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

Model Number CI24RE (CA)

Device Problem Expulsion (2933)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 3, 2020.

Event Description

Per the clinic, the patient experienced repeated inflammation and electrode extrusions.Cartilage grafting of the extrusion site was attempted twice.The mastoid cavity frequently developed polyps and purulent discharge.The infection was treated with oral antibiotics.The device was explanted on (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

This report is submitted on may 4, 2020.

• Brand Name: NUCLEUS CI24RE (CA) COCHLEAR 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: 9919037
• MDR Text Key: 186751201
• Report Number: 6000034-2020-01005
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)100522(17)120521
• 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: 04/14/2020

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: 05/21/2012
• Device Model Number: CI24RE (CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 05/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR