MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI24RE (CA) FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (CA)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 13, 2020.

Event Description

Per the clinic, the patient developed an infection and cellulitis at the implant site.Treatment of antibiotics for a duration of 4 months was unsuccessful, subsequently, the device was explanted on (b)(6) 2020.The electrode array was left insitu to preserve the cochlea for future reimplantation.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on september 3, 2020.Attachment: [01753 device analysis report.Pdf].

• Brand Name: NUCLEUS CI24RE (CA) FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 10262325
• MDR Text Key: 198496533
• Report Number: 6000034-2020-01753
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)140311(17)160310
• 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: 08/14/2020

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: 03/10/2016
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/12/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention