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 user facility report with the FDA on 2017-11-13 for NUCLEUS HYBRID L24 CI24RE (L24) N/A manufactured by Cochlear Ltd.

Event Text Entries

[91877026] This report is submitted on november 14, 2017, by cochlear limited on behalf of cochlear americas. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[91877027] Per the clinic, the patient experienced poor performance with device use and a subsequent reduction in clinical benefit, resulting in the decision to explant. The device was explanted on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5


[107370616]
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number6000034-2017-02081
MDR Report Key7026950
Report SourceUSER FACILITY
Date Received2017-11-13
Date of Report2017-12-19
Date of Event2017-10-25
Date Mfgr Received2017-12-19
Device Manufacturer Date2016-03-11
Date Added to Maude2017-11-13
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. 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 Received2017-11-13
Returned To Mfg2017-12-05
Model NumberCI24RE (L24)
Catalog NumberN/A
Lot NumberN/A
Device Expiration Date2018-03-10
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 2017-11-13

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