MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Headache (1880)

Event Date 09/30/2022

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on november 04, 2022.

Event Description

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.The patient experienced headaches and was treated with steroids (specific type, date and duration not reported).Surgery to reposition the magnet is planned but has not taken place at the time of this report.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2022 and the patient was reimplanted with another cochlear device during the same surgery.This report is submitted on december 19, 2022.

Manufacturer Narrative

Device analysis indicated device failure.Device analysis report attached.This report is submitted on february 20, 2023.

• Brand Name: NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT 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: kalai tamilselvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15733081
• MDR Text Key: 303238366
• Report Number: 6000034-2022-03260
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

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 Expiration Date: 03/17/2012
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/24/2022; 02/03/2023
• Supplement Dates FDA Received: 12/19/2022; 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2010
• 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
• Patient Age: 19 YR
• Patient Sex: Male