Brand Name | NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
Manufacturer (Section G) |
COCHLEAR LTD |
1 university avenue |
|
macquarie university, nsw 2109 |
AS
2109
|
|
Manufacturer Contact |
laura
blair
|
10350 park meadows rd |
lone tree, CO 80124
|
|
MDR Report Key | 16916960 |
MDR Text Key | 315063325 |
Report Number | 6000034-2023-01463 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502036580 |
UDI-Public | (01)09321502036580(11)211014(17)231013 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/24/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/11/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 10/13/2023 |
Device Model Number | CI632 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/24/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/14/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 57 YR |
Patient Sex | Female |