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 Code	Circuit Failure (1089)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, the patient had very unreliable behavioral responses and typically cried with the external processors on or off.During the clinical appointment on (b)(6) 2026, impedance testing showed that all electrodes were open across the array in all modes.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 it has not been made available 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
• MDR Report Key: 50851017
• Report Number: 6000034-2026-03395
• Device Sequence Number: 15841262
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/22/2026
• Report Date (Section F): 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: 05/29/2026
• Device Model Number: CI622
• Device Catalogue Number: P783829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/27/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• 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: 09/22/2026