NUCLEUS HYBRID L24 CI24RE (L24) NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for NUCLEUS HYBRID L24 CI24RE (L24) NA manufactured by Cochlear Ltd.

Event Text Entries

[173877908] This report is submitted on 07 january 2020.
Patient Sequence No: 1, Text Type: N, H10


[173877909] Per the clinic, the patient experienced poor performance with device use; subsequently the device was explanted on (b)(6) 2019. 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 Number6000034-2020-00131
MDR Report Key9556070
Date Received2020-01-06
Date of Report2019-12-13
Date of Event2019-12-13
Date Facility Aware2019-12-13
Report Date2020-01-07
Date Reported to FDA2020-01-07
Date Added to Maude2020-01-06
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 HYBRID L24
Generic NameNUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
Product CodePGQ
Date Received2020-01-06
Model NumberCI24RE (L24)
Catalog NumberNA
Lot NumberNA
Device Expiration Date2015-12-15
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOCHLEAR LTD
Manufacturer Address1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, 2109 AS 2109


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-06

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