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

Model Number CI612

Device Problems Failure to Read Input Signal (1581); Unexpected Therapeutic Results (1631)

Patient Problems Head Injury (1879); Failure of Implant (1924)

Event Date 12/20/2023

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loss of connection to the internal device subsequent to sustaining a head trauma on (b)(6) 2023.Reimplantation is planned but had not taken place at the time of this report.

Event Description

Per the clinic, the device was explanted on (b)(6) 2024.The patient was re-implanted with another cochlear device 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: 18523748
• MDR Text Key: 332973960
• Report Number: 6000034-2024-00224
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)230321(17)250320
• 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,Followup
• Report Date: 04/25/2024,03/29/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2024
• Distributor Facility Aware Date: 03/29/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male