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

Model Number CI422

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 29, 2023.

Event Description

Per the clinic, the patient experienced an infection at the implant site.The patient was treated with oral antibiotics (specific date and duration not reported) and hospitalized for administration of iv antibiotics (specific date and duration not reported), however, the issue did not resolve.Subsequently, the device was explanted on december 06, 2023.It is unknown if there are plans to reimplant the patient as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient experienced an extrusion of receiver/stimulator at implant site (specific date not reported).Additional information has been requested but has not been made available as of the date of this report.Device analysis report attached.This report is submitted on february 22, 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: asyikin zulkhairi ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18417253
• MDR Text Key: 331577834
• Report Number: 6000034-2023-04196
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032629
• UDI-Public: (01)09321502032629(11)221111(17)241110
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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): Required Intervention; Hospitalization
• Patient Sex: Male