MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI422 Cochlear Implant with Straight Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI422
Medical Device Problem Codes	Circuit Failure (1089); High impedance (1291); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, the patient experienced high impedance with some electrodes and poor performance with implanted device.Troubleshooting and 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 to reimplant the patient with a new device as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

• Brand Name: Nucleus CI422 Cochlear Implant with Straight 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: hema dewi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50536364
• Report Number: 6000034-2026-03081
• Device Sequence Number: 14965212
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 07/17/2020
• Device Model Number: CI422
• Device Catalogue Number: Z190574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2018
• 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: Other
• Patient Sex: Female