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)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a wound dehiscence and infection at the incision site, exposing the receiver/stimulator.The patient was subsequently treated with oral antibiotics on (b)(6) 2023, for 10 days, and administered with another antibiotics (type not reported) on (b)(6) 2023 for 8 days.The device was explanted on (b)(6) 2023.There are plans to re-implant the patient with a new device; however, this has not occurred 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: 18900726
• MDR Text Key: 337617770
• Report Number: 6000034-2024-00837
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)230223(17)250222
• 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: 03/14/2024,02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2024
• Distributor Facility Aware Date: 02/15/2024
• Date Report to Manufacturer: 02/15/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female