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

Model Number CI512

Device Problem No Device Output (1435)

Patient Problem Failure of Implant (1924)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on october 20, 2020.

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Troubleshooting attempts were made; however, the issue could not be resolved.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

It was reported that the device was explanted on (b)(6) 2020.This report is submitted on 24 november 2020.

• 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: 10702432
• MDR Text Key: 213161032
• Report Number: 6000034-2020-02807
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)110513(17)130512
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2013
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR