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	Head Injury (1879)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user sustained trauma to the implant site, followed by progressive swelling and inflammation.Despite prolonged conservative management with oral antibiotics for two months, the condition deteriorated, leading to skin breakdown over the implant site with device exposure, granulation tissue formation, and a significant soft tissue defect.The user was subsequently admitted and treated with intravenous antibiotics.However, following multidisciplinary evaluation (ent, cochlear implant surgeon, and plastic surgery team), it was concluded that salvage of the implant was not feasible.Explantation was performed with a plan for soft tissue reconstruction and infection control.Given the current limitations in healthcare resources and the user_s living conditions, no further conservative or surgical salvage options were viable.
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.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to an infection and extrusion of the device through the skin, which could not be treated with antibiotics.Reportedly the recipient suffered from a head impact, which led to an inflammation and swelling at the implant site and clearly contributed to the observed issue.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.The investigation findings code for this report is c1902.
Event or Problem Description
The user sustained trauma to the implant site, followed by progressive swelling and inflammation.Despite prolonged conservative management with oral antibiotics for two months, the condition deteriorated, leading to skin breakdown over the implant site with device exposure, granulation tissue formation, and a significant soft tissue defect.The user was subsequently admitted and treated with intravenous antibiotics.However, following multidisciplinary evaluation (ent, cochlear implant surgeon, and plastic surgery team), it was concluded that salvage of the implant was not feasible.\ explantation was performed with a plan for soft tissue reconstruction and infection control.Given the current limitations in healthcare resources and the user_s living conditions, no further conservative or surgical salvage options were viable.

• 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: 25078338
• Report Number: 9710014-2026-00411
• Device Sequence Number: 10418337
• Product Code: MCM
• UDI-Device Identifier: 09008737385453
• UDI-Public: (01)09008737385453
• 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: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/24/2025
• 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: 04/26/2026
• Supplement Date Received by Manufacturer: 04/26/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 01/24/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male