MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI522 Cochlear Implant with Slim Straight Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI522
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient underwent an mri in 2024 (specific date not reported).Following the mri, the patient experienced pain while wearing the sound processor, and no connection could be established with the implant.A revision surgery was subsequently performed (specific date not reported) to replace the magnet; however, connection with the implant could still not be established following the procedure.Subsequently, the device was explanted on (b)(6)2026.The patient was reimplanted with another cochlear device during the same surgery.Additional information has been requested but has not been made available as of the date of this report.
Additional Manufacturer Narrative
Device analysis indicated device failure.Device analysis report attached.

• Brand Name: Nucleus CI522 Cochlear Implant with Slim Straight 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: dini aziz ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50800696
• Report Number: 6000034-2026-03296
• Device Sequence Number: 10589645
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/17/2026

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: 01/22/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2018
• 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