MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Tissue Breakdown (2681); Fluid Discharge (2686)

Event Date 12/19/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 2, 2021.

Event Description

Per the clinic, the patient experienced recurrent infection and a fluid collection (abscess) with discharge, at the implant site.The abscess was drained, and the device was explanted on (b)(6) 2020.The patient has not been reimplanted with a new device as of the date of this report.

Manufacturer Narrative

The device analysis report is attached.It ha now been reported that oral antibiotics were administered for the infection.This report is submitted on april 1, 2021.

Manufacturer Narrative

It has now been reported that the patient experienced skin breakdown at the implant site.This report is submitted on may 11, 2023.

• Brand Name: NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11396968
• MDR Text Key: 234204708
• Report Number: 6000034-2021-00517
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)161103(17)181102
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/02/2018
• Device Model Number: CI522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• 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 Age: 4 YR
• Patient Sex: Female