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

Model Number CI622

Device Problem Biofilm coating in Device (1062)

Patient Problems Post Operative Wound Infection (2446); Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on mar 29, 2022.

Event Description

Per the clinic, the patient experienced post-operative wound infection (specific date not reported) and subsequently, was treated with oral antibiotics for a 12 days course (specific date not reported).It was also reported that the patient underwent a surgical drainage (specific date not reported), however, the issue could not be resolved.The device was explanted (specific date not reported).

Manufacturer Narrative

Per the clinic, the patient was hospitalized from on (b)(6) 2022.This report is submitted on may 25, 2022.

Manufacturer Narrative

Device analysis report is attached.This report is submitted on july 03, 2022.

Manufacturer Narrative

Per the clinic, the patient was treated with iv antibiotics (specific date and duration not reported).This report is submitted on march 12, 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: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 13936394
• MDR Text Key: 288084548
• Report Number: 6000034-2022-00891
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)210922(17)230921
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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,Followup,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2023
• Device Model Number: CI622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• 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