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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI512
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Tinnitus (2103)
Event Date 11/25/2023
Event Type  Injury  
Event Description
Per the clinic, the device was electively explanted on (b)(6) 2023 due to tinnitus.There are no plans to reimplant the patient with a new device as of the date of this report.
 
Manufacturer Narrative
Device analysis report attached.This report is submitted on february 19, 2024.
 
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Brand Name
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE 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
thevamalar jayamagentharan
unit ug-1, vertical podium
no. 8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key18729172
MDR Text Key335699449
Report Number6000034-2024-00559
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUK
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 01/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/04/2020
Device Model NumberCI512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2024
Date Manufacturer Received01/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2018
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 Age68 YR
Patient SexFemale
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