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	12/12/2024
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
In (b)(6) of 2024, three weeks after activation, the wound began to break down, resulting in partial implant exposure.Under general anesthesia, the wound was cleaned, re_explored, and a temporoparietal fascia (tpf) flap was performed.In (b)(6) 2025, the user presented with swelling.The user declined aspiration of the fluid procedure and user was then lost to follow_up for four months.The user returned in (b)(6) 2025 with discharge from a partially dehiscent wound.A pus sample for culture and sensitivity was collected.The wound was irrigated with saline and antibiotics and subsequently sutured.This procedure was performed twice.
Event or Problem Description
In (b)(6) 2024, three weeks after activation the wound began to break down, resulting in partial implant exposure.Under general anesthesia, the wound was cleaned, re_explored, and a temporoparietal fascia (tpf) flap was performed.In (b)(6) 2025, the user presented with swelling.The user declined aspiration of the fluid procedure and user was then lost to follow_up for four months.The user returned in (b)(6) 2025 with discharge from a partially dehiscent wound.A pus sample for culture and sensitivity was collected.The wound was irrigated with saline and antibiotics and subsequently sutured.This procedure was performed twice.The device was explanted in (b)(6) 2025 to prevent further issue.
Additional Manufacturer Narrative
Conclusion: 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.In addition device investigation revealed minor damage to the active electrode, however this would have no influence on the hearing performance.Other mechanical damages found are attributable to the removal surgery.This is a final report.Please note: c1902 is the appropriate imdrf c code, however it is currently not accepted by fda system.

• 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- 57788-5626
• MDR Report Key: 24468276
• Report Number: 9710014-2026-00204
• Device Sequence Number: 9581683
• Product Code: MCM
• 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: 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): 05/27/2026

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 Model Number: MI1260 SONATA 2
• 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: 02/21/2026
• Supplement Date Received by Manufacturer: 02/21/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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: Female