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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI622
Device Problems Electrical Lead/Wire (452); Migration (4003)
Patient Problem No Code Available (3191)
Event Date 06/15/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on 7 july 2020.

 
Event Description

Per the clinic, the patient's device was explanted on (b)(6) 2020 due to migration of the electrode array outside of the cochlea. The patient was re-implanted with a new device during the same surgery.

 
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Brand NameNUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
Type of DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS 2109
Manufacturer Contact
bianca pries
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key10237894
MDR Text Key197741054
Report Number6000034-2020-01699
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCI622
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/21/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/08/2019
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: 07/06/2020 Patient Sequence Number: 1
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