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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI612
Device Problems Electrical Lead/Wire (452); Migration (4003)
Patient Problem No Code Available (3191)
Event Date 07/27/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on 27 august 2020.

 
Event Description

Per the clinic, the patient experienced migration of the electrode array resulting in explant of the device on (b)(6) 2020. The patient was re-implanted with another device during the same surgery.

 
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Brand NameCI612 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
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key10457815
MDR Text Key204506290
Report Number6000034-2020-02229
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCI612
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/18/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2020
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: 08/26/2020 Patient Sequence Number: 1
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