MAUDE Adverse Event Report: Cochlear Ltd Cochlear¿ Nucleus® Nexa® cochlear implant with Slim Modiolar electrode; Cochlear¿ Nucleus® Nexa® System

Model Number	CI1032
Medical Device Problem Codes	Circuit Failure (1089); Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, open circuits were noted on all electrodes during initial surgery and activation.The device could not be programmed, hence, the patient received no sound with the device.Troubleshooting attempts were made; however, the issue could not be resolved.The implanted device remains.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.

• Brand Name: Cochlear¿ Nucleus® Nexa® cochlear implant with Slim Modiolar electrode
• Common Device Name: Cochlear¿ Nucleus® Nexa® System
• Manufacturer (Section D): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 50863895
• Report Number: 6000034-2026-03617
• Device Sequence Number: 9380078
• Product Code: MCM
• UDI-Device Identifier: 09321502053099
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026
• Report Date (Section F): 09/23/2026

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 Model Number: CI1032
• Device Catalogue Number: P1434929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/28/2026
• Date Report to Manufacturer: 08/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2026
• 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: 09/23/2026