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

Model Number	CI422
Medical Device Problem Codes	Circuit Failure (1089); Failure to Deliver Shock/Stimulation (1133); Expulsion (2933)
Health Effect - Clinical Code	Ear Pain (4812)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced sharp ear pain.On (b)(6) 2026; the patient was sedated for the earwax removal and due to the professional's manipulation of the external ear leads to extrusion of the electrode, non-auditory stimulation and open circuits were noted on all electrodes.However, this did not alleviate the problem resulting in a decision to explant the device.The implanted device remains.
Additional Manufacturer Narrative
It was reported that the patient was placed under local anesthesia for the earwax removal.The previous or initial mdr submitted on (b)(6) 2026; was filed inadvertently.No planned explant.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM 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: shalini rajandran krishnan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 24258298
• Report Number: 6000034-2026-00281
• Device Sequence Number: 8064890
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)150727(17)170726
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 03/03/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/26/2017
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2015
• 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 Age: 12 YR
• Patient Sex: Female