MAUDE Adverse Event Report: MED-EL Elektromedizinische Geraete GmbH SONATA; Cochlear Implant

Model Number	SONATA
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Infectious Otitis Media (4815)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user went to an ent clinic for ear canal cleaning.The doctor by mistake sucked the electrode out of the cochlea.The active electrode now is in the eac.The user has been explanted.
Event or Problem Description
The user went to an ent clinic for ear canal cleaning.The doctor by mistake sucked the electrode out of the cochlea.The active electrode now is in the eac.The user has been explanted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the active electrode was accidentally pulled out of cochlea during an ear cleaning procedure.Reportedly during explantation surgery an infection in the middle ear was found, which was likely the cause for the ear cleaning.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.The concerned device was explanted but has not been received for investigation yet.
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.

• 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: 50084387
• Report Number: 9710014-2026-00715
• Device Sequence Number: 21512672
• Product Code: MCM
• UDI-Device Identifier: 09008737049133
• UDI-Public: (01)09008737049133
• 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: 2021
• Device Explanted Year: 2026
• 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): 08/18/2026

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 Expiration Date: 02/24/2024
• Device Model Number: SONATA
• 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: 07/27/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 02/24/2021
• 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: 11 YR
• Patient Sex: Male