MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 24 CONTOUR ADVANCE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24R (CA)

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

Patient Problem Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 01, 2022.

Event Description

Per the clinic, the patient experienced a meningitis infection (specific date not reported).Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Correction: the previous or initial mdr submitted on november 01,2022 was filed inadvertently.Patient was misdiagnosed with meningitis.This report is submitted on november 30, 2022.

• Brand Name: NUCLEUS 24 CONTOUR ADVANCE
• 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: belinder gill ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15705679
• MDR Text Key: 302759234
• Report Number: 6000034-2022-03428
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (CA)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2022
• 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): Life Threatening; Required Intervention
• Patient Sex: Female