MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Skin Infection (4544)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 19, 2020.

Event Description

Per the clinic, the patient experienced an infection at the implant site and was treated with an antibiotic ointment on (b)(6) 2020.On (b)(6) 2020, it was reported the patient experienced an extrusion of the receiver/stimulator and pus drainage from the wound.Explantation of the device is planned but has not yet taken place at the time of this report.

Manufacturer Narrative

It has now been reported that the device was explanted on (b)(6) 2020.Patient was re-implanted with a new device during the same surgery.This report is submitted on november 20, 2020.

Manufacturer Narrative

This report is submitted february 12, 2021.

• Brand Name: NUCLEUS 24
• 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: 10694981
• MDR Text Key: 211853570
• Report Number: 6000034-2020-02812
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2021

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 Model Number: CI24M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/18/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 01/22/2021
• Supplement Dates FDA Received: 11/19/2020; 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR