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

Model Number CI612

Device Problem No Device Output (1435)

Patient Problem Failure of Implant (1924)

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on december 09, 2022.

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Hardware exchange attempts were made; however, the issue could not be resolved.The implanted device remains.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6), 2023, and the patient was reimplanted with another cochlear device during the same surgery.Correction: the correct serial number is (b)(6); not (b)(6) as previously reported.This report is submitted on april 13, 2023.

Manufacturer Narrative

Device analysis indicated device failure.This report is submitted on may 11, 2023.

• Brand Name: NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 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: mastura ruhanet ; 1 university avenue; no. 8 jalan kerinchi,; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 15947412
• MDR Text Key: 305242342
• Report Number: 6000034-2022-03703
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)210329(17)230328
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2023
• Device Model Number: CI612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 03/28/2023; 05/09/2023
• Supplement Dates FDA Received: 04/13/2023; 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• 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): Other; Required Intervention
• Patient Age: 3 YR
• Patient Sex: Male