MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 22; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI22M
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced an implant pain and poor performance with the device.The patient also require mri for his back resulting in a decision to explant the device.The device was explanted on (b)(6) 2024, and there are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report.

• Brand Name: NUCLEUS 22
• 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: ashwinii chelvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 20793699
• Report Number: 6000034-2024-04035
• Device Sequence Number: 14293340
• Product Code: MCM
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P840024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1987
• Device Explanted Year: 2024
• 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): 01/03/2025

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 Model Number: CI22M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 82 YR
• Patient Sex: Male