MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI624 COCHLEAR IMPLANT WITH SLIM 20 ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI624

Device Problem Expulsion (2933)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Per the clinic, the patient developed a wound infection at the implant site, exposing the electrode.Subsequently, the patient was treated with topical antibiotics (specific date and duration not reported).The patient was hospitalized for an overnight stay (specific date and duration not reported) for administration of iv antibiotics.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on december 12, 2023.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2023.There are no plans to reimplant the patient with a new device as of the date of this report.This report is submitted on february 15, 2024.

• Brand Name: NUCLEUS CI624 COCHLEAR IMPLANT WITH SLIM 20 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: 18308504
• MDR Text Key: 330221318
• Report Number: 6000034-2023-04040
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502046329
• UDI-Public: (01)09321502046329(11)230606(17)250605
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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