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

Model Number	SONATA
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the left implant was removed for further treatment of a skin flap infection.Bacterial culture confirmed methicillin-resistant staphylococcus aureus (mrsa).The infection spread to the level of the implant.No trauma has been reported.
Additional Manufacturer Narrative
The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
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 infection of the skin leading to an extrusion of the device.According to the information received on the device explantation report form the skin over the implant was no longer intact.Review of the device_s sterilization records show 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.This is a final report.
Event or Problem Description
On (b)(6) 2026, the left implant was removed for further treatment of a skin flap infection.
Event or Problem Description
On (b)(6)2026, the left implant was removed for further treatment of a skin flap infection.
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 infection of the skin leading to an extrusion of the device.According to the information received on the device explantation report the skin over the implant was no longer intact.Review of the device_s sterilization records show 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.Additional information: the remainder part of the active electrode has been received.Damages found during device investigation are most likely related to the explantation surgery.The results above are still applicable.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()577885626
• MDR Report Key: 24143397
• Report Number: 9710014-2026-00048
• Device Sequence Number: 12987410
• Product Code: MCM
• UDI-Device Identifier: 09008737083618
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/17/2026

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: 09/21/2022
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2026
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 01/15/2026; 01/15/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/26/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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: 6 YR
• Patient Sex: Female