04/10/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/13/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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: 7 YR
• Patient Sex: Male