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

Model Number	Mi1260 SONATA 2
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Tissue Breakdown (2681)
Date of Event	12/15/2025
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
On (b)(6) 2025 parents noticed discharge from the incision site.They contacted the surgeon and the wound was managed immediately with iv and oral antibiotics.After four weeks of extensive treatment, no improvement was noticed and implant was fully exposed.To prevent further spread of infection, the device was explanted on (b)(6) 2026.
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.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
On (b)(6) 2025 parents noticed discharge from the incision site.They contacted the surgeon and the wound was managed immediately with iv and oral antibiotics.After four weeks of extensive treatment no improvement was noticed and implant was fully exposed.To prevent further spread of infection, the device was explanted on (b)(6) 2026.
Event or Problem Description
In (b)(6)2025 parents noticed discharge from the incision site.They contacted the surgeon and the wound was managed immediately with iv and oral antibiotics.After four weeks of extensive treatment no improvement was noticed and implant was fully exposed.To prevent further spread of infection, the device was explanted in (b)(6)2026.
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 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.Re-implantation with a new device is planned.This is a final report.Note: c1902 is chosen imdrf inv finding 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: 24200666
• Report Number: 9710014-2026-00073
• Device Sequence Number: 12152007
• 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: 01/24/2026
• Supplement Date Received by Manufacturer: 01/24/2026; 01/24/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/09/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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: 24 MO
• Patient Sex: Female