MAUDE Adverse Event Report: COCHLEAR LIMITED COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH CONTOUR ADVANCE® ELECTRODE; COCHLEAR¿ NUCLEUS® NEXA® SYSTEM

Model Number	CI1012
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bacterial Infection (1735); Swelling/ Edema (4577); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the clinic, it was reported that the patient underwent a surgical procedure under general anesthesia on (b)(6) 2026 where incision and drainage with washout was performed.The patient was also treated with oral and iv antibiotics (specific date and duration not reported).
Event or Problem Description
Per the clinic, the patient experienced an infection, swelling and fluid accumulation around the receiver/stimulator site.The patient was subsequently treated with a pressure headwrap, antibiotics therapy (specific type, date and duration not reported), and surgical intervention requiring a three-night inpatient hospital stay (specific date not reported).The implanted device remains.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 CONTOUR ADVANCE® ELECTRODE
• Common Device Name: COCHLEAR¿ NUCLEUS® NEXA® SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 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: amalia azman ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25145955
• Report Number: 6000034-2026-01710
• Device Sequence Number: 21521737
• Product Code: MCM
• UDI-Device Identifier: 09321502069847
• UDI-Public: (01)09321502069847(11)250714(17)270713
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P970051/S225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: CI1012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female