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

Model Number	CI24RE (L24)
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced poor sound quality, poor device performance since activation and progressive loss of residual low frequency hearing.The sound quality was also described as too high pitched and screechy.Reprogramming attempts were made; however, the issue could not be resolved.Subsequently, the device was explanted on (b)(6) 2025, and the patient was reimplanted with another cochlear device during the same surgery.
Event or Problem Description
Correction: the previous or initial mdr submitted on december 04, 2025, was filed inadvertently.The correct date of awareness is october 30, 2025; not november 07, 2025 as previously reported.

• Brand Name: NUCLEUS HYBRID L24
• Common Device Name: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 23715219
• Report Number: 6000034-2025-04321
• Device Sequence Number: 16021128
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)220311(17)240310
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026
• Report Date (Section F): 01/19/2026

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: 03/10/2024
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/19/2026
• 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 Age: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/19/2026