Brand Name | NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LIMITED |
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 |
debbie
ang
|
unit ug-1 vertical podium |
no. 8 jalan kerinchi |
kuala lumpur, wilayah persekutuan 59200
|
MY
59200
|
|
MDR Report Key | 10172156 |
MDR Text Key | 195712681 |
Report Number | 6000034-2020-01628 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502032643 |
UDI-Public | (01)09321502032643(11)190328(17)210327 |
Combination Product (y/n) | N |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
03/04/2022 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 03/27/2021 |
Device Model Number | CI24RE(ST) |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/04/2020 |
Initial Date FDA Received | 06/18/2020 |
Supplement Dates Manufacturer Received | 07/21/2020 03/04/2022
|
Supplement Dates FDA Received | 08/09/2020 03/22/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/28/2019 |
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 | 3 YR |
Patient Sex | Male |