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

Model Number CI422

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Necrosis (1971); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 06, 2024.

Event Description

Per the clinic, the patient experienced skin necrosis and infection at the implant site, exposing the receiver/stimulator.Subsequently, the patient was hospitalized twice on (b)(6) 2023 and (b)(6) 2023.The patient also underwent skin flap revision surgeries on (b)(6) 2023 under general anesthesia.The patient was treated with oral and iv antibiotics (specific date and duration not reported); however, the issue could not be resolved.The device was explanted on (b)(6) 2024.There are no plans to reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient experienced wound dehiscence.Device analysis report attached.This report is submitted on march 22.2024.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT 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: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18647926
• MDR Text Key: 334609059
• Report Number: 6000034-2024-00512
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2024
• Device Model Number: CI422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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): Required Intervention; Hospitalization
• Patient Sex: Female