MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24M

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Troubleshooting, reprogramming and hardware exchange attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2023 and the patient was implanted with a new device during the same surgery.

Manufacturer Narrative

This report is submitted on september 08, 2023.

• Brand Name: NUCLEUS 24
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: rosdeelaila zulkifli ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17708847
• MDR Text Key: 322924097
• Report Number: 6000034-2023-02905
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female