MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA; COCHLEAR IMPLANT

Model Number	MI1260 SONATA 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Facial Paralysis (4585)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
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
During a recent fitting session, the audiologist adjusted the stimulation parameters by modifying the minimum pulse duration and switching from biphasic to triphasic pulses.Despite these adjustments, the user continued to experience facial nerve stimulation, both with and without the audio processor (ap) in place.Following a calibration session, the user initially reported an improvement.However, the facial stimulation symptoms reappeared a few days later and the user is still suffering by fns at the moment.Further proceedings are currently unknown.
Event or Problem Description
The user experienced facial paralysis immediately after the implantation surgery, which improved with physical therapy.During a recent fitting session, the audiologist adjusted the stimulation parameters by modifying the minimum pulse duration and switching from biphasic to triphasic pulses.Despite these adjustments, the user continued to experience facial symptoms, both with and without the audio processor (ap) in place.Following a calibration session, the user initially reported an improvement.However, the facial symptoms reappeared a few days later.As per latest information received, the facial nerve paralysis has fully resolved with medication and physical therapy.
Additional Manufacturer Narrative
Additional information: according to the information received, the user experienced temporary facial nerve paralysis, which could be fully resolved with medication and physical therapy.Further, the observed subtle facial fasciculations appear to be related to the facial paralysis recovery, while the involuntary muscle movements affecting various facial muscles bilaterally are most likely of medical origin, and not related to the use of the cochlear implant.In situ measurements are indicative of a functional device.The device remains implanted and in use.

• 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 ; 57788
• MDR Report Key: 22892979
• Report Number: 9710014-2025-00773
• Device Sequence Number: 8852208
• Product Code: MCM
• UDI-Device Identifier: 09008737385446
• UDI-Public: (01)09008737385446
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/28/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MI1260 SONATA 2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/29/2025
• Date Device Manufactured: 03/15/2024
• 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: 46 YR
• Patient Sex: Male