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); Purulent Discharge (1812); Unspecified Infection (1930); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an extrusion of receiver/stimulator, an infection with purulent discharge and wound dehiscence at the implant site (specific date not reported).Subsequently, the patient was treated with oral antibiotics for 10 days beginning (b)(6) 2023.On (b)(6) 2023, the patient was treated with another oral antibiotic prescribed till (b)(6) 2023.Following that, the patient was treated with iv antibiotic for a day, and topical antibiotic (specific date not reported) however, the symptoms did not resolve.The device was explanted on (b)(6) 2023.

• 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: 17892784
• MDR Text Key: 325232762
• Report Number: 6000034-2023-03223
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)230516(17)250515
• 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: 10/09/2023,09/18/2023

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2023
• Distributor Facility Aware Date: 09/18/2023
• Date Report to Manufacturer: 09/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male