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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI522
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Vertigo (2134)
Event Date 05/03/2022
Event Type  Injury  
Event Description
Per the clinic, the device was explanted on (b)(6) 2022 due to pain and vertigo.It is unknown if there are plans to reimplant the patient as of the date of this report.
 
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Brand Name
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
Manufacturer (Section G)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS   2109
Manufacturer Contact
yaneesa vetsandonphong
unit ug-1 vertical podium
no. 8 jalan kerinchi
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key14644216
MDR Text Key294032645
Report Number6000034-2022-01654
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502032599
UDI-Public(01)09321502032599(11)170601(17)190531
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/31/2019
Device Model NumberCI522
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2022
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age26 YR
Patient SexFemale
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