MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Edema (1820)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 31, 2020.

Event Description

Per the surgeon, the patient developed a skin flap edema in (b)(6) 2019, and underwent revision surgery to drain fluid from the implant site (date not reported).It was reported that the flap edema reoccurred, and the patient subsequently underwent a second revision in (b)(6) 2020 to further drain fluid.The issue reportedly did not resolve, resulting in explantation of the device on (b)(6) 2020.It is unknown if the patient was reimplanted, as of the date of this report.

Manufacturer Narrative

Device analysis report is attached.This report is submitted on may 22, 2024.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM 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: ken yian chow ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 10348432
• MDR Text Key: 201385513
• Report Number: 6000034-2020-01943
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)170119(17)190118
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2019
• Device Model Number: CI422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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: Female