MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

Device Problems High impedance (1291); Low impedance (2285)

Patient Problem Failure of Implant (1924)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on april 13, 2021.

Event Description

Per the clinic, the patient experienced poor performance with the device.The implanted device remains.There are plans to explant the device; however, this has not yet occurred as of the date of this report.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2021 and the patient was re-implanted with another cochlear device during the same surgery.This report is submitted on december 07, 2021.

Manufacturer Narrative

Device analysis indicated device failure.This report is submitted on july 01, 2022.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT 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: sharannya karthiyeyan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 11654346
• MDR Text Key: 245071527
• Report Number: 6000034-2021-00963
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032643
• UDI-Public: (01)09321502032643(11)170202(17)190201
• Combination Product (y/n): N
• Reporter Country Code: BG
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2019
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• 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: 7 YR
• Patient Sex: Female