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

Model Number CI24RE (CA)

Device Problem Extrusion (2934)

Patient Problems Bacterial Infection (1735); Pain (1994)

Event Date 11/05/2017

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 22, 2017, by cochlear ltd.On behalf of cochlear americas.(b)(4).

Event Description

Per the clinic, the patient developed an infection at the implant site resulting in a breakdown of the skinflap and subsequent extrusion of the receiver stimulator.On (b)(6) 2017, the device was explanted and the patient was reimplanted with another cochlear device.

Manufacturer Narrative

It was reported the patient was prescribed oral antibiotics for treatment of the infection (date and duration unknown).

• Brand Name: NUCLEUS FREEDOM 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: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7141018
• MDR Text Key: 95584276
• Report Number: 6000034-2017-02307
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)121017(17)141016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

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: 10/16/2014
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/20/2017; 01/11/2018
• Supplement Dates FDA Received: 01/16/2018; 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2012
• 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: 47 YR