MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 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 Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Per the clinic, the patient developed a post-operative infection at the incision site.Subsequently, the patient was treated with multiple rounds of oral antibiotics (specific dates and duration not reported).However, this did not alleviate the problem resulting in a decision to explant the device.The device was explanted on (b)(6) 2024 and there are no plans to reimplant the patient with a new device as of the date of this report.The patient underwent skin revision surgery during the same surgery.

• Brand Name: NUCLEUS 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: 18957019
• MDR Text Key: 338303076
• Report Number: 6000034-2024-01012
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)230616(17)250615
• 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
• Type of Report: Initial
• Report Date: 03/22/2024,02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2024
• Distributor Facility Aware Date: 02/28/2024
• Date Report to Manufacturer: 02/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female