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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI532
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative

This report is submitted on april 6, 2020.

 
Event Description

Per the clinic, it was reported that the surgeon attempted implantation on (b)(6) 2019, with a device that had exceeded it's shelf life. The device was subsequently rejected at surgery and sent back to the manufacturer. The patient was implanted with the backup device, and there was no report of patient injury associated with this event.

 
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Brand NameNUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
Type of DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, 2109
AS 2109
Manufacturer Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key9931068
MDR Text Key186817815
Report Number6000034-2020-01024
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodePL
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 03/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/10/2019
Device MODEL NumberCI532
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/10/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/11/2017
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: 04/06/2020 Patient Sequence Number: 1
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