MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Unspecified Infection (1930); Necrosis (1971); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 19, 2024.

Event Description

Per the clinic, the patient experienced skin breakdown (burn) over the magnet and at implant site (specific date not reported).The patient also developed an infection at the implant site and subsequently was treated with iv antibiotics for more than two months (specific date not reported).The device was explanted on (b)(6) 2023.There are plans to re-implant the patient with a new 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.

Manufacturer Narrative

Per the clinic, the patient experienced an extrusion of the receiver/stimulator and skin necrosis.Device analysis report.This report is submitted on february 27, 2024.

• Brand Name: NUCLEUS CI522 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: aini yusof ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18540632
• MDR Text Key: 333193878
• Report Number: 6000034-2024-00132
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2018
• Device Model Number: CI522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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 Sex: Female