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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CI512
Device Problem Connection Problem (2900)
Patient Problem Hearing Impairment (1881)
Event Date 10/22/2019
Event Type  Injury  
Event Description
Per the clinic, the patient experienced intermittencies with device use.Reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.Explantation is scheduled.
 
Manufacturer Narrative
This report is submitted 03 december 2019.
 
Event Description
It was reported that the device was explanted on (b)(6) 2019 and the patient was re-implanted with a new device during the same surgery.
 
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Brand Name
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, 2109
AS  2109
MDR Report Key9307758
MDR Text Key166175471
Report Number6000034-2019-02340
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502014564
UDI-Public(01)09321502014564(11)100907(17)120906
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 12/03/2019,11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/06/2012
Device Model NumberCI512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2019
Distributor Facility Aware Date11/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age27 YR
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