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

Model Number	Mi1250 SYNCHRONY 2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Meningitis (2389)
Type of Reportable Event	Death
Event or Problem Description
The recipient was implanted on (b)(6) 2026.Approximately 3 weeks post-op, she developed meningitis.She was hospitalized and died within a few days.
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.

• 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: 50883832
• Report Number: 9710014-2026-00890
• Device Sequence Number: 18598452
• Product Code: MCM
• UDI-Device Identifier: 09008737366742
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 09/18/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 11/18/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Death; Required Intervention
• Patient Age: 30 MO
• Patient Sex: Female