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

Model Number	SONATA
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
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
Last month, the user experienced a skin infection and electrode extrusion in the ear canal.Infection had spread to the implant.The user was explanted on (b)(6) 2025.At explantation it was found that the coil had extruded through the skin and the device had migrated posteriorly.
Event or Problem Description
Last month, the user experienced a skin infection and electrode extrusion in the ear canal.Infection had spread to the implant.The user was explanted.At explantation it was found that the coil had extruded through the skin and the device had migrated posteriorly.
Additional Manufacturer Narrative
Conclusion: device investigation 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 an extrusion of the device through the skin.In addition, the electrode lead extruded into the external ear canal.A review of the device sterilization records shows 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.The implant housing had also migrated from its intended position.In situ measurements whilst implanted showed two channels involved in a short circuit, however the damage could be not confirmed during device investigation as the device was damaged during explantation 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 ; 57788
• MDR Report Key: 23815863
• Report Number: 9710014-2025-01170
• Device Sequence Number: 13286487
• Product Code: MCM
• UDI-Device Identifier: 09008737083618
• UDI-Public: (01)09008737083618
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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
• Report Date (Section B): 03/25/2026

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: 02/22/2019
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2016
• 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: 13 YR
• Patient Sex: Female