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

Model Number	Mi1260 SONATA 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent a reimplantation on (b)(6) 2026 (new device: (b)(6)).Following the intervention, the clinical outcome was not satisfactory, as telemetry results raised concerns regarding a possible extracochlear position of the electrode array.Despite these findings, the patient proceeded to activation on (b)(6) 2026.During activation session, fitting could not be completed as there was no auditory perception in any of the channels.
Event or Problem Description
Patient underwent a re-implantation in (b)(6) 2026.Following the intervention, the clinical outcome was not satisfactory, as telemetry results raised concerns regarding a possible extracochlear position of the electrode array.Despite these findings, the patient proceeded to activation in (b)(6) 2026.During activation session, fitting could not be completed as there was no auditory perception in any of the channels.
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.
Additional Manufacturer Narrative
Additional information: according to the information received, the active electrode array migrated out of cochlea.In addition six channels have been outside of the cochlea since initial implantation confirmed per irc.Further plans are not available at the moment.

• 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: 25905558
• Report Number: 9710014-2026-00684
• Device Sequence Number: 5854248
• Product Code: MCM
• UDI-Device Identifier: 09008737385392
• 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: 2026
• 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 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: 07/10/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 09/04/2025
• 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
• Patient Age: 57 YR
• Patient Sex: Male