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

Model Number CI632

Device Problem Expulsion (2933)

Patient Problems Bacterial Infection (1735); Tissue Breakdown (2681); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Per the clinic, it was reported that the patient experienced tenderness at the implant site in (b)(6) 2021 and was treated with oral antibiotics (specific date and duration not reported).In (b)(6) 2021, the patient experienced drainage at the implant site and was treated with topical antibiotics (specific date and duration not reported).Subsequently, in (b)(6) 2022 (date not reported) , the patient experienced exposure of the receiver/stimulator and underwent a revision surgery in (b)(6) 2022 (date not reported) in order to repair the site.The patient also experienced bacterial infection exposing the device for the second time.The patient was again treated with oral antibiotics (specific date and duration not reported).The device was explanted on (b)(6) 2022.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR 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: 16110444
• MDR Text Key: 306777190
• Report Number: 6000034-2023-00100
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)201030(17)221029
• 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: 01/06/2023,12/16/2022

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 Expiration Date: 10/29/2022
• Device Model Number: CI632
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2023
• Distributor Facility Aware Date: 12/16/2022
• Date Report to Manufacturer: 12/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male