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 from a health professional report with the FDA on 2017-10-23 for NUCLEUS HYBRID L24 CI24RE (L24) NA manufactured by Cochlear Ltd.

Event Text Entries

[90024671] This report is submitted on (b)(6) 2017, by (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[90024672] Per the clinic, the patient reportedly developed an inner ear infection and was subsequently treated with antibiotic ear drops. The implanted device remains and the patient continues to clinically managed by their healthcare provider.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2017-01884
MDR Report Key6970152
Report SourceHEALTH PROFESSIONAL
Date Received2017-10-23
Date of Report2017-10-03
Date Mfgr Received2017-10-03
Device Manufacturer Date2017-04-06
Date Added to Maude2017-10-23
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 BIANCA PRIES
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 NameNUCLEUS HYBRID L24
Generic NameNUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
Product CodePGQ
Date Received2017-10-23
Model NumberCI24RE (L24)
Catalog NumberNA
Lot NumberNA
Device Expiration Date2019-04-05
OperatorLAY USER/PATIENT
Device AvailabilityN
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 2017-10-23

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