MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI24RE (CA) Cochlear Implant with Contour Advance Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI24RE (CA)
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Output Problem (3005); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Discomfort (2330); Implant Pain (4561); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced non-auditory stimulation and poor performance with the device.It was also reported that the patient experienced pain, buzzing, and facial nerve stimulation, which led to inconsistent use of the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2026, and the patient was re-implanted with another cochlear device during the same surgery.

• Brand Name: Nucleus CI24RE (CA) Cochlear Implant with Contour Advance Electrode
• Common Device Name: Nucleus 24 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: shahqifah latif ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50662312
• Report Number: 6000034-2026-03177
• Device Sequence Number: 18681572
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 06/07/2014
• Device Model Number: CI24RE (CA)
• Device Catalogue Number: Z60353
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2012
• 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 Sex: Female