MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problem Expulsion (2933)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 1 july 2020.

Event Description

Per the clinic, the patient experienced extrusion of the electrode array outside of the cochlea.Revision surgery is planned but has not taken place as of the date of this report.

Event Description

There was no extrusion as reported in 6000034-2020-01604.

Manufacturer Narrative

There was no extrusion as reported in 6000034-2020-01604.This report is submitted on july 24, 2020.

• Brand Name: NUCLEUS CI512 COCHLEAR 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: 10215897
• MDR Text Key: 197941827
• Report Number: 6000034-2020-01605
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)121101(17)141031
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/24/2020,07/02/2020

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: 10/31/2014
• Device Model Number: CI422
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2020
• Distributor Facility Aware Date: 06/08/2020
• Date Report to Manufacturer: 07/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention