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

Model Number	SONATA
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hearing performance of the device is affected.
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
Since (b)(6) 2026, the user's hearing performance with the device has been affected.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.In addition, according to the implant registration card, a full insertion was not achieved at implantation surgery with one channel remaining extra-cochlear.However, to determine an exact root cause device investigation would be necessary.Re-implantation has been done but the explanted device has not been received for investigation yet.

• 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: 25076970
• Report Number: 9710014-2026-00409
• Device Sequence Number: 16126119
• Product Code: MCM
• UDI-Device Identifier: 09008737049119
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/17/2026

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: 07/25/2024
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 04/27/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/26/2026; 09/17/2026
• Date Device Manufactured: 07/25/2021
• 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: 6 YR
• Patient Sex: Female