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

Model Number CI622

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced skin breakdown and an extrusion of the device.The patient also experienced an infection and wound dehiscence at the implant site (specific date not reported).The patient was treated with oral antibiotics (specific date and duration not reported) and underwent debridement procedure to clean wound dehiscence (specific date not reported).The patient was placed under general anesthesia on (b)(6) 2024, for a surgical procedure to remove the implant receiver stimulator with the electrode cut in the mastoid; however, this did not alleviate the problem resulting in a decision to explant the device.Subsequently, the device was explanted during the same surgery.There are no plans to re-implant the patient with another cochlear device as of the date of this report.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT 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: 18628655
• MDR Text Key: 334366403
• Report Number: 6000034-2024-00331
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)230309(17)250308
• 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: 02/02/2024,01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2024
• Distributor Facility Aware Date: 01/09/2024
• Date Report to Manufacturer: 01/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female