NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE CI24RE (CA) NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE CI24RE (CA) NA manufactured by Cochlear Ltd.

Event Text Entries

[186732582] This report is submitted on 01 april 2020.
Patient Sequence No: 1, Text Type: N, H10


[186732603] Per the clinic, the patient experienced a performance decrement with device use resulting in explant of the device on (b)(6) 2020. 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 Number6000034-2020-00910
MDR Report Key9908742
Date Received2020-03-31
Date of Report2020-03-10
Date of Event2020-03-02
Date Facility Aware2020-03-10
Report Date2020-04-01
Date Reported to FDA2020-04-01
Date Added to Maude2020-03-31
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Generic NameNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Product CodeMCM
Date Received2020-03-31
Returned To Mfg2020-03-16
Model NumberCI24RE (CA)
Catalog NumberNA
Lot NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by Mfgr*
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.