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

Model Number CI24RE (ST)

Device Problem Expulsion (2933)

Patient Problems Purulent Discharge (1812); Post Operative Wound Infection (2446)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 15, 2020.

Event Description

Per the clinic, the patient experienced a wound infection and purulent discharge at the implant incision site, and an extrusion of the electrode array.The patient was subsequently hospitalised and treated with intravenous antibiotics (specific date not reported).The patient underwent a revision surgery on (b)(6) 2020 to revise the skin, clean the wound, and remove excess tissue, but ultimately the device was explanted.Reimplantation is planned but has not taken place as of the date of this report.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on november 19, 2020.

• 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: 10273997
• MDR Text Key: 198855353
• Report Number: 6000034-2020-01770
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032643
• UDI-Public: (01)09321502032643(11)190902(17)210901
• 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: 10/27/2020

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: 09/01/2021
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 MO