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

Model Number	Mi1260 SONATA 2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hematoma (1884); Swelling/ Edema (4577)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it 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
A revision surgery was performed to clean and drain a hematoma.
Event or Problem Description
The user, who is bilaterally implanted, presented two months ago with a spontaneous hematoma, without trauma, in the right temporal region over the magnet of the right cochlear implant.A revision surgery was performed to clean and drain the hematoma in (b)(6) 2026.During the procedure, it was observed that the magnet was outside the pocket.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the recipient underwent a surgery to drain a hematoma that has not been described in detail, at the implant site.During this procedure it was noticed that the implant magnet was out of the magnet pocket.However, it could be pushed back into the pocket and the surgery was completed successfully without further issues.The magnet very likely got out of the pocket during the surgical process by inadequate handling.

• 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: 24882533
• Report Number: 9710014-2026-00357
• Device Sequence Number: 18604671
• Product Code: MCM
• UDI-Device Identifier: 09008737385446
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/05/2026
• Device Model Number: Mi1260 SONATA 2
• Was Device Available for Evaluation?: No
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 02/05/2023
• 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