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

Model Number	Mi1250 SYNCHRONY 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Facial Paralysis (4585)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user is experiencing non-auditory sensations with device stimulation, present at activation.Both pain and discomfort is noted.No auditory perception is noted without discomfort.4 days post implantation left sided facial paralysis started, which has not resolved so far.
Event or Problem Description
The user is experiencing non-auditory sensations with device stimulation, present at activation.Both pain and discomfort is noted.No auditory perception is noted without discomfort.4 days post implantation left sided facial paralysis started.At most recent follow-up the user had minimal auditory percepts on a few electrodes.Her facial nerve function has not returned. .
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: based on the received information, the recipient experienced non auditory sensations with stimulation, likely due to an incomplete insertion of the electrode in the cochlea.Furthermore, the recipient reports pain and discomfort with stimulation, which is a known post-operative side effect of otologic surgery and it is unclear if the extra cochlea channel stimulation might have contributed to the reported pain.In addition a post-operative facial paralysis has been reported, which is not resolved.However, no further information is available on the treatment of the reported issues.

• Brand Name: SYNCHRONY
• 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: 50470619
• Report Number: 9710014-2026-00793
• Device Sequence Number: 10264538
• Product Code: MCM
• UDI-Device Identifier: 09008737395452
• UDI-Public: (01)09008737395452
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 10/02/2026

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 Model Number: Mi1250 SYNCHRONY 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: 08/24/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 08/25/2025
• 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: 31 YR
• Patient Sex: Female