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

Model Number CI24RE (ST)

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

Patient Problems Blister (4537); Skin Infection (4544)

Event Date 12/27/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 15, 2021.

Event Description

Per the clinic, the patient developed a blister and infection at the implant site, and was treated with intravenous antibiotics twice each day for 10 days.The device was explanted on (b)(6) 2020.It is unknown if there are plans to reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

This report is submitted on 31 mar 2021.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH 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: 11175402
• MDR Text Key: 226994760
• Report Number: 6000034-2021-00267
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032643
• UDI-Public: (01)09321502032643(11)161216(17)181215
• 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
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/15/2018
• Device Model Number: CI24RE (ST)
• 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): Required Intervention
• Patient Age: 7 YR