MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI422
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced extrusion of the receiver/stimulator, resulting in exposure of the device through the skin.The patient also reported occasional mild pain and nuisance at the implant site.Additional information has been requested but has not been made available as of the date of this report.The implanted device remains.
Additional Manufacturer Narrative
Correction: initial mdr [6000034-2026-01239] submitted on april 09, 2026 was filed inadvertently.The was no occurrence of extrusion.It was reported that the receiver/stimulator was seen through the skin due to thin skin flap.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT 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: hema dewi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 24826765
• Report Number: 6000034-2026-01239
• Device Sequence Number: 21444316
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)140912(17)160911
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 05/12/2026

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 Expiration Date: 09/11/2016
• Device Model Number: CI422
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2014
• 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
• Patient Sex: Female