Brand Name | NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
MDR Report Key | 10237894 |
MDR Text Key | 197741054 |
Report Number | 6000034-2020-01699 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502036573 |
UDI-Public | (01)09321502036573(11)190808(17)210807 |
Combination Product (y/n) | N |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
08/07/2020 |
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 | 08/07/2021 |
Device Model Number | CI622 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/21/2020 |
Initial Date Manufacturer Received |
06/15/2020 |
Initial Date FDA Received | 07/06/2020 |
Supplement Dates Manufacturer Received | 08/07/2020
|
Supplement Dates FDA Received | 08/31/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 10 YR |