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

Model Number CI24M

Device Problem No Device Output (1435)

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

Event Date 11/25/2022

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced a loss of connection to the internal device subsequent to sustaining a head trauma (date not reported).Troubleshooting attempts were made; however, the issue could not be resolved.The implanted device remains.

Manufacturer Narrative

This report is submitted on december 16, 2022.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2023, and the patient was reimplanted with another cochlear device during the same surgery.This report is submitted on april 03, 2023.

Manufacturer Narrative

Device analysis indicated device failure.This report is submitted on june 27, 2023.

• Brand Name: NUCLEUS 24
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 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: ken yian chow ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15992967
• MDR Text Key: 305584541
• Report Number: 6000034-2022-03788
• 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,Followup,Followup
• Report Date: 06/08/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 03/13/2023; 06/08/2023
• Supplement Dates FDA Received: 04/03/2023; 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Male