MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS HYBRID L24; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

Model Number	CI24RE (L24)
Medical Device Problem Codes	Circuit Failure (1089); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced pain, facial twitching and performance decrement with the device use.Fluctuating impedances were observed across the electrode array and open circuit was noted on 1 electrode.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2025, and the patient was re-implanted 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: 23601655
• Report Number: 6000034-2025-04177
• Device Sequence Number: 21326712
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)161010(17)181009
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025
• Report Date (Section F): 11/20/2025

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: 10/09/2018
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• 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 Age: 68 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/20/2025