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

Model Number CI632

Device Problems Inadequacy of Device Shape and/or Size (1583); Decreased Sensitivity (2534); Patient Device Interaction Problem (4001)

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on nov 27, 2023.

Event Description

Per the clinic, the patient experienced a swelling at the magnet site resulting in poor magnet retention.The patient had a skin revision on (b)(6) 2023 under a general anaesthetic.The implant remains in-situ.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 18207832
• MDR Text Key: 328957068
• Report Number: 6000034-2023-03805
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)220914(17)240913
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2023,11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2023
• Distributor Facility Aware Date: 11/06/2023
• Date Report to Manufacturer: 11/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male