NUCLEUS HYBRID L24 CI24RE (L24) N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for NUCLEUS HYBRID L24 CI24RE (L24) N/A manufactured by Cochlear Ltd.

Event Text Entries

[133180589] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[133180590] Per the clinic, the patient experienced poor performance with device use, subsequently the device was explanted on (b)(6) 2018. The patient was re-implanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5


[134618636] This report is filed on january 31, 2019.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number6000034-2019-00024
MDR Report Key8251521
Date Received2019-01-15
Date of Report2019-01-22
Date of Event2018-11-14
Date Mfgr Received2019-01-22
Device Manufacturer Date2017-01-16
Date Added to Maude2019-01-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMRS. SUJEEWA WIJESINGHE
Manufacturer Street1 UNIVERSITY AVENUE
Manufacturer CityMACQAURIE UNIVERSITY, NSW 2109
Manufacturer CountryAS
Manufacturer Postal2109
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 Received2019-01-15
Returned To Mfg2019-01-07
Model NumberCI24RE (L24)
Catalog NumberN/A
Lot NumberN/A
Device Expiration Date2019-01-15
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2019-01-15

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