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 |
sujeewa
wijesinghe
|
1 university avenue |
macqaurie university, nsw 2109
|
AS
2109
|
|
MDR Report Key | 7632793 |
MDR Text Key | 112183955 |
Report Number | 6000034-2018-01281 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502014564 |
UDI-Public | (01)09321502014564(11)110119(17)130118 |
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Audiologist
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/20/2018 |
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 Date | 01/18/2013 |
Device Model Number | CI512 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/09/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/29/2018 |
Initial Date FDA Received | 06/24/2018 |
Supplement Dates Manufacturer Received | 10/05/2018 11/20/2018
|
Supplement Dates FDA Received | 10/30/2018 11/27/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/19/2011 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 36 YR |