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

Model Number	CI1022
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Malposition of Device (2616); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced poor sound quality and poor performance with the device with electrode tip foldover in the mid-portion of the array.Troubleshooting and hardware exchange attempts were made; however, the issue could not be resolved.The device was subsequently 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 Straight 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: 50832382
• Report Number: 6000034-2026-03305
• Device Sequence Number: 16021936
• Product Code: MCM
• UDI-Device Identifier: 09321502053082
• UDI-Public: (01)09321502053082(11)260129(17)280128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/19/2026
• Report Date (Section F): 09/19/2026

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: CI1022
• Device Catalogue Number: Z334204
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/24/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2026
• 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: Female
• Date Report Sent to FDA: 09/19/2026