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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI532
Device Problems Electrical Lead/Wire (452); Expulsion (2933)
Patient Problem No Code Available (3191)
Event Date 07/15/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on 5 august 2020.

 
Event Description

Per the clinic, the device was explanted on (b)(6) 2020 due to extrusion of the electrode array. It is unknown if the patient was re-implanted with a new device as of the date of this report.

 
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Brand NameNUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
Type of DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS 2109
Manufacturer Contact
kristel kohne
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key10365611
MDR Text Key201659983
Report Number6000034-2020-02054
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
Type of Report Initial
Report Date 07/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/04/2020
Device MODEL NumberCI532
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/05/2018
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: 08/04/2020 Patient Sequence Number: 1
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