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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 CONTOUR NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS 24 CONTOUR NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI24R (CS)
Device Problems No Device Output (1435); Receiver Stimulator Unit (3101)
Patient Problems Head Injury (1879); Hearing Impairment (1881)
Event Date 12/19/2017
Event Type  Malfunction  
Manufacturer Narrative

This report is filed on december 22, 2017.

 
Event Description

Per the clinic, the patient experienced intermittencies and a loss of connection to the internal device subsequent to sustaining a head injury. 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 reimplant the patient with a new device as of the date of this report.

 
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Brand NameNUCLEUS 24 CONTOUR
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 Key7141156
MDR Text Key95762140
Report Number6000034-2017-02397
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 12/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberCI24R (CS)
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 Received12/19/2017
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: 12/21/2017 Patient Sequence Number: 1
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