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

Model Number CI24RE (ST)

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 05, 2024.

Event Description

Per the clinic, the patient experienced a performance decrement due to migration of internal device.Additional information has been requested but has not been made available as of the date of this report.The implanted device remains.

• Brand Name: NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: 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: nurshahqifah latif ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 19048200
• MDR Text Key: 339430660
• Report Number: 6000034-2024-01298
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502009317
• UDI-Public: (01)09321502009317(11)200110(17)220109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2022
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2020
• 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 Sex: Male