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

Model Number CI24RE (ST)

Device Problem Extrusion (2934)

Patient Problem Bacterial Infection (1735)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

This report is submitted (b)(6) 2016.

Event Description

Per the clinic, the patient developed an infection that resulted in extrusion of the device through the skin flap.Subsequently, the device was explanted on (b)(6) 2016.The patient was reimplanted with another cochlear device during the same surgery.

• 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, nsw 2109 ; AS 2109
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109, ; 94286555
• MDR Report Key: 6214568
• MDR Text Key: 63606119
• Report Number: 6000034-2016-02556
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502009317
• UDI-Public: (01)09321502009317(11)131202(17)151202
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/02/2015
• Device Model Number: CI24RE (ST)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR