Brand Name | NUCLEUS FREEDOM 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 | 7792255 |
MDR Text Key | 117433391 |
Report Number | 6000034-2018-01703 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502007320 |
UDI-Public | (01)09321502007320(11)160111(17)180110 |
Combination Product (y/n) | N |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
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 |
|
Date FDA Received | 08/16/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 01/10/2018 |
Device Model Number | CI24RE(CA) |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/06/2018 |
Date Manufacturer Received | 11/20/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/11/2016 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 3 YR |