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

Model Number CI24RE (CA)

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 10/24/2023

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2023, due to an infection (site of infection not confirmed).There are no plans to re-implant the patient with a new device as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

Event Description

It was also reported that the patient experienced a skin infection at the implant site, exposing the receiver/stimulator, and was subsequently treated with oral antibiotics (specific date and duration not reported).The patient was rei-mplanted with another cochlear device on january 23, 2024.

• Brand Name: NUCLEUS FREEDOM 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: 18315665
• MDR Text Key: 330326782
• Report Number: 6000034-2023-03984
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)121024(17)141023
• 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

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2014
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female