MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI632 Profile Plus with Slim Modiolar Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI632
Medical Device Problem Codes	Circuit Failure (1089); Decreased Sensitivity (2534); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Purulent Discharge (1812); Mastoiditis (4835); Cholesteatoma (4920)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient developed progressive cholesteatoma in (b)(6) 2025 (specific date not reported), resulting in a markedly enlarged mastoid cavity with the electrode lead visibly exposed within the cavity.Hearing performance was initially stable; however, the patient reported sudden hearing loss in approximately early (b)(6) 2026.Reprogramming attempts were made; however, the issue could not be resolved.Subsequently, the device was explanted on (b)(6) 2026.During surgery, the electrode placement site was cleansed, and pus was observed within the cochlea.Postoperative antibiotics (specific type, date and duration not reported) were administered to treat the infection.The patient was reimplanted with another cochlear device during the same surgery.

• Brand Name: Nucleus CI632 Profile Plus with Slim Modiolar Electrode
• Common Device Name: Nucleus 24 Cochlear Implant 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: amalia azman ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50558992
• Report Number: 6000034-2026-03046
• Device Sequence Number: 16079058
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 08/04/2022
• Device Model Number: CI632
• Device Catalogue Number: P783831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2020
• 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: Male