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

Model Number CI512

Device Problem Impedance Problem (2950)

Patient Problem No Code Available (3191)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on august 21, 2020.

Event Description

Per the clinic, the patient experienced poor performance with the device.The implanted device remains.It is unknown if there are plans to explant the device and reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

The device was explanted on (b)(6) 2021.The patient was reimplanted with a new device during the same surgery.This report is submitted on april 20, 2021.

• Brand Name: NUCLEUS CI512 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: 10435235
• MDR Text Key: 203814141
• Report Number: 6000034-2020-02151
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)180907(17)200906
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2020
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR