MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI632 Profile Plus with Slim Modiolar Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI632
Medical Device Problem Codes	Circuit Failure (1089); Failure to Deliver Shock/Stimulation (1133); Output Problem (3005); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, the patient sustained a head impact on (b)(6) 2026.Subsequently, the patient experienced no sound and poor performance with the device use.An open circuit was noted on 19 electrodes.Hardware exchange attempts were made; however, the issue could not be resolved.The implanted device remains.It is unknown if there are plans to explant the device and reimplant the patient with another cochlear device as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

• Brand Name: Nucleus CI632 Profile Plus with Slim Modiolar Electrode
• Common Device Name: Nucleus 24 Cochlear Implant System
• Manufacturer (Section D): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 50706358
• Report Number: 6000034-2026-03172
• Device Sequence Number: 18801724
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/10/2026
• Report Date (Section F): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/25/2025
• Device Model Number: CI632
• Device Catalogue Number: P783831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/13/2026
• Date Report to Manufacturer: 08/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2026
• 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: Other
• Patient Sex: Male
• Date Report Sent to FDA: 09/10/2026