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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI422
Device Problem Insufficient Information (3190)
Patient Problems No Code Available (3191); Missing Value Reason (3192)
Event Date 01/08/2018
Event Type  Injury  
Manufacturer Narrative

This report is submitted on july 1st , 2019.

 
Event Description

Per the clinic, the device was explanted on january 08, 2018(reason of explantation not reported).

 
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Brand NameNUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
Type of DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, 2109
AS 2109
Manufacturer Contact
bianca pries
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key8746925
MDR Text Key149615797
Report Number6000034-2019-01142
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/26/2018
Device MODEL NumberCI422
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/13/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/27/2016
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: 06/30/2019 Patient Sequence Number: 1
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