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

Model Number CI24RE(ST)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 19 june 2020.

Event Description

Per the clinic, the patient developed a post-operative infection at the implant site and subsequently was treated with medications (specific medication not reported).The patient then developed the second infection in (b)(6) 2020 (specific date not reported) and was treated with medications (specific medication not reported).And third infection on (b)(6) 2020, patient was treated with oral and topical antibiotics medications and the issue was resolved.The implanted device remains.

Manufacturer Narrative

It was reported the device was explanted on (b)(6) 2020.There are no plans to re-implant the patient with a new device as of the date of this report.This report is submitted 10 august 2020.

Manufacturer Narrative

Device analysis report attached.This report is submitted on march 22, 2022.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH 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 (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: 10172156
• MDR Text Key: 195712681
• Report Number: 6000034-2020-01628
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032643
• UDI-Public: (01)09321502032643(11)190328(17)210327
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2021
• Device Model Number: CI24RE(ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• 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: 3 YR
• Patient Sex: Male