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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 No Device Output (1435)
Patient Problems Head Injury (1879); Hearing Impairment (1881)
Event Date 12/20/2017
Event Type  malfunction  
Manufacturer Narrative
This report is filed on december 20, 2017.
 
Event Description
Per the clinic, the patient experienced intermittencies and a loss of connection to the internal device subsequent to sustaining a head injury.Reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.Explant and re-implantation is planned but has not taken place as of the date of this report.
 
Manufacturer Narrative
It was reported that the device was explanted on (b)(6) 2017.
 
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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, nsw 2109
AS  2109
Manufacturer Contact
bianca pries
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7132777
MDR Text Key95394615
Report Number6000034-2017-02383
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09321502014564
UDI-Public(01)09321502014564(11)160209(17)180208
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Audiologist
Type of Report Initial,Followup,Followup
Report Date 02/20/2018
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 Expiration Date02/08/2018
Device Model NumberCI512
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/05/2017
Initial Date FDA Received12/19/2017
Supplement Dates Manufacturer Received01/05/2018
02/20/2018
Supplement Dates FDA Received02/05/2018
03/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age33 MO
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