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

Model Number CI422

Device Problems No Device Output (1435); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on march 06, 2024.

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Hardware exchange, troubleshooting, and reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.It is unknown if there are plans to explant the device and reimplant the patient with another cochlear device as of the date of this report, (b)(6) 2024.

Manufacturer Narrative

Per the clinic, it was discovered that the implant magnet was dislocated.The device was explanted on (b)(6) 2024 and the patient was re-implanted with another cochlear device during the same surgery.This report is submitted on april 15, 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: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18843867
• MDR Text Key: 336955820
• Report Number: 6000034-2024-00721
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032629
• UDI-Public: (01)09321502032629(11)220225(17)240224
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/24/2024
• Device Model Number: CI422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2022
• 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): Other; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male