NUCLEUS 22 CI22M 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 2020-03-31 for NUCLEUS 22 CI22M NA manufactured by Cochlear Ltd.

Event Text Entries

[186353955] This report is submitted on april 1, 2020.
Patient Sequence No: 1, Text Type: N, H10


[186353956] Per the patient's surgeon, the device was explanted on march 9, 2020, due to elective non-use of the device. There are no plans to reimplant the patient as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00904
MDR Report Key9908873
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-09
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
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 22
Generic NameNUCLEUS 22 COCHLEAR IMPLANT SYSTEM
Product CodeMCM
Date Received2020-03-31
Returned To Mfg2020-03-19
Model NumberCI22M
Catalog NumberNA
Lot NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
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 2020-03-31

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