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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 Appropriate Term/Code Not Available (3191)
Patient Problems Hearing Loss (1882); Failure of Implant (1924)
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on may 1, 2020.
 
Event Description
Per the clinic, the patient experienced no sound when using the device.Reprogramming attempts were made; however, the issue could not be resolved.
 
Manufacturer Narrative
Per the clinic, the device was explanted on (b)(6) 2020 and the patient was reimplanted with a new device during the same surgery.This report is submitted on (b)(6) 2020.
 
Manufacturer Narrative
The date of awareness was april 7, 2020.This report is submitted on may 1, 2020.
 
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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 Key10016370
MDR Text Key189586537
Report Number6000034-2020-01152
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502014564
UDI-Public(01)09321502014564(11)110307(17)130306
Combination Product (y/n)N
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 05/28/2020,05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCI512
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/28/2020
Date Report to Manufacturer05/22/2020
Initial Date Manufacturer Received 04/09/2020
Initial Date FDA Received04/30/2020
Supplement Dates Manufacturer Received05/04/2020
05/04/2020
Supplement Dates FDA Received05/03/2020
05/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age10 YR
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