MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

Device Problem Expulsion (2933)

Patient Problem Tissue Breakdown (2681)

Event Date 04/12/2024

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 28, 2024.

Event Description

Per the clinic, the patient experienced a skin breakdown, exposing the implanted body.The patient was treated with antibiotics (specific type, date and duration not reported).The implanted device remains.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient also was hospitalized (specific date and duration not reported.There are plans to explant the device; however, this has not occurred as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.This report is submitted on april 29, 2024.

Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2024, to reposition the device.The implanted device remains.This report is submitted on may 24, 2024.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 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: ashwinii chelvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18794614
• MDR Text Key: 336393495
• Report Number: 6000034-2024-00685
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024

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 Expiration Date: 06/28/2023
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 04/02/2024; 04/29/2024
• Supplement Dates FDA Received: 04/29/2024; 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male