MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problems Circuit Failure (1089); Unexpected Therapeutic Results (1631)

Patient Problems Failure of Implant (1924); Skin Erosion (2075); Impaired Healing (2378)

Event Date 11/15/2022

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.The implanted device remains.It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on january 24, 2022.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2022, due to an infection (non-device related).There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report.This report is submitted on january 30, 2023.

Manufacturer Narrative

This report is submitted on nov 13, 2023.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: thanaletchumi manogaran ; 1 university avenue; no. 8 jalan kerinchi,; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 13330729
• MDR Text Key: 284281207
• Report Number: 6000034-2022-00094
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)181003(17)201002
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2020
• Device Model Number: CI422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 10/25/2023
• Supplement Dates FDA Received: 01/29/2023; 11/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• 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): Other; Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female