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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 Problems Magnet (482); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Patient Problem Pain (1994)
Event Date 05/08/2019
Event Type  Malfunction  
Event Description

Per the clinic, the patient experienced pain and a magnet dislodgement during an mri (1. 5 tesla) on (b)(6) 2019. Surgery to re-position the magnet under a local anaesthetic was completed on (b)(6) 2019. The implanted device remains.

 
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Brand NameNUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Type of DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS 2109
Manufacturer Contact
weiting zhen
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key10204644
MDR Text Key197297253
Report Number6000034-2020-01553
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 06/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/08/2016
Device MODEL NumberCI512
Device Catalogue NumberZ209051
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/09/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/28/2020 Patient Sequence Number: 1
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