MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Necrosis (1971); Skin Infection (4544)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 25, 2023.

Event Description

Per the surgeon, the patient experienced an infection at the wound site that was treated with topical antibiotics.There was a wound dehiscence, a skin necrosis and the device was extruding.A skin graft was applied and the wound was closed.The patient was hospitalised.

Manufacturer Narrative

Per the clinic, the device was repositioned under general anesthesia on (b)(6) 2023.The implanted device remains.This report is submitted on october 10, 2023.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM 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: 17386551
• MDR Text Key: 319649159
• Report Number: 6000034-2023-02429
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025706
• UDI-Public: (01)09321502025706(11)220715(17)240714
• Combination Product (y/n): N
• Reporter Country Code: AJ
• 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,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI422
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2022
• 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 Age: 4 YR
• Patient Sex: Female