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 2020-03-17 for NUCLEUS HYBRID L24 CI24RE (L24) NA manufactured by Cochlear Ltd.

Event Text Entries

[183857666] This report is submitted on march 17, 2020.
Patient Sequence No: 1, Text Type: N, H10


[183857667] Per the clinic the device was electively explanted (reason unknown) on (b)(6) 2019. The patient was not reimplanted with a new device
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00746
MDR Report Key9839117
Date Received2020-03-17
Date of Report2020-02-20
Date of Event2019-11-05
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-17
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
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 Received2020-03-17
Returned To Mfg2020-02-20
Model NumberCI24RE (L24)
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, 2109 AS 2109


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-17

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