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

Model Number CI512

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 26, 2020.

Event Description

Per the clinic, the patient experienced skin breakdown at implant site.Subsequently the patient underwent a surgical procedure on (b)(6) 2020 to repair the skin flap.The implanted device remains.

Manufacturer Narrative

It was reported that the patient's device had extruded.Explant and re-implantation is planned but has not taken place as of the date of this report.This report is submitted 03 september 2020.

Manufacturer Narrative

It is reported that the device was explanted on (b)(6) 2020.This report is submitted on 14 oct 2020.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on november 13, 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: 10198241
• MDR Text Key: 197942897
• Report Number: 6000034-2020-01635
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)160524(17)180523
• 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,Followup,Followup
• Report Date: 10/20/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/23/2018
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 08/12/2020; 09/17/2020; 10/20/2020
• Supplement Dates FDA Received: 09/02/2020; 10/13/2020; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR