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

Model Number	CI24R (CS)
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Meningitis (2389)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
This report is submitted on 9 december 2020.

• Brand Name: NUCLEUS 24 CONTOUR
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 10222377
• Report Number: 6000034-2020-01745
• Device Sequence Number: 11404359
• Product Code: MCM
• UDI-Device Identifier: 09321502002349
• UDI-Public: (01)09321502002349
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CI24R (CS)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/03/2020; 11/17/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/25/2020; 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention