MAUDE Adverse Event Report: Cochlear Ltd Nucleus Hybrid L24; Nucleus Hybrid Cochlear Implant System

Model Number	CI24RE (L24)
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a performance decrement and tingling sensation with the implanted device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2026 and the patient was reimplanted with another cochlear device during the same surgery.

• Brand Name: Nucleus Hybrid L24
• Common Device Name: Nucleus Hybrid Cochlear Implant System
• Manufacturer (Section D): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 50111554
• Report Number: 6000034-2026-02783
• Device Sequence Number: 10744273
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)170920(17)190919
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 08/03/2026
• Report Date (Section F): 08/03/2026

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: 09/19/2019
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• 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: 08/03/2026