MAUDE Adverse Event Report: Cochlear Ltd Nucleus Freedom Implant with Contour Advance Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI24RE (CA)
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Twitching (2172)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a facial nerve stimulation and tims results indicating electrical cross talk.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2026.The patient was reimplanted with another cochlear device during the same surgery.

• Brand Name: Nucleus Freedom Implant with Contour Advance Electrode
• Common Device Name: Nucleus 24 Cochlear Implant System
• Manufacturer (Section D): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 50927644
• Report Number: 6000034-2026-03450
• Device Sequence Number: 13138902
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026
• Report Date (Section F): 09/29/2026

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 Expiration Date: 10/14/2010
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/07/2026
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 09/29/2026