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	Unspecified Infection (1930)
Date of Event	03/10/2025
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
It was reported that the recipient suffered from redness at the implant area since (b)(6) 2024.The redness then turned into swelling.In (b)(6) 2024, the skin was corrected with revision for implant site exposure.In early 2025 the infection re-occurred.Since the infection antibiotic treatment and creams thinned the skin.The recipient was explanted.Re-implantation will be considered after 6 months depending on the healing status of the implant site.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to infection and extrusion of the devive 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.
Event or Problem Description
It was reported that the recipient suffered from redness at the implant area since (b)(6) 2024.The redness then turned into swelling.In (b)(6) 2024, the skin was corrected with revision for implant site exposure.In early 2025 the infection re-occurred.Antibiotic treatment and creams thinned the skin.The recipient was explanted.Re-implantation will be considered after 6 months depending on the healing status of the implant site.
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 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.
Event or Problem Description
It was reported that the recipient suffered from redness at the implant area since (b)(6) 2024.The redness then turned into swelling.In (b)(6) 2024, the skin was corrected with revision for implant site exposure.In early 2025 the infection re-occurred.Antibiotic treatment and creams thinned the skin.The recipient was 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: 21617837
• Report Number: 9710014-2025-00251
• Device Sequence Number: 6837717
• Product Code: MCM
• UDI-Device Identifier: 09008737385408
• UDI-Public: (01)09008737385408
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2025

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 Expiration Date: 06/12/2025
• Device Model Number: MI1260 SONATA 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 03/14/2025; 03/14/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/02/2025; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2022
• 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: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male