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

Model Number CI24R (CS)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 23, 2020.

Event Description

Per the clinic, the patient developed an infection and abscess at the implant site in 2019.The patient was hospitalised and treated with intravenous antibiotics (specific dates and durations not reported).Explant and reimplantation is planned but has not taken place at the time of this report.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2021, due to the reported infection.It is unknown whether the patient was reimplanted, as of the date of this report.

Manufacturer Narrative

This report is submitted on 15 mar 2021.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10881849
• MDR Text Key: 217631885
• Report Number: 6000034-2020-03186
• Device Sequence Number: 1
• Product Code: MCM
• 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: 02/19/2021

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: CI24R (CS)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/22/2020
• Supplement Dates Manufacturer Received: 01/20/2021; 02/19/2021
• Supplement Dates FDA Received: 02/11/2021; 03/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 28 YR