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U.S. Department of Health and Human Services

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

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COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24RE (ST)
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

Additional information has been requested; however, not made available as of the date of this report. This report is submitted on july 1, 2020.

 
Event Description

Per the clinic, it was reported the device was explanted due to an unreported reason on an unknown date.

 
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Brand NameNUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
Type of DeviceNUCLEUS 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
macquarie university, nsw 2109
AS   2109
MDR Report Key10216202
MDR Text Key197944120
Report Number6000034-2020-01675
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/27/2010
Device MODEL NumberCI24RE (ST)
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/28/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/30/2020 Patient Sequence Number: 1
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