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 from a health professional report with the FDA on 2018-01-29 for NUCLEUS HYBRID L24 CI24RE (L24) N/A manufactured by Cochlear Ltd.

Event Text Entries

[98515329]
Patient Sequence No: 1, Text Type: N, H10


[98515330] Per the clinic, the patient experienced a performance decrement with device use, reprogramming attempts were made however the issue could not be resolved. It was found that the electrode array had migrated out of the cochlea, resulting in the decision to explant. The device was explanted on (b)(6) 2017 and the patient was re-implanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5


[108182149]
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number6000034-2018-00200
MDR Report Key7226660
Report SourceHEALTH PROFESSIONAL
Date Received2018-01-29
Date of Report2018-03-05
Date of Event2017-12-07
Date Mfgr Received2018-03-05
Device Manufacturer Date2015-05-26
Date Added to Maude2018-01-29
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
Manufacturer ContactMS. KRISTEL KOHNE
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 Received2018-01-29
Returned To Mfg2018-01-15
Model NumberCI24RE (L24)
Catalog NumberN/A
Lot NumberN/A
Device Expiration Date2017-05-25
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 2018-01-29

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