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

Model Number CI24RE (CA)

Device Problems Failure to Read Input Signal (1581); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced no connection to his device.An integrity test was attempted today, (b)(6) 2023.We were unable to connect to the internal implant with my equipment and with the programming software.This indicates evidence of malfunction of the internal implant.The implant remains in-situ.It is unknown if there are plans to explant/re-implant the patient with another device.

Manufacturer Narrative

This report is submitted on may 11, 2023.

Event Description

It has now been determined through an integrity test that it was inconclusive that there was a device failure.

Manufacturer Narrative

It has now been determined through an integrity test that it was inconclusive that there was a device failure.This report is submitted on may 15, 2023.

• 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: 16908678
• MDR Text Key: 314971590
• Report Number: 6000034-2023-01625
• Device Sequence Number: 1
• Product Code: MCM
• 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: 05/15/2023,05/12/2023

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 Model Number: CI24RE (CA)
• 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: 05/15/2023
• Distributor Facility Aware Date: 05/12/2023
• Date Report to Manufacturer: 05/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male