MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

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

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 9, 2020.

Event Description

Per the surgeon, the patient experienced an infection at the implant site that was treated with oral antibiotics.The implant remains in-situ.

Manufacturer Narrative

Per the clinic, the skin was debrided using silver nitrate.This report is submitted on march 31, 2020.

Manufacturer Narrative

Per the clinic, it was reported that the patient underwent wound revision on (b)(6) 2020, due to pain, swelling and blood drainage at the implant site.The patient has been treated with oral steroids and antibiotics.This report is submitted july, 2020.

Manufacturer Narrative

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

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR 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: 9567150
• MDR Text Key: 174279957
• Report Number: 6000034-2020-00178
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)190917(17)210916
• 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: 03/31/2020,09/11/2020

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: 09/16/2021
• Device Model Number: CI632
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2020
• Date Report to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 06/04/2020; 09/11/2020
• Supplement Dates FDA Received: 03/31/2020; 07/05/2020; 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention