MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI622 Cochlear Implant with Slim Straight Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI622
Medical Device Problem Codes	Circuit Failure (1089); Failure to Deliver Shock/Stimulation (1133); Unexpected Therapeutic Results (1631); Noise, Audible (3273)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Head Injury (1879); Swelling/ Edema (4577)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, the patient experienced a small amount of swelling on top of pinna, with bruising and a small cut after sustaining a head impact.The patient is reportedly able to hear; however, the sound is fuzzy and beeping which eventually leads to a complete loss of sound percept.Open circuits were noted on a few electrodes.Troubleshooting, hardware exchange and reprogramming 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.

• Brand Name: Nucleus CI622 Cochlear Implant with Slim 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: shahqifah latif ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50850138
• Report Number: 6000034-2026-03391
• Device Sequence Number: 15941012
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 10/31/2025
• Device Model Number: CI622
• Device Catalogue Number: P783829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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