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 Problems Wound Dehiscence (1154); Ossification (1428); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 11, 2023.

Event Description

Per the clinic, the patient experienced an infection at the impant site and was treated with antibiotics (specific type and duration not reported) and wound washing with antibiotics.The device then extruded and the patient underwent revision surgery on (b)(6) 2023, under general anaesthetic to wash the wound with antibiotics.The patient experienced wound dehiscence after the revision surgery and the patient underwent another revision surgery to close the wound under general anaesthetic.However, the issue could not be resolved.The device was then explanted on (b)(6) 2023.It is unknown if there are plans to reimplant the patient as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient was hospitalised overnight due to the adverse events (duration unknown).This report is submitted on september 5, 2023.

• 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: debbie ang ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17295627
• MDR Text Key: 318739748
• Report Number: 6000034-2023-02162
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025683
• UDI-Public: (01)09321502025683(11)220708(17)240707
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE(ST)
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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 Sex: Male