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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 Electrode (451); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 05/14/2020
Event Type  Malfunction  
Manufacturer Narrative

This report is submitted on june 16 2020.

 
Event Description

Per the clinic the device was explanted on (b)(6) 2020 due to improper placement of the electrode array. The patient was reimplanted 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 (Section G)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS 2109
Manufacturer Contact
kristel kohne
1 university avenue
no. 8 jalan kerinchi,
macqaurie university, nsw 2109
AS   2109
MDR Report Key10156209
MDR Text Key195228976
Report Number6000034-2020-01514
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberCI622
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/25/2019
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: 06/15/2020 Patient Sequence Number: 1
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