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

Model Number CI512

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Skin Inflammation (2443); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 20, 2020.

Event Description

Per the clinic, it was reported that the patient developed postauricular skin atrophy and skin breakdown over the implant site.Subsequently, the patient was treated with topical antibiotics for a duration of 8 weeks.The patient is continuing to be clinically managed by their healthcare provider.

Manufacturer Narrative

A skin revision and closure of the site was performed on (b)(6) 2020.This report is submitted on april 17, 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, 2109 ; AS 2109
• MDR Report Key: 9729231
• MDR Text Key: 181750210
• Report Number: 6000034-2020-00450
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)110121(17)130120
• 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: 04/17/2020,03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2013
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2020
• Date Report to Manufacturer: 03/24/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention