MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI532 Cochlear Implant with Slim Modiolar Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI532
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Therapeutic or Diagnostic Output Failure (3023); Unstable Impedance (4085)
Health Effect - Clinical Codes	Dizziness (2194); Balance Problems (4401); Implant Pain (4561)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a decrement in sound quality and speech perception; and fluctuating impedance measurements with the implanted device.The patient also experienced dizziness, a decrease in stability when walking, pain and a pumping sensation at the implant site.Troubleshooting and reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2026 and the patient was re-implanted with a new device during the same surgery.

• Brand Name: Nucleus CI532 Cochlear Implant 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: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50863699
• Report Number: 6000034-2026-03377
• Device Sequence Number: 21160759
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/23/2026

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: 10/03/2019
• Device Model Number: CI532
• Device Catalogue Number: Z285654
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2017
• 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