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 Problem Skin Infection (4544)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 8, 2020.

Event Description

Per the clinic, the patient developed an infection at the implant site, subsequent to inadvertently opening the skin during a hairdressing appointment, exposing the implant electrodes.The patient was treated with antibiotics (specific type and duration not reported), and underwent a surgical procedure on (b)(6) 2020, in order to revise the skin, wash out and close the wound.The implanted device remains.

Manufacturer Narrative

It was reported that the receiver-stimulator was explanted on (b)(6) 2020, the electrode array remains in-situ.This report is submitted on 8 december 2020.

Manufacturer Narrative

This report is submitted on 15 march 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: 10500352
• MDR Text Key: 205880588
• Report Number: 6000034-2020-02421
• 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

• Date FDA Received: 09/07/2020
• 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?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR