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)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a performance decrement resulting in the decision to discontinue use of the device.The implanted device remains.The device was explanted (b)(6) 2026.The patient was reimplanted with a new device (specific date not reported).

• 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: 50835151
• Report Number: 6000034-2026-03329
• Device Sequence Number: 9957392
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/21/2026
• Report Date (Section F): 09/21/2026

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: 11/08/2017
• Device Model Number: CI24RE (L24)
• 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: 08/27/2026
• Date Report to Manufacturer: 08/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2026
• 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: 09/21/2026