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  

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

This report is submitted on may 5, 2022.

Event Description

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.

• 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
• MDR Report Key: 14297275
• MDR Text Key: 290954020
• Report Number: 6000034-2022-01319
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2022,05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2022
• Distributor Facility Aware Date: 05/03/2022
• Date Report to Manufacturer: 05/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male