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

Model Number CI612

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 21 august 2020.

Event Description

Per the clinic, the patient experienced infection at implant site and subsequently was treated with iv and oral antibiotics unsuccessfully.There are plans to explant the device however this has not taken place as of the date of this report.

Manufacturer Narrative

It was reported that the device was explanted on (b)(6) 2020, re-implantation is planned but has not taken place as of the date of this report.This report is submitted on 10 september 2020.

Event Description

It was reported that the device was explanted on (b)(6) 2020, re-implantation is planned but has not taken place as of the date of this report.

• 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: 10435148
• MDR Text Key: 203800799
• Report Number: 6000034-2020-02220
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)190824(17)210823
• 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: 09/10/2020,08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/23/2021
• Device Model Number: CI612
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2020
• Distributor Facility Aware Date: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention