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

Model Number CI624

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735)

Event Type  Injury  

Event Description

Per the clinic, the patient developed mrsa infection around the implant site followed by a wound dehiscence.The patient was treated with oral antibiotics for 20 days (specific date not reported) to clear the infection; however, this did not alleviate the problem resulting in a decision to explant the device.The device was explanted on (b)(6) 2022 and the patient was re-implanted with another cochlear device during the same surgery.

• Brand Name: NUCLEUS CI624 COCHLEAR IMPLANT WITH SLIM 20 ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 18137500
• MDR Text Key: 328107483
• Report Number: 6000034-2023-03673
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502046329
• UDI-Public: (01)09321502046329(11)200710(17)220709
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2023,10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2022
• Device Model Number: CI624
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2023
• Distributor Facility Aware Date: 10/24/2023
• Date Report to Manufacturer: 10/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female