Brand Name | NUCLEUS HYBRID L24 |
Type of Device | NUCLEUS HYBRID 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 |
thevamalar
jayamagentharan
|
unit ug-1, vertical podium |
no. 8 jalan kerinchi, |
kuala lumpur, wilayah persekutuan 59200
|
MY
59200
|
|
MDR Report Key | 18909829 |
MDR Text Key | 337728542 |
Report Number | 6000034-2024-00924 |
Device Sequence Number | 1 |
Product Code |
PGQ
|
UDI-Device Identifier | 09321502012089 |
UDI-Public | (01)09321502012089(11)161015(17)181014 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P130016 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/27/2024 |
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 | 10/14/2018 |
Device Model Number | HYBRID L24 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/26/2024 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/20/2024
|
Initial Date FDA Received | 03/15/2024 |
Supplement Dates Manufacturer Received | 03/27/2024
|
Supplement Dates FDA Received | 04/24/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/15/2016 |
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) |
Required Intervention;
|
Patient Age | 73 YR |
Patient Sex | Male |
|
|