FREEDOM HYBRID L24 COCHLEAR IMPLANT 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 2018-08-30 for FREEDOM HYBRID L24 COCHLEAR IMPLANT CI24RE (L24) N/A manufactured by Cochlear Ltd.

Event Text Entries

[118726031] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[118726032] Per the clinic, the patient experienced poor performance and subsequent loss of connection to the internal device; resulting in the decision to explant the device (date not reported). The patient was reimplanted with a new device during the same surgery.
Patient Sequence No: 1, Text Type: D, B5


[131392409] This report is filed on october 11, 2018. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number6000034-2018-01807
MDR Report Key7831512
Report SourceHEALTH PROFESSIONAL
Date Received2018-08-30
Date of Report2018-10-09
Date Mfgr Received2018-10-09
Device Manufacturer Date2017-04-06
Date Added to Maude2018-08-30
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 ContactMRS. 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 NameFREEDOM HYBRID L24 COCHLEAR IMPLANT
Generic NameNUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
Product CodePGQ
Date Received2018-08-30
Returned To Mfg2018-09-18
Model NumberCI24RE (L24)
Catalog NumberN/A
Lot NumberN/A
Device Expiration Date2019-04-05
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 2018-08-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.