CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NA manufactured by Cochlear Ltd.

Event Text Entries

[186344303] This report is submitted on 01 april 2020.
Patient Sequence No: 1, Text Type: N, H10


[186344304] It was reported that the device was explanted on (b)(6) 2020 due to an unknown reason. The patient was re-implanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-01023
MDR Report Key9908765
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-10
Date of Event2020-01-16
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KRISTEL KOHNE
Manufacturer Street1 UNIVERSITY AVENUE
Manufacturer CityMACQUARIE UNIVERSITY, NSW 2109,
Manufacturer CountryAS
Manufacturer Postal2109,
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Generic NameNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Product CodeMCM
Date Received2020-03-31
Returned To Mfg2020-03-10
Model NumberCI612
Catalog NumberNA
Lot NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOCHLEAR LTD
Manufacturer Address1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS 2109


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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