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 Unspecified Infection (1930); Necrosis Of Flap Tissue (1972)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 28 2020.

Event Description

Per the clinic, the patient experienced granulation, infection & central necrosis which exposed the receiver-stimulator.The patient was treated with oral and topical antibiotics (date and duration not reported) the device was subsequently explanted on (b)(6) 2020.The patient has not been reimplanted with a new device as of this report on (b)(6) 2020.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on november 20, 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: 10096105
• MDR Text Key: 193097281
• Report Number: 6000034-2020-01415
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025683
• UDI-Public: (01)09321502025683(11)160217(17)180216
• 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: 10/30/2020

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: 02/16/2018
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention