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U.S. Department of Health and Human Services

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

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COCHLEAR LTD NUCLEUS 24 CONTOUR ADVANCE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24R (CA)
Device Problems No Device Output (1435); Receiver Stimulator Unit (3101)
Patient Problem Hearing Impairment (1881)
Event Date 12/05/2017
Event Type  Malfunction  
Manufacturer Narrative

This report is filed on (b)(6) 2017.

 
Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device. Reprogramming attempts were made; however, the issue could not be resolved. The implanted device remains. It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report.

 
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Brand NameNUCLEUS 24 CONTOUR ADVANCE
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
macquarie university, nsw 2109,
AS   2109,
MDR Report Key7153465
MDR Text Key96012969
Report Number6000034-2017-02433
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 12/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberCI24R (CA)
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/05/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/28/2017 Patient Sequence Number: 1
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