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

Model Number CI24M

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 28, 2021.

Event Description

Per the clinic, the patient experienced an extrusion of the device from the implant bed and the skin.The device was explanted on (b)(6) 2021.There are no plans to reimplant the patient with another cochlear device as of the date of this report.

Manufacturer Narrative

Device analysis report attached.This report is submitted on march 4, 2022.

• 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: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 13091595
• MDR Text Key: 282804137
• Report Number: 6000034-2021-03895
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• 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