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

Model Number CI24RE (CA)

Device Problem Expulsion (2933)

Patient Problems Purulent Discharge (1812); Pain (1994); Tissue Breakdown (2681); Skin Infection (4544); Swelling/ Edema (4577)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 31, 2022.

Event Description

Per the clinic, the patient experienced pain, swelling and purulent drainage at the implant site.There was a skin breakdown, extrusion of the electrode and an infection which was treated with topical antibiotics.The device was explanted on (b)(6) 2022.It is unknown if there are plans to re-implant the patient with another device.

• 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: 15697775
• MDR Text Key: 302679766
• Report Number: 6000034-2022-03177
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)140716(17)160715
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2022,10/07/2022

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 Expiration Date: 07/15/2016
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2022
• Distributor Facility Aware Date: 10/07/2022
• Date Report to Manufacturer: 10/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male