NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE 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 2020-03-26 for NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE N/A manufactured by Cochlear Ltd.

Event Text Entries

[186378720] This report is submitted on march 27, 2020.
Patient Sequence No: 1, Text Type: N, H10


[186378721] Per the surgeon, the patient experienced an infection at the implant site. The patient was hospitalised and treated with iv antibiotics. The device was explanted on (b)(6) 2020. It is unknown if there are plans to re-implant the patient with another device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00879
MDR Report Key9887135
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-26
Date of Report2020-03-03
Date of Event2020-01-27
Date Mfgr Received2020-03-03
Device Manufacturer Date2018-12-19
Date Added to Maude2020-03-26
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. ROBERTA LOVEDAY
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 CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
Generic NameNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Product CodeMCM
Date Received2020-03-26
Model NumberCI522
Catalog NumberN/A
Lot NumberN/A
OperatorLAY USER/PATIENT
Device AvailabilityN
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. Hospitalization; 2. Required No Informationntervention 2020-03-26

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