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

Model Number CI612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Pain (1994); Fluid Discharge (2686); Drug Resistant Bacterial Infection (4553); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 5, 2022.

Event Description

Per the clinic, the patient experienced discomfort, swelling and discharge at the incision site.There was an infection (mrsa) and a fistula at the wound site which was treated with an oral antibiotic.The fistula was closed but pain persists.

Manufacturer Narrative

Per the clinic, the patient was hospitalised for an overnight stay on (b)(6) 2022 (duration not specified).During the hospitalisation, the device was explanted and the patient was treated with iv antibiotics.It is unknown if there are plans to reimplant the patient as of the date of this report.This report is submitted on may 27, 2022.

Manufacturer Narrative

Device analysis report is attached.This report is submitted on july 09, 2022.

• Brand Name: NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: yaneesa vetsandonphong ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 14297350
• MDR Text Key: 290953817
• Report Number: 6000034-2022-01318
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)210526(17)230525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2022

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: 05/25/2023
• Device Model Number: CI612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 05/03/2022; 06/17/2022
• Supplement Dates FDA Received: 05/27/2022; 07/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male