MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 04/05/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 28, 2020.

Event Description

Per the clinic, the patient experienced an infection with recurrent discharge and pus from his ear which was treated with oral antibiotics.The device was explanted on (b)(6) 2020.The infection is unresolved.Clinical management is ongoing.

Manufacturer Narrative

Per the clinic, prior to the explant, there was a skin flap revision surgery (date unknown).This report is submitted on (b)(6) 2020.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on november 20, 2020.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT 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: 10003622
• MDR Text Key: 189585956
• Report Number: 6000034-2020-01146
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025683
• UDI-Public: (01)09321502025683(11)141202(17)161201
• 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
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2016
• Device Model Number: CI24RE (ST)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR