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

Model Number CI512

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 22, 2020.

Event Description

Per the clinic, the patient experienced pain during an mri which was completed without the prescribed head wrap.Initially the magnet was pushed back into place but later dislodged again.The magnet is to be replaced on (b)(6) 2020.

Manufacturer Narrative

This report is submitted on 29 january 2021.

Event Description

It was reported that the patient underwent revision surgery to reposition the internal magnet on 6 january 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, 2109 ; AS 2109
• MDR Report Key: 11052398
• MDR Text Key: 223065668
• Report Number: 6000034-2020-03527
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)150922(17)170921
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/29/2021,01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2017
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2021
• Distributor Facility Aware Date: 01/08/2021
• Date Report to Manufacturer: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR