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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
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
kristel kohne
1 university avenue
macqaurie university, nsw  2109
  2109
MDR Report Key8746925
Report Number6000034-2019-01142
Device Sequence Number1
Product CodeMCM
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/02/2019
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 Received07/02/2019
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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