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

Model Number	SONATA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient was implanted in october 2014.The audiologist attempted to perform auto art, however, he reported significant discomfort, particularly in the left ear, which was more sensitive than the right.She verified that he had previously shown neural responses; however, it was no longer able to visualize any responses during (b)(6)2025's session.This may be partly due to the lower current levels used in this session.However, even during the follow-up appointment, when higher current levels were applied, no responses were recorded.The user has been re-implanted.
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: 50668807
• Report Number: 9710014-2026-00836
• Device Sequence Number: 10235696
• Product Code: MCM
• UDI-Device Identifier: 09008737049133
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 06/01/2015
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 07/01/2013
• 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: 15 YR
• Patient Sex: Male