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 Wound Dehiscence (1154); Abscess (1690); Bacterial Infection (1735); Cellulitis (1768); Fistula (1862); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 04, 2024.

Event Description

Per the clinic, the patient was hospitalized (specific date and duration not reported) due to swelling and cellulitis at the implant site and the patient was subsequently treated with iv and oral antibiotics (specific date and duration not reported).On (b)(6) 2023, a procedure was performed to drain an abscess that developed at the implant incision site.On (b)(6) 2023, the patient was administered with a ten-day prescription of oral antibiotics due to fluctuance and fluid collection.On (b)(6) 2023, cultures returned as positive for bacterial infection and the patient was treated with oral, iv and topical antibiotics (specific date and duration not reported).On (b)(6) 2024, it was discovered that the patient developed a wound breakdown with limited drainage at the implant site and the patient was treated with antibiotics (specific type, date and duration not reported).The patient continues to have drainage and a fistula was discovered at the implant site during a follow-up visit four weeks later (specific date not reported).A decision was made to explant the device and 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.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Device analysis report attached.This report is submitted on may 31, 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: rosdeelaila zulkifli ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 19039482
• MDR Text Key: 339318899
• Report Number: 6000034-2024-01447
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)230629(17)250628
• 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: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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): Required Intervention; Hospitalization
• Patient Sex: Female