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

Model Number CI24RE (CA)

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 25, 2020.

Event Description

Per the clinic, the patient underwent surgery for debridement and explantation of the device 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

It was reported that the patient experienced infection prior to explant.This report is submitted on 15 september 2020.

Manufacturer Narrative

Per the clinic, the patient had an extrusion (not specified what had extruded and where it had extruded to).This report is submitted on november 9, 2020.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE 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: 10446461
• MDR Text Key: 204174501
• Report Number: 6000034-2020-02197
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)130404(17)150403
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/03/2015
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR