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	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a decline in speech performance and residual hearing.Reprogramming attempts were performed; however, the issue could not be resolved.The patient is no longer a hybrid user and requires regular mri examinations.The device was subsequently explanted on (b)(6) 2026 under general anesthesia.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
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: amalia azman ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25439334
• Report Number: 6000034-2026-02029
• Device Sequence Number: 20355135
• Product Code: PGQ
• UDI-Device Identifier: 09321502012089
• UDI-Public: (01)09321502012089(11)150527(17)170526
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P130016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 05/26/2017
• Device Model Number: CI24RE (L24)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female