MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Swelling/ Edema (4577)

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 19, 2023.

Event Description

Per the clinic, the patient experienced swelling, accumulation of fluid and infection at the incision site that was treated with iv and oral antibiotics.Cultures taken showed h.Influenzae.The incision site was washed out in theatre and the patient was hospitalised.The device remains in-situ.

Event Description

Per the clinic, the patient underwent incision & drainage procedures on (b)(6) 2023.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 17770398
• MDR Text Key: 323679073
• Report Number: 6000034-2023-03083
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)230314(17)250313
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024,03/28/2024

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: CI632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2024
• Distributor Facility Aware Date: 03/28/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 14 MO
• Patient Sex: Female