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	Failure to Read Input Signal (1581); Impedance Problem (2950)
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, the patient experienced no connection to the internal device during activation and no impedances could be measured.Troubleshooting attempts and hardware exchange at the clinic did not resolve the issue and the clinic requested a cochlear specialist to verify the device function.The implanted device remains in-situ.Additional information has been requested but has not been made available as of the date of this report.

• 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
• Manufacturer (Section G): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50850040
• Report Number: 6000034-2026-03429
• Device Sequence Number: 13174602
• Product Code: MCM
• UDI-Device Identifier: 09321502053082
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/22/2026

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: CI1022
• Device Catalogue Number: Z334204
• 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: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2026
• 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: Female