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

Model Number CI422

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 22, 2023.

Event Description

Per the clinic, the patient developed an infection at the incision site.Additional information has been requested but has not been made available as of the date of this report.The implanted device remains.

Manufacturer Narrative

Correction: the previous or initial mdr submitted on december 22, 2023 was filed inadvertently.No device malfunction/ explantation or serious injury has occurred.This report is submitted on february 08, 2024.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 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: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18380108
• MDR Text Key: 331177059
• Report Number: 6000034-2023-04360
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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 Model Number: CI422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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