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

Model Number	CI24M
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, the patient experienced a performance decrement leading to device non-use.The device was then explanted on (b)(6) 2022.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 june 22, 2023.
Additional Manufacturer Narrative
Device analysis indicated device failure.Device analysis report is attached.This report is submitted on december 29, 2023.

• Brand Name: NUCLEUS 24
• 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: ken yian chow ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17179796
• Report Number: 6000034-2023-01964
• Device Sequence Number: 12377417
• Product Code: MCM
• UDI-Device Identifier: 09321502003216
• UDI-Public: (01)09321502003216(11)121120(17)141119
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/19/2014
• Device Model Number: CI24M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2012
• 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: 20 YR
• Patient Sex: Male