MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ossification (1428)

Event Date 06/09/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 3, 2023.

Event Description

Per the clinic, the device was explanted on (b)(6) 2023, due to cochlear ossification.

Manufacturer Narrative

This report is submitted on august 1, 2023.

• Brand Name: NUCLEUS CI612 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
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: debbie ang ; 1 university avenue; no. 8 jalan kerinchi; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 17244601
• MDR Text Key: 318263074
• Report Number: 6000034-2023-02101
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)230114(17)250113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI612
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female