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

Model Number CI422

Device Problems Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Head Injury (1879)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 18, 2020.

Event Description

Per the clinic, the patient was hospitalised in (b)(6) 2020 (specific date not reported), and treated with oral antibiotics, after sustaining trauma to the cochlear implant side of the head in (b)(6) 2019.However, the issue could not be resolved.On (b)(6) 2020, the patient underwent a skin flap rotation, and a culture confirmed the presence of an (b)(6) infection, and was treated with oral antibiotics.The implanted device remains.

Manufacturer Narrative

The device analysis report is attached.It is now reported that there had been an extrusion of the implant.This report is submitted on april 1, 2021.

Manufacturer Narrative

It was reported that the device was explanted on (b)(6) 2021.This report is submitted on 2 march 2021.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10551716
• MDR Text Key: 207492994
• Report Number: 6000034-2020-02492
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)140520(17)160519
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2016
• Device Model Number: CI422
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7 YR