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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 Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 06/10/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on (b)(6) 2020.

 
Event Description

Per the clinic, the patient experienced a performance decrement with device use resulting in an elective explant of the device on (b)(6) 2020. The patient was re-implanted with a new device during the same surgery.

 
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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
MDR Report Key10216163
MDR Text Key197214981
Report Number6000034-2020-01693
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 07/01/2020,06/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCI24R (CS)
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/18/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/01/2020
Distributor Facility Aware Date06/08/2020
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/30/2020 Patient Sequence Number: 1
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