MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem No Device Output (1435)

Patient Problems Head Injury (1879); Failure of Implant (1924)

Event Date 11/25/2022

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on december 16, 2022.

Event Description

Per the clinic, the patient experienced loss of connection to the internal device subsequent to sustaining a head trauma twice in august 2022 (specific dates not reported).Hardware exchange attempts were made; however, the issue could not be resolved.The implanted device remains.Explant and reimplantation is planned but has not taken place at the time of this report.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6)2023 and was reimplanted with another cochlear device during the same surgery.This report is submitted on february 20, 2023.

Manufacturer Narrative

Device analysis indicated device failure.This report is submitted on march 14, 2023.

• Brand Name: NUCLEUS CI512 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: ken yian chow ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15992909
• MDR Text Key: 305584436
• Report Number: 6000034-2022-03789
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)181213(17)201212
• 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: 03/09/2023

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: 12/12/2020
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/30/2023; 03/09/2023
• Supplement Dates FDA Received: 02/20/2023; 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2018
• 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; Other
• Patient Age: 4 YR
• Patient Sex: Male