MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24K; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI24R (ST)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the device was explanted on (b)(6) 2023, due to electrode out of cochlea and an infection (non-device related).There are no plans to reimplant the patient with a new device as of the date of this report.
Additional Manufacturer Narrative
This report is submitted on november 24, 2023.

• Brand Name: NUCLEUS 24K
• 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: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18203020
• Report Number: 6000034-2023-03797
• Device Sequence Number: 7345708
• Product Code: MCM
• UDI-Device Identifier: 09321502002332
• UDI-Public: (01)09321502002332(11)080812(17)100811
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• 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): 11/04/2023

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: 08/11/2010
• Device Model Number: CI24R (ST)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2023
• Initial Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2008
• 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: 23 YR
• Patient Sex: Male