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

Model Number CI24M

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/24/2024

Event Type  Injury  

Event Description

Per the clinic, the patient is a non-user and was explanted on (b)(6) 2024 due to pain post mri.There are no plans to re-implant the patient with a new device as of the date of this report.

Manufacturer Narrative

This report is submitted on february 21, 2024.

Manufacturer Narrative

Per the clinic, the patient experienced a magnet dislodgement during an mri (1.5 tesla).The patient's head was wrapped as recommended by cochlear.This report is submitted on april 05, 2024.

Manufacturer Narrative

Device analysis report attached.This report is submitted on may 06, 2024.

• 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: ashwinii chelvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18744891
• MDR Text Key: 335808692
• Report Number: 6000034-2024-00700
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/10/2024

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 Model Number: CI24M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/20/2024; 04/10/2024
• Supplement Dates FDA Received: 04/05/2024; 05/06/2024
• 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): Other; Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female