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

Model Number CI612

Device Problem 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.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on september 11, 2020.

• 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: 10365440
• MDR Text Key: 201660826
• Report Number: 6000034-2020-01996
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)200106(17)220105
• 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: 08/21/2020

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 Expiration Date: 01/05/2022
• Device Model Number: CI612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR