MAUDE Adverse Event Report: COCHLEAR LTD CI624 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI624

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 23 october 2020.

Event Description

Per the clinic, the patient's device was explanted due to poor performance, the patient was re-implanted with another device.

• Brand Name: CI624 COCHLEAR IMPLANT WITH CONTOUR ADVANCE 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: 10723416
• MDR Text Key: 212691006
• Report Number: 6000034-2020-02912
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502046329
• UDI-Public: (01)09321502046329(11)200106(17)220105
• 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: 10/23/2020,10/05/2020

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: 01/05/2022
• Device Model Number: CI624
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2020
• Distributor Facility Aware Date: 10/05/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention