MAUDE Adverse Event Report: COCHLEAR LTD CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI612

Device Problems Electrical Lead/Wire (452); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 5 august 2020.

Event Description

Per the clinic, the device was explanted on (b)(6) 2020 due to migration of the electrode array out of the cochlear. The patient was re-implanted with another cochlear device during the same surgery.

• Brand Name: CI612 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: 10365438
• MDR Text Key: 201660993
• Report Number: 6000034-2020-01997
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/05/2020,07/15/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/04/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: CI612
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2020
• Distributor Facility Aware Date: 07/15/2020
• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 08/04/2020 Patient Sequence Number: 1