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

Model Number CI24R (CS)

Device Problem Output Problem (3005)

Patient Problem Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested regarding the patient's episode of meningitis; however, information has not been made available as of the date of this report.Should further information be provided, a supplementary report shall be submitted.

Event Description

Per the clinic, it was reported that the patient developed meningitis in 2020 (specific date not reported) which was successfully treated with antibiotics (type and duration not reported) and was healed in (b)(6) 2020.Following the episode of meningitis, the patient began to experience pain around the implant site and a performance decrement with device use.It is unknown whether there are plans to explant the device, as of the date of this report.The patient continues to be clinically monitored by their healthcare provider.

Manufacturer Narrative

It was reported that the device was explanted and the patient was re-implanted with another device during the same surgery.This report is submitted on 26 august 2020.

Manufacturer Narrative

This report is submitted on 9 december 2020.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 10222377
• MDR Text Key: 197571905
• Report Number: 6000034-2020-01745
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502002349
• UDI-Public: (01)09321502002349
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (CS)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention