MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 08/11/2023

Event Type  Injury  

Event Description

Per the clinic, the patient experienced poor sound quality with the device.Troubleshooting, hardware exchange and reprogramming attempts were made; however, the issue could not be resolved.It is unknown if there are plans to explant the device and to reimplant 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.

Manufacturer Narrative

This report is submitted on august 30, 2023.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2023 and the patient was reimplanted with a new cochlear device during the same surgery.This report is submitted on january 16, 2024.

Manufacturer Narrative

Device analysis report attached.This report is submitted on april 12, 2024.

• Brand Name: NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• 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: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17647721
• MDR Text Key: 322254238
• Report Number: 6000034-2023-02823
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)100201(17)120131
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/20/2024

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 Expiration Date: 01/31/2012
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 03/20/2024
• Supplement Dates FDA Received: 01/16/2024; 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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: 16 YR
• Patient Sex: Male