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 Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced electrode lead displacement during the initial implantation surgery, with the electrode array partially inserted and positioned in the mastoid cavity.Subsequently, the patient underwent repositioning surgery on(b)(6) 2026 during which the device was inserted into a new sheath and reimplanted into the cochlea.The implanted device remains.

• 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: 50897573
• Report Number: 6000034-2026-03379
• Device Sequence Number: 10684186
• Product Code: MCM
• UDI-Device Identifier: 09321502053099
• UDI-Public: (01)09321502053099(11)251023(17)271022
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026
• Report Date (Section F): 09/25/2026

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?: No
• 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: 09/02/2026
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2026
• 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: 09/25/2026