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 Necrosis (1971); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 21, 2022.

Event Description

Per the clinic, the patient experienced skin breakdown (an ulcer) at the implant site (treatment is unknown).The implant remains in-situ.Further information is being sought from the clinic.

Event Description

Per the clinic, it was also reported that the patient experienced a skin flap necrosis.The implant remains in-situ.

• 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: 13835469
• MDR Text Key: 287521025
• Report Number: 6000034-2022-00714
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)210519(17)230518
• 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: 04/14/2022,03/25/2022

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: 05/18/2023
• 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: 04/14/2022
• Distributor Facility Aware Date: 03/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male