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

Model Number CI24R (CS)

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

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on august 25, 2023.

Event Description

Per the clinic, the patient experienced pain at the magnet site and subsequently, was treated with antibiotics (type, date and duration not reported).

Manufacturer Narrative

Per the clinic, the patient experienced magnet dislodgement during an mri in (b)(6) 2023 (specific tesla strength and date not reported).The device was explanted on (b)(6) 2023 and the patient was re-implanted with a new cochlear device during the same surgery.This report is submitted on january 16, 2024.

Manufacturer Narrative

Device analysis indicated device failure.Device analysis report is attached.This report is submitted on march 21, 2024.

• Brand Name: NUCLEUS 24 CONTOUR
• 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: 17620944
• MDR Text Key: 321917060
• Report Number: 6000034-2023-02698
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/27/2024

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: CI24R (CS)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 02/27/2024
• Supplement Dates FDA Received: 01/16/2024; 03/20/2024
• 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): Required Intervention
• Patient Sex: Male