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

Model Number	MI1260 SONATA 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	03/20/2025
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
The recipient had a skin infection at the implant site for the second time.There was a skin necrosis with opening of the skin.Antibiotic treatment was provided, however, did not resolve the issue.Cultures were performed and showed pseudomonas aeruginosa.The recipient has been explanted.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which is expected to have been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the device was explanted due to an infection and necrosis at the implant site with no response to antibiotic treatment.A 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.
Event or Problem Description
The recipient had a skin infection at the implant site for the second time.There was a skin necrosis with opening of the skin.Antibiotic treatment was provided, however did not resolve the issue.Cultures were performed and showed pseudomonas aeruginosa.The recipient has been explanted.

• 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: 21785009
• Report Number: 9710014-2025-00315
• Device Sequence Number: 8676189
• Product Code: MCM
• UDI-Device Identifier: 09008737385446
• UDI-Public: (01)09008737385446
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/12/2025

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 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: 04/02/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: 3 YR
• Patient Sex: Male