MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE(CA)

Device Problem Extrusion (2934)

Patient Problem No Code Available (3191)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 26 april, 2018.

Event Description

It was reported that the patient experienced an extrusion of the electrode array.Revision surgery is planned; however, has yet to occur as of the date of this report.

Manufacturer Narrative

It was reported that the device was explanted on (b)(6) 2018.

Manufacturer Narrative

This report is filed on septebmer 24, 2018.(b)(4).

• Brand Name: NUCLEUS CI24RE (CA) 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
• Manufacturer Contact: tamara martin ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7463522
• MDR Text Key: 106580921
• Report Number: 6000034-2018-00882
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)130417(17)150416
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2015
• Device Model Number: CI24RE(CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR