Brand Name | NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, 2109 |
AS 2109 |
|
Manufacturer Contact |
roberta
loveday
|
1 university avenue |
macquarie university, nsw 2109
|
AS
2109
|
|
MDR Report Key | 10187311 |
MDR Text Key | 196203913 |
Report Number | 6000034-2020-01569 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502032643 |
UDI-Public | (01)09321502032643(11)190124(17)210123 |
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 01/23/2021 |
Device Model Number | CI24RE(ST) |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/03/2020 |
Initial Date FDA Received | 06/24/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/24/2019 |
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 | 5 YR |