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

Model Number CI422

Device Problems Circuit Failure (1089); Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 03/13/2024

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a performance decrement with the device.The implanted device remains.

Manufacturer Narrative

This report is submitted on february 06, 2024.

Manufacturer Narrative

Per the clinic, open circuits were noted on 10 electrodes.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.This report is submitted on march 04, 2024.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2024, and the patient was re-implanted with another cochlear device during the same surgery.Device analysis indicated device failure.Device analysis report attached.This report is submitted on april 26, 2024.

• Brand Name: NUCLEUS CI422 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: ashwinii chelvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18647812
• MDR Text Key: 334610238
• Report Number: 6000034-2024-00433
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/02/2024

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: CI422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 01/23/2024; 04/02/2024
• Supplement Dates FDA Received: 03/03/2024; 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• 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; Other
• Patient Age: 6 YR
• Patient Sex: Male