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	Swelling/ Edema (4577)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the extracochlear electrode were nicked during csf leak repair on (b)(6), 2026.Open circuit were noted on all electrodes and the patient experienced no sound from external device.Soft tissue edema along the right temporal scalp and around the receiver stimulator complex obsereved as well.Troubleshooting, hardware exchange and reprogramming attempts were made; however, the issue could not be resolved.Subsequently, the device was explanted on (b)(6) 2026, and the patient was reimplanted with another cochlear device during the same surgery.

• 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: 50557692
• Report Number: 6000034-2026-03276
• Device Sequence Number: 18772173
• Product Code: MCM
• UDI-Device Identifier: 09321502053099
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/02/2026
• Report Date (Section F): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/03/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2026
• 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: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 09/02/2026