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

Model Number CI24RE (CA)

Device Problem Expulsion (2933)

Patient Problems Fall (1848); Head Injury (1879)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a fall/traura to site and subsequently exposing the receiver/stimulator.The device was explanted on (b)(6) 2023.There are no plans to re-implant the patient with another cochlear device as of the date of this report.

Manufacturer Narrative

This report is submitted on march 28, 2023.

Manufacturer Narrative

Device analysis report attached.This report is submitted on april 27, 2023.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE 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: debbie ang ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16625398
• MDR Text Key: 312097563
• Report Number: 6000034-2023-00966
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)120330(17)140329
• 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,Followup
• Report Date: 04/06/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/29/2014
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2012
• 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: Female