MAUDE Adverse Event Report: Cochlear Limited 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 Limited; 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: mastura ruhanet ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50863899
• Report Number: 6000034-2026-03616
• Device Sequence Number: 18498104
• Product Code: MCM
• UDI-Device Identifier: 09321502053099
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P970051/S225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2026
• 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: Male