MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI24RE (CA) FREEDOM 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 Problems Headache (1880); Pain (1994); Dizziness (2194)

Event Type  Injury  

Event Description

Per the clinic, it was reported that the patient was experiencing, pain, headaches and dizziness with and without device use.The patient was treated with oral antibiotics and steriods (date not reported); however, the issue did not resolve.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2020.This report is submitted on september 3, 2020.

Event Description

Per the clinic, the device was explanted on (b)(6) 2020.

• Brand Name: NUCLEUS CI24RE (CA) FREEDOM 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: 10262225
• MDR Text Key: 198490406
• Report Number: 6000034-2020-01782
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)130115(17)150114
• 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: 09/04/2020,08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2015
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2020
• Distributor Facility Aware Date: 06/18/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention