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 |
weiting
zhen
|
1 university avenue |
macquarie university, nsw 2109,
|
AS
2109,
|
|
MDR Report Key | 10204644 |
MDR Text Key | 197297253 |
Report Number | 6000034-2020-01553 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502014564 |
UDI-Public | (01)09321502014564(11)141209(17)161208 |
Combination Product (y/n) | N |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial |
Report Date |
06/03/2020 |
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 Expiration Date | 12/08/2016 |
Device Model Number | CI512 |
Device Catalogue Number | Z209051 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/03/2020 |
Initial Date FDA Received | 06/28/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/09/2014 |
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 | 66 YR |