MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (CA)

Device Problems Biofilm coating in Device (1062); Circuit Failure (1089); Electrical Shorting (2926); Expulsion (2933)

Patient Problem Skin Infection (4544)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 20, 2023.

Event Description

Per the clinic, the patient experienced an extrusion of r/s and infection.On (b)(6) 2023, the patient underwent revision surgery to reposition the device.It was noted that a biofilm layer was observed on the r/s plate.Intra-operative tests were done and showed multiple open and short circuits, thus the device was explanted during the same surgery.The patient was re-implanted with a new cochlear device.

• Brand Name: NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 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: roberta loveday ; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 17358545
• MDR Text Key: 319371124
• Report Number: 6000034-2023-02289
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025690
• UDI-Public: (01)09321502025690(11)191112(17)211111
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2021
• Device Model Number: CI24RE (CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2019
• 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): Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male