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

Model Number	CI24R (ST)
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Breakdown (2681); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on march 21, 2019.
Event or Problem Description
It was reported that the patient experienced breakdown of wound and extrusion of the device.Subsequently, the patient was treated with antibiotics (date not reported).The implanted device remains.
Additional Manufacturer Narrative
Additional: it has since been reported that the patient underwent surgery on (b)(6) 2019 to explant the device.It is unknown if the patient has been re-implanted as of the date of this report.This report is submitted on may 6, 2019.
Additional Manufacturer Narrative
Per the clinic, the patient experienced an infection at implant site (specific date not reported).This report is submitted on november 29, 2023.

• Brand Name: NUCLEUS 24K
• 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: nabila zahari ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 8439072
• Report Number: 6000034-2019-00351
• Device Sequence Number: 2978414
• Product Code: MCM
• UDI-Device Identifier: 09321502002332
• UDI-Public: (01)09321502002332(11)120425(17)140424
• Combination Product (Y/N): N
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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: 04/24/2014
• Device Model Number: CI24R (ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 11/07/2023
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 05/06/2019; 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2012
• 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 Sex: Male