MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Drug Resistant Bacterial Infection (4553); Insufficient Information (4580)

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

Device analysis report attached.This report is submitted on february 19, 2024.

Event Description

Per the clinic, the device was explanted on (b)(6) 2023 due to an infection (site of infection not confirmed).It is unknown if there are plans to reimplant the patient 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 developed a drug resistant superinfection at implant site.Subsequently, the patient was hospitalized (specific date not reported) and was treated with intravenous antibiotics (specific date and duration not reported).This report is submitted on march 18, 2024.

• Brand Name: NUCLEUS CI622 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: 18729198
• MDR Text Key: 335697160
• Report Number: 6000034-2024-00551
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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
• Patient Age: 40 YR
• Patient Sex: Male