NUCLEUS 24 CI24M NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for NUCLEUS 24 CI24M NA manufactured by Cochlear Ltd.

Event Text Entries

[185896959] This report is submitted on march 27, 2020.
Patient Sequence No: 1, Text Type: N, H10


[185896960] Per the clinic, the patient developed a cochlesteatoma and the electrode array is exposed in the middle ear. The device was explanted on (b)(6) 2020. It is unknown if the patient has been re-implanted with another device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00861
MDR Report Key9887092
Date Received2020-03-26
Date of Report2020-03-03
Date of Event2020-01-27
Report Date2020-03-27
Date Reported to FDA2020-03-27
Date Reported to Mfgr2020-03-03
Date Mfgr Received2020-03-03
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
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUCLEUS 24
Generic NameNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Product CodeMCM
Date Received2020-03-26
Model NumberCI24M
Catalog NumberNA
Lot NumberNA
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. Required No Informationntervention 2020-03-26

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