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	Expulsion (2933)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Fall (1848); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient sustained a fall following the implantation and was reported to have poor wound healing.Approximately two weeks post-implantation, the patient developed granulation tissue at the post-auricular incision site.One month later, the patient experienced wound dehiscence resulting in exposure of the implant.The patient was treated with oral and topical antibiotics (specific date and duration not reported).Subsequently, the patient underwent a wound washout procedure on (b)(6) 2026.During the procedure, infection was observed leading to the decision to explant the device.The device was subsequently explanted.Reimplantation is planned but had not taken place at the time 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
• MDR Report Key: 25387386
• Report Number: 6000034-2026-01959
• Device Sequence Number: 5251767
• Product Code: MCM
• UDI-Device Identifier: 09321502053082
• UDI-Public: (01)09321502053082(11)251024(17)271023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2026
• Report Date (Section F): 06/04/2026

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/08/2026
• Date Report to Manufacturer: 05/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2026
• 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: 06/04/2026