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 Wound Dehiscence (1154)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

This report is submitted on (b)(6) 2018.

Event Description

It was reported the patient experienced a wound breakdown and extrusion of the implant, resulting in the decision to explant the device on (b)(6) 2017 under a general anaesthetic.The patient was reimplanted with another cochlear device during the same surgery.

• 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: bianca pries ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7272444
• MDR Text Key: 100117344
• Report Number: 6000034-2018-00355
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)111118(17)131117
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 02/16/2018

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: 11/17/2013
• Device Model Number: CI24RE(CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2011
• 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: 15 YR