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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 24K; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LIMITED NUCLEUS 24K; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24R (ST)
Device Problems Expulsion (2933); Extrusion (2934)
Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on july 05, 2018.
 
Event Description
It was reported that the patient's device was explanted on (b)(6) 2018 due extrusion of the electrode into the ear canal.The patient was reimplanted with another device during the same surgery.
 
Manufacturer Narrative
Device analysis report attached.This report is submitted on may 8, 2024.
 
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Brand Name
NUCLEUS 24K
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LIMITED
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
mastura ruhanet
unit ug-1, vertical podium
no.8 jalan kerinchi
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key7662910
MDR Text Key113154404
Report Number6000034-2018-01342
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502002332
UDI-Public(01)09321502002332(11)080903(17)100902
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/02/2010
Device Model NumberCI24R (ST)
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/19/2018
Initial Date FDA Received07/05/2018
Supplement Dates Manufacturer Received04/12/2024
Supplement Dates FDA Received05/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2008
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 SexMale
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