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 Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the clinic, the patient developed a staphylococcus infection affecting both the middle ear and the implant site.Microbial cultures obtained from swabs of the implant site tested positive for methicillin-resistant staphylococcus aureus (mrsa).The patient was subsequently hospitalized and treated with intravenous antibiotics; however, the condition did not resolve.Consequently, the device was explanted on (b)(6) 2026.As of the date of this report, it is unknown whether there are plans for reimplantation.

• 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: hakim muhaimin jamil ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25453855
• Report Number: 6000034-2026-02079
• Device Sequence Number: 10340416
• Product Code: MCM
• UDI-Device Identifier: 09321502053082
• UDI-Public: (01)09321502053082(11)250930(17)270929
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P970051/S225
• 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: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Male