MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Drug Resistant Bacterial Infection (4553)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

This report has been submitted on april 01, 2021.

Event Description

Per the clinic, the patient experienced an mrsa infection at implant site and subsequently was treated with oral and injectable antibiotics (date and duration not reported).However, the issue did not resolve.The device was then explanted (b)(6) 2021.Reimplantation is planned but had not taken place at the time of this report, (b)(6) 2021.

Manufacturer Narrative

Per the clinic, the device was extruded out of the head (specific date not reported).This report is submitted on march 10, 2023.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: 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: sharannya karthiyeyan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 11600767
• MDR Text Key: 243319400
• Report Number: 6000034-2021-00824
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025683
• UDI-Public: (01)09321502025683(11)160407(17)180406
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/06/2018
• Device Model Number: CI24RE (ST)
• Date Manufacturer Received: 03/06/2021
• Date Device Manufactured: 04/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Sex: Female