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U.S. Department of Health and Human Services

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

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COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
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).

 
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Brand NameNUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Type of DeviceNUCLEUS 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 Key7141018
MDR Text Key95584276
Report Number6000034-2017-02307
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP970051
Number of Events Reported1
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
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/16/2014
Device MODEL NumberCI24RE (CA)
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/20/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/17/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/21/2017 Patient Sequence Number: 1
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