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	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The device was explanted.
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
The user noticed redness of skin at the site of the implant about 3 months after activation and use of the external device.The user was initially immediately treated with antibiotics.However, the redness increased with erosion of skin and exposure of implant occurred.The surgeon covered the implant with a skin graft and injectable antibiotics were given for a couple of weeks.The graft failed, with infection spreading to adjacent skin leading to implant exposure.Since the infection was not controlled, the surgeon decided to explant the device and treat the infection.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to a skin infection and extrusion of the device through the skin.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.However, the presence of the device might have contributed to its subsequent development.The explanted device has not been received for investigation yet.Please note: imdrf code c assigned is c1902.However this code is not yet accepted by fda system.
Event or Problem Description
The user noticed redness of skin at the site of the implant about 3 months after activation and use of the external device.The user was initially immediately treated with antibiotics.However, the redness increased with erosion of skin and exposure of implant occurred.The surgeon covered the implant with a skin graft and injectable antibiotics were given for a couple of weeks.The graft failed, with infection spreading to adjacent skin leading to implant exposure.Since the infection was not controlled, the surgeon decided to explant the device and treat the infection.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage.According to the information received from the field the device was explanted due to a skin infection and extrusion of the device through the skin.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.However, the presence of the device might have contributed to its subsequent development.This is a final report.Note: c1902 is chosen imdrf inv findings code.

• 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: 24896039
• Report Number: 9710014-2026-00365
• Device Sequence Number: 8858979
• Product Code: MCM
• UDI-Device Identifier: 09008737385385
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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 Model Number: Mi1260 SONATA 2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 04/13/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/28/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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: Male