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

Model Number CI512

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a magnet dislodgement during an mri (1.5 tesla).The implanted device remains.Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on march 10, 2023.

Manufacturer Narrative

Per the clinic, the patient underwent a magnet replacement surgery (specific date not reported).This report is submitted on april 17, 2024.

• Brand Name: NUCLEUS CI512 COCHLEAR 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
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: dzafira dzul 'karnain ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16519932
• MDR Text Key: 311036066
• Report Number: 6000034-2023-00885
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)190124(17)210123
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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: 01/23/2021
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2019
• 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