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 Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Cellulitis (1768)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the device was explanted on (b)(6) 2026 due to infection (cellulitis) at the magnet/receiver stimulator site.There are no plans to re-implant the patient with a new device as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

• 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: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25089765
• Report Number: 6000034-2026-01788
• Device Sequence Number: 5078750
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)190430(17)210429
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 04/29/2021
• Device Model Number: CI532
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2019
• 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